General characteristics. Compound. Side effects of Askofen


Askofen-Darnitsa- the drug has an analgesic, antipyretic and anti-inflammatory effect. The components that make up the drug are synergists.
The antipyretic effect of acetylsalicylic acid is realized through the central nervous system by inhibiting the synthesis of PGF2 prostaglandins in the hypothalamus in response to exposure to endogenous pyrogens. Analgesic effect has both peripheral and central origin: peripheral effect - inhibition of the synthesis of prostaglandins in inflamed tissues; central effect- influence on the centers of the hypothalamus. Acetylsalicylic acid also reduces platelet aggregation. Paracetamol has an analgesic, antipyretic and very weak anti-inflammatory effect, which is associated with its effect on the thermoregulatory center in the hypothalamus and a weak ability to inhibit the synthesis of prostaglandins in peripheral tissues. Caffeine excites the central nervous system. It also enhances positive conditioned reflexes, stimulates motor activity, reduces the severity of the action of hypnotics and narcotic substances enhances the action of analgesics and antipyretics.

Indications for use

Indications for the use of the drug Askofen-Darnitsa are: mild or moderate pain syndrome: headache and toothache, myalgia, arthralgia, neuralgia, rheumatic diseases, primary dysmenorrhea and diseases accompanied by fever.

Mode of application

Askofen-Darnitsa take orally 1 tablet 2-3 times a day after meals. The duration of the course of treatment should not exceed 10 days.

Side effects

When using the drug Askofen-Darnitsa such side effects:
From the side of cardio-vascular system: tachycardia, palpitations, hypertension.
From the blood and lymphatic system: anemia, sulfate hemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, pain in the heart), hemolytic anemia due to antiplatelet action on platelets acetylsalicylic acid may increase the risk of bleeding. Bleeding such as intraoperative hemorrhages, hematomas, bleeding from organs genitourinary system, epistaxis, gum bleeding, gastrointestinal bleeding and cerebral hemorrhage.
From the nervous system: headache, dizziness, tremor, paresthesia, fear, anxiety, agitation, irritability, sleep disturbance, insomnia, anxiety, general weakness, ringing in the ears.
From the gastrointestinal tract: dyspeptic syndrome (nausea, vomiting, discomfort and pain in the epigastrium, heartburn), abdominal pain, inflammatory diseases, erosive and ulcerative lesions, which may rare cases cause gastrointestinal bleeding and perforation with appropriate laboratory and clinical manifestations.
From the skin and subcutaneous tissue: itching, rash on the skin and mucous membranes, including erythematous rashes; urticaria, angioedema, erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the side endocrine system: hypoglycemia, up to hypoglycemic coma.
From the side immune system: hypersensitivity reactions, including anaphylaxis, anaphylactic shock, rhinitis, nasal congestion.
From the hepatobiliary system: increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).
Others: bleeding can lead to acute and chronic post-hemorrhagic anemia / iron deficiency anemia(due to latent microbleeding) with corresponding laboratory manifestations and clinical symptoms (asthenia, pallor skin hypoperfusion, non-cardiogenic pulmonary edema).

Contraindications

A drug Askofen-Darnitsa it is contraindicated to use if there is hypersensitivity to the components of the drug, other xanthine derivatives (theophylline, theobromine), other salicylates; history of asthma caused by salicylates or other NSAIDs; congenital hyperbilirubinemia, congenital deficiency of glucose-6-phosphate dehydrogenase; leukopenia, anemia and other blood diseases; acute gastrointestinal ulcers, hemorrhagic diathesis, severe renal failure, severe liver failure, heavy cardiovascular diseases, including rhythm disturbance, severe atherosclerosis, severe form IHD, severe heart failure, severe hypertension; states of increased arousal, sleep disturbances, old age, glaucoma, alcoholism. When using MAO inhibitors, as well as within 2 weeks after stopping their use. Combination with methotrexate at a dose of ≥15 mg / week.

Pregnancy

Tablets Askofen-Darnitsa Do not use during pregnancy and breastfeeding.

Interaction with other drugs

Contraindicated combinations for the drug Askofen-Darnitsa:
Methotrexate - with combined application with salicylates at a dose of ≥15 mg / week, the hematological toxicity of methotrexate increases due to a decrease in the renal clearance of methotrexate by anti-inflammatory agents and its displacement from its association with blood plasma proteins, therefore this combination is contraindicated.
MAO inhibitors - when combined with caffeine, a dangerous increase in blood pressure is possible, so this combination is contraindicated.
Combinations to be used with caution
Paracetamol: antidepressants and other stimulants of microsomal oxidation - increase the production of hydroxylated active metabolites that affect liver function, causing the development of severe intoxication with a small overdose of the drug. The rate of absorption of paracetamol may increase when used with metoclopramide and domperidone and decrease when used with cholestyramine. Paracetamol reduces the effectiveness of diuretics. Derivatives of coumarin (warfarin) long-term use paracetamol increase the risk of bleeding. Under the influence of paracetamol, T½ of chloramphenicol increases by 5 times.
Caffeine: cimetidine, hormonal contraceptives, isoniazid increase the effect of caffeine.
Caffeine reduces the effect of opioid analgesics, anxiolytics, hypnotics and sedatives, is an antagonist of drugs for anesthesia and other drugs that depress the central nervous system, a competitive antagonist of drugs that depress the central nervous system, a competitive antagonist of adenosine and ATP drugs. With the simultaneous use of caffeine with ergotamine, the absorption of ergotamine in the gastrointestinal tract improves, with thyroid-stimulating agents, the thyroid effect increases. Caffeine reduces the concentration of lithium in the blood. Caffeine enhances the effect (improves bioavailability) of antipyretic analgesics, potentiates the effects of xanthine derivatives, α- and β-agonists, psychostimulants.
Acetylsalicylic acid: simultaneous use with uricosuric agents such as benzobromarone, probenecid, reduces the effect of excretion of uric acid (due to competition with the excretion of uric acid renal tubules).

With simultaneous use with digoxin, the concentration of the latter in the blood plasma increases due to a decrease in renal excretion. ACE inhibitors in combination with high doses of acetylsalicylic acid, they cause a decrease in glomerular filtration due to inhibition of vasodilatory prostaglandins and a decrease in the severity of the hypotensive effect.
Selective serotonin reverse inhibitors: Increased risk of upper hemorrhage digestive tract due to the possibility of a synergistic effect. When used simultaneously with valproic acid, acetylsalicylic acid displaces it from its association with plasma proteins, increasing toxicity.
The drug enhances the effect of drugs that reduce blood clotting and platelet aggregation, side effects of corticosteroids, sulfonylurea, methotrexate.
Combination with barbiturates, anticonvulsants, salicylates, rifampicin, alcohol should be avoided.

Overdose

In case of drug overdose Askofen-Darnitsa symptoms of paracetamol overdose appear. In adults who took paracetamol at a dose of 10 g or more, in children who took the drug at a dose of 150 mg / kg of body weight, liver damage. Liver damage may occur 12-48 hours after taking the drug in excessive doses. During the first 24 hours, there may be the following symptoms: pallor, nausea, vomiting, anorexia, abdominal pain, hepatonecrosis, increased activity of hepatic transaminases, increased prothrombin index. In severe poisoning, liver failure can lead to encephalopathy, a coma with a fatal outcome. AKI with acute tubular necrosis can develop even in the absence of severe kidney damage. Glucose metabolism disorders and metabolic acidosis may occur. Cardiac arrhythmias were also noted. With prolonged use in high doses, aplastic anemia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia, leukopenia may occur.
Symptoms of an overdose of acetylsalicylic acid. An overdose of salicylates is possible due to chronic intoxication resulting from long-term therapy (the use of> 100 mg / kg / day for more than 2 days can cause toxic effects), as well as due to acute intoxication, life-threatening (overdose), the causes of which may be accidental use by children or unforeseen overdose.
Chronic poisoning with salicylates may be latent, since its signs are nonspecific. Moderate chronic intoxication caused by salicylates, or salicylism, is noted, as a rule, only after repeated doses in high doses. Main symptoms: imbalance, dizziness, ringing in the ears, deafness, hyperhidrosis, nausea and vomiting, headache, confusion. These symptoms can be controlled by lowering the dose. Ringing in the ears can occur when the concentration of salicylates in the blood plasma> 150-300 mcg / ml. serious adverse reactions detected when the concentration of salicylates in the blood plasma> 300 mcg / l. With acute intoxication - pronounced change acid-base balance, which differs depending on the age and severity of intoxication. The severity of the condition cannot be determined solely on the basis of the concentration of salicylates in the blood plasma.
Symptoms of a caffeine overdose. Caffeine in high doses can cause pain in the epigastric region, vomiting, diuresis, rapid breathing, extrasystole, tachycardia or cardiac arrhythmia, effects on the central nervous system (dizziness, insomnia, nervous excitement, irritability, affective state, anxiety, tremor, convulsions).
Treatment. In case of an overdose, emergency medical attention is necessary, even if there are no symptoms of an overdose. Administration of oral methionine or acetylcysteine ​​may result in positive effect within 48 hours after an overdose. It is also necessary to apply general supportive measures, symptomatic therapy, including the use of beta-adrenergic receptor antagonists, which can eliminate cardiotoxic effects.

Storage conditions

Tablets Askofen-Darnitsa should be stored in the original packaging at a temperature not exceeding 25 ° C

Release form

Askofen-Darnitsa - tablets in a blister pack, No. 6, No. 10.

Compound

1 tablet Askofen-Darnitsa contains:
Acetylsalicylic acid - 0.2 g
Caffeine - 0.04 g
Paracetamol - 0.2 g
Other Ingredients: Citric acid monohydrate, potato starch, povidone, calcium stearate.

Additionally

A drug Askfoen-Darnitsa should be used with caution in patients with a history of gastrointestinal ulcers, including chronic or recurrent peptic ulcer or gastrointestinal bleeding in history, with the simultaneous use of anticoagulants, impaired renal and / or liver function.
Concomitant liver diseases increase the risk of liver damage with paracetamol. The risk of overdose is higher in patients with non-cirrhotic alcoholic diseases liver.
At surgical operations(including dental) the use of drugs containing acetylsalicylic acid may increase the likelihood of the appearance / increase in bleeding due to inhibition of platelet aggregation for some time after the use of acetylsalicylic acid.
When using the drug, the excretion of uric acid may decrease. This can lead to gout in patients with reduced uric acid excretion.
During treatment, it is not recommended to consume excessive amounts of drinks that contain caffeine (eg coffee, tea). This can cause sleep disturbances, tremors, feelings of tension, irritability, discomfort behind the sternum due to increased heartbeat.
During treatment, you should refrain from drinking alcoholic beverages.

main parameters

Name: ASKOFEN-DARNITSIA
ATX code: N02BA51 -


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fluent speeches: acetylsalicylic acid, paracetamol, caffeine;

1 tablet to take: acetylsalicylic acid 200 mg, paracetamol 200 mg, caffeine 40 mg;

additional speeches: citric acid monohydrate, potato starch, povidone, calcium stearate.

Pharmaceutical form

Tablets.

The main physical and chemical authorities: tablets of white color, flat-cylindrical form, with chamfer and notch. Marmur is allowed on the surface of the tablets.

Pharmacotherapeutic group

Analgesics. Other analgesics and antipyretics. Acetylsalicylic acid, combinations without psycholeptics. ATX code N02B A51.

Pharmacological authorities

Pharmacodynamics.

Lіkarskiy zasіb to repair analgesic, antipyretic and antispasmodic. Components, which enter the warehouse of the medical care, help one another.

The antipyretic effect of acetylsalicylic acid is realized through the central nervous system in a way that stimulates the synthesis of prostaglandin PGF 2 in the hypothalamus in response to the influx of endogenous pyrogens. Analgesic effect may be both peripheral and central: peripheral effect - inhibition of the synthesis of prostaglandins in inflamed tissues; central effect - injection on the center of the hypothalamus. Acetylsalicylic acid also changes platelet aggregation.

Paracetamol has an analgesic, antipyretic and even weak anti-inflammatory effect, as it is associated with a surge in the thermoregulatory center in the hypothalamus and a weakly pronounced inhibition of prostaglandin synthesis in peripheral tissues.

Caffeine stimulates the central nervous system. It also strengthens positive mental reflection, stimulates rukhovu activity, weakens the effect of narcotic and narcotic speech, strengthens the effect of analgesics and antipyretic effects.

Pharmacokinetics.

Didn't twist.

Indication

Therapy of mild or moderate pain syndrome: with headache or toothache, neuralgia, myalgia, arthralgia, with primary dysmenorrhea, as well as antipyretic symptoms in case of ailments that are accompanied by fever.

Contraindication

  • Increased sensitivity to drug components, hypersensitivity to other worse xanthines (theophylline, theobromine), other salicylates;
  • bronchial asthma, kropivyanka or rhinitis, as a result of congestion of salicylates or other NSAIDs in the anamnesis;
  • congenital hyperbilirubinemia, pronounced nirk deficiency or hepatic insufficiency, Gilbert's syndrome, congenital deficiency of glucose-6-phosphate dehydrogenase;
  • blood disease, hemophilia, hemorrhagic diathesis, hypoprothrombinemia, anemia, leukopenia, progression to bleeding, thrombosis, thrombophlebitis, hemorrhagic ailments;
  • gostrі shlunkovo-intestinal virazki, shlunkovo-intestinal bleeding, surgical intrusion, which are accompanied by significant bleeding;
  • severe cardiovascular disease, including disrupted rhythm, paroxysmal tachycardia, manifestations of atherosclerosis, severe form of ischemic heart disease, pronounced heart failure, hostile myocardial infarction, pronounced arterial hypertension, pre-existing hypertension, portal hypertension;
  • sleep disturbance, summer age, alcoholism, glaucoma, hyperthyroidism, hostrial pancreatitis, hypertrophy of the anterior slough, severe forms of circulatory diabetes.

Stopping overnight with MAO inhibitors, as well as stretching 2 days after the injection of stopping. Combination with methotrexate at a dose of 15 mg/day or more.

It is contraindicated in patients who are taking tricyclic antidepressants or β-blockers.

Interactions with other medical procedures and other types of interactions

Combination contraindications.

Methotrexate- when combined with salicylates at a dose of 15 mg / day, hematological toxicity of methotrexate is more pronounced due to a decrease in the nirk clearance of methotrexate by antispasmodic agents and an association with plasma proteins, such as proteocases of the combination.

MAO inhibitors- in case of combined stasis with coffee, it is possible to unsafely increase the arterial pressure, so this combination is contraindicated.

Combinations, yakі it is necessary to zastosovuvat z oberezhnіstyu.

Paracetamol:Антисудомні лікарські засоби (включаючи фенітоїн, барбітурати, карбамазепін), антидепресанти та інші стимулятори мікросомального окислення – ці лікарські засоби збільшують продукцію гідроксильованих активних метаболітів, що впливають на функцію печінки, зумовлюючи можливість розвитку тяжких інтоксикацій при невеликих передозуваннях лікарського засобу.

With one-hour stagnation with hepatotoxic causes, the toxic influx of drug effects on the liver increases. Overnight exposure to high doses of paracetamol with isoniazid increases the risk of hepatotoxic syndrome.

The speed of ingestion of paracetamol may increase with one-hour ingestion of metoclopramide and domperidone and may change with ingestion of cholestyramine. Paracetamol reduces the effectiveness of diuretics. Pokhіdnі coumarin (warfarin) with long-term congestion of paracetamol increase the risk of bleeding. Do not stagnate overnight with alcohol.

Under the injection of paracetamol, it increases 5 times during the period of administration of chloramphenicol.

Caffeine: cimetidine, hormonal contraceptives, isoniazid potentiate caffeine. Кофеїн знижує ефект опіоїдних аналгетиків, анксіолітиків, снодійних і седативних засобів, є антагоністом засобів для наркозу та інших лікарських засобів, що пригнічують центральну нервову систему (ЦНС), конкурентним антагоністом лікарських засобів, що пригнічують ЦНС, конкурентним антагоністом лікарських засобів аденозину, АТФ. With an one-hour stagnation of caffeine with ergotamine, the soaking of ergotamine from the herbal tract is reduced, with thyroid-stimulating effects, a thyroid effect develops. Caffeine reduces the concentration of lithium in the blood. Caffeine promoting effect (improving bioavailability) of analgesics-antiretics, xanthine-like potentiating effects, α- and β-adrenergic agonists, psychostimulant agents.

Acetylsalicylic acid: overnight with uricosuric drugs, such as benzobromarone, probenecid, which reduce the effect of excretion of sechoic acid (competition of the excretion of sechoic acid by nirk tubules). With one-hour ingestion with digoxin, the concentration of the rest in the blood plasma rises in the aftermath of a decrease in nirk excretion. ACE inhibitors in combination with high doses of acetylsalicylic acid and cause a decrease in filtration in the glomeruli due to inhibition of vasodilator prostaglandins and a decrease in hypotensive effect. Selective inhibitors of serotonin intoxication: increased risk of bleeding from the upper branches of the herbal tract through the possibility of a synergistic effect. With one-hour exposure to valproic acid, acetylsalicylic acid binds to blood plasma proteins, increasing toxicity.

The medicinal product helps to reduce blood clotting and platelet aggregation, along with corticosteroids, sulfonyl sechovin, methotrexate.

Slid unique combinations with barbiturates, anti-suicide drugs, salicylates, rifampicin, alcohol.

Features

Before the appointment of a doctor, you should consult with a doctor.

Do not overestimate the doses prescribed by the doctor. For short stays.

Do not zastosovuvat likarsky zasib s іnshimi zashim, scho to avenge paracetamol, acetylsalicylic acid.

We are ill with a functional deficiency of the liver and the dose of the drug is necessary to change or increase the interval between doses. If the functions of the liver and liver are damaged, the interval between the intakes is to blame but not less than 8 years.

Okilki Acetylsalcilov Acid, Yak I.L. Non -Elequitative Disipalni Likarsky Zasobi, Inflap the Grace of the Infant tract, Likarsky Vymati Pislya, Milotye, Water, with lounges of the pods, by gums, by rosema by the gums of the pins.

In case of a trivial zastosuvanni karskogo zabou need to check the presence of blood in feces for the manifestation of ulcerogenic activity and blood analysis (influence on platelet aggregation, anticoagulant activity).

In case of hyperthermia, the medical problem may be recognized only in terms of inefficiency of other analgesics-antipyretics, but there is a risk of developing Reye's syndrome. As a result of the zastosuvannya likarskogo zasobu vynikne vomitting, then the next thing to suspect is Reye's syndrome.

It is necessary to take care that the risk of hepatotoxic disease of paracetamol is increased in patients with alcoholic liver disease. Infection of the liver increases the risk of liver damage with paracetamol. Nebezpeka overdose є vishchoy in patients with non-cirrhotic alcoholic diseases of the liver.

Patients with severe infections, such as sepsis, are accompanied by a decrease in glutathione levels, while taking paracetamol, there is a risk of metabolic acidosis. The symptoms of metabolic acidosis are gliboke, accelerated chi difficulty in breathing, tedium, vomiting, loss of appetite. Slid negligently turn to the doctor when these symptoms appear.

During surgical operations (including dental ones), the stagnation of medical conditions, as a way to eliminate acetylsalicylic acid, promotes the appearance / intensification of bleeding, which is related to the aggregation of platelet acid aggregation during the last hour. For 5 - 7 days before surgery, it is necessary to take into account the medical care (to reduce the risk of increased bleeding).

The patient is guilty of being ahead of the doctor about taking the doctor's order Askofen-Darnitsa.

У пацієнтів з алергічними ускладненнями, у тому числі з бронхіальною астмою, алергічним ринітом, кропив'янкою, шкірним свербежем, набряком слизової оболонки і полінозом носа, а також при їх поєднанні з хронічними інфекціями дихальних шляхів та у хворих із гіперчутливістю до нестероїдних протизапальних засобів можливий the development of bronchospasm or an attack of bronchial asthma, which is contraindicated by the congestion of NPZZ in this category of patients.

Acetylsalicylic acid, which enters the warehouse of the likarskogo zabobu, in small doses can reduce the excretion of sechoic acid from the body, which can cause a severe attack of gout in sensitive patients.

Under the hour of liquor, it is not recommended to get used to the superworldly quantity of alcohol in order to drink coffee (for example, cavi, tea). It can also cause sleep disturbance, tremors, apparent tension, drastically, inability to feel behind the sternum through heartbeat.

It is necessary to consult a doctor for patients, if they take analgesics for skin daily with mild arthritis; in times, as a patient, congestion with warfarin is similar to drug treatment, which may have an anticoagulant effect; in case of drug addiction before the cob, I will take ibuprofen as an analgesic treatment.

Не слід застосовувати при гіперчутливості до аналгетичних, протизапальних, протиревматичних засобів, та з обережністю, при одночасному застосуванні антикоагулянтів, хворим з порушеннями кровообігу (наприклад, патологія судин нирки, застійна серцева недостатність, гіповолемія, обширні операції, сепсис або сильні кровотечі), оскільки ацетилсаліцилова acid also reduces the risk of impaired function of nirk and acute nirk deficiency. Ibuprofen may change the inhibitory effect of acetylsalicylic acid on platelet aggregation.

The medicinal value can be influenced by the results of laboratory studies of glucose and sechoic acid in the blood.

Under the hour of rejoicing, do not get drunk on alcohol (advance of the risk of intestinal bleeding).

If the symptoms do not appear, then turn to the doctor.

As the head bіl becomes fast, they turn back to the doctor.

It is contra-indicated for symptoms of bronchial asthma, with advanced bleeding, and with special care for one-hour therapy with anticoagulants (coumarin and heparin), with impaired liver function and ailments, as well as with one-hour antiseptic therapy.

Take care of the medical zasib posture in the field of the dawn of children and in a place inaccessible to children.

Stagnation in the period of pregnancy or breastfeeding.

The medical zasib should not stagnate in the period of vagity or breastfeeding.

Acetylsalicylic acid may be teratogenic; in case of congestion in the period of pregnancy in the I trimester, cause up to vadi development - splitting of the upper tummy, in the III trimester - to galvanic flatness (inhibition of the synthesis of prostaglandins), occlusion of the arterial duct in the fetus, which causes small vasodilatation of blood vessels, colitis disruption of the functions of the drug with a possible onset of development of the deficiency of the drug with oligohydroamnosis, increased bleeding time, antiplatelet effect, which may be caused by the ingestion of even low doses.

Caffeine raises the risk of a spontaneous weekend.

The medicinal factor penetrates breast milk, which increases the risk of bleeding in children due to impaired platelet function.

Zdatnіst vplivat on shvidkіst reaction when keruvannya motor transport or other mechanisms.

Shards can be blamed for side reactions from the side of the nervous system (confusion, increased alertness, impaired orientation and respect), in case of a medical emergency due to the lack of car care and robotics that require psychomotor rehabilitation.

Method of stosuvannya that dose

Likarskiy zasіb prescribe grown-up 1 tablet 2-3 times for production after receiving a hedgehog. The maximum additional dose of the drug should be 6 tablets (for 3 doses). Trivality to the course of healing to lie down in the face of an overdose and severity of an illness that cannot be overcome for 5 days at the time of a zastosuvannya likarskogo zasobu, like an anti-painful zasobu and 3 days - at a time of stasis, like an antipyretic zasobu.

Do not take at the same time with other medical precautions to get rid of paracetamol.

Children.

Do not zastosovuvat children through the risk of development of Rey's syndrome (hyperpyrexia, metabolic acidosis, damage from the side of the nervous system and the psyche, vomiting, impaired liver function) in case of hyperthermia on aphids.

Overdose

Paracetamol overdose symptoms.

Liver damage is more likely in adults who have taken 10 g or more of paracetamol, and in children who have taken more than 150 mg/kg body weight. У пацієнтів з факторами ризику (тривале лікування карбамазепіном, фенобарбітоном, фенітоїном, примідоном, рифампіцином, звіробоєм чи іншими лікарськими засобами, що індукують ферменти печінки; регулярний прийом надмірних кількостей етанолу; глутатіонова кахексія (розлади травлення, муковісцидоз, ВІЛ-інфекція, голод, кахексія ) taking 5 g or more paracetamol can cause damage to the liver.

Symptoms of overdose in the first 24 years: pallor, nausea, vomit, anorexia and also in the abdomen. Liver damage may become evident 12–48 years after overdose. May be blamed on impaired glucose metabolism and metabolic acidosis. In severe liver failure, it can progress to encephalopathy, hemorrhage, hypoglycemia, and maternal death. Hospital insufficiency with hostile tubular necrosis can be manifested by severe transverse pain, hematuria, proteinuria and develop in the presence of a severe infection of the kidneys. Cardiac arrhythmia and pancreatitis were also indicated.

In case of trivial drug exposure in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia can develop along the side of the hematopoietic organs. When taking large doses from the side of the central nervous system, confusion, psychomotor agitation and impaired orientation can be blamed; on the side of the sciatic system - nephrotoxicity (nirk colic, interstitial nephritis, capillary necrosis).

Likuvannya: in case of an overdose, a medical supplement is necessary. The patient should be taken to the librarian, to induce even daily early symptoms of overdose. The symptoms may be accompanied by nausea and vomit, or they may not show the severity of the overdose of organ damage. Let's take a look at the dosage of the treatment of the activating vugs, as if the supra-world dose of paracetamol was taken at the time of 1 year. The concentration of paracetamol in blood plasma is due to decrease after 4 years or later after taking it (greater early concentrations are unreliable). Treatment with N-acetylcysteine ​​can be delayed for 24 years after taking paracetamol, but the maximum effect can be eliminated with prolonged exposure for 8 years after taking paracetamol. The effectiveness of the antidote is sharply reduced later in the day. If necessary, the patient should be given intravenous N-acetylcysteine ​​according to official recommendations. When vomiting is common, oral methionine can be congested as a viable alternative in remote areas of the hospital. It is also necessary to zastosuvat zagalnopodtrimuyuchi come in.

Symptoms of an overdose of acetylsalicylic acid.

Overdust to the saliCilates can be through the Khronychnu іntoxicat, the viklikla vnasslikov is trivalo therapy (the gap is 100 mg/kg per doba more than 2 days of reference), and one of the gostosta is vyna, it was vinta. zastosuvannya children or not peredbachene overdose.

Chronic poisoning by salicylates can be the mother of addictions, the shards of it are nonspecific signs. Chronic intoxication subsides, caused by salicylates, otherwise salicylism develops, as a rule, only after repeated administration of large doses. The main symptoms: disorder of the extremity, confusion, swelling in the ears, deafness, increased sweating, nausea and vomit, headache, confusion of the mind. Significant symptoms can be controlled by lowering the dose. Dzvіn vukhah can be indicated at a concentration of salicylates in blood plasma over 150-300 mcg / ml. Serious side effects are more pronounced at salicylate concentrations in blood plasma above 300 µg/ml. About gostra intoxication to note the change in the acid-lub balance, which can be cooled down in the fall due to the severity of intoxication. The severity of the disease cannot be determined solely on the basis of the concentration of salicylates in the blood plasma.

Absorption of acetylsalicylic acid can be improved in the ligament with the tuck of the duct vilification, formation of calculi at the duct.

Likuvannya: Intoxication, caused by an overdose of acetylsalicylic acid, is determined by the degree of severity, clinical symptoms and are treated by standard methods, which can stop at an illness. You must come in and try to direct yourself to the speedy removal of the medical care and the restoration of the electrolyte and acid-lub balance. Zastosovuyut aktivane vugillya, forced puddle diuresis. In the fallow, in the presence of acid-puddle balance and electrolyte balance, it is necessary to carry out an infusion of electrolytes. In case of severe disorders, hemodialysis is indicated. Long-term exposure to high doses may cause aplastic anemia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia, leukopenia. When taking high doses, damage can be caused from the side of the central nervous system (confusion, psychomotor agitation, impaired orientation and respect, sleeplessness, tremor, nervousness, restlessness), from the side of the cross-sectional system - nephrotoxicity, papillary nephritis). In times of overdose, it may cause sweating, psychomotor agitation or CNS depression, drowsiness, impaired viability, impaired cardiac rhythm, tachycardia, extrasystole, tremor, hyperreflexia, sudomi.

Symptoms of caffeine overdose.

Великі дози кофеїну можуть зумовити біль в епігастральній ділянці, блювання, діурез, прискорене дихання, екстрасистолію, тахікардію або серцеву аритмію, вплив на центральну нервову систему (запаморочення, безсоння, нервозність, нервове збудження, синдром підвищеної нервово-рефлекторної збудливості, головний біль, дратівливість , become an affect, anxiety, restlessness, tremor, judgment). Clinically significant symptoms of caffeine overdose are also associated with paracetamol liver damage.

Likuvannya. In case of an overdose, a medical aid is necessary, to bring on the symptoms of an overdose daily. Oral administration of methionine or intravenous acetylcysteine ​​may produce a positive effect for up to 48 years after overdose. It is also necessary to administer galoppidtrimuyuchi, symptomatic therapy, including zastosuvaniya antagonist β-adrenergic receptors, as it may cause cardiotoxic effects. Specific antidote daily.

Side reactions

In case of drug exposure in other ailments, side reactions can be observed, which are typical for drug treatment of acetylsalicylic acid, paracetamol or caffeine.

From the side of the organization gap: ruined dawn.

From the side of the organs of hearing and the vestibular apparatus: cracked at the vuhah, damaged orientation.

From the side of the respiratory system, the organs of the chest and the middle wall: rhinitis, nasal congestion, bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs.

From the side of the shlunkovo-intestinal tract: dyspeptic disorders, including nausea, vomiting, discomfort in the epigastrium, liver, abdominal pain; inflammation of the mucosal-intestinal tract, erosive-virazkovy lesions of the mucosal-intestinal tract, which can in single cases cause mucosal-intestinal bleeding and perforation with obvious laboratory and clinical manifestations, lesions on the mucous membrane of the mouth.

From the side of the liver and zhovchovividnyh paths: an increase in the activity of liver enzymes, as a rule, without development of liver disease, hepatonecrosis (dose-delayed effect), transient liver failure due to an increase in liver transaminases.

From the side of the nirok and the sieve system: nephrotoxicity (nirkova colic, interstitial nephritis, papillary necrosis).

From the side of the endocrine system: hypoglycemia, right up to hypoglycemic Komi.

From the side of the nervous system: headache, nervousness, restlessness, confusion, tremor, paresthesia, trembling in the ears, broken eyesight, which can be evidence of overdose: sleeplessness, disturbed sleep, increased alertness, impaired orientation, anxiety, irritability.

From the side of the psyche: aware of fear, restlessness, anxiety.

From the side of the cardiovascular system: tachycardia, heartbeat, arterial hypertension, arrhythmia.

From the side of the blood and lymphatic system: anemia, sulfahemoglobinemia and methemoglobinemia (cyanosis, back pain, pain in the heart), hemolytic anemia, syncope bleeding, with severe congestion at high doses - aplastic anemia, pancytopenia, neutropenia, thrombocytopenia, agranulocytosis. Through antiplatelet action on platelets, acetylsalicylic acid increases the risk of bleeding. Спостерігалися такі кровотечі, як інтраопераційні геморагії, гематоми, кровотечі з органів сечостатевої системи, носові кровотечі, кровотечі з ясен, шлунково-кишкові кровотечі та мозкові геморагії (особливо у пацієнтів із неконтрольованою артеріальною гіпертензією та/або при одночасному застосуванні антигемостатичних засобів), які у alone vipadkah threatened life.

From the side of the immune system: hypersensitivity reactions, including anaphylaxis, anaphylactic shock.

Patients with individual sensitivity to salicylates may develop allergic reactions of the upper arm, including such symptoms as hyperemia of the upper arm, sensing heat, drooping, kropivyanka, swollen, swollen, nasal, angioneurotic. In patients with bronchial asthma, it is possible to increase the frequency of bronchospasm; allergic reactions of an insignificant to a deadly degree, which can affect the skin, dyshalny ways, the herbal tract, the cardiovascular system and manifest themselves in visually visipive, bloody, swollen, overthrown.

On the side of the shkіri and pіdshkіrnoї kіtkovini: shkіrniy sverbіzh, visip on the mucosa and mucus membranes (significant generalizations of visip, erythematous, kropivyanka), angioedema, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

Zagalni discord: blatant weakness.

Other: The bleeding can be drafted to the Gronsky post -Gemorage /ANEMICHICA (VNASLIDOKOLIKOVIKOVIKOVARY MIKROVOTHECHI)

The term of appurtenance

Do not zastosovuvat likarsky zasib after the end of the term of applicability, designated on the packaging.

Wash away the savings

Store in a place inaccessible to children in the original packaging at a temperature not higher than 25 °C.

Package

6 or 10 tablets per contour charunka pack; 1 contour pack in packs; 6 or 10 tablets in contour charoon packs.

Admission category

Without recipe.

Virobnik

PJSC “Pharmaceutical firm “Darnitsa”.

Mіstseznahodzhennya virobnik i yogo address mіstsya provadzhennya dіyalnostі

Ukraine, 02093, m. Kiev, st. Boryspilska, 13.

INSTRUCTIONS

on the medical use of a medicinal product

Askofen-Darnitsa

(Ascophen-Darnitsa)

Compound

active substances: acetylsalicylic acid, paracetamol, caffeine;

1 tablet contains: acetylsalicylic acid 200 mg, paracetamol 200 mg, caffeine 40 mg;

Excipients: citric acid monohydrate, potato starch, povidone, calcium stearate.

Dosage form. Tablets.

Basic physical and chemical properties: tablets of white color, ploskotsilindrichesky form, with a facet and risk. Marbling is allowed on the surface of the tablets.

Pharmacotherapeutic group. Analgesics. Other analgesics and antipyretics. Acetylsalicylic acid, combinations without psycholeptics. ATX code N02B A51.

Pharmacological properties

Pharmacodynamics.

The drug has an analgesic, antipyretic and anti-inflammatory effect. The components that make up the drug enhance the effects of each other.

The antipyretic effect of acetylsalicylic acid is realized through the central nervous system by inhibiting the synthesis of prostaglandins PGF 2 in the hypothalamus in response to exposure to endogenous pyrogens. The analgesic effect has both peripheral and central origin: peripheral effect - inhibition of the synthesis of prostaglandins in inflamed tissues; central effect - influence on the centers of the hypothalamus. Acetylsalicylic acid also reduces platelet aggregation.

Paracetamol has an analgesic, antipyretic and very weak anti-inflammatory effect, which is associated with its effect on the thermoregulatory center in the hypothalamus and a weak ability to inhibit the synthesis of prostaglandins in peripheral tissues.

Caffeine excites the central nervous system. It also enhances positive conditioned reflexes, stimulates motor activity, weakens the effect of sleeping pills and narcotic substances, enhances the effect of analgesics and antipyretics.

Pharmacokinetics.

Has not been studied.

clinical characteristics.

Indications

Therapy of mild or moderate pain syndrome: for headache or toothache, neuralgia, myalgia, arthralgia, for primary dysmenorrhea, and also as an antipyretic for diseases that are accompanied by fever.

Contraindications

  • Hypersensitivity to the components of the drug, hypersensitivity to other xanthine derivatives (theophylline, theobromine), other salicylates;
  • bronchial asthma, urticaria or rhinitis caused by taking salicylates or other NSAIDs in history;
  • congenital hyperbilirubinemia, severe renal failure or liver failure, Gilbert's syndrome, congenital deficiency of glucose-6-phosphate dehydrogenase;
  • blood diseases, hemophilia, hemorrhagic diathesis, hypoprothrombinemia, anemia, leukopenia, increased bleeding tendency, thrombosis, thrombophlebitis, hemorrhagic diseases;
  • acute gastrointestinal ulcers, gastrointestinal bleeding, surgical interventions accompanied by significant bleeding;
  • severe cardiovascular disease, including arrhythmias, paroxysmal tachycardia, severe atherosclerosis, severe coronary heart disease, severe heart failure, acute myocardial infarction, severe arterial hypertension, portal hypertension, a tendency to vasospasm;
  • states of increased arousal, sleep disturbances, old age, alcoholism, glaucoma, hyperthyroidism, acute pancreatitis, prostatic hypertrophy, severe forms of diabetes mellitus.

Use simultaneously with MAO inhibitors, as well as within 2 weeks after stopping their use. Combination with methotrexate at a dose of 15 mg/week or more.

Contraindicated in patients using tricyclic antidepressants or β-blockers.

Interaction with others medicines and other types of interactions.

Contraindicated combinations.

Methotrexate- when combined with salicylates at a dose of 15 mg / week or more, the hematological toxicity of methotrexate increases due to a decrease in the renal clearance of methotrexate by anti-inflammatory agents and its displacement from plasma protein binding, therefore this combination is contraindicated.

MAO inhibitors- when combined with caffeine, a dangerous increase in blood pressure is possible, therefore this combination is contraindicated.

Combinations to be used with caution.

Paracetamol: Anticonvulsant drugs (including phenytoin, barbiturates, carbamazepine), antidepressants and other stimulants of microsomal oxidation - these drugs increase the production of hydroxylated active metabolites that affect liver function, predetermining the possibility of developing severe intoxications with small drug overdoses.

With simultaneous use with hepatotoxic drugs, the toxic effect of drugs on the liver increases. The simultaneous use of high doses of paracetamol with isoniazid increases the risk of hepatotoxic syndrome.

The rate of absorption of paracetamol may increase when used with metoclopramide and domperidone and decrease when used with cholestyramine. Paracetamol reduces the effectiveness of diuretics. Derivatives of coumarin (warfarin) with prolonged use of paracetamol increase the risk of bleeding. Do not use simultaneously with alcohol.

Under the influence of paracetamol, the half-life of chloramphenicol increases by 5 times.

Caffeine: cimetidine, hormonal contraceptives, isoniazid increase the effect of caffeine. Caffeine reduces the effect of opioid analgesics, anxiolytics, hypnotics and sedatives, is an antagonist of drugs for anesthesia and other drugs that depress the central nervous system (CNS), a competitive antagonist of drugs that depress the central nervous system, a competitive antagonist of drugs of adenosine, ATP. With the simultaneous use of caffeine with ergotamine, the absorption of ergotamine from the digestive tract improves, with thyroid-stimulating agents, the thyroid effect increases. Caffeine reduces the concentration of lithium in the blood. Caffeine enhances the effect (improves bioavailability) of antipyretic analgesics, potentiates the effects of xanthine derivatives, α- and β-agonists, psychostimulants.

Acetylsalicylic acid: simultaneous use with uricosuric agents, such as benzobromarone, probenecid, reduces the effect of excretion of uric acid (due to the competition of excretion of uric acid by the renal tubules). With simultaneous use with digoxin, the concentration of the latter in the blood plasma increases due to a decrease in renal excretion. ACE inhibitors in combination with high doses of acetylsalicylic acid cause a decrease in glomerular filtration due to inhibition of vasodilatory prostaglandins and a decrease in the hypotensive effect. Selective serotonin reuptake inhibitors: increased risk of bleeding from the upper gastrointestinal tract due to the possibility of a synergistic effect. When used simultaneously with valproic acid, acetylsalicylic acid displaces it from its association with plasma proteins, increasing toxicity.

The drug enhances the effect of drugs that reduce blood clotting and platelet aggregation, side effects of corticosteroids, sulfonylurea, methotrexate.

It is necessary to avoid combinations with barbiturates, anticonvulsants, salicylates, rifampicin, alcohol.

Application features

Before using the drug, you should consult with your doctor.

Do not exceed the indicated doses of the drug. For short term use.

Do not use the drug with other drugs containing paracetamol, acetylsalicylic acid.

Patients with functional insufficiency of the liver and kidneys should reduce the dose of the drug or increase the interval between doses. In case of impaired renal and hepatic function, the interval between doses should be at least 8 hours.

Since acetylsalicylic acid, like all non-selective non-steroidal anti-inflammatory drugs, causes irritation of the mucous membrane of the digestive tract, the drug should be taken only after meals, drinking water, alkaline mineral waters, a solution of sodium bicarbonate (best of all - milk).

With prolonged use of the drug, it is necessary to check the presence of blood in the feces to detect ulcerogenic effects and do blood tests (effect on platelet aggregation, some anticoagulant activity).

With hyperthermia, it is advisable to prescribe the drug only if other antipyretic analgesics are ineffective, since there is a risk of developing Reye's syndrome. If vomiting occurs as a result of the use of the drug, Reye's syndrome should be suspected.

It should be borne in mind that in patients with alcoholic liver damage, the risk of hepatotoxic action of paracetamol increases. Liver disease increases the risk of liver damage with paracetamol. The risk of overdose is higher in patients with non-cirrhotic alcoholic liver disease.

In patients with severe infections, such as sepsis, which are accompanied by a decrease in glutathione levels, when taking paracetamol, the risk of metabolic acidosis increases. Symptoms of metabolic acidosis are deep, rapid or labored breathing, nausea, vomiting, and loss of appetite. You should immediately consult a doctor if these symptoms appear.

During surgical operations (including dental), the use of drugs containing acetylsalicylic acid increases the likelihood of the appearance / intensification of bleeding, which is due to the inhibition of platelet aggregation for some time after the use of acetylsalicylic acid. 5-7 days before surgical intervention it is necessary to cancel the use of the drug (to reduce the risk of increased bleeding).

The patient must warn the doctor in advance about taking the drug Askofen-Darnitsa.

Bronchospasm may develop in patients with allergic complications, including bronchial asthma, allergic rhinitis, urticaria, pruritus, edema of the mucous membrane and pollinosis of the nose, as well as in combination with chronic respiratory infections and in patients with hypersensitivity to non-steroidal anti-inflammatory drugs. or an attack of bronchial asthma, therefore, the use of NSAIDs in this category of patients is contraindicated.

Acetylsalicylic acid, which is part of the drug, even in small doses, can reduce the excretion of uric acid from the body, which can cause acute attack gout in sensitive patients.

During treatment with the drug, it is not recommended to consume an excessive amount of drinks containing caffeine (for example, coffee, tea). This can cause sleep disturbances, tremors, a feeling of tension, irritability, discomfort behind the sternum due to palpitations.

It is necessary to consult a doctor for patients who take analgesics every day for mild arthritis; if the patient is taking warfarin or similar drugs that have an anticoagulant effect; when using the drug before starting ibuprofen as an analgesic.

Do not use in case of hypersensitivity to analgesic, anti-inflammatory, antirheumatic drugs, and with caution, while using anticoagulants, in patients with circulatory disorders (for example, pathology of the kidney vessels, congestive heart failure, hypovolemia, major surgery, sepsis or severe bleeding), since acetylsalicylic acid also increases the risk of impaired renal function and acute renal failure. Ibuprofen may reduce the inhibitory effect of acetylsalicylic acid on platelet aggregation.

The drug may affect the results of laboratory tests regarding the content of glucose and uric acid in the blood.

During treatment, do not drink alcoholic beverages (increased risk of gastrointestinal bleeding).

If the symptoms do not disappear, you should consult a doctor.

If the headache becomes persistent, you should consult a doctor.

It is contraindicated to prescribe to patients with bronchial asthma, with increased bleeding, and with extreme caution with simultaneous therapy with anticoagulants (coumarin and heparin), with impaired liver function and kidney disease, as well as with simultaneous anti-inflammatory therapy.

Keep the medicine out of the sight of children and out of the reach of children.

Use during pregnancy or lactation.

The drug should not be used during pregnancy or lactation.

Acetylsalicylic acid has a teratogenic effect; when used during pregnancy in the first trimester leads to a malformation - splitting upper sky, in the III trimester - to inhibition of labor activity (inhibition of prostaglandin synthesis), closure ductus arteriosus in the fetus, which causes hyperplasia of the pulmonary vessels and hypertension in the vessels of the pulmonary circulation, impaired renal function with the possible subsequent development of renal failure with oligohydroamniosis, prolongation of bleeding time, antiplatelet effect, which can occur even after the use of very low doses.

Caffeine increases the risk of spontaneous miscarriage.

The drug penetrates into breast milk, which increases the risk of bleeding in children due to impaired platelet function.

The ability to influence the rate of reactions when driving vehicles or using other mechanisms.

Since there may be adverse reactions from the nervous system (dizziness, irritability, impaired orientation and attention), when using the drug, driving and work requiring increased attention and speed of psychomotor reactions should be avoided.

Dosage and administration

The drug is prescribed for adults 1 tablet 2-3 times a day after meals. The maximum daily dose of the drug is 6 tablets (in 3 divided doses). The duration of the course of treatment depends on the course and severity of the disease and should not exceed 5 days when using the drug as an anesthetic and 3 days when used as an antipyretic.

Do not take with other medicines containing paracetamol.

Children.

The drug should not be used in children because of the risk of developing Reye's syndrome (hyperpyrexia, metabolic acidosis, disorders of the nervous system and psyche, vomiting, abnormal liver function) with hyperthermia on the background of viral diseases.

Overdose

Paracetamol overdose symptoms.

Liver damage is possible in adults who have taken 10 g or more of paracetamol and in children who have taken more than 150 mg/kg body weight. In patients with risk factors ( long-term treatment carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's wort, or other drugs that induce liver enzymes; regular intake excess quantities ethanol; glutathione cachexia (indigestion, cystic fibrosis, HIV infection, hunger, cachexia) taking 5 g or more of paracetamol can lead to liver damage.

Overdose symptoms in the first 24 hours: pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may occur 12 to 48 hours after an overdose. Glucose metabolism disorders and metabolic acidosis may occur. In severe poisoning, liver failure may progress to encephalopathy, hemorrhage, hypoglycemia, coma and have fatal outcome. Acute renal failure with acute tubular necrosis may present with severe low back pain, hematuria, proteinuria, and develop even in the absence of severe kidney damage. Cardiac arrhythmia and pancreatitis were also noted.

With prolonged use of the drug in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia may develop from the hematopoietic organs. When taking large doses from the side of the central nervous system, dizziness may occur, psychomotor agitation and disorientation; from the urinary system - nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis).

Treatment: overdose requires emergency medical attention. The patient should be immediately taken to the hospital, even if there are no early symptoms of an overdose. Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or the risk of organ damage. Treatment with activated charcoal should be considered if an overdose of paracetamol has been taken within 1 hour. Paracetamol plasma concentration should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine ​​can be applied within 24 hours after taking paracetamol, but the maximum protective effect is obtained when it is used within 8 hours after taking it. The effectiveness of the antidote drops sharply after this time. If necessary, N-acetylcysteine ​​is administered intravenously to the patient according to current recommendations. In the absence of vomiting, oral methionine can be used as an appropriate alternative in remote areas outside the hospital. It is also necessary to apply general supportive measures.

Symptoms of an overdose of acetylsalicylic acid.

An overdose of salicylates is possible due to chronic intoxication that has arisen as a result of long-term therapy (the use of more than 100 mg / kg per day for more than 2 days can cause toxic effects), as well as due to acute intoxication, which is life-threatening (overdose), and the causes of which may be accidental use by children or unforeseen overdose.

Chronic poisoning with salicylates may be latent, since its signs are nonspecific. Moderate chronic intoxication caused by salicylates, or salicylism, occurs, as a rule, only after repeated high doses. Main symptoms: imbalance, dizziness, ringing in the ears, deafness, increased sweating, nausea and vomiting, headache, confusion. These symptoms can be controlled by lowering the dose. Ringing in the ears can occur when the concentration of salicylates in the blood plasma is more than 150-300 mcg / ml. More serious adverse reactions occur when the concentration of salicylates in the blood plasma is more than 300 mcg / ml.

Acute intoxication is evidenced by a pronounced change in the acid-base balance, which may vary depending on the age and severity of intoxication. The severity of the condition cannot be determined solely on the basis of the concentration of salicylates in the blood plasma.

The absorption of acetylsalicylic acid may be slowed down due to delayed gastric release, the formation of calculi in the stomach.

Treatment: intoxication caused by an overdose of acetylsalicylic acid is determined by the severity, clinical symptoms and is treated with standard methods that are used for poisoning. All Taken measures should be aimed at accelerating the removal of the drug and the restoration of electrolyte and acid-base balance. Apply activated charcoal, forced alkaline diuresis. Depending on the state acid-base balance and electrolyte balance, infusion administration of electrolyte solutions is carried out. In severe poisoning, hemodialysis is indicated. With prolonged use of high doses, aplastic anemia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia, leukopenia are possible. When taking high doses, there may be disorders from the central nervous system (dizziness, psychomotor agitation, impaired orientation and attention, insomnia, tremor, nervousness, anxiety), from the urinary system - nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis). In case of an overdose, increased sweating, psychomotor agitation or CNS depression, drowsiness, impaired consciousness, impaired heart rate, tachycardia, extrasystole, tremor, hyperreflexia, convulsions.

Symptoms of a caffeine overdose.

Large doses of caffeine can cause pain in the epigastric region, vomiting, diuresis, rapid breathing, extrasystole, tachycardia or cardiac arrhythmia, effects on the central nervous system (dizziness, insomnia, nervousness, nervous excitement, increased neuro-reflex excitability syndrome, headache, irritability , affective state, anxiety, restlessness, tremor, convulsions). Clinically significant symptoms of caffeine overdose are also associated with paracetamol liver damage.

Treatment. In case of an overdose, emergency medical attention is necessary, even if there are no symptoms of an overdose. The administration of oral methionine or intravenous acetylcysteine ​​may have a positive effect within 48 hours after an overdose. It is also necessary to apply general supportive measures, symptomatic therapy, including the use of β-adrenergic antagonists, which can eliminate cardiotoxic effects. There is no specific antidote.

Adverse reactions

When using the drug in some patients, adverse reactions characteristic of drugs of acetylsalicylic acid, paracetamol or caffeine may be observed.

From the side of the organs of vision: visual impairment.

From the side of the hearing and vestibular apparatus: ringing in the ears, disorientation.

From the respiratory system, organs chest and mediastinum: rhinitis, nasal congestion, bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs.

From the side gastrointestinal tract: dyspeptic disorders, including nausea, vomiting, epigastric discomfort and pain, heartburn, abdominal pain; inflammation of the gastrointestinal tract, erosive and ulcerative lesions of the gastrointestinal tract, which in rare cases can cause gastrointestinal bleeding and perforation with relevant laboratory and clinical manifestations, ulcers on the oral mucosa.

From the side of the liver and biliary tract: increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect), transient liver failure with an increase in the level of liver transaminases.

From the side of the kidneys and urinary system: nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis).

From the endocrine system: hypoglycemia, up to hypoglycemic coma.

From the nervous system: headache, nervousness, anxiety, dizziness, tremor, paresthesia, tinnitus, visual disturbances, which may indicate an overdose: insomnia, sleep disturbance, irritability, disorientation, anxiety, irritability.

From the side of the psyche: feeling of fear, anxiety, anxiety.

From the side of the cardiovascular system: tachycardia, palpitations, arterial hypertension, arrhythmia.

From the blood and lymphatic system: anemia, sulfate hemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, pain in the heart), hemolytic anemia, bruising or bleeding, with prolonged use in high doses - aplastic anemia, pancytopenia, neutropenia, thrombocytopenia, agranulocytosis. Due to the antiplatelet effect on platelets, acetylsalicylic acid increases the risk of bleeding. Bleedings such as intraoperative hemorrhages, hematomas, bleedings from the organs of the genitourinary system, nosebleeds, bleedings from the gums, gastrointestinal bleedings and cerebral hemorrhages were observed (especially in patients with uncontrolled arterial hypertension and / or with the simultaneous use of antihemostatic agents), which in isolated cases were life threatening.

From the immune system: hypersensitivity reactions, including anaphylaxis, anaphylactic shock.

Patients with individual hypersensitivity to salicylates may develop allergic skin reactions, including symptoms such as flushing of the skin, feeling hot, rash, urticaria, swelling, itching, angioedema, rhinitis, nasal congestion. In patients with bronchial asthma, an increase in the incidence of bronchospasm is possible; mild to moderate allergic reactions that may affect the skin, Airways, digestive tract, cardiovascular system and manifest itself in the form of a rash, urticaria, edema, itching.

From the skin and subcutaneous tissue:pruritus, rash on the skin and mucous membranes (usually generalized rash, erythematous, urticaria), angioedema, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

General violations: general weakness.

Other: bleeding can lead to acute and chronic post-hemorrhagic / iron deficiency anemia (due to the so-called latent microbleeding) with relevant laboratory manifestations and clinical symptoms, such as asthenia, pallor of the skin, hypoperfusion; non-cardiogenic pulmonary edema.

Best before date

Do not use the medicinal product after the expiration date indicated on the package.

Storage conditions

Keep out of the reach of children in the original packaging at a temperature not exceeding 25 °C.

Package

6 or 10 tablets in a blister pack; 1 blister pack in a pack; 6 or 10 tablets in blisters.

Manufacturer

PJSC “Pharmaceutical firm “Darnitsa”.

Location of the manufacturer and its address of the place of business.

Ukraine, 02093, Kyiv, st. Borispolskaya, 13.

The summary (instruction for use) of the product Askofen-Darnitsa, approved by the manufacturer, is presented for informational purposes only and is not a reason for self-treatment.
Only your doctor can decide on the need to use Askofen-Darnitsa, prescribe treatment regimens and dosages, as well as discuss the compatibility of Askofen-Darnitsa with the medicines you use, explain side effects and contraindications.
Remember - self-medication is dangerous for your health.

Askofen-Darnitsa- a drug with analgesic, antipyretic and anti-inflammatory effects on the body. The components that make up the drug are synergists.
The antipyretic effect of acetylsalicylic acid is realized through the central nervous system by inhibiting the synthesis of PGF2 prostaglandins in the hypothalamus in response to exposure to endogenous pyrogens. The analgesic effect has both peripheral and central origin: peripheral effect - inhibition of the synthesis of prostaglandins in inflamed tissues; central effect - influence on the centers of the hypothalamus. Acetylsalicylic acid also reduces platelet aggregation. Paracetamol has an analgesic, antipyretic and very weak anti-inflammatory effect, which is associated with its effect on the thermoregulatory center in the hypothalamus and a weak ability to inhibit the synthesis of prostaglandins in peripheral tissues. Caffeine excites the central nervous system. It also enhances positive conditioned reflexes, stimulates motor activity, reduces the severity of the action of hypnotics and narcotic substances, enhances the action of analgesics and antipyretics.

Indications for use:
Indications for the use of the drug Askofen-Darnitsa are: mild or moderate pain syndrome: headache and toothache, myalgia, arthralgia, neuralgia, rheumatic diseases, primary dysmenorrhea and diseases accompanied by fever.

Mode of application:
Askofen-Darnitsa take orally 1 tablet 2-3 times a day after meals. The duration of the course of treatment should not exceed 10 days.

Side effects:
When using the drug Askofen-Darnitsa the following side effects were observed:
From the side of the cardiovascular system: tachycardia, palpitations, hypertension.
On the part of the blood and lymphatic system: anemia, sulfate hemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, pain in the heart), hemolytic anemia, due to the antiplatelet effect on platelets, acetylsalicylic acid may increase the risk of bleeding. Hemorrhages such as intraoperative hemorrhages, hematomas, bleeding from the genitourinary system, nosebleeds, bleeding from the gums, gastrointestinal bleeding and cerebral hemorrhages were noted.
From the nervous system: headache, dizziness, tremor, paresthesia, fear, anxiety, agitation, irritability, sleep disturbance, insomnia, anxiety, general weakness, tinnitus.
From the gastrointestinal tract: dyspeptic syndrome (nausea, vomiting, discomfort and pain in the epigastrium, heartburn), abdominal pain, inflammatory diseases, erosive and ulcerative lesions, which can rarely cause gastrointestinal bleeding and perforation with relevant laboratory and clinical manifestations .
From the side of the skin and subcutaneous tissue: itching, rash on the skin and mucous membranes, including erythematous rashes; urticaria, angioedema, erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the endocrine system: hypoglycemia, up to hypoglycemic coma.
From the immune system: hypersensitivity reactions, including anaphylaxis, anaphylactic shock, rhinitis, nasal congestion.
From the hepatobiliary system: increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).
Others: bleeding can lead to acute and chronic post-hemorrhagic anemia / iron deficiency anemia (due to hidden microbleeding) with relevant laboratory findings and clinical symptoms (asthenia, pallor of the skin, hypoperfusion, non-cardiogenic pulmonary edema).

Contraindications:
A drug Askofen-Darnitsa it is contraindicated to use if there is hypersensitivity to the components of the drug, other xanthine derivatives (theophylline, theobromine), other salicylates; history of asthma caused by salicylates or other NSAIDs; congenital hyperbilirubinemia, congenital deficiency of glucose-6-phosphate dehydrogenase; leukopenia, anemia and other blood diseases; acute gastrointestinal ulcers, hemorrhagic diathesis, severe renal failure, severe liver failure, severe cardiovascular diseases, including rhythm disturbance, severe atherosclerosis, severe coronary artery disease, severe heart failure, severe hypertension; states of increased arousal, sleep disturbances, old age, glaucoma, alcoholism. When using MAO inhibitors, as well as within 2 weeks after stopping their use. Combination with methotrexate at a dose of ≥15 mg / week.

Pregnancy:
Tablets Askofen-Darnitsa Do not use during pregnancy and breastfeeding.

Interaction with other drugs:
Contraindicated combinations for the drug Askofen-Darnitsa:
Methotrexate - when combined with salicylates at a dose of ≥15 mg / week, the hematological toxicity of methotrexate increases due to a decrease in the renal clearance of methotrexate by anti-inflammatory agents and its displacement from its association with blood plasma proteins, therefore this combination is contraindicated.
MAO inhibitors - when combined with caffeine, a dangerous increase in blood pressure is possible, so this combination is contraindicated.
Combinations to be used with caution
Paracetamol: antidepressants and other stimulants of microsomal oxidation - increase the production of hydroxylated active metabolites that affect liver function, causing the development of severe intoxication with a small overdose of the drug. The rate of absorption of paracetamol may increase when used with metoclopramide and domperidone and decrease when used with cholestyramine. Paracetamol reduces the effectiveness of diuretics. Coumarin derivatives (warfarin) with prolonged use of paracetamol increase the risk of bleeding. Under the influence of paracetamol, T½ of chloramphenicol increases by 5 times.
Caffeine: cimetidine, hormonal contraceptives, isoniazid increase the effect of caffeine.
Caffeine reduces the effect of opioid analgesics, anxiolytics, hypnotics and sedatives, is an antagonist of drugs for anesthesia and other drugs that depress the central nervous system, a competitive antagonist of drugs that depress the central nervous system, a competitive antagonist of adenosine and ATP drugs. With the simultaneous use of caffeine with ergotamine, the absorption of ergotamine in the gastrointestinal tract improves, with thyroid-stimulating agents, the thyroid effect increases. Caffeine reduces the concentration of lithium in the blood. Caffeine enhances the effect (improves bioavailability) of antipyretic analgesics, potentiates the effects of xanthine derivatives, α- and β-agonists, psychostimulants.
Acetylsalicylic acid: simultaneous use with uricosuric agents such as benzobromarone, probenecid, reduces the effect of excretion of uric acid (due to competition with the excretion of uric acid by the renal tubules). With simultaneous use with digoxin, the concentration of the latter in the blood plasma increases due to a decrease in renal excretion. ACE inhibitors in combination with high doses of acetylsalicylic acid cause a decrease in glomerular filtration due to inhibition of vasodilatory prostaglandins and a decrease in the severity of the hypotensive effect.
Selective serotonin reverse inhibitors: Increased risk of bleeding from the upper gastrointestinal tract due to the possibility of a synergistic effect. When used simultaneously with valproic acid, acetylsalicylic acid displaces it from its association with plasma proteins, increasing toxicity.
The drug enhances the effect of drugs that reduce blood clotting and platelet aggregation, side effects of corticosteroids, sulfonylurea, methotrexate.
Combination with barbiturates, anticonvulsants, salicylates, rifampicin, alcohol should be avoided.

Overdose:
In case of drug overdose Askofen-Darnitsa symptoms of paracetamol overdose appear. In adults who took paracetamol at a dose of 10 g or more, in children who took the drug at a dose of 150 mg / kg of body weight, liver damage. Liver damage may occur 12-48 hours after taking the drug in excessive doses. In the first 24 hours, the following symptoms may occur: pallor, nausea, vomiting, anorexia, abdominal pain, hepatonecrosis, increased activity of hepatic transaminases, an increase in the prothrombin index. In severe poisoning, liver failure can lead to encephalopathy, a coma with a fatal outcome. AKI with acute tubular necrosis can develop even in the absence of severe kidney damage. Glucose metabolism disorders and metabolic acidosis may occur. Cardiac arrhythmias were also noted. With prolonged use in high doses, aplastic anemia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia, leukopenia may occur.
Symptoms of an overdose of acetylsalicylic acid. An overdose of salicylates is possible due to chronic intoxication resulting from long-term therapy (the use of >100 mg / kg / day for more than 2 days can cause toxic effects), as well as due to acute life-threatening intoxication (overdose), the causes of which may be accidental use by children or unexpected overdose.
Chronic poisoning with salicylates may be latent, since its signs are nonspecific. Moderate chronic intoxication caused by salicylates, or salicylism, is noted, as a rule, only after repeated doses in high doses. Main symptoms: imbalance, dizziness, ringing in the ears, deafness, hyperhidrosis, nausea and vomiting, headache, confusion. These symptoms can be controlled by lowering the dose. Ringing in the ears can occur when the concentration of salicylates in the blood plasma> 150-300 mcg / ml. Serious adverse reactions are detected when the concentration of salicylates in the blood plasma> 300 mcg / l. In acute intoxication - a pronounced change in the acid-base balance, which differs depending on the age and severity of intoxication. The severity of the condition cannot be determined solely on the basis of the concentration of salicylates in the blood plasma.
Symptoms of a caffeine overdose. Caffeine in high doses can cause pain in the epigastric region, vomiting, diuresis, rapid breathing, extrasystole, tachycardia or cardiac arrhythmia, effects on the central nervous system (dizziness, insomnia, nervous agitation, irritability, affective state, anxiety, tremor, convulsions).
Treatment. In case of an overdose, emergency medical attention is necessary, even if there are no symptoms of an overdose. The administration of oral methionine or acetylcysteine ​​may give a positive effect within 48 hours after an overdose. It is also necessary to apply general supportive measures, symptomatic therapy, including the use of beta-adrenergic receptor antagonists, which can eliminate cardiotoxic effects.

Storage conditions:
Tablets Askofen-Darnitsa should be stored in the original packaging at a temperature not exceeding 25 ° C

Release form:
Askofen-Darnitsa- tablets in blister pack, No. 6, No. 10.

Compound:
1 tablet Askofen-Darnitsa contains:
Acetylsalicylic acid - 0.2 g
Caffeine - 0.04 g
Paracetamol - 0.2 g
Other Ingredients: Citric acid monohydrate, potato starch, povidone, calcium stearate.

Additionally:
A drug Askfoen-Darnitsa should be used with caution in patients with a history of gastrointestinal ulcers, including a history of chronic or recurrent peptic ulcer or gastrointestinal bleeding, with concomitant use of anticoagulants, impaired renal and / or liver function.
Concomitant liver diseases increase the risk of liver damage with paracetamol. The risk of overdose is higher in patients with non-cirrhotic alcoholic liver disease.
During surgical operations (including dental), the use of drugs containing acetylsalicylic acid may increase the likelihood of the appearance / increase in bleeding due to inhibition of platelet aggregation for some time after the use of acetylsalicylic acid.
When using the drug, the excretion of uric acid may decrease. This can lead to gout in patients with reduced uric acid excretion.
During treatment, it is not recommended to consume excessive amounts of drinks that contain caffeine (eg coffee, tea). This can cause sleep disturbances, tremors, a feeling of tension, irritability, discomfort behind the sternum due to an increased heartbeat.
During treatment, you should refrain from drinking alcoholic beverages.

Registration number:

Validity registration certificate:

02/15/2013 to 02/15/2018

Title in English:

ASCOPHEN-DARNITSA

The composition of the medicinal product

active substances: 1 tablet contains: acetylsalicylic acid 200 mg; paracetamol 200 mg; caffeine 40 mg;

Excipients: citric acid monohydrate, potato starch, povidone, calcium stearate.

Dosage form

Tablets.

Tablets of white color, ploskotsilindrichesky form, with a facet and risk. Marbling is allowed on the surface of the tablets.

Name and location of the manufacturer

PJSC “Pharmaceutical firm “Darnitsa”. Ukraine, 02093, Kyiv, st. Borispolskaya, 13.

Askofen-Darnitsa: packaging photo

Pharmacotherapeutic group

Analgesics and antipyretics. Acetylsalicylic acid, combinations without psycholeptics. ATC code N02B A51.

The drug has an analgesic, antipyretic and anti-inflammatory effect. The components that make up the drug enhance the effects of each other.

The antipyretic effect of acetylsalicylic acid is realized through the central nervous system by inhibiting the synthesis of prostaglandins PGF 2 in the hypothalamus in response to exposure to endogenous pyrogens. The analgesic effect has both peripheral and central origin: peripheral effect - inhibition of the synthesis of prostaglandins in inflamed tissues; central effect - influence on the centers of the hypothalamus. Acetylsalicylic acid also reduces platelet aggregation.

Paracetamol has an analgesic, antipyretic and very weak anti-inflammatory effect, which is associated with its effect on the thermoregulatory center in the hypothalamus and a weak ability to inhibit the synthesis of prostaglandins in peripheral tissues.

Caffeine excites the central nervous system. It also enhances positive conditioned reflexes, stimulates motor activity, weakens the effect of sleeping pills and narcotic substances, enhances the effect of analgesics and antipyretics.

Indications for use

Therapy of mild or moderate pain syndrome: for headache or toothache, neuralgia, myalgia, arthralgia, for primary dysmenorrhea, and also as an antipyretic for diseases that are accompanied by fever.

Contraindications

Hypersensitivity to the components of the drug, other xanthine derivatives (theophylline, theobromine), other salicylates; bronchial asthma caused by taking salicylates or other NSAIDs in history; congenital hyperbilirubinemia, congenital deficiency of glucose-6-phosphate dehydrogenase, blood diseases, leukopenia, anemia, acute gastrointestinal ulcers, hemorrhagic diathesis, severe renal failure, severe liver failure, Gilbert's syndrome, severe cardiovascular diseases, including rhythm disturbance, severe atherosclerosis , a severe form of coronary heart disease, severe heart failure, severe arterial hypertension; states of increased arousal, sleep disturbances, old age, glaucoma, alcoholism. When using MAO inhibitors, as well as within 2 weeks after stopping their use. Combination with methotrexate at a dosage of 15 mg/week or more.

Appropriate safety precautions for use

Do not use the drug with other products containing paracetamol, acetylsalicylic acid. Do not exceed the indicated doses of the drug.

The drug should be used with caution in history of gastrointestinal ulcers, including chronic or recurrent peptic ulcer or history of gastrointestinal bleeding; simultaneous use of anticoagulants. It is necessary to consult a doctor regarding the possibility of using the drug in patients with impaired renal and hepatic functions.

It should be borne in mind that in patients with alcoholic liver damage, the risk of hepatotoxic action of paracetamol increases. Existing diseases liver increase the risk of liver damage with paracetamol. The risk of overdose is higher in patients with non-cirrhotic alcoholic liver disease.

In patients with severe infections, such as sepsis, which are accompanied by a decrease in glutathione levels, the risk of metabolic acidosis increases when taking paracetamol. Symptoms of metabolic acidosis are deep, rapid or labored breathing, nausea, vomiting, and loss of appetite. You should immediately consult a doctor if these symptoms appear.

During surgical operations (including dental), the use of drugs containing acetylsalicylic acid may increase the likelihood of the appearance / increase in bleeding, which is due to the inhibition of platelet aggregation for some time after the use of acetylsalicylic acid.

When using the drug, the excretion of uric acid may decrease. This can lead to gout in patients with reduced uric acid excretion.

During treatment with the drug, it is not recommended to consume an excessive amount of drinks containing caffeine (for example, coffee, tea). This can cause sleep disturbances, tremors, a feeling of tension, irritability, discomfort behind the sternum due to palpitations.

Patients taking analgesics every day for mild arthritis should consult a doctor.

The drug may affect the results of laboratory tests regarding the content of glucose and uric acid in the blood.

During treatment, do not drink alcoholic beverages.

If the symptoms do not disappear, you should consult a doctor.

If the headache becomes persistent, you should consult a doctor.

Keep the drug out of sight of children and out of the reach of children.

Special precautions

Use during pregnancy or lactation

The drug should not be used during pregnancy or lactation.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms.

In the event of dizziness, potentially hazardous activities should be avoided, such as driving a car and / or performing work that requires increased attention and speed of psychomotor reactions.

Children

The drug should not be used in children due to the risk of developing Reye's syndrome (hyperpyrexia, metabolic acidosis, disorders of the nervous system and psyche, vomiting, abnormal liver function) with hyperthermia on the background of viral diseases.

Dosage and administration

The drug is prescribed for adults 1 tablet 2-3 times a day after meals. The maximum daily dose of the drug is 6 tablets (in 3 divided doses). The duration of the course of treatment depends on the course and severity of the disease and should not exceed 5 days as an anesthetic and 3 days as an antipyretic.

Do not take with other medicines containing paracetamol.

Overdose

Paracetamol overdose symptoms.

Liver damage is possible in adults who have taken 10 g or more of paracetamol and in children who have taken more than 150 mg/kg body weight. In patients with risk factors (long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. ) taking 5 g or more of paracetamol can lead to liver damage.

Overdose symptoms in the first 24 hours: pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may occur 12-48 hours after an overdose. Glucose metabolism disorders and metabolic acidosis may occur. In severe poisoning, liver failure can progress to encephalopathy, hemorrhage, hypoglycemia, and coma and be fatal. Acute renal failure with acute tubular necrosis may present with severe low back pain, hematuria, proteinuria, and develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have also been noted. With prolonged use of the drug in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia may develop from the hematopoietic organs. When taking large doses from the side of the central nervous system - dizziness, psychomotor agitation and disorientation; from the urinary system - nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis).

In case of an overdose, emergency medical attention is required. The patient should be immediately taken to the hospital, even if there are no early symptoms of an overdose. Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or the risk of organ damage. Treatment with activated charcoal should be considered if an overdose of paracetamol has been taken within 1 hour. Paracetamol plasma concentration should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine ​​can be applied within 24 hours after taking paracetamol, but the maximum protective effect is obtained when it is used within 8 hours after taking it. The effectiveness of the antidote drops sharply after this time. If necessary, N-acetylcysteine ​​is administered intravenously to the patient according to the established list of doses. In the absence of vomiting, oral methionine can be used as an appropriate alternative in remote areas outside the hospital.

Symptoms of an overdose of acetylsalicylic acid.

An overdose of salicylates is possible due to chronic intoxication that has arisen as a result of long-term therapy (the use of more than 100 mg / kg / day for more than 2 days can cause toxic effects), as well as due to acute intoxication, which is life-threatening (overdose), and the causes of which may be accidental use by children or unforeseen overdose.

Chronic poisoning with salicylates may be latent, since its signs are nonspecific. Moderate chronic intoxication caused by salicylates, or salicylism, occurs, as a rule, only after repeated high doses. Main symptoms: imbalance, dizziness, ringing in the ears, deafness, increased sweating, nausea and vomiting, headache, confusion. These symptoms can be controlled by lowering the dose. Ringing in the ears can be observed when the concentration of salicylates in the blood plasma is over 150-300 mcg / ml. More serious adverse reactions occur when the concentration of salicylates in the blood plasma is more than 300 mcg / ml.

Acute intoxication is evidenced by a pronounced change in the acid-base balance, which may vary depending on the age and severity of intoxication. The severity of the condition cannot be determined solely on the basis of the concentration of salicylates in the blood plasma.

Symptoms of a caffeine overdose.

Large doses of caffeine can cause pain in the epigastric region, vomiting, diuresis, rapid breathing, extrasystole, tachycardia or cardiac arrhythmia, effects on the central nervous system (dizziness, insomnia, nervous agitation, irritability, affective state, anxiety, tremor, convulsions).

Treatment. In case of an overdose, emergency medical attention is necessary, even if there are no symptoms of an overdose. The administration of oral methionine or intravenous acetylcysteine ​​may have a positive effect within 48 hours after an overdose. It is also necessary to apply general supportive measures, symptomatic therapy, including the use of beta-adrenergic antagonists, which can eliminate cardiotoxic effects.

Side effects

From the side of the cardiovascular system: tachycardia, palpitations, arterial hypertension.

From the blood and lymphatic system: anemia, sulfate hemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, pain in the heart), hemolytic anemia, bruising or bleeding, thrombocytopenia, agranulocytosis. Due to the antiplatelet effect on platelets, acetylsalicylic acid may increase the risk of bleeding. Bleedings such as intraoperative hemorrhages, hematomas, bleedings from the organs of the genitourinary system, nosebleeds, bleedings from the gums, gastrointestinal bleedings and cerebral hemorrhages were observed.

From the nervous system: headache, dizziness, tremor, paresthesia, fear, anxiety, agitation, irritability, sleep disturbance, insomnia, anxiety, general weakness, tinnitus.

From the digestive tract: dyspeptic disorders, including nausea, vomiting, epigastric discomfort and pain, heartburn, abdominal pain; inflammation of the gastrointestinal tract, erosive and ulcerative lesions of the gastrointestinal tract, which in rare cases can cause gastrointestinal bleeding and perforation with relevant laboratory and clinical manifestations.

From the skin and subcutaneous tissue: pruritus, rash on the skin and mucous membranes (usually generalized rash, erythematous, urticaria), angioedema, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

From the endocrine system: hypoglycemia, up to hypoglycemic coma.

From the immune system: hypersensitivity reactions, including anaphylaxis, anaphylactic shock, rhinitis, nasal congestion.

From the hepatobiliary system: increased activity of liver enzymes, as a rule, without the development of jaundice, hepatonecrosis (dose-dependent effect).

From the side of the respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs.

Other: bleeding can lead to acute and chronic post-hemorrhagic anemia / iron deficiency anemia (due to the so-called latent microbleeding) with relevant laboratory manifestations and clinical symptoms, such as asthenia, pallor of the skin, hypoperfusion; non-cardiogenic pulmonary edema.

Interaction with other medicinal products and other forms of interaction

Contraindicated combinations.

Methotrexate- when combined with salicylates at a dose of 15 mg / week or more, the hematological toxicity of methotrexate increases due to a decrease in the renal clearance of methotrexate by anti-inflammatory agents and its displacement from plasma protein binding, therefore this combination is contraindicated.

MAO inhibitors- when combined with caffeine, a dangerous increase in blood pressure is possible, therefore this combination is contraindicated.

Combinations to be used with caution.

Paracetamol: Anticonvulsants (including phenytoin, barbiturates, carbamazepine), antidepressants and other stimulants of microsomal oxidation - these drugs increase the production of hydroxylated active metabolites that affect liver function, predetermining the possibility of developing severe intoxications with small overdoses of the drug.

With simultaneous use with hepatotoxic drugs, the toxic effect of drugs on the liver increases. The simultaneous use of high doses of paracetamol with isoniazid increases the risk of hepatotoxic syndrome.

The rate of absorption of paracetamol may increase when used with metoclopramide and domperidone and decrease when used with cholestyramine. Paracetamol reduces the effectiveness of diuretics. Derivatives of coumarin (warfarin) with prolonged use of paracetamol increase the risk of bleeding. Do not use simultaneously with alcohol.

Under the influence of paracetamol, the half-life of chloramphenicol increases by 5 times.

Caffeine: cimetidine, hormonal contraceptives, isoniazid increase the effect of caffeine. Caffeine reduces the effect of opioid analgesics, anxiolytics, hypnotics and sedatives, is an antagonist of drugs for anesthesia and other drugs that depress the central nervous system (CNS), a competitive antagonist of drugs that depress the central nervous system, a competitive antagonist of adenosine and ATP drugs. With the simultaneous use of caffeine with ergotamine, the absorption of ergotamine from the digestive tract improves, with thyroid-stimulating agents, the thyroid effect increases. Caffeine reduces the concentration of lithium in the blood. Caffeine enhances the effect (improves bioavailability) of antipyretic analgesics, potentiates the effects of xanthine derivatives, alpha- and beta-agonists, psychostimulants.

Acetylsalicylic acid: simultaneous use with uricosuric agents, such as benzobromarone, probenecid, reduces the effect of excretion of uric acid (due to the competition of excretion of uric acid by the renal tubules). With simultaneous use with digoxin, the concentration of the latter in the blood plasma increases due to a decrease in renal excretion. ACE inhibitors in combination with high doses of acetylsalicylic acid cause a decrease in glomerular filtration due to inhibition of vasodilatory prostaglandins and a decrease in the hypotensive effect. Selective serotonin reverse inhibitors: Increased risk of bleeding from the upper gastrointestinal tract due to the possibility of a synergistic effect. When used simultaneously with valproic acid, acetylsalicylic acid displaces it from its association with plasma proteins, increasing toxicity.

The drug enhances the effect of drugs that reduce blood clotting and platelet aggregation, side effects of corticosteroids, sulfonylurea, methotrexate.

It is necessary to avoid combinations with barbiturates, anticonvulsants, salicylates, rifampicin, alcohol.

Best before date

Do not use the drug after the expiration date indicated on the package.

Storage conditions

Keep out of the reach of children in the original packaging at a temperature not exceeding 25 °C.

Package

6 or 10 tablets in a blister pack; 1 blister pack in a pack; 6 or 10 tablets in blisters.

Holiday category

Without recipe.

End of the text of the official instructions

Additional Information

Acetylsalicylic acid combinations excl. psycholeptics

Pharmacotherapeutic group:

Analgesics and antipyretics. Acetylsalicylic acid, combinations without psycholeptics.

COMPOSITION AND FORM OF RELEASE:

tab. contour cells. pack., No. 6, No. 10

No. UA/7528/01/01 from 12/27/2007 to 12/27/2012

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics. Askofen-Darnitsa is a combined drug that has analgesic, antipyretic, anti-inflammatory, antiplatelet effects. The main mechanism of action of the drug is the inhibition of the activity of the COX enzyme, resulting in changes in the synthesis of prostaglandins, prostacyclins and thromboxane. Due to a decrease in the production of prostaglandins, the pyrogenic effect of prostaglandins on the thermoregulation center decreases. In addition, the sensitizing effect of prostaglandins on nerve endings decreases, which leads to a decrease in their sensitivity to pain mediators. A decrease in the synthesis of thromboxane A 2 in platelets causes the antiplatelet effect of Askofen-Darnitsa, which is enhanced by inhibition of COX activity in endothelial cells.
Pharmacokinetics. After oral administration, Askofen-Darnitsa is rapidly absorbed from the gastrointestinal tract. Therapeutic concentration of Askofen-Darnitsa in blood plasma is reached after 30 minutes. Part of the drug is absorbed in the stomach, most - in the small intestine. Metabolized by 50% during the first passage through the liver. It is excreted from the body with urine.

INDICATIONS:

as an analgesic for mild to moderate pain syndrome: headache and toothache, myalgia, arthralgia, neuralgia, rheumatic diseases, primary dysmenorrhea and diseases accompanied by fever (ARVI, influenza).

APPLICATION:

Askofen-Darnitsa is taken orally 1 tablet 2-3 times a day after meals. The duration of the course of treatment should not exceed 10 days.

CONTRAINDICATIONS:

peptic ulcer of the stomach and duodenum, gastrointestinal bleeding, decreased blood clotting, 1st trimester of pregnancy, lactation period, deficiency of glucose-6-phosphate dehydrogenase, hypersensitivity to the components of the drug.

SIDE EFFECTS:

nausea, anorexia, diarrhea, pain in the epigastric region, erosive and ulcerative lesions of the stomach. Very rarely with prolonged use - thrombocytopenia, impaired renal function, liver. Possible allergic reactions - skin rashes, bronchospasm in patients with BA.

SPECIAL INSTRUCTIONS:

in patients with asthma, allergic diseases, hypersensitivity to NSAIDs, it is possible to develop allergic reaction or exacerbation of the underlying disease.
During the period of application of Askofen-Darnitsa, one should refrain from drinking alcohol.
The drug slows down the excretion of uric acid from the body, which can cause an acute attack of gout.
During pregnancy and breastfeeding. In the I and III trimester of pregnancy, Askofen-Darnitsa should be avoided due to the risk of fetal deformities, bleeding and weakening of labor. Do not use the drug during breastfeeding.
Children. Children under the age of 14 are prescribed only in cases of ineffectiveness of other antipyretic drugs.

INTERACTIONS:

enhances the effect of anticoagulants, side effects and the effect of oral antidiabetic agents (sulfonylurea derivatives), methotrexate, sulfonamides, triiodothyronine. Simultaneous reception Askofen-Darnitsa and ethanol, ethanol-containing drugs and glucocorticoids increases the risk of gastrointestinal bleeding.
Askofen-Darnitsa weakens the effect of furosemide, spironolactone, antihypertensive, anti-gout drugs. With the simultaneous use of Askofen-Darnitsa with barbiturates, tricyclic antidepressants, rifampicin, alcohol, the risk of developing a hepatotoxic effect increases.

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