Panadol tablets are soluble. Panadol: side effects. Release form, composition and packaging

Registration number: P N014375/01-050214
Trade name: PANADOL®
International non-proprietary name: paracetamol.
Dosage form: soluble tablets

Composition (per tablet)
Active substance: paracetamol 500 mg.
Excipients: sorbitol 50 mg, sodium saccharinate 10 mg, sodium bicarbonate 1342 mg, povidone 1 mg, sodium lauryl sulfate 0.1 mg, dimethicone 1 mg, citric acid 925 mg, sodium carbonate 134.2 mg.

Description.
Flat white tablets with a bevelled edge, scored on one side. The surface on both sides of the tablet may be slightly rough.

Pharmacotherapeutic group: analgesic non-narcotic agent.
ATX code: N02BE01

Pharmacological properties

The drug has analgesic and antipyretic properties. It blocks COX1 and COX2 mainly in the central nervous system, affecting the centers of pain and thermoregulation. The anti-inflammatory effect is practically absent. Does not cause irritation of the mucous membrane of the stomach and intestines. It does not affect the water-salt metabolism, since it does not affect the synthesis of prostaglandins in peripheral tissues.

Pharmacokinetics.

Absorption is high, TCmax is reached in 0.5-2 hours; Cmax - 5-20 mcg / ml. Communication with plasma proteins - 15%. Penetrates through the BBB. Less than 1% of the dose of paracetamol taken by a nursing mother passes into breast milk. Therapeutically effective plasma concentration of paracetamol is achieved when administered at a dose of 10-15 mg/kg. Metabolized in the liver (90-95%): 80% enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione to form already inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The CYP2E1 isoenzyme is also involved in the metabolism of the drug. The half-life (T1 / 2) is 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% unchanged. In elderly patients, the clearance of the drug decreases and the half-life increases.

Indications for use

Panadol® is used to relieve headaches, migraines, toothaches, sore throats, lower back pains, muscle pains, painful periods. "Panadol®" is also used for the symptomatic treatment of febrile syndrome (as an antipyretic); at elevated body temperature against the background of "cold" diseases and influenza. The drug is intended to reduce pain at the time of use and does not affect the progression of the disease.

Contraindications

Hypersensitivity;
- children's age up to 6 years.

Carefully

Use with caution in renal and hepatic insufficiency, benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, glucose-6-phosphate dehydrogenase deficiency, alcoholic liver damage, alcoholism, in old age.

Use during pregnancy and during breastfeeding

According to epidemiological studies among pregnant women, paracetamol does not have adverse effects when used at recommended doses during pregnancy. However, use during pregnancy is possible only after consulting a doctor.
Paracetamol passes into breast milk in small quantities. According to published data, use during breastfeeding is not contraindicated.

Dosage and administration:

inside.
"Panadol®", soluble tablets, should be dissolved in at least 100 ml (half a glass) of water before taking.
Adults (including the elderly):
1-2 tablets (0.5 - 1 g) up to 4 times a day, as needed. The maximum single dose is 2 tablets (1 g). The maximum daily dose is 8 tablets (4 g). The interval between doses is at least 4 hours.
Children
The dose is calculated based on the child's body weight: the maximum single dose is 15 mg/kg of body weight, the maximum daily dose is 60 mg/kg of body weight.
Children (6-9 years): 1/2 tablet (250 mg) up to 4 times daily, as needed. The maximum single dose is 1/2 tablet (250 mg). Maximum daily - 2 tablets (1 g). The interval between doses is at least 4 hours.
Children (9-12 years): 1 tablet (500 mg) up to 4 times daily, as needed. The maximum single dose is 1 tablet (500 mg). The maximum daily dose is 4 tablets (2 g). The interval between doses is at least 4 hours.
In adults, the drug is not recommended to be used for more than 5 days as an anesthetic and for more than 3 days as an antipyretic without prescription and supervision of a doctor. In children, the drug is not recommended for more than 3 days without prescription and supervision of a doctor.
Do not exceed the indicated dose. If you exceed the recommended dose, contact your doctor immediately, even if you feel well, as there is a risk of delayed serious liver damage.
An increase in the daily dose of the drug or the duration of treatment is possible only under medical supervision.

Side effect

At recommended doses, the drug is usually well tolerated. The following side effects were detected spontaneously during post-registration use of the drug.
Side effects are classified by organ system and frequency. The frequency of side effects is defined as follows: very often (greater than or equal to 1/10), often (greater than or equal to 1/100 and less than 1/10), infrequently (greater than or equal to 1/1000 and less than 1/100), rarely ( greater than or equal to 1/10,000 and less than 1/1000) and very rarely (greater than or equal to 1/100,000 and less than 1/10,000).
Allergic reactions:
Very rarely - in the form of rashes on the skin, itching, angioedema, Stevens-Johnson syndrome, anaphylaxis;
From the hematopoietic system:
Very rarely - thrombocytopenia, methemoglobinemia, hemolytic anemia;
From the respiratory system:
Very rarely - bronchospasm (in patients with hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs);
From the hepatobiliary system:
Very rarely - a violation of liver function.
With prolonged use in high doses, the likelihood of impaired liver and kidney function (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis) increases, blood picture control is necessary.
If you experience any of the listed side effects, stop taking the drug and contact your doctor immediately.

Overdose

Symptoms: during the first 24 hours after an overdose, nausea, vomiting, stomach pain, sweating, pallor of the skin, anorexia. After 1-2 days, signs of liver damage are determined (pain in the liver, increased activity of "liver" enzymes). Perhaps the development of disorders of carbohydrate metabolism and metabolic acidosis. In adult patients, liver damage develops after taking more than 10 g of paracetamol. In the presence of factors that affect the toxicity of paracetamol to the liver (see section "Interaction with other drugs", "Special instructions"), liver damage is possible after taking 5 or more grams of paracetamol. In severe cases of overdose as a result of liver failure, encephalopathy (impaired brain function), bleeding, hypoglycemia, cerebral edema, and even death may develop. Perhaps the development of acute renal failure with acute tubular necrosis, the characteristic features of which are pain in the lumbar region, hematuria (an admixture of blood or red blood cells in the urine), proteinuria (increased protein content in the urine), while severe liver damage may be absent. There were cases of cardiac arrhythmia, pancreatitis.
Treatment: If an overdose is suspected, even in the absence of the first symptoms expressed, it is necessary to stop using the drug and immediately seek medical help. Within 1 hour after an overdose, it is recommended to wash the stomach and take enterosorbents (activated charcoal, polyphepan). The level of paracetamol in the blood plasma should be determined, but not earlier than 4 hours after the overdose (earlier results are unreliable). Administration of acetylcysteine within 24 hours of an overdose. The maximum protective effect is provided within the first 8 hours after an overdose, over time, the effectiveness of the antidote drops sharply. If necessary, enter acetylcysteine intravenously. In the absence of vomiting before the patient enters the hospital, methionine may be used. The need for additional therapeutic measures (further administration of methionine, intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration. Treatment of patients with severe liver dysfunction 24 hours after taking paracetamol should be carried out in conjunction with specialists from a poison control center or a specialized department for liver diseases.

Interaction with other drugs

Long-term combined use of paracetamol and NSAIDs increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, the onset of end-stage renal failure.
Simultaneous long-term use of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.
When taken regularly for a long time, the drug enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Episodic administration of a single dose of the drug does not significantly affect the effect of indirect anticoagulants.
Diflunisal increases the plasma concentration of paracetamol by 50%, which increases the risk of hepatotoxicity.
Barbiturates, carbamazepine, phenytoin, primidone, ethanol, rifampicin, zidovudine, flumecinol, phenylbutazone, St. ). Inhibitors of microsomal liver enzymes (cimetidine) reduce the risk of hepatotoxicity. Under the influence of paracetamol, the elimination time of chloramphenicol increases by 5 times. The simultaneous use of paracetamol and alcoholic beverages increases the risk of developing liver damage and acute pancreatitis.
Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol.
The drug may reduce the effectiveness of uricosuric drugs.

special instructions

Before taking Panadol®, you should consult your doctor if you are taking any of the drugs listed in the "Interaction with other drugs" section.
If the condition does not improve while taking the drug or the headache becomes constant, you should consult a doctor.
Glutathione deficiency due to eating disorders, cystic fibrosis, HIV infection, starvation, malnutrition causes the possibility of developing severe liver damage with overdoses of paracetamol (5 g or more).
The drug should not be taken simultaneously with other paracetamol-containing drugs.
Patients on a salt-free or low-salt diet should take into account the sodium content per tablet (427 mg) when calculating the daily salt intake.
When conducting tests to determine uric acid and blood glucose, you should inform your doctor about taking the drug.
The drug should be used with caution in fructose intolerance, since the drug contains sorbitol.
TO AVOID LIVER TOXIC DAMAGE, PARACETAMOL SHOULD NOT BE COMBINED WITH ALCOHOLIC DRINKS AND ALSO BE TAKEN BY PERSONS PRONE TO CHRONIC ALCOHOL CONSUMPTION
With the consumption of sodium bicarbonate in high doses, it is possible to develop disorders of the gastrointestinal tract, including belching, nausea; it is also possible to develop hypernatremia, in this case it is necessary to monitor the water and electrolyte balance and apply appropriate tactics for managing the patient.

Active substance

Paracetamol

Release form

soluble tablets

Primary packaging

Amount in a package

Manufacturer

Composition and form of release

1 coated tablet contains paracetamol 500 mg; 12 pcs in a blister, 1 blister in a box.

1 tablet soluble - 500 mg; 2 pieces in a laminated strip, 6 strips in a box.

Pharmacological actions

Suppresses the synthesis of PG in the central nervous system, reduces the excitability of the hypothalamic center of thermoregulation, increases heat transfer.

Pharmacokinetics

Rapidly and almost completely absorbed from the gastrointestinal tract. Plasma concentration reaches a peak after 30-60 minutes, T 1/2 plasma - 1-4 hours. Metabolized in the liver. It is excreted in the urine, mainly in the form of esters with glucuronic and sulfuric acids; less than 5% is excreted unchanged.

Pharmacodynamics

Has analgesic and antipyretic properties; the last are shown in the conditions of a feverish syndrome of any genesis.

Panadol: indications

Pain of mild to moderate intensity (headache, migraine, back pain, arthralgia, myalgia, neuralgia, toothache, menalgia). Feverish syndrome with colds.

Panadol: contraindications

Hypersensitivity.

Dosage and administration

inside, adults- 2 tab. up to 4 times a day with an interval between doses of at least 4 hours (maximum daily dose - 8 tablets), children from 6 to 12 years old- 1/2–1 tab. up to 4 times a day with an interval between doses of at least 4 hours (the maximum daily dose is 4 tablets). Soluble tablets are dissolved in 1/2 glass of water before taking.

Panadol side effects

Allergic reactions in the form of skin rashes.

Interaction

Enhances the effect of indirect anticoagulants (coumarin derivatives). Metoclopramide or domperidone increase, and cholestyramine reduces the rate of absorption.

Overdose

Symptoms of an overdose in the first 24 hours are pallor, nausea, vomiting and pain in the abdominal region. 12-48 hours after administration, damage to the kidneys and liver with the development of liver failure (encephalopathy, coma, death) may occur. Liver damage is possible when taking 10 g or more (in adults). Acute renal failure with tubular necrosis may develop in the absence of severe liver damage. Other manifestations of overdose are cardiac arrhythmias and pancreatitis. Treatment - taking methionine orally or in / in the introduction of N-acetylcysteine.

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Medical and
pharmaceutical activities
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From "__" ________ 201_

Instructions for medical use

medicinal product

PANADOL®

Tradename

PANADOL®

International non-proprietary name

Paracetamol

Dosage form

Soluble tablets 500 mg

Compound

One tablet contains

active substance- paracetamol 500 mg

Excipients: sorbitol, sodium saccharin, sodium bicarbonate (especially thin), povidone, sodium lauryl sulfate, dimethicone, anhydrous citric acid, anhydrous sodium carbonate, purified water.

Description

Flat white tablets with a bevelled edge, smooth on one side and scored on the other.

Pharmacotherapeutic group

Other analgesics-antipyretics. Anilides. Paracetamol.

ATX code N02BE01.

Pharmacological properties

Pharmacokinetics

Paracetamol is rapidly and almost completely absorbed (96%) from the gastrointestinal tract. The maximum concentration in the blood is about 6 μg / ml, the time to reach the maximum concentration is 10-60 minutes. Communication with proteins is less than 10%. Paracetamol is metabolized in the liver, most of it enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites and is excreted in the urine in the form of sulfate and glucuronic conjugates. The elimination half-life is 1-4 hours.

Pharmacodynamics

Paracetamol is an analgesic-antipyretic. It has an analgesic and antipyretic effect by suppressing the synthesis of prostaglandins in the hypothalamus. It has weak anti-inflammatory activity.

The drug has analgesic and antipyretic properties. Does not cause irritation of the mucous membrane of the stomach and intestines. It does not affect the water-salt metabolism, since it does not affect the synthesis of prostaglandins in peripheral tissues.

Indications for use

Pain syndrome: headache, migraine, toothache, neuralgia, joint and muscle pain, lower back pain, sore throat, painful menstruation, osteoarthritis pain.

Feverish syndrome: fever and pain with colds and flu.

A single dose is possible to reduce the temperature after vaccination.

Dosage and administration

Panadol® tablets should be dissolved in at least 100 ml (1/2 cup) of water before ingestion.

Children (6-11 years old) - 1/2-1 tablet 3-4 times a day, if necessary. The interval between doses is at least 4 hours. The maximum single dose for children is 1 tablet (0.5 g), the maximum daily dose is 2 tablets. The dose for children is calculated based on the body weight of the child: the maximum single dose is 10-15 mg / kg of body weight, the maximum daily dose is 60 mg / kg of body weight.

Children (12-18 years): 1 tablet 3-4 times daily as needed. The interval between doses is at least 4 hours. The maximum single dose is 1 tablet (0.5 g), the maximum daily dose is 4 tablets (2 g).

Adults: Usually 1-2 tablets 3-4 times daily as needed. The interval between doses is at least 4 hours. The maximum single dose for adults is 2 tablets (1g), the maximum daily dose is 8 tablets (4g).

In case of overdose, contact your doctor immediately, even if you feel well.

Side effects

Very rarely

Hypersensitivity reactions (skin rash, angioedema, anaphylaxis, Stevens-Johnson syndrome)

Blood disorders (anemia, thrombocytopenia, methemoglobinemia).

With prolonged use in high doses, the likelihood of impaired liver and kidney function (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis) increases and blood picture control is necessary.

In patients with hypersensitivity to acetylsalicylic acid and other NSAIDs, bronchospasm is possible.

If you experience unusual symptoms, you should consult a doctor.

Contraindications

Hypersensitivity to paracetamol or any other

drug ingredient

Severe liver or kidney dysfunction

Genetic absence of glucose-6-phosphate dehydrogenase

hereditary fructose intolerance

Children's age up to 6 years

Drug Interactions

The drug, when taken for a long time, enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding.

Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenin, carbamazepine, rifampicin, zidovudine, phenytoin, St.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.

Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol.

Ethanol contributes to the development of acute pancreatitis. The drug may reduce the activity of uricosuric drugs.

Before taking the drug, you need to consult a doctor if:

Chronic liver or kidney disease

Metoclopramide, domperidone, cholesterol-lowering drugs (colestyramine) or anticoagulants

Paracetamol is not recommended as an analgesic for the treatment of chronic pain for a long time. The drug should be used with caution in fructose intolerance, since it contains sorbitol (62.5 mg / tab). The drug contains sodium (427 mg/tab). People who abuse alcohol should consult a doctor before taking the drug. If the recommended dose is exceeded, paracetamol can have a toxic effect on the liver.

Pregnancy and lactation

Before taking the drug, consult your doctor

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

There are no restrictions on driving a car and working with mechanisms

Overdose

Symptoms: nausea, vomiting, stomach pain, sweating, pale skin. After 1-2 days, signs of liver damage appear (pain in the liver, increased activity of "liver" enzymes). In severe cases, liver failure, encephalopathy and coma develop.

Panadol is available in tablet form: soluble Panadol tablets and film-coated tablets.

Soluble tablets have a white color, a flat shape, a rough surface, a beveled edge in a circle and a risk on one side.

Film-coated tablets have a capsule shape, flat edges, white color, at risk on one side and a special embossing "Panadol" on the other side.

pharmachologic effect

Antipyretic analgesic. The active ingredient has antipyretic, analgesic effects. The principle of action is based on the blocking of COX-1,2 mainly in the central part of the nervous system. The active ingredient acts on the centers of thermoregulation and pain.

The anti-inflammatory effect of Paracetamol is practically not expressed. The active ingredient does not irritate the mucous membranes of the digestive tract (intestines, stomach). Panadol is not able to affect the synthesis process in peripherally located tissues, so the drug does not affect water-salt exchange .

Pharmacodynamics and pharmacokinetics

The drug is rapidly absorbed from the lumen of the digestive tract through passive transport. The active ingredient is absorbed mainly from the small intestine. The maximum concentration of paracetamol after a single dose of 500 mg is recorded after 10-60 minutes (C (max) = 6 μg / ml). Already after 6 hours, the indicator smoothly reaches the level of 11-12 mcg / ml.

The active substance is characterized by uniform distribution in liquid media and tissues of the body, without getting into the cerebrospinal fluid and adipose tissue.

Plasma protein binding does not exceed 10%, slightly increasing with overdose. Glucuronide and sulfate metabolites are not able to bind to plasma proteins even at relatively high dosages. Panadol is metabolized mainly in the hepatic system due to conjugation with sulfate and glucuronide, as well as due to oxidation involving cytochrome P450 and mixed hepatic oxidases.

N-acetyl-p-benzoquinoneimine (a hydroxylated metabolite with a negative effect), formed in the renal and hepatic systems in small amounts as a result of the interaction of mixed forms of oxidases, is detoxified due to binding to glutathione. In case of overdose, accumulation of N-acetyl-p-benzoquinoneimine occurs, which can cause tissue damage. A significant part of paracetamol binds to glucuronic acid, a small part - to sulfuric acid. The listed conjugated metabolites do not have a biological effect and do not have activity. Newborns and premature babies are characterized by metabolism with the formation of sulfate metabolites.

The elimination half-life is 1-3 hours. At T1\2 it increases significantly. Renal clearance reaches 5%. Through the renal system, the drug is excreted in the urine in the form of sulfate and glucuronide conjugates. Less than 5% paracetamol is excreted unchanged.

Indications for use, from which Panadol tablets

The drug is used for symptomatic therapy and relief pain syndrome :

painful menstruation;
muscle pain;
burn pain;
toothache;
post-traumatic pain;
algomenorrhea ;
pain in the back, lower back;
sore throat.

As an antipyretic (), the drug is prescribed at elevated body temperature (cold, infection). The drug does not affect the progression and course of the underlying disease and is used only to reduce the severity of pain symptoms.

Contraindications

With individual hypersensitivity, Panadol is not prescribed. Age limit - up to 6 years.

Relative contraindications:

Gilbert's syndrome;
liver failure;
benign hyperbilirubinemia;
alcoholic damage to the hepatic system;
kidney failure;
pregnancy;
viral hepatitis;
elderly age;
deficiency of glucose-6-phosphate dehydrogenase;
alcoholism;
breast-feeding.

Side effects

Negative changes in the urinary system:

interstitial nephritis ;
renal colic ;
papillary necrosis ;
nonspecific bacteriuria .

Other reactions:

anemia ;
neutropenia ;
skin rashes;
dyspeptic phenomena;
thrombocytopenia ;
skin itching;
methemoglobinemia ;
hepatotoxic effect, liver damage.

Application instruction of Panadol (Way and dosage)

Regular tablets Panadol, instructions for use

Adults are prescribed 500-1000 mg up to 4 times a day if necessary. The recommended time interval between doses is 4 hours. You can take no more than 8 tablets per day. Long-term use of Panadol as an anesthetic (maximum 5 days) and antipyretic (maximum 3 days) is not allowed. The decision to increase the daily dosage or duration of therapy is made by the attending physician.

Effervescent tablets Panadol, instructions for use

Tablets are dissolved in a glass of water before use. You can take no more than 4 tablets per day. Soluble Panadol is prescribed mainly for difficulty swallowing tablets and in pediatric practice.

Overdose

The manufacturer recommends taking the medication only in the dosages indicated in the instructions. When taking higher doses, immediate medical attention is required, even in the absence of negative symptoms, because. possible delayed damage to the hepatic system. In adult patients, the first signs of liver damage are observed when taking more than 10 grams of medication. Taking more than 5 grams has a toxic effect in a certain category of citizens with risk factors:

the use of alcoholic beverages in large quantities and with high frequency;
reception , , , , drugs Hypericum perforatum and other medicines that stimulate the production of liver enzymes;
glutathione deficiency (with, cystic fibrosis , malnutrition, malnutrition and starvation).

Signs of poisoning:

nausea;
epigastric pain;
pallor of the skin;
vomit.

In severe poisoning, it may develop acute renal failure , coma , tubular necrosis , .

Treatment includes gastric lavage, the use of enterosorbent drugs (,), the introduction of precursors for the synthesis of glutathione-methionine and donators of SH groups. With severe lesions of the hepatic system, treatment is carried out under the guidance of specialists from the toxicological center.

Interaction

The risk of hepatotoxic damage increases with simultaneous treatment with inducers of microsomal hepatic enzymes and drugs that exhibit a hepatotoxic effect. A moderately pronounced or slight increase in the indicator is registered prothrombin time .

The absorption of Paracetamol is reduced when anticholinergic drugs are prescribed. The severity of the analgesic effect decreases, and excretion is accelerated during treatment. Paracetamol inhibits activity uricosuric drugs . The bioavailability index of Panadol decreases when taken activated carbon . Decrease in excretion is registered.

Analogues

Coincidence in the ATX code of the 4th level:

Paracetamol ;
Prohodol ;
Perfalgan ;
Cefcon D .

children

Children 6-9 years old the medication is prescribed 3-4 times a day, 2 tablets. The manufacturer's recommended time interval between doses is 4 hours. The maximum daily dosage is 1000 mg (2 tablets).

Children 9-12 years old the medication is prescribed up to 4 times a day, 1 tablet. You can take no more than 4 tablets per day.

Panadol during pregnancy (and lactation)

The active ingredient is able to pass through placental barrier . The negative effect of Panadol on the fetus has not been registered, which allows the use of the drug during pregnancy if necessary.

panadol while breastfeeding

The active substance is excreted during lactation with milk at a concentration of 0.04-0.23% of the dose of Paracetamol taken by the mother. Before treatment, an assessment is made of the need to take Panadol and the expected harm to the fetus / child. The conducted experimental studies did not establish the teratogenic, embryotoxic and mutagenic effects of Paracetamol.

Reviews about Panadol

The drug is well tolerated and, subject to the terms of treatment, dosage recommendations, rarely causes negative reactions. Feedback from patients and doctors is mostly positive. One of the advantages of the drug is its availability and low cost.

Panadol price, where to buy

The price of Panadol depends on the region of sale, pharmacy network and rarely exceeds 100 rubles in Russia.

Internet pharmacies in Russia Russia
Internet pharmacies in Ukraine Ukraine
Internet pharmacies in Kazakhstan Kazakhstan

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Instructions for the medical use of the medicinal product

PANADOL® JUNIOR

Tradename

PANADOL® JUNIOR

International non-proprietary name

Paracetamol

Dosage form

Soluble tablets 500 mg

One tablet contains

active substance - paracetamol 500 mg

excipients: sorbitol, sodium saccharin, sodium bicarbonate (especially thin), povidone, sodium lauryl sulfate, dimethicone, anhydrous citric acid, anhydrous sodium carbonate, purified water.

Description

Flat white tablets with a bevelled edge, smooth on one side and scored on the other.

Pharmacological group

Other analgesics-antipyretics. Anilides.

ATC code N02BE01

Pharmacological properties

Pharmacokinetics

Paracetamol is rapidly and almost completely absorbed (96%) from the gastrointestinal tract. The maximum concentration in the blood is about 6mcg / ml, the time to reach the maximum concentration is 10-60 minutes. Communication with proteins is less than 10%. Paracetamol is metabolized in the liver, most of it enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites and is excreted in the urine as sulfate and glucuronic conjugates. The elimination half-life is 1-4 hours.

Pharmacodynamics

Paracetamol is an analgesic-antipyretic. It has an analgesic and antipyretic effect by suppressing the synthesis of prostaglandins in the hypothalamus. Possesses weak anti-inflammatory activity.

Indications for use

Pain syndrome: headache, migraine, toothache, neuralgia, joint and muscle pain, lower back pain, sore throat with sore throat, painful menstruation

Feverish syndrome: fever and pain in colds and flu.

Dosage and administration

Panadol® Junior tablets should be dissolved in at least 100 ml (1/2 cup) of water before ingestion.

Children (6-12 years old) - 1/2-1 tablet 3-4 times a day, if necessary. The interval between doses is at least 4 hours. The maximum single dose for children is 1 tablet (0.5 g), the maximum daily dose is 2 tablets. The dose for children is calculated based on the child's body weight: the maximum single dose is 15 mg/kg of body weight, the maximum daily dose is 60 mg/kg of body weight.

Children (12-18 years): 1 tablet 3-4 times daily as needed. The interval between doses is at least 4 hours. The maximum single dose is 1 tablet (0.5 g), the maximum daily dose is 4 tablets (2 g).

Adults: Usually 1-2 tablets 3-4 times daily as needed. The interval between doses is at least 4 hours. The maximum single dose for adults is 2 tablets (1g), the maximum daily dose is 8 tablets (4g).

The drug is not recommended to be used for more than five days as an analgesic and for more than three days as an antipyretic without a doctor's prescription. An increase in the daily dose of the drug or the duration of treatment is possible only under medical supervision. Do not exceed the indicated dose.

In case of overdose, contact your doctor immediately, even if you feel well.

Side effects

Allergic skin rash, angioedema

Rarely - disorders of the blood system (anemia, thrombocytopenia, methemoglobinemia)

If you experience unusual symptoms, you should contact your doctor.

Contraindications

Hypersensitivity to paracetamol or any other

drug ingredient

Severe liver or kidney dysfunction

Genetic absence of glucose-6-phosphate dehydrogenase

Children's age up to 6 years

Drug Interactions

The drug, when taken for a long time, enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenin, carbamazepine, rifampicin, zidovudine, phenytoin, St. John's wort, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxic effects in case of overdose. Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic action. Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol. Ethanol contributes to the development of acute pancreatitis. The drug may reduce the activity of uricosuric drugs.

Before taking the drug, you need to consult a doctor if:

Chronic liver or kidney disease

The use of metoclopramide, domperidone, as well as drugs that lower blood cholesterol levels (colestyramine) or anticoagulants

Paracetamol is not recommended as an analgesic for the treatment of chronic pain over a long period of time. The drug should be used with caution in fructose intolerance, since it contains sorbitol. The drug contains sodium (427 mg/tab). People who abuse alcohol should consult a doctor before taking the drug. If the recommended dose is exceeded, paracetamol can have a damaging effect on the liver.

Pregnancy and lactation

Before taking the drug, consult your doctor

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

There are no restrictions on driving a car and working with mechanisms

Overdose

Symptoms: nausea, vomiting, stomach pain, sweating, pale skin. After 1-2 days, signs of liver damage are determined (pain in the liver area, increased activity of "liver" enzymes). In severe cases, liver failure, encephalopathy and coma develop.