Instructions for use aertal tablets. Aertal - description and important information. Contraindications for use

Active ingredient – aceclofenac. He suppresses inflammatory processes and relieves pain at the site of inflammation. Basically, the drug is used in orthopedic and neurological practice.

pharmachologic effect

After entering the gastrointestinal tract, aceclofenac is rapidly absorbed. A few hours after application, aceclofenac in in large numbers deposited in the synovial fluid. Only a small part of the drug undergoes the process of metabolization. It is excreted along with urine.

Indications for use

• Elimination of the inflammatory process;
• elimination pain syndrome in joints and soft tissues;
• relief of toothache.

• humeroscapular periarthritis;
• rheumatism;
• lumbago;
• spondylitis;
• osteoarthritis;
• osteochondrosis.

Instructions for use (how to take pills)

How long can the drug be taken?

Side effects

Contraindications

• Allergy to aceclofenac;
• stomach ulcer;
• liver pathology;
• hyperkalemia;
• bleeding from the intestines (including suspected bleeding);
• postoperative period after coronary artery bypass grafting;
• pregnancy;
• teenagers under 18 years old.

• with ischemia;
• at frequent use alcohol;
• in violation of lipid metabolism;
• in violation of blood circulation.

During pregnancy

During lactation, the drug should also not be used. If, according to indications, the reception is very important, then breastfeeding should be abandoned.

Interaction

• In combination with Phenytoin, Digoxin, Methotrexate, Aertal increases their plasma concentration.
• Enhances the damaging effect of non-steroidal anti-inflammatory drugs on the gastric mucosa.
• Reduces the effect of antihypertensive and diuretic drugs.
• It provokes the appearance of hyperkalemia when combined with potassium preparations.
• Enhances the action of Cyclosporine, which leads to the development of nephrotoxic phenomena.
• Affects blood sugar levels, which is important for diabetic patients.
• When Aertal is combined with acetylsalicylic acid, the plasma concentration of aceclofenac decreases, which requires dosage adjustment.
• In combination with anticoagulants and antiplatelet agents, the drug increases the risk of bleeding.

Overdose

pharmachologic effect

Aertal is rapidly and completely absorbed, actively binding to plasma proteins. The maximum concentration of the active substance Aertal is observed 3 hours after ingestion in the intra-articular fluid. Aertal is excreted by the kidneys, unchanged after 8 hours.

Indications for use

• Suppression of pain and inflammatory processes in rheumatic diseases of soft tissues, sharp attacks of pain in the lower back, inflammation of the shoulder joint, dental diseases;
• Rheumatoid inflammation osteoarthritis (as part of a medicinal complex).

Mode of application

Application Features:

The use of Aertal in the following cases should be carried out with caution and under the close supervision of medical personnel:

• Presence in the history of diseases of diseases digestive system;
• A history of liver disease;
• A history of kidney disease;
• High blood pressure;
• Cardiac ischemia;
• Decrease in the volume of circulating blood;
• Smoking patients;
• Violations of cerebral circulation;
• Patients who drink alcohol;
• Diabetes;
• Violations of fat metabolism;
• Elderly patients.

Side effects

• When taking Aertal, disorders of the digestive system are possible (disorders of the stool, pain in the stomach, nausea, vomiting, inflammation oral cavity, spasm of the intestine, inflammation of the pancreas, decreased appetite, inflammation of the liver, ulcerative lesions, bleeding of the digestive system, increased activity of liver enzymes);
• Violations of the urinary system (the appearance of protein and blood in the urine, inflammation of the kidneys, swelling, functional failure of the kidneys);
• Violations nervous system(dizziness, headaches, memory loss, trembling of limbs, sleep disturbances, apathy, convulsions, increased emotional excitability, meningitis);
• Sensory disorders (change in taste perception, decreased vision, hearing loss, the appearance of tinnitus);
• Violation of cardio-vascular system(increase blood pressure, violation heart rate, heart failure associated with stagnation);
• Violation hematopoietic system (various violations percentage shaped elements blood);
• When taking Aertal, various allergic reactions (anaphylactic shock, skin rashes, angioedema, bronchospasm, various dermatitis, inflammation vascular wall, urticaria, Lyell's syndrome, pruritus, Stevens-Johnson syndrome).

Contraindications

• Individual intolerance to Aertal or its components;
• Ulcerative lesions of the mucous membranes of the digestive system;
• Individual intolerance to non-steroidal anti-inflammatory drugs;
• Bleeding of the digestive system;
• Hypersensitivity to Aertal or its components;
• Treatment of patients with high content potassium ions in the blood;
• Hypersensitivity to non-steroidal anti-inflammatory drugs;
• The period after coronary artery bypass grafting;
• Violation of the hematopoietic system;
• Functional disorders of the kidneys;
• Pregnancy and the period of breastfeeding;
• Functional disorders of the liver;
• blood clotting disorders;
• Patients under 18 years of age.

During pregnancy and lactation

Interaction with other drugs

• The simultaneous use of Aertal with drugs containing lithium ions, Digoxin and Phenytoin, there is an increase in the concentration of Aertal in the blood;
• Simultaneous use with potassium-sparing diuretic drugs or drugs containing potassium ions in their composition, there is a sharp increase in the concentration of potassium ions in the blood;
• Simultaneous use with diuretics or drugs that lower blood pressure, leads to a decrease therapeutic effect the latter;
• Simultaneous use with Acetylsalicylic acid leads to a decrease in the concentration of the active substance Aertal in the blood plasma;
• Simultaneous use with Cyclosporine leads to increased toxic action on the kidneys of the latter;
• Simultaneous use with drugs that have a blocking effect on the reuptake of serotonin, drugs that prevent the ability of platelets to stick together and thin the blood, bleeding of the digestive system is noted;
• Simultaneous use of Aertal with Metatrexate leads to sharp increase plasma concentrations of the latter.

Overdose

• Nervous system disorders (headaches, dizziness, tendency to convulsions);
• Digestive system disorders (nausea, vomiting, abdominal pain);
• Violations respiratory system(hyperventilation).

Release form

Storage conditions

Shelf life - no more than 4 years.

Compound

In 1 package of Aertal powder:

• aceclofenac - 100 mg;
• Excipients: sorbitol, sodium saccharinate, aspartame, colloidal silicon dioxide, hypromellose, titanium dioxide, milk flavor, caramel flavor, cream flavor.

In 1 g of Aertal cream:

• aceclofenac (100% micronized) - 15 mg;
• Excipients: emulsion wax, liquid paraffin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, water.

In 1 tablet of Aertal:

• aceclofenac - 100 mg;
• Excipients: microcrystalline cellulose, povidone, glyceryl distearate (type I), croscarmellose sodium.

Today our topic is: Aertal: instructions for use, price, reviews and analogues.

In the off-season, almost everything begins to worsen chronic diseases, especially those caused by inflammatory and degenerative changes in the musculoskeletal system. To relieve pain, patients are most often recommended to use non-steroidal anti-inflammatory drugs, which include airtal. However, before taking it, especially for a long time, you should familiarize yourself with the indications, contraindications and side effects this medicine.

1. Aertal: instructions for use, price, reviews and analogues

1.1 What are non-steroidal anti-inflammatory drugs (NSAIDs)

By themselves, these medicines they are not able to cure diseases, but they relieve the main symptoms of inflammatory processes: pain, fever and swelling. Their main action is associated with the inhibition of the work of the enzyme released during inflammation - cyclooxygenases, and both of its varieties. Due to this, inflammatory mediators such as prostaglandins and thromboxane are no longer synthesized from arachidonic acid.

Most of the funds from this group are acids (salicylic, indolacetic, phenylacetic, propionic) or their derivatives. But in last years non-acid agents appeared, for example nimesulide or paracetamol.

The whole group has almost the same properties: medications, which are included in it, are able to reduce inflammation by reducing the exudation of fluid in the tissue, and some drugs, such as indomethacin, diclofenac and aertal, may also reduce collagen synthesis and tissue sclerosis.

Almost all nonsteroidal drugs able to reduce pain in muscles, joints, nerve trunks, they also cope well with headache, toothache and postoperative pain. AT varying degrees they reduce fever, for example acetylsalicylic acid and paracetamol have long been known as strong antipyretics.

In small doses, they reduce the adhesion of platelets, preventing the formation of blood clots, which is why pharmacists have long used aspirin to prevent myocardial infarction. If the funds are taken long enough, they depress the immune system due to a violation of the binding of antibodies to antigens.

1.2 Indications for the use of NSAIDs

They also eliminate pain syndrome in case of injuries and degenerative diseases of bones, joints, peripheral nerves, with spasms smooth muscle, including the walls of the uterus, after operations, with renal colic. NSAIDs are recommended when body temperature rises above 37.5 ° C to reduce fever, some of them, such as aspirin, are prescribed to prevent thrombosis.

You can not use the group of NSAIDs:

• in the presence of inflammatory and erosive processes in the gastrointestinal tract,
• history of peptic ulcer
• hepatic, cardiac and kidney failure,
• severe hypertension,
• bronchial asthma,
• pregnancy and breastfeeding,
• allergic reactions to the drug.

1.3 Adverse reactions to nonsteroidal drugs

Most often, complications are from the digestive system: nausea, vomiting, diarrhea or pain in the stomach and intestines, the formation of erosions and ulcers on the mucosa, bleeding, and even perforation of the wall, complicated by peritonitis and death of the patient.

In elderly patients, the last two complications may appear suddenly, without any symptoms of mucosal damage. Factors such as smoking, alcoholism, simultaneous reception two or more NSAIDs, as well as their combination with anticoagulants, corticosteroid hormones and immunosuppressants.

1.4 Airtal tablets: instructions for use

This medicine contains the active ingredient aceclofenac, which is derived from phenylacetic acid. Its peculiarity is the ability to penetrate into synovial fluid joint, due to which aertal can eliminate its inflammation.

The drug is well absorbed by the body and excreted from it with urine, therefore, with renal failure, it is contraindicated. Airtal tablets are able to reduce pain, relieve fever and reduce swelling and inflammatory response in tissues.

Indications for its use are rheumatoid arthritis and other inflammatory and degenerative diseases of the joints, osteochondrosis and radiculopathy, dental, muscle, menstrual and other pain.

You can't drink aertal

• with erosions or ulcers in the gastrointestinal tract,
• bleeding and hematopoietic disorders,
• chronic renal, heart and liver failure,
• pregnancy and lactation,
• an allergic reaction to the active substance and in children under 18 years of age.

There is another group of patients who absolutely cannot use this medicine, they always have three symptoms: nasal sinus polyposis, bronchial asthma and aspirin intolerance.

Even if there is an indication, aertal is used with caution or canceled altogether in the presence of such side effects as

• nausea,
• vomit,
• severe pain in the abdomen,
• headache,
• patient agitation,
• tremor of limbs and convulsions,
• noise in ears,
• taste change,
• arrhythmia,
• increase in blood pressure,
• nephritis,
• anemia,
• skin rashes

AT severe cases severe allergic reactions to aceclofenac may develop: angioedema and even anaphylactic shock.

When used simultaneously with other drugs, it is worth considering their interaction. For example, airtal reduces the effectiveness of diuretics and antihypertensive drugs, but enhances the effects of corticosteroids, anticoagulants and antiplatelet agents, increases the concentration of digoxin in the blood.

Together with cyclosporine, it increases the toxic effect on the kidneys, and in diabetes mellitus, the dose of insulin will have to be adjusted due to the use of aceclofenac.

1.5 Forms of release, dosage and prices

Aertal pharmaceutical companies produce in tablets, each contains 100 mg of aceclofenac and excipients. The package can be from 10 to 90 pieces, average price his - 320-350 rubles for 20 tablets.

It is not recommended to take more than 200 mg of the drug per day, it is consumed after meals and washed down large quantity liquids. For internal use pharmaceutical companies offer soluble 100 mg per sachet, there are 20 of them in a package.

Since the drug has a lot of contraindications, and the effectiveness of local use not bad, it is also produced in the form of an ointment or cream. This form of release received a good response from athletes, as thanks to it it is possible to quickly eliminate the consequences of various injuries.

Aertal 1.5% cream produced in tubes of 60 g of the drug and it costs about 300 rubles. It is well absorbed, but requires preliminary rubbing into the skin at the site of inflammation or applying it as a compress. Therefore, such an ointment aertal is contraindicated in case of integrity violations skin, pustules and others skin rashes. It can also not be used in case of an allergic reaction to the drug. You can not use it during pregnancy, as well as in children under 18 years of age.

1.6 Non-steroidal analogues

1.6.1 What are miorexans

All NSAIDs are able, like aertal, to reduce pain and inflammation, but you should also not forget about another group of drugs, which is also able to eliminate dysfunction of the musculoskeletal system, but in a different way.

This group is called muscle relaxants for the ability to eliminate spasm of striated muscles. They remove excessive stretching and overstrain of muscles, eliminating pain in them and surrounding tissues, and also restore the ability to move in the area of ​​damaged joints.

According to their effect, muscle relaxants are divided into central and peripheral:

1. the former block the transmission of signals at the level of the brain,
2. the latter act at the level of synapses between nerve endings and muscle cells.

The central ones include sirdalud, metopronate, flexin, isoprotan, baclofen and mydocalm,

to the second - dithylin, dixonium, arduan and mellictin.

Physicians often prescribe central muscle relaxants as NSAID analogues to relieve pain in the joints and spine.

1.6.2 Mydocalm: use and price of the medicine

Its active ingredient is tolperisone. average cost tablets of 50 mg - about 330-380 rubles, 150 mg - from 350 to 480 rubles. The price of a 1% solution for injection for 5 ampoules is approximately 450 rubles. The use of the drug mydocalm is recommended for multiple sclerosis, encephalitis, myelopathy, lumboischialgia, arthrosis, Raynaud's disease, muscle hypertonicity and contractures, postoperative period after orthopedic surgery, for treatment trophic ulcers with thrombophlebitis.

The instruction prohibits prescribing midokalm for myasthenia gravis, pregnancy, in children under 3 years of age and with allergic reactions to it. Overdose can cause convulsions, shortness of breath, imbalance, and even paralysis. respiratory center, and therefore it is better to adhere to medical recommendations and not take more than 450 mg per day.

1.6.3 Sirdalud: instructions and price

Another, more cheap analogue aertal tablets, which also belongs to the central muscle relaxants, is sirdalud, each tablet of which contains 4 mg of tizanidine. It is prescribed for spasms skeletal muscles that are accompanied by pain, and multiple sclerosis and degenerative diseases spinal cord, functional disorders work of the spine, myelopathy and cerebrovascular accident.

You can not use it in the presence of liver and kidney failure, in the elderly over 65 years of age, nursing mothers and children, as well as allergies to the drug. Sirdalud is not used simultaneously with ciprofloxacin and its other analogues. But muscle relaxants central action perfectly combined with NSAIDs, including airtal in complex treatment osteochondrosis to relieve pain.

In conclusion, a video on a given topic with Elena Malysheva “Live Healthy! Symptoms and treatment rheumatoid arthritis»:

That's all I wanted on the topic "Aertal: instructions for use, price, reviews and analogues." I hope, my readers, acquaintance with some non-steroidal anti-inflammatory drugs and their analogues will help you in choosing medicines that can reduce inflammation and pain in diseases of the musculoskeletal system.

Aertal is a non-steroidal anti-inflammatory drug. There are several forms of the drug. On sale you can find powders for the manufacture of suspensions. One sachet - 3 grams of medicine. You can also find tablets with a 100-milligram content of the active substance. There are also creams. The weight of the tube is 60 grams.

Aertal - what helps

Aertal relieves symptoms such as joint stiffness, inflammation, fever, swelling. Also, the drug has good efficacy in toothache and rheumatism. The active substance in Aertal is 1.5 g, the rest is auxiliary.

current active substance is aceclofenac. It slows down the creation of prostacyclins and prostaglandins in the body, thereby preventing and eliminating inflammatory processes. Specifically, the substance inhibits an enzyme such as cyclooxygenase.

Contraindications for use

Aertal should not be taken in diseases of the stomach (gastritis or ulcers). It is also not used for blood clotting disorders, heart failure. It is also prohibited for pregnant women and children.

If allergic reactions or wounds are observed on the skin, then the medicine is prohibited for use. In the form of an ointment, care must be taken when using the drug.

How and how much to take aertal

Aertal tablets are taken orally, swallowed whole with a full glass of water. It is recommended to use the medicine after meals. The duration of treatment with the drug is prescribed by the doctor on an individual basis. Usually, in most cases, tablets are prescribed 2 times a day, but the dose of 200 mg in 24 hours should not be exceeded.

For elderly patients, the course of treatment should be carried out under serious supervision, because adverse changes in the functioning of the kidneys and liver may occur, and it is also possible negative reactions. In this case, the dosages are not reduced.

For patients suffering from hepatic insufficiency, daily dose medication should not exceed 100 mg. To eliminate the minimal chances of gastrointestinal bleeding, doctors prescribe the shortest possible course with minimal doses due to the fact that Aertal is a powerful drug.

Side effects

Basically everything possible side effects associated with the gastrointestinal tract, that is, with the digestive organs. There may be pain, nausea, vomiting, constipation, flatulence. Adverse phenomena can also occur in the functionality of the nervous system - this is increased irritability, sleep disturbance, memory problems, dizziness, tremor, convulsions.

Visual and hearing impairments may also occur. In some cases, a change in taste is acceptable, but this happens extremely rarely. Problems can also arise in the urinary system, namely, we are talking about kidney failure, proteinuria, hematuria, nephritis.

More may appear skin rash, increase blood pressure.

Aertal and alcohol

The presented drug called Aertal is forbidden to be taken with alcohol, which can cause increased side effects. Usually it does not come to this, but the effectiveness of drug treatment is reduced to zero. There is also a deterioration general condition sick. If you have allowed such a case, then you must first increase your water intake, and best of all, seek help from a medical specialist.

P N013504/01-030810

Trade name:

International non-proprietary name:

aceclofenac

Dosage form:

coated tablets film sheath

Compound

One tablet contains:
Active substance: aceclofenac 100 mg.
Excipients: microcrystalline cellulose 89.2 mg; povidone 6.6 mg; glyceryl distearate, type I 2.6 mg; croscarmellose sodium 6.6 mg.
Shell composition
Sepifilm 752 white 9 mg: hypromellose 40%, microcrystalline cellulose 32%, titanium dioxide 20%, macrogol stearate, type I 8%.

Description

Round, biconvex tablets white color film-coated, about 8 mm in diameter. The letter "A" is engraved on one side.

Pharmacotherapeutic group:

non-steroidal anti-inflammatory drug (NSAID)

ATX code: M01AB16

Pharmacological characteristics

Pharmacodynamics
Aceclofenac has anti-inflammatory, analgesic and antipyretic effects. It inhibits the synthesis of prostaglandins and thus affects the pathogenesis of inflammation, pain and fever. In rheumatic diseases, anti-inflammatory and analgesic action aceclofenac contributes to a significant reduction in the severity of pain, morning stiffness, swelling of the joints, which improves functional state patient.
Pharmacokinetics
Suction
After oral administration, aceclofenac is rapidly absorbed, its bioavailability is close to 100%. The maximum concentration (Cmax) in the blood plasma is reached 1.25-3 hours after ingestion. Eating slows down absorption, but does not affect its degree.
Distribution
Aceclofenac is highly bound to plasma proteins (> 99.7%). Aceclofenac penetrates into the synovial fluid, where its concentration reaches 60% of its plasma concentration. The volume of distribution is 30 liters.
Metabolism.
It is believed that aceclofenac is metabolized by the CYP2C9 isoenzyme with the formation of the metabolite 4-OH-aceclofenac, whose contribution to clinical action drug is likely to be minimal. Diclofenac and 4-OH-diclofenac are among the numerous metabolites of aceclofenac.
breeding
The average half-life (t1 / 2) is 4-4.3 hours. The clearance is 5 l/h. Approx 2/3 taken dose excreted by the kidneys, mainly in the form of conjugated hydroxymetabolites. Only 1% of the dose after oral administration is excreted unchanged.

Indications

Relief of inflammation and pain syndrome in case of lumbago, toothache, humeroscapular periarthritis, rheumatic lesions of soft tissues, for symptomatic treatment rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.
The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Contraindications

Erosive and ulcerative lesions gastrointestinal tract in the acute phase (including ulcerative colitis, Crohn's disease);
gastrointestinal bleeding or suspicion of it;
bronchospasm, urticaria, rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) in history (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);
hypersensitivity to aceclofenac or components of the drug;
heavy liver failure or active disease liver;
disorders of hematopoiesis and coagulation;
severe renal failure (creatinine clearance< 30 мл/мин), прогрессирующие заболевания почек, confirmed hyperkalemia;
severe heart failure;
the period after coronary artery bypass grafting;
pregnancy and lactation;
childhood up to 18 years old.

Carefully

Diseases of the liver, kidneys and gastrointestinal tract in history, the presence of infection Helicobacter pylori, bronchial asthma, arterial hypertension, decrease in circulating blood volume (including immediately after extensive surgical interventions), ischemic disease heart, chronic renal, hepatic and heart failure, creatinine clearance less than 60 ml / min, ulcerative lesions of the gastrointestinal tract (GIT) in history, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes, peripheral arterial disease, smoking, elderly age, long use of NSAIDs, heavy somatic diseases, alcoholism.

Use during pregnancy and lactation

Pregnancy
Aertal ® , film-coated tablets, 100 mg is contraindicated in pregnancy. There is no information on the use of aceclofenac during pregnancy.
Inhibition of prostaglandin synthesis can adversely affect the course of pregnancy and / or the development of the embryo / fetus.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors:
having cardiopulmonary toxicity, can cause premature closure of the ductus arteriosus with development pulmonary hypertension;
may cause impaired fetal renal function, which may progress to renal failure in combination with polyhydramnios.
Mothers and newborns later dates pregnancy: the drug may affect the duration of bleeding due to the antiplatelet effect, which can develop even after the use of very low doses;
the drug can suppress uterine contractions, leading to delayed labor or prolonged labor.
Lactation
Aertal ® , film-coated tablets, 100 mg should not be taken while breastfeeding. Data on the allocation of aceclofenac with human milk are not available; when radioactive 14 C-aceclofenac was administered to lactating rats, no noticeable transfer of radioactivity into milk was observed.
Fertility
Non-steroidal anti-inflammatory drugs (NSAIDs) may affect fertility and are not recommended for women who are planning a pregnancy.

Dosage and administration

inside. Tablets should be swallowed whole with plenty of water. Usually, adults are prescribed 1 tablet of 100 mg 2 times a day (one tablet in the morning and one in the evening).

Side effect

The following are the adverse events reported in the clinical research and during post-marketing surveillance; adverse events are grouped according to organ system classes according to the Medical Dictionary for Regulatory Practice (MedDRA) and frequency of occurrence. Very often (≥1/10); often (from ≥1/100 to<1/10); нечасто (от ≥1/1000 до <1/100), редко (от ≥1/10000 до <1/1000), очень редко (<1/10000).
Blood and lymphatic system disorders
Rare: anemia;
Very rare: bone marrow suppression, granulocytopenia, thrombocytopenia, neutropenia, hemolytic anemia;
Immune System Disorders
Rarely: anaphylactic reactions, including shock, hypersensitivity;
Nutritional and metabolic disorders
Very rare: hyperkalemia;
Mental disorders
Very rare: depression, unusual (atypical) dreams, insomnia;
Nervous System Disorders
Often: dizziness;
Very rarely: paresthesia, tremor, drowsiness, headache, dysgeusia (taste perversion);
Violations of the organ of vision
Rare: blurred vision;
Hearing and labyrinth disorders
Very rare: vertigo, tinnitus;
Heart disorders
Rare: heart failure;
Very rare: palpitations;
Vascular disorders
Rarely: increased blood pressure;
Very rarely: flushing of the skin, "hot flashes" (a short-term sensation of heat, accompanied by sweating), vasculitis;
Respiratory, thoracic and mediastinal disorders
Rare: shortness of breath;
Very rare: bronchospasm;
Gastrointestinal disorders
Often: dyspepsia, abdominal pain, nausea, diarrhea;
Uncommon: flatulence, gastritis, constipation, vomiting, ulceration of the oral mucosa;
Rare: melena, ulceration of the mucosa of the gastrointestinal tract, hemorrhagic diarrhea, hemorrhages of the mucosa of the gastrointestinal tract;
Very rare: stomatitis, vomiting of blood, intestinal perforation, worsening of Crohn's disease and ulcerative colitis, pancreatitis;
Liver and biliary tract disorders
Often: increased activity of "liver" enzymes;
Very rare: liver damage (including hepatitis), increased alkaline phosphatase activity;
Skin and subcutaneous tissue disorders
Uncommon: itching, rash, dermatitis, urticaria;
Rare: angioedema;
Very rare: purpura, eczema, severe reactions from the skin and mucous membranes (including Stevens-Johnson syndrome and toxic epidermal necrolysis);
In some cases, serious skin infections and soft tissue infections have been observed when taking NSAIDs during chickenpox.
Renal and urinary tract disorders
Infrequently: an increase in the concentration of urea and creatinine in the blood serum;
Very rare: nephrotic syndrome, renal failure, interstitial nephritis;
Systemic disorders and complications at the injection site
Very rarely: edema, fatigue, muscle spasms of the lower extremities;
Data from laboratory studies
Very rare: weight gain.
If the patient noted the worsening of any of the listed adverse events or the occurrence of an adverse event not listed in this leaflet, he should contact his doctor.

Overdose

There are no data on overdose of aceclofenac in humans.
Possible symptoms: nausea, vomiting, pain in the stomach, dizziness, headache, hyperventilation phenomena with increased convulsive readiness.
Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy. Forced diuresis, hemodialysis is not effective enough.

Interaction with other drugs

With the exception of warfarin, no drug interaction studies have been conducted. Aceclofenac is metabolized by the CYP2C9 isoenzyme; in vitro data indicate that aceclofenac may be an inhibitor of this enzyme. Thus, the risk of pharmacokinetic interaction is possible when taken simultaneously with phenytoin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfafenazole. As with other non-steroidal anti-inflammatory drugs, there is an increased risk of pharmacokinetic interactions with other drugs that are excreted from the body by active renal secretion, such as methotrexate and lithium preparations. Aceclofenac is almost completely bound to plasma albumin and, therefore, there is the possibility of displacement-type interactions with other drugs that bind to proteins.
The following is class-specific information for NSAIDs:
Methotrexate: NSAIDs inhibit tubular secretion of methotrexate; moreover, there may be a small metabolic interaction, which leads to a decrease in the clearance of methotrexate. Therefore, when using high doses of methotrexate, NSAIDs should be avoided.
Lithium and digoxin preparations: Some NSAIDs inhibit the renal clearance of lithium and digoxin, resulting in an increase in serum concentrations of both substances. Co-administration should be avoided unless frequent monitoring of lithium and digoxin concentrations is carried out.
Anticoagulants: NSAIDs inhibit platelet aggregation and damage the mucosa of the gastrointestinal tract, which can lead to an increase in the effect of anticoagulants and increase the risk of gastrointestinal bleeding while taking anticoagulants. The combined use of aceclofenac and oral anticoagulants of the coumarin group, ticlopidine and thrombolytics should be avoided unless the patient's condition is carefully monitored.
Antiplatelet agents and selective serotonin reuptake inhibitors(SSRIs) when used together with NSAIDs may increase the risk of gastrointestinal bleeding.
Cyclosporine, tacrolimus: While taking NSAIDs with cyclosporine or tacrolimus, the risk of increased nephrotoxicity due to a decrease in the formation of renal prostacyclin should be considered. Therefore, while taking it, you should carefully monitor the indicators of kidney function.
Other NSAIDs: While taking acetylsalicylic acid or other NSAIDs, the incidence of side effects may increase, so caution should be exercised.
Glucocorticosteroids: increases the risk of ulcers or gastrointestinal bleeding.
Diuretics: Aceclofenac, like other NSAIDs, may inhibit the activity of diuretics, may reduce the diuretic effect of furosemide and bumetanide, and the antihypertensive effect of thiazides. Co-administration with potassium-sparing diuretics may lead to an increase in serum potassium.
Aceclofenac did not affect blood pressure control when co-administered with bendrofluazid, although interactions with other diuretics cannot be ruled out.
Antihypertensive drugs: NSAIDs may also reduce the effect of antihypertensive drugs. Co-administration of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor antagonists and NSAIDs may lead to impaired renal function. The risk of acute renal failure, which is usually reversible, may be increased in some patients with impaired renal function, such as the elderly or those who are dehydrated. Therefore, when combined with NSAIDs, caution should be exercised. Patients should consume the required amount of fluid and be under appropriate supervision (monitoring of kidney function at the beginning of joint use and periodically during treatment).
Hypoglycemic agents: Clinical studies show that diclofenac can be used in conjunction with oral hypoglycemic agents without affecting their clinical effect. However, there are separate reports of hypoglycemic and hyperglycemic effects of the drug. Thus, when taking aceclofenac, the doses of drugs that can cause hypoglycemia should be adjusted.
Zidovudine: Concomitant use of NSAIDs and zidovudine increases the risk of haematological toxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive (human immunodeficiency virus) patients with hemophilia receiving zidovudine and ibuprofen.

special instructions

Avoid concomitant use of the drug Aertal ® , film-coated tablets, 100 mg and other NSAIDs, including selective inhibitors of cyclooxygenase-2 (COX-2).
Adverse events can be minimized by using the lowest effective dose and reducing the duration of treatment needed to control symptoms.
Influence on the gastrointestinal tract (GIT)
Bleeding, ulceration or perforation of the gastrointestinal tract with a fatal outcome was observed when taking any NSAIDs at any period of treatment, both in the presence of relevant symptoms and the presence of serious diseases of the gastrointestinal tract in history (gastric and duodenal ulcer, Crohn's disease, ulcerative colitis, etc.), so and without them.
The risk of bleeding, ulceration and perforation of the gastrointestinal tract increases with increasing dose of NSAIDs in patients with a history of peptic ulcer, especially if it was accompanied by bleeding or perforation, as well as in elderly patients. These patients should take the lowest effective dose of the drug. They need combination therapy with protective drugs (eg, misoprostol or proton pump inhibitors). Such treatment is necessary for patients who take small doses of aspirin or other drugs that adversely affect the state of the gastrointestinal tract.
Patients with gastrointestinal disease, including the elderly, should report any unusual gastrointestinal symptoms (especially bleeding), including when first taking the drug. Particular caution should be observed in patients taking concomitant drugs that may increase the risk of bleeding or ulcers, such as systemic glucocorticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors or antiplatelet agents (such as acetylsalicylic acid).
If gastrointestinal bleeding or ulceration occurs in patients taking Aertal ® , film-coated tablets, 100 mg, treatment should be discontinued.
Influence on the cardiovascular and central nervous system
Patients with arterial hypertension and / or mild to moderate congestive heart failure require appropriate monitoring, since fluid retention in the body and edema are associated with the use of NSAIDs.
Clinical studies and epidemiological data show that the use of some NSAIDs (particularly at high doses and with long-term use) may slightly increase the risk of arterial thrombosis (eg, myocardial infarction or stroke). There is no reliable data on the absence of this risk when taking aceclofenac.
Patients with uncontrolled arterial hypertension, chronic heart failure, established coronary heart disease, peripheral arterial atherosclerosis and / or cerebrovascular accident should be especially careful when taking aceclofenac. Also, before the first dose, caution should be exercised in patients with risk factors for the cardiovascular system (for example, arterial hypertension, hyperlipidemia, diabetes mellitus and smoking).
Effects on the liver and kidneys
Taking NSAIDs can cause a dose-dependent decrease in the formation of prostaglandins and acute renal failure. The importance of prostaglandins in ensuring renal blood flow should be considered when taking the drug in patients with impaired cardiac, renal or hepatic function, in patients receiving diuretics or in patients after surgery, as well as in the elderly.
Caution should be exercised when prescribing the drug to patients with mild or moderate hepatic and renal impairment, as well as to patients with other conditions predisposing to fluid retention in the body. In these patients, NSAIDs can lead to impaired renal function and fluid retention. Patients taking diuretics, persons with an increased risk of hypovolemia should also be careful when taking the drug Aertal ® , film-coated tablets, 100 mg. It is necessary to prescribe the minimum effective dose and regular medical monitoring of kidney function. Renal adverse events usually resolve after discontinuation of aceclofenac.
Aceclofenac should be discontinued if changes in liver function tests persist or worsen, clinical signs or symptoms of liver disease develop, or other manifestations occur (eosinophilia, rash). Hepatitis can develop without prodromal symptoms.
The use of NSAIDs in patients with hepatic porphyria may provoke an attack.
Hypersensitivity and skin reactions
As with other NSAIDs, this drug may cause allergic reactions, including anaphylactic/anaphylactoid reactions, even if the drug is taken for the first time.
Severe skin reactions (some of which can be fatal), including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been observed very rarely after taking NSAIDs. The highest risk of these reactions in patients is observed at the beginning of taking the drug, and the development of these adverse reactions is observed during the first month of taking the drug. If a skin rash, damage to the oral mucosa, or other signs of hypersensitivity occur, aceclofenac should be discontinued.
In some cases, with chickenpox, infections of the skin and soft tissues can occur.
At present, the role of NSAIDs in worsening the course of these infections cannot be ruled out. Therefore, you should avoid taking the drug Aertal ® , film-coated tablets, 100 mg for chicken pox.
Hematological disorders
Aceclofenac can cause reversible inhibition of platelet aggregation.
Respiratory system disorders
Caution should be exercised when taking the drug in patients with a history of or current bronchial asthma, since taking NSAIDs can provoke the development of sudden bronchospasm in such patients.
Elderly patients
Caution should be exercised when taking the drug in elderly patients, as they are more likely to experience side effects (especially bleeding and perforation of the gastrointestinal tract) when taking NSAIDs. Complications can lead to death. Also, older patients are more likely to suffer from diseases of the kidneys, liver or cardiovascular system.
Long-term use
All patients receiving long-term treatment with non-steroidal anti-inflammatory drugs should be closely monitored (eg complete blood count, liver and kidney function tests).

Influence on the ability to drive vehicles and work with mechanisms

You should refrain from driving and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, as the drug may cause dizziness and other side effects that may affect these abilities.

Release form

Film-coated tablets, 100 mg. 10 film-coated tablets in a blister made of PA/AL/PVC-film and aluminum foil. 1,2, 3, 4, 6 or 9 blisters with instructions for use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 °C.
Keep out of the reach of children.

Best before date

3 years.
Do not use after the expiration date.

Terms of dispensing from pharmacies

On prescription.

Registration certificate holder:

Almiral S.A.
General Mitr, 151, 08022 Barcelona, ​​Spain

Manufacturer:
OJSC "Gedeon Richter"
1103 Budapest, st. Dömröy, 19-21, Hungary.

Consumer complaints should be directed to:
Moscow Representative Office of JSC "Gedeon Richter"
119049 Moscow, 4th Dobryninsky lane, building 8