Aceclofenac | Aertal tablets 0.1 g, 20 pcs.

Release form

Film-coated tablets.

Packing

20 pcs. 0.1 g each

Pharmacological action

Aceclofenac has anti-inflammatory, analgesic and antipyretic effects. Inhibits the synthesis of GHG, etc. affects the pathogenesis of inflammation, the onset of pain and fever. In rheumatic diseases, the anti-inflammatory and analgesic effect of aceclofenac significantly reduces the severity of pain, morning stiffness, swelling of the joints, which improves the patient’s functional state.

Indications

Treatment of pain in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, as well as other diseases of the musculoskeletal system (eg, brachiocephalic periarthritis).

As an anesthetic (including lumbago, toothache and primary dysmenorrhea).

Contraindications

Hypersensitivity to aceclofenac or any of the components of the drug.

Patients with drugs with a similar effect (for example, acetylsalicylic acid or other NSAIDs) have caused attacks of bronchial asthma, bronchospasm, acute rhinitis or urticaria, or in the presence of hypersensitivity to these drugs.

Acute or recurrent peptic ulcer of the stomach or duodenum or the presence of these diseases in the anamnesis, gastrointestinal bleeding, bleeding of a different genesis.

Acute heart failure or severe hepatic or renal impairment (creatinine Cl less than 30 ml / min).

The period after coronary artery bypass grafting.

Crohn's disease, ulcerative colitis.

Pregnancy.

Lactation.

Age to 18 years.

With caution: a history of liver, kidney, and gastrointestinal diseases bronchial asthma dyspeptic symptoms at the time of administration of the drug arterial hypertension decrease in bcc (including immediately after extensive surgery) coronary heart disease chronic renal, hepatic and heart failure Cl creatinine <60 ml / min anamnestic data on the development of gastric ulcer, presence of Helicobacter pylori infection cerebrovascular disease dyslipidemia / hyperlipidemia diabetes mellitus peripheral artery disease smoking old age long-term use of NSAIDs diuretics use frequent alcohol heavy severe somatic diseases.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy. Regular use of NSAIDs in the last trimester of pregnancy can lead to decreased tone and weaker uterine contractions. The use of NSAIDs can lead to premature closure of the Botallov duct in the fetus and possibly to prolonged pulmonary hypertension in the newborn, a delay in the onset of labor and an increase in the duration of labor.

Aertal should not be taken during lactation. There are no data on the allocation of Aertal with human milk.

Special instructions

The severity of adverse reactions can be corrected by reducing the effective single dose needed to control symptoms.

Patients with arterial hypertension and / or mild to moderate congestive heart failure should have a proper medical supervision and medical advice, as fluid retention and edema have been reported in the treatment of NSAIDs.

Data from clinical and epidemiological studies suggest that the use of certain NSAIDs (especially in high doses and with long-term use) may increase the risk of arterial thrombosis (for example, myocardial infarction or stroke). Not enough data allowing to exclude such a risk for aceclofenac.

Patients with uncontrolled arterial hypertension, congestive heart failure, coronary heart disease, peripheral arterial pathology and / or cerebrovascular disease should take aceclofenac only after a thorough analysis of the clinical situation. With the same caution, a decision must be made before starting long-term treatment of patients with a risk of cardiovascular disease (for example, hypertension, hyperlipidemia, diabetes mellitus and smokers).

Aceclofenac should be taken with caution and under close medical supervision in patients suffering from gastrointestinal tract diseases, a peptic ulcer in the anamnesis, after acute cerebrovascular accident, with systemic lupus erythematosus, porphyria, and disorders of the hematopoietic system and blood clotting.

Patients with Crohn's disease, ulcerative colitis, the drug is not recommended.

Caution is required in patients with hepatic, renal, heart failure, as well as in patients with other diseases predisposed to the development of edema. NSAIDs in this category of patients may lead to impaired renal excretion and the occurrence of edema. Patients taking diuretics, or with an increased risk of hypovolemia, should also be careful when taking AertalВ®.

Caution is required in older patients, as they are more likely to experience side effects. Gastrointestinal bleeding and / or perforation may occur during treatment, especially if there is a history of gastrointestinal diseases. In addition, elderly patients are more likely to experience liver, kidney, РЎРЎРЎ.

All patients receiving long-term treatment with NSAIDs need monitoring to reduce the risk of adverse reactions (for example, a general urinalysis, a general and biochemical blood test).

The simultaneous use of AertalВ® with any drug that suppresses COX activity and GHG synthesis can reduce fertility and is not recommended for women planning a pregnancy. Women with a history of infertility should stop taking AertalВ®.

Each sachet of AertalВ® powder contains 2.64 g of sorbitol, which can cause indigestion and diarrhea. Fructose intolerant patients should not take this drug.

AertalВ® Powder contains aspartame, a source of phenylalanine. Patients with phenylketonuria should consider that each sachet contains 5.61 mg of phenylalanine.

Influence on the ability to drive vehicles and work with mechanisms

Patients with a feeling of weakness, dizziness, or other disorders of the central nervous system when taking NSAIDs should not drive or operate machinery.

Composition

1 tablet contains:

Active ingredient: aceclofenac 100 mg.

Excipients: MCC - 89.2 mg povidone - 6.6 mg glyceryl distearate type I - 2.6 mg croscarmellose sodium - 6.6 mg film coat: Sepifilm 752 white (hypromellose, MCC, macrogol stearate type I, titanium dioxide ) - 9 mg.

Dosage and Administration

Inside. Film-coated tablets are swallowed whole with a sufficient amount of liquid.

Adults: usually 1 tablet. (100 mg) 2 times a day: 1 tab. in the morning and 1 in the evening.

Elderly: dose adjustment usually not required.

Hepatic insufficiency: patients with moderate hepatic impairment should reduce the dose of aceclofenac. The recommended initial dose is 100 mg daily.

Renal failure: no evidence, that the dose of aceclofenac should be reduced in patients with mild renal failure, but caution is recommended.

Side effects

Adverse effects listed below presented by system organ classes in accordance with the MedDRA classification with the following frequency: Often -? 1/100 to <1/10.

Infrequently -? 1/1000 to <1/100.

Rarely -? 1/10000 to <1/1000.

Very rare - <1/10000.

From the blood and lymphatic system: rarely - anemia is very rare - bone marrow depression, granulocytopenia, neutropenia, hemolytic anemia.

From the side of the immune system: rarely - anaphylactic reaction (including shock), hypersensitivity.

From the side of metabolism and nutrition: very rarely - hyperkalemia.

Mental disorders: very rarely - depression, unusual dreams, insomnia.

From the nervous system: often - dizziness is very rare - paresthesia, tremors, drowsiness, headache, dysgeusia.

From the side of the organ of vision: rarely - visual disturbances.

On the part of the organ of hearing and the labyrinth: very rarely - vertigo, ringing in the ears.

From the CCC side: rarely - heart failure, arterial hypertension, aggravated arterial hypertension very rarely - tachycardia, hot flashes, vasculitis.

From the respiratory system, chest and mediastinal organs: rarely - shortness of breath very rarely - bronchospasm.

From the gastrointestinal tract: often - dyspepsia (7.5%), abdominal pain (6.2%), nausea (1.5%), diarrhea (1.5%) infrequently - flatulence, gastritis, constipation, vomiting, mucosal ulcer rarely - melena, gastrointestinal ulcer, diarrhea with blood, gastrointestinal bleeding very rarely - stomatitis, vomiting of blood, stomach ulcer, perforation of the small intestine, worsening of Crohn’s disease and ulcerative colitis, pancreatitis.

From the liver and biliary tract: often - an increase in the activity of liver enzymes is very rare - liver damage (including hepatitis), an increase in the activity of alkaline phosphatase.

From the skin and subcutaneous tissue: infrequently - itching, rash, dermatitis, urticaria rash rarely - angioedema very rare - purpura, eczema, reactions from the skin and mucous membranes, bullous skin reactions, including Stevens-Johnson syndrome and acute epidermal necrolysis .

From the kidneys and urinary tract: infrequently - increased blood urea concentration, increased blood creatinine concentration is very rare - interstitial nephritis, nephrotic syndrome, renal failure.

General disorders and disorders at the injection site: very rarely - swelling, weakness, muscle cramps, weight gain.

Drug Interactions

No drug interaction studies have been performed, with the exception of warfarin.

Aceclofenac is metabolized by the cytochrome P450 system - CYP2C9, and in vitro data indicate that aceclofenac may be an inhibitor of this enzyme. Therefore, there is a risk of pharmacokinetic interaction with phenytoin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfafenazole.

As with other NSAIDs, there is a risk of pharmacokinetic interaction with drugs metabolized in the liver, such as methotrexate and lithium preparations.

Aceclofenac almost completely binds to plasma proteins, and therefore, it is necessary to take into account the possibility of substitution with other drugs that strongly bind to plasma proteins.

Due to the lack of studies on pharmacokinetic interaction, the following information is based on information obtained from other NSAIDs.

The following combinations should be avoided

NSAIDs inhibit tubular secretion of methotrexate, and a metabolic interaction may also be observed, leading to a decrease in clearance of methotrexate. Therefore, during treatment with large doses of methotrexate, NSAIDs should always be avoided.

Some NSAIDs inhibit lithium excretion by the kidneys, resulting in elevated serum lithium concentrations. This combination should not be allowed if serum lithium concentration cannot be monitored frequently.

NSAIDs inhibit platelet aggregation and damage the gastrointestinal mucosa, which can increase anticoagulant activity and increase the risk of gastrointestinal bleeding in patients taking anticoagulants.

Avoid the combination of aceclofenac with the oral anticoagulants of the coumarin group, ticlopidine, thrombolytics, and heparin in the absence of close monitoring.

The following combinations may require dose adjustment and precautions.

Possible interactions of NSAIDs and methotrexate should be considered, especially in patients with renal failure. When taking both drugs, kidney function control is necessary. Precautions should be taken while taking NSAIDs and methotrexate for 24 hours, because the concentration of methotrexate may increase, leading to increased toxicity of methotrexate.

NSAIDs and cyclosporine or tacrolimus are thought to increase the risk of nephrotoxicity due to decreased prostacyclin synthesis in the kidneys. Therefore, while taking drugs, it is important to control kidney function.

Concomitant use of acetylsalicylic acid and other NSAIDs may increase the incidence of adverse reactions, and therefore care must be taken when they are taken together.

NSAIDs may decrease the diuretic effect of furosemide, bumetanide, and the hypotensive effect of thiazide diuretics. Simultaneous treatment with potassium-sparing diuretics may be associated with an increase in the level of potassium in the blood serum, therefore control of the potassium content in the blood is necessary.

NSAIDs may also reduce the effects of certain antihypertensive drugs. ACE inhibitors or angiotensin II receptor antagonists in combination with NSAIDs can lead to kidney failure. The risk of developing acute renal failure, which is usually reversible, may increase in some patients with impaired renal function, such as elderly patients or patients experiencing fluid deficiency. Therefore, the combination of such drugs with NSAIDs should be used with caution, patients should receive a sufficient amount of fluid with food, and renal function should be monitored.

The effect of aceclofenac on blood pressure was not detected when it was taken concomitantly with bendrofluazide, although interaction with other antihypertensive drugs, such as β-blockers, cannot be ruled out.

Other possible interactions

Isolated cases of hypoglycemia and hyperglycemia have been reported. Therefore, for aceclofenac, it is necessary to adjust the dose of drugs that cause hypoglycemia.

When used simultaneously with Aertal®: Digoxin, phenytoin, or lithium preparations, the level of these drugs in the plasma may increase.

Diuretics and antihypertensive drugs - the effect of these drugs may be weakened.

Potassium-sparing diuretics - can lead to the development of hyperglycemia and hyperkalemia.

Other NSAIDs or GCS - the risk of side effects from the gastrointestinal tract increases.

SSRIs (citalopram, fluoxetine, paroxetine, sertraline) - the risk of developing gastrointestinal bleeding increases.

Cyclosporine - The toxic effects of the latter on the kidneys may increase.

Antidiabetic agents - can cause both hypo- and hyperglycemia. With this combination of drugs, blood sugar control is necessary.

Acetylsalicylic acid - the concentration of aceclofenac in the blood decreases.

Antiplatelet agents and anticoagulants - increases the risk of bleeding (requires regular monitoring of blood coagulation).

Overdose

Symptoms: headache, dizziness, hyperventilation with increased convulsive readiness, abdominal pain, nausea, vomiting.

Treatment: gastric lavage, activated charcoal administration, symptomatic therapy are indicated. There is no specific antidote to the drug. Forced diuresis, hemodialysis are ineffective.

Storage conditions

Do not store above 25 РC. Keep out of reach of children.

Shelf life

3 years.

Deystvuyushtee substance

Aceclofenac

Terms and conditions

prescription

Dosage PMA



Prescribing

Prescribing

For adults as prescribed by a doctor

Almiral S.A., Spain