Aceclofenac welpharm 100 mg 20 pcs. film-coated tablets

Aceclofenac welpharm 100 mg 20 pcs. film-coated tablets

Application of Aceclofenac welpharm 100 mg 20 pcs. film-coated tablets during pregnancy and breastfeeding

The use of the drug during pregnancy and breastfeeding is contraindicated.

special instructions

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

Patients with a history of arterial hypertension and/or chronic heart failure of NYMA functional class I-II require proper monitoring and consultation with a physician, because Fluid retention and edema have been reported during treatment with NSAIDs. Data from clinical and epidemiological studies suggest that the use of some NSAIDs (especially in high doses and long-term use) may increase the risk of arterial thrombosis (eg, myocardial infarction or stroke). There is insufficient data to exclude such a risk for aceclofenac.

Patients with uncontrolled arterial hypertension, congestive heart failure, coronary artery disease, peripheral arterial pathology and/or cerebrovascular disease should take aceclofenac only after a thorough analysis of the clinical situation. The same caution should be taken before initiating long-term treatment in patients at risk of cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, and smokers).

Aceclofenac should be taken with caution and under close medical supervision in patients with diseases of the gastrointestinal tract, a history of peptic ulcers, after acute cerebrovascular accident, systemic lupus erythematosus, porphyria, disorders of the hematopoietic system and bleeding disorders.

Aceclofenac may cause reversible inhibition of platelet aggregation.

The drug is not recommended for patients with Crohn's disease or ulcerative colitis. Caution should be exercised in patients with liver, kidney, or heart failure, as well as in patients with other diseases predisposed to the development of edema. Taking NSAIDs in this category of patients can lead to worsening renal excretion and the occurrence of edema.

Patients taking diuretics, or with an increased risk of hypovolemia, also need to exercise caution when taking Aceclofenac Welfarm.

Caution should be exercised in elderly patients, because... 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, older patients are more likely to have problems with the liver, kidneys, and cardiovascular system.

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

Concomitant use of Aceclofenac Velpharm with any drug that inhibits cyclooxygenase/prostaglandin synthesis may reduce fertility and is not recommended for women planning pregnancy.

Women with a history of infertility should stop taking Aceclofenac Velpharm.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

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

Treatment: gastric lavage, administration of activated carbon, symptomatic therapy. There is no specific antidote. Forced diuresis, hemodialysis, and blood transfusion are ineffective.

Side effects Aceclofenac velpharm 100 mg 20 pcs. film-coated tablets

The most frequently identified adverse reactions in clinical studies were from the gastrointestinal tract (dyspepsia - 7.5%; abdominal pain - 6.2%; nausea - 1.5%; diarrhea - 1.5%); sometimes - dizziness. Itching, rash, and changes in the activity of liver enzymes and blood creatinine concentrations were also noted.

The undesirable effects listed below are presented by organ system class according to the MedDRA classification with the following frequency: often: ≥1/100 to

Allergic reactions: skin rash, urticaria, eczema, erythroderma, systemic anaphylactoid reactions, bronchial asthma, in some cases - vasculitis, pneumonitis, polymorphic exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

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

From the gastrointestinal tract: often - dyspepsia, abdominal pain, nausea, diarrhea; uncommon - flatulence, gastritis, constipation, vomiting, ulceration of the oral mucosa; rarely - melena, ulceration of the gastrointestinal tract, diarrhea with blood, gastrointestinal bleeding; very rarely - stomatitis, vomiting blood, gastric ulcer, perforation of the small intestine, worsening of Crohn's disease and ulcerative colitis, pancreatitis.

From the cardiovascular system: rarely - heart failure, increased blood pressure; very rarely - tachycardia, hot flashes, vasculitis.

From the liver and biliary tract: often - increased activity of liver enzymes; very rarely - liver damage (including hepatitis), increased blood alkaline phosphatase activity.

From the nervous system: often - dizziness; very rarely - paresthesia, tremor, drowsiness, headache, fatigue, dysgeusia.

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

From the skin and subcutaneous tissue: infrequently - itching, rash, dermatitis, urticarial rash; rarely - angioedema; very rarely - purpura, reactions from the skin and mucous membranes, bullous skin reactions.

From the hematopoietic organs: thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, aplastic anemia.

From the blood and lymphatic system: rarely - anemia; very rarely - bone marrow suppression, granulocytopenia, neutropenia, hemolytic anemia.

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

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

From the organ of vision: rarely - visual impairment.

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

Metabolism and nutrition: very rarely - hyperkalemia, weight gain.

Systemic disorders: very rarely - muscle spasms of the lower extremities.

Drug interactions

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

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

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

Aceclofenac is almost completely bound to plasma proteins, and, therefore, it is necessary to consider the possibility of substitution with other drugs that are highly bound to plasma proteins.

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

The following combinations should be avoided

NSAIDs inhibit tubular secretion of methotrexate, and a metabolic interaction may also occur leading to decreased clearance of methotrexate. Therefore, during treatment with large doses of methotrexate (more than 20 mg/week), NSAIDs should always be avoided.

Some NSAIDs inhibit the renal excretion of lithium, resulting in increased serum lithium concentrations. This combination should be avoided unless frequent monitoring of serum lithium concentrations is possible.

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

The combination of aceclofenac with oral anticoagulants of the coumarin group, ticlopidine, thrombolytics and heparin should be avoided unless carefully monitored.

The following combinations may require dose adjustment and precautions:

The possible interaction of NSAIDs and methotrexate must be taken into account, especially in patients with renal failure. When taking both drugs, monitoring of kidney function is necessary.

Precautions should be taken when taking NSAIDs and methotrexate simultaneously within 24 hours, because methotrexate concentrations may increase, resulting in increased methotrexate toxicity. It is believed that taking NSAIDs with cyclosporine or tacrolimus increases the risk of nephrotoxicity due to decreased renal prostacyclin synthesis. Therefore, when taking drugs simultaneously, it is important to monitor renal function.

Concomitant use of acetylsalicylic acid and other NSAIDs may increase the incidence of adverse reactions and, therefore, caution is required when taking them together.

NSAIDs may reduce 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 concentration of potassium in the blood serum, therefore monitoring the potassium level in the blood is necessary.

NSAIDs may also reduce the effect of some antihypertensive medications.

Angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists in combination with NSAIDs can lead to renal failure. The risk of developing acute renal failure, which is usually reversible, may be increased in some patients with impaired nocturnal function, such as elderly patients or patients who are fluid-depleted. Therefore, the combination of such drugs with NSAIDs should be used with caution, patients should receive sufficient fluids with food, and renal function should be monitored.

There was no effect of aceclofenac on blood pressure when it was taken concomitantly with bendroflumethiazide, although interaction with other antihypertensive drugs such as beta-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 the drug Aceclofenac Velpharm:

• digoxin, phenytoin or lithium preparations - the plasma concentration of these drugs 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 glucocorticosteroids - increases the risk of side effects from the gastrointestinal tract;
• selective serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline) - increases the risk of gastrointestinal bleeding;
• cyclosporine - the toxic effect of the latter on the kidneys may increase;
• hypoglycemic 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 - the risk of bleeding increases (regular monitoring of blood clotting indicators is necessary);
• zidovudine - increases the risk of hematological toxicity.

Pharmacodynamics and pharmacokinetics

The drug does not selectively suppress the work of COX1 and COX2 , thus inhibiting the processes of prostaglandin . As a result, inflammation is significantly reduced, body temperature is normalized, and pain relief occurs.

After taking the tablets, the medicine is quickly absorbed into the gastrointestinal tract and penetrates the systemic circulation. The product has high bioavailability. The maximum concentration in blood plasma can be observed after 1.5 -3 hours. Concurrent food intake does not affect the degree of absorption of the drug, but somewhat slows down the absorption process.

The degree of binding to blood proteins is high - about 99%. The substance is able to penetrate into the synovial fluid (concentration in synovial fluid is 60%). The volume of distribution of the product is 30 liters.

Metabolism of the drug occurs with the participation of the isoenzyme CYP2C9 , then the metabolite 4-OH-aceclofenac (inactive) is formed. The half-life of the drug is approximately 4 hours. The drug is excreted mainly in the form of metabolites with the kidneys and slightly - unchanged.

special instructions

As a precautionary measure, it is recommended to use the minimum effective and active dosage during treatment with the drug. Periodic monitoring of the liver and kidneys, peripheral blood picture, stool condition (lack of blood), and the functioning of the cardiovascular system are also indicated.

During treatment, you should not drive a car or perform potentially hazardous activities.

The risk of allergies or skin reactions is higher in the first months of taking the medicine. If damage to the oral mucosa, skin rashes, or other signs of allergy occur, therapy must be interrupted.

platelet inhibition during treatment with the drug is reversible; blood composition returns to normal some time after discontinuation of the drug.

Indications for use

The drug is prescribed:

• as part of complex treatment of inflammatory diseases of the musculoskeletal system ( osteoarthritis , rheumatoid , psoriatic and juvenile arthritis , podargue , ankylosing spondylitis or spondylitis );
• for the relief of pain and inflammation in rheumatism , toothache, and glenohumeral periarthritis .

The use of Aceclofenac is not able to completely cure these diseases, but quickly reduces inflammation and pain.

Reviews of Aceclofenac

Reviews about the medicine are mostly good. The product relieves inflammation and relieves pain in arthritis, toothache, rheumatism and intercostal neuralgia . However, the drug does not help everyone. There are reports of no or insufficient effect from taking the pills. Adverse reactions from the gastrointestinal tract, drowsiness and general weakness also often develop.

Interaction

Anticoagulants when combined with tablets increase the risk of bleeding. During treatment, it is recommended to periodically monitor blood clotting parameters.

Aceclofenac tablets increase the plasma concentration of digoxin, phenytoin , and lithium-based drugs.

The substance, when combined with antihypertensive drugs and diuretics, reduces the effectiveness of the latter.

The combination of the drug with potassium-sparing diuretics increases the likelihood of developing hyperkalemia .

Caution should be used when combining the drug with NSAIDs and glucocorticosteroids ; the drug increases the toxicity of methotrexate and cyclosporine .

Aspirin reduces the plasma concentration of Aceclofenac.

The combination of the drug with hypoglycemic drugs requires constant monitoring of blood glucose

Drugs containing (Aceclofenac analogues)

Level 4 ATC code matches:
Voltaren

Rapten

Zerodol

Dickloberl Retard

Dikloberl N 75

Dicloberl

Ketanov

Dolak

Panoxen

Ketorolac

Naklofen Duo

Naklofen

Olfen-100

Olfen-75

Neurodiclovit

Nizilat

Fanigan

Aertal

Methindol retard

Ortofen

Trade names of the product: Aertal , Alental , Asinak , Infenak , Zerodol .

Diclofenac and Aceclofenac, which is better?

Both drugs are derivatives of phenylacetic acid . Unlike diclofenac , the original has fewer side effects, does not accumulate in the body, and has a more gentle effect on metabolic processes in cartilage. Research into the therapeutic properties of Aceclofenac continues.