Aceclofenac Welfarm pills 100 mg, 20 pcs.

Composition

Composition per tablet:Active ingredient:Aceclofenac-100 mgsupport substances:Core composition:Calcium stearate-3 mg zinc – 9 mg Silicon dioxide colloidal (aerosil) – 1.5 mg Microcrystalline cellulose-85 mg Croscarmellose sodium (primellose) – 10.5 mg Lactose monohydrate (milk sugar) – 91 mg Core mass-300 mg Shell composition: Opadray white 03F180011-10 mg (hypromellose-60.0%, titanium dioxide-25.0%, macrogol-15.0%)Weight of the tablet-310 mg

. Pharmacological action

Pharmacotherapy group: NSAIDs ATX code: M01avpharmacodynamics:

Aceclofenac is a phenylacetic acid derivative that inhibits cyclooxygenase types I and II.

It has anti-inflammatory analgesic and antipyretic effects.

Inhibits the synthesis of prostaglandins and thus affects the pathogenesis of inflammation, pain and fever. In rheumatic diseases, the anti-inflammatory and analgesic effect of aceclofenac significantly reduces the severity of pain, morning stiffness, and joint swelling, which improves the patient’s functional state.

Pharmacokinetics:

Aceclofenac is rapidly and completely absorbed after oral administration. The time to reach the maximum concentration is 125-3 hours. Penetrates the synovial fluid where its concentration reaches 57% of the plasma concentration level and the time to reach the maximum concentration is 2-4 hours later than in plasma. The volume of distribution is 25 liters.

Binding to plasma proteins (albumins) is 99%. Aceclofenac circulates mainly in unchanged form, its main metabolite is 4′ – hydroxyaceclofenac.

The elimination half-life is 4 hours. It is mainly excreted by the kidneys in the form of hydroxy derivatives (about 2/3 of the administered dose).

Indications

The drug is prescribed:

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

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

Contraindications

– Erosive-ulcerative lesions of the gastrointestinal tract in acute phase of gastrointestinal bleeding or suspicion of it;

– complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance of acetylsalicylic acid or other NSAIDs (including in the anamnesis);

– hypersensitivity to aceclofenac or components of the drug;

– the period after the coronary artery bypass grafting;

– severe hepatic impairment or active liver disease;

– severe renal failure (creatinine clearance less than 30 ml/. min) progressive kidney diseases hyperkalemia;

– inflammatory bowel diseases (Crohn’s disease ulcerative colitis) in the acute phase;

– decompensated heart failure;

– hematopoiesis and coagulation disorders;

– pregnancy and lactation;

– lactose deficiency lactose intolerance glucose-galactose malabsorption;

– children under 18 years of age.

With caution:

A history of liver, kidney and gastrointestinal diseases bronchial asthma arterial hypertension decreased blood volume (including after surgery) coronary heart disease mild to moderate chronic renal failure (creatinine clearance from 30 to 60 ml / min) mild to moderate liver failure chronic heart failure cerebrovascular diseases dyslipidemia/hyperlipidemia. diabetes mellitus peripheral arterial diseases smoking advanced age long term use of NSAIDs in the anamnesis presence of Helicobacter pylori infection frequent alcohol consumption concomitant therapy with the following drugs:

• anticoagulants (e. g. warfarin);
• antiplatelet agents (e. g. acetylsalicylic acid clopidogrel);
• oral glucocorticosteroids (e. g. prednisone);
• selective serotonin reuptake inhibitors (e. g. citalopram fluoxetine paroxetine sertraline).

Side effects

The most frequently detected adverse reactions in clinical trials were from the gastrointestinal tract (dyspepsia-75%; abdominal pain-62%; nausea-15%; diarrhea-15%); sometimes-dizziness. Itching, rash, and changes in the activity of “liver” enzymes and blood creatinine concentrations were also noted.

The adverse effects listed below are classified by organ-system classification according to MedDRA with the following frequency: common: ≥1/100 to <1/10; uncommon: ≥1/1000 to <1/100; rare: ≥1/10000 to <1/1000; very rare:

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; infrequently-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 of blood stomach 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.

Liver and biliary tract disorders: often – an increase in the activity of “liver” enzymes; very rarely-liver damage (including hepatitis) – an increase in the activity of alkaline phosphatase in the blood.

Nervous system disorders: often – dizziness; very rarely-paresthesia tremor drowsiness headache fatigue dysgeusia.

Mental disorders: very rarely – depression atypical dreams insomnia.

Skin and subcutaneous tissue disorders: infrequently-pruritus rash dermatitis urticarial rash; rarely-angioedema; very rarely-purpura skin and mucosal reactions bullous skin reactions.

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

Blood and lymphatic system disorders: rarely-anemia; very rarely-bone marrow depression granulocytopenia neutropenia hemolytic anemia.

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

Respiratory system thoracic and mediastinal disorders: rarely-shortness of breath; very rarely-bronchospasm.

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

From the side of the organ of hearing and labyrinth: very rare – vertigo ringing in the ears.

From the side of metabolism and nutrition: very rarely – hyperkalemia weight gain.

System violations: very rarely-muscle spasms of the lower extremities.

Interaction

Drug interaction studies have not been conducted with the exception of warfarin.

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

As with other NSAIDs, there is a risk of pharmacokinetic interactions 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 bind strongly 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 the tubular secretion of methotrexate and there may also be a metabolic interaction leading to a decrease in the clearance of methotrexate. Therefore, during treatment with high doses of methotrexate (more than 20 mg/week), NSAIDs should always be avoided.

Some NSAIDs inhibit the excretion of lithium by the kidneys, which leads to increased serum lithium concentrations. This combination should be avoided if the serum lithium concentration cannot be monitored frequently.

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

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

The following combinations may require dose adjustment and precautionary measures::

Possible interactions between NSAIDs and methotrexate should be considered, especially in patients with renal insufficiency.When taking both drugs, monitoring of renal function is necessary.

Precautions should be taken when taking NSAIDs and methotrexate simultaneously for 24 hours, as the concentration of methotrexate may increase, leading to increased toxicity of methotrexate. Taking NSAIDs together with cyclosporine or tacrolimus is thought to increase the risk of nephrotoxicity due to reduced prostacyclin synthesis in the kidneys. Therefore, when taking medications at the same time, it is important to monitor kidney function.

Concomitant administration of acetylsalicylic acid and other NSAIDs may increase the frequency 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, so it is necessary to monitor the content of potassium in the blood.

NSAIDs may also reduce the effect of certain 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 increase in some patients with impaired renal function for example in elderly patients or patients with fluid deficiency. 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.

No effect of aceclofenac on blood pressure was found when it was taken concomitantly with bendroflumethiazide, although interaction with other antihypertensive drugs such as beta-blockers cannot be excluded.

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 concomitantly with Aceclofenac Velpharm:

digoxin or phenytoin drugs lithium may increase the plasma concentration of these drugs;

– diuretics and antihypertensive drugs can weaken the effect of these medicines;

– potassium-sparing diuretics can lead to the development of hyperglycemia and hyperkalemia;

– other NSAIDs or corticosteroids increases the risk of side effects from the gastrointestinal tract;

– selective reuptake inhibitors of serotonin (citalopram fluoxetine paroxetine sertraline) – increases the risk of gastrointestinal bleeding;

– cyclosporine – morepolitical to the toxic effects of the latter on the kidneys;

– hypoglycemic agents, can cause 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 parameters is necessary);

– zidovudine-the risk of hematological toxicity increases.

How to take, course of administration and dosage

The drug should be taken at the lowest effective dose for as short a period of time as possible.

Inside. Tablets are swallowed whole with a sufficient amount of liquid.

Dosage of the drug for all indications:

Adults are prescribed 100 mg 2 times a day,1 tablet in the morning and 1 in the evening.

The course of treatment is prescribed by the doctor individually.

Liver failure

Patients with moderate hepatic insufficiency should reduce the dose of aceclofenac. The recommended initial dose is 100 mg daily.

Kidney failure

There is no evidence that the dose of aceclofenac should be reduced in patients with mild renal insufficiency but caution is recommended.

Overdose

Symptoms: dizziness headache hyperventilation of the lungs with increased convulsive readiness nausea vomiting abdominal pain.

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

Special instructions

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

Patients with a history of arterial hypertension and / or chronic heart failure of the NYMA functional Class I-II should be properly monitored and consulted by a doctor, as fluid retention and edema have been reported during NSAID treatment. Data from clinical and epidemiological studies suggest that the use of certain NSAIDs (especially in high doses and with prolonged use) may increase the risk of arterial thrombosis (for example, myocardial infarction or stroke). There are insufficient data to exclude this risk for aceclofenac.

Patients with uncontrolled hypertension congestive heart failure ischaemic heart disease peripheral arterial pathology and / or cerebrovascular diseases should take aceclofenac only after a thorough analysis of the clinical situation. The same care should be taken before starting long-term treatment of patients at risk of cardiovascular disease (for example, those with arterial hypertension, hyperlipidemia, diabetes mellitus, and smokers).

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

Aceclofenac may cause reversible inhibition of platelet aggregation.

Patients with Crohn’s disease and ulcerative colitis should not be prescribed the drug. Caution should be exercised in patients with hepatic renal and cardiac insufficiency as well as in patients with other diseases predisposed to the development of edema. The use of NSAIDs in this category of patients can lead to deterioration of renal excretion and the appearance of edema.

Patients taking diuretic medications or with an increased risk of hypovolemia should also exercise caution when taking Aceclofenac Velpharm.

Caution should be exercised in elderly patients because they are more likely to experience side effects. Bleeding from the gastrointestinal tract and / or perforation may occur during treatment, especially if there is a history of gastrointestinal diseases. In addition, older patients are more likely to experience liver, kidney, and cardiovascular disorders.

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

Concomitant administration of Aceclofenac Velpharm with any drug that suppresses 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.

Influence on the ability to drive vehicles and mechanisms:

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

Form of production

Film-coated tablets 100 mg.

Storage conditions

Store in a dark place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

Aceclofenac

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Weight

Weight: 20 g.