Aceclofenac STELLA 100 mg

Rx

Indications

• The relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

Dosage

• The lowest effective daily dose for the shortest duration possible.
• Adults: 200 mg daily divided two 100 mg doses, in the morning and evening.
• Hepatic insufficiency: an initial daily dose of 100 mg.

Usage

• Swallow whole with a sufficient quantity of liquid.

• Known hypersensitivity to any of the ingredients.
• Patients with history of or active or suspected peptic ulcer or gastrointestinal bleeding.
• Patients with moderate to severe hepatic and renal impairment.
• Active bleedings or bleeding disorders.
• Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
• Patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
• Aceclofenac should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used.
• Aceclofenac is not recommended for use in children under 18 years of age.

Common

• Dizziness, dyspepsia, abdominal pain, nausea, diarrhoea, hepatic enzyme increased.

Uncommon

• Flatulence, gastritis, constipation, vomiting, mouth ulceration;
• Pruritus, rash, dermatitis, urticaria;
• Blood urea increased, blood creatinine increased.

• Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
• The elderly have an increased frequency of adverse reactions to NSAIDs.
• The use of aceclofenac with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.
• Caution is required if administered to patients suffering from, or with a previous history of cardiac impairment, hypertension, bronchial asthma.
• Close medical surveillance is necessary in patients with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics or recovering from major surgery, and the elderly.
• Patients with congestive heart failure (NYHA-I) and patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with aceclofenac after careful consideration.
• Aceclofenac should also be administered with caution and under close medical surveillance to patients with a history of cerebrovascular bleeding.
• NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, either of which can be fatal. To minimize the risk for an adverse cardiovascular event in patients treated with Aceclofenac STELLA 100 mg, prescribe the lowest effective daily dose for the shortest duration possible.
• When gastrointestinal bleeding or ulceration occurs in patients receiving aceclofenac, the treatment should be withdrawn.
• Aceclofenac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. It is advisable to avoid use of aceclofenac in case of varicella.
• You should not take Aceclofenac STELLA 100 mg if you have wheat allergy (different from coeliac disease), and/or rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
• The use of aceclofenac may impair female fertility. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of aceclofenac should be considered.
• Aceclofenac is contraindicated during the third trimester of pregnancy.
• The use of aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the foetus.
• If aceclofenac administered, patients should not drive or operate machinery due to dizziness, drowsiness, fatigue and visual disturbances are possible after taking the drug.