ACECLOFENAC MONOGRAPH PDF

Each film-coated tablet contains mg of Aceclofenac. Aceclofenac film- coated tablets are indicated for the relief of pain and inflammation in osteoarthritis . Page 1 of PRODUCT MONOGRAPH. Pr. VOLTAREN*. VOLTAREN* SR. ( diclofenac sodium). 50 mg Enteric-Coated Tablets. 75 and Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) with marked anti- inflammatory and analgesic properties. It is reported to have a higher.

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Company contact details Accord Healthcare Limited. The volume of distribution is approximately 25 L.

Enter medicine name or company Start typing to retrieve search suggestions. Aceclofenac should also be administered with caution and under close medical surveillance to patients with congestive heart failure, significant risk factors for cardiovascular events and history of cerebrovascular bleeding. History of active bleedings or bleeding disorders NSAIDS are aceclofrnac in patients who have previously shown hypersensitivity reactions e. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: Avoid concomitant use of two or more NSAIDs including aspirin as this may increase the risk of adverse effects see section 4.

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Aceclofenac 100 mg film-coated Tablets

Adults The recommended dose is mg daily, taken as two separate mg doses, one tablet in the morning and one in the evening. Aceclofenac was not considered to have any mutagenic activity in three in vitro studies and an in vivo study in the mouse.

Effects on renal function are usually reversible on withdrawal of Aceclofenac Tablets. Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. In case of frequent or prolonged convulsions, patients should be treated with intravenous diazepam. Patients with mild to moderate renal impairment should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function.

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Aceclofenac | C16H13Cl2NO4 – PubChem

The use of Aceclofenac Tablets should therefore be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the foetus. Caution should be advised in patients receiving concomitant medications which could minograph the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or antiplatelet agents such as aspirin see section 4.

Although it was not shown to affect blood pressure control when co-administered with bendrofluazide, interactions with other diuretics cannot be ruled out. Flatulence Gastritis Constipation Vomiting Mouth ulceration.

Exceptionally, occurrence of serious cutaneous and soft tissues infections complications during varicella has been reported in association with NSAID treatment. The aluminium foil is 0. If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur eosinophilia, rashAceclofenac Tablets should be discontinued. Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.

Good urine output should be ensured. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Aceclofenac Tablets should be considered. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation see section 4. The possible interaction between NSAIDs and methotrexate should be born in mind also when low doses of methotrexate are used, especially in patients with decreased renal function.

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There are insufficient data to exclude such a risk for aceclofenac. There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children under 18 years acecclofenac age. The use of Aceclofenac Tablets may impair female fertility and is not recommended in women attempting to conceive. Marketing authorisation number s 9. Dyspepsia Abdominal pain Nausea Diarrhoea.

Depression Abnormal dreams Insomnia.

Aceclofenac

The pharmacokinetics of Aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency. When Aceclofenac was administered to fasting and fed healthy volunteers only the rate and not the extent of aceclofenac absorption was affected.

Renal function should be monitored in these patients see also section 4. Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, occasionally convulsions.

Close medical surveillance is imperative in patients with: These patients should commence treatment on the lowest dose available. However, there have been isolated reports moograph hypoglycaemic and hyperglycaemic effects.

The principal target monogarph was the gastro-intestinal tract. Continue typing to refine. These may consist of a non-specific allergic reactions and anaphylaxis b respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or c assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, aceclfenac rarely exfoliative and bullous dermatoses including epidermal necrolysis and erythema multiforme.

The risk is believed to increase with dose and duration of therapy.