Aceclofenac-BP

Aceclofenacum

Each Aceclofenac-BP 100 mg tablet contains aceclofenac 100 mg. Excipient with known effect: lactose monohydrate.

Indication: Symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, as well as other painful musculoskeletal disorders. Analgesic in painful episodes (including low back and dental pain and primary dysmenorrhoea).

Contraindications (SmPC sec. 4.3): 4.3 Contraindications Aceclofenac is contraindicated in the following situations: − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; − In patients in whom the administration of substances with a similar action (e.g., acetylsalicylic acid or other NSAIDs) precipitates attacks of bronchial asthma, bronchospasm, acute rhinitis or urticaria, or hypersensitivity to these substances; − Patients with a history of gastrointestinal bleeding or perforation related to previous NSAID treatment. Active or recurrent history of peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding); − Patients with active bleeding or bleeding disorders (haemophilia or coagulation disorders); − Patients with diagnosed congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease; − Patients with severe impairment of hepatic or renal function; − Pregnancy, especially during the last three months of pregnancy, unless there are compelling reasons to do so. In this case, the lowest effective dose must be used (see section 4.6).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Concomitant use of aceclofenac with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Adverse reactions can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and the gastrointestinal and cardiovascular risks below). Gastrointestinal (GI) effects Fatal GI bleeding, ulceration or perforation has been reported with all NSAIDs at any time during treatment, with or without warning symptoms, with or without a history of severe gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses in patients with a history of ulcer, particularly if complicated by haemorrhage or perforation (see section 4.3)