Nimesulid-BP (tab)

Nimesulidum

Each Nimesulide-BP tablet contains nimesulide 100 mg.

Indication: Nimesulide-BP is indicated for treatment of acute pain and primary dysmenorrhoea; it should be prescribed only as second-line treatment, based on individual assessment of the patient's risk profile.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications Hypersensitivity to nimesulide or to any of the excipients listed in section 6.1. History of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. History of hepatotoxic reactions to nimesulide. Concomitant exposure to substances with hepatotoxic potential. Alcoholism, drug dependence. History of gastrointestinal haemorrhage or perforation associated with previous NSAID treatment. Active gastric or duodenal ulcer, or a history of recurrent/haemorrhagic peptic ulcer (two or more distinct episodes of proven ulceration or bleeding). Cerebrovascular haemorrhage or other types of active bleeding. Severe coagulation disorders. Severe heart failure. Severe renal impairment. Hepatic impairment. Patients with fever and/or flu-like symptoms. Children under 12 years of age. Third trimester of pregnancy and breast-feeding (see sections 4.6 and 5.3).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use The risk of adverse reactions can be reduced by using Nimesulid-BP 100 mg tablets for the shortest possible period (see section 4.2). Treatment must be discontinued if no improvement is observed. Hepatic disorders Rarely, the use of nimesulide has been reported to be associated with serious hepatic reactions, very rarely including fatal cases (see section 4.8). In patients who develop symptoms suggestive of liver injury during treatment with nimesulide (e.g. anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine), or in whom abnormal liver function test values are found, treatment must be discontinued. In these patients, resumption of nimesulide is not recommended. Liver injury has been reported after short-term use, in most cases […]