Analgin-BP (tab)

Metamizol sodic

Each tablet contains metamizole sodium monohydrate 500 mg. Excipients with known effect: lactose monohydrate, sodium.

Indication: Post-traumatic and post-operative pain, colic, pain syndrome in oncology patients, various severe acute or chronic pain when other treatments are not indicated, and fever not controlled by other antipyretics. Metamizole sodium is used as an alternative agent when safer medicines are ineffective.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Hypersensitivity to other pyrazolone derivatives (e.g. phenazone, propyphenazone) or pyrazolidines (e.g. phenylbutazone, oxyphenbutazone), including a history of agranulocytosis caused by one of these substances. - History of agranulocytosis induced by metamizole, other pyrazolones or pyrazolidines. - Impaired bone marrow function or diseases of the haematopoietic system. - History of bronchospasm or other anaphylactoid reactions (e.g. urticaria, rhinitis, angioedema) to analgesics such as: salicylates (acetylsalicylic acid), paracetamol, diclofenac, ibuprofen, indometacin, naproxen. - Hepatic porphyria (risk of exacerbating porphyria). - Congenital glucose-6-phosphate dehydrogenase deficiency (risk of haemolysis). - Severe renal, hepatic or cardiac impairment; - Third trimester of pregnancy (see section 4.6). Analgin-BP 500 mg tablets must not be given to children under 15 years of age (< 53 kg). Other pharmaceutical forms/strengths suitable for younger children are available.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Rarely, potentially life-threatening adverse reactions induced by metamizole may occur during treatment: agranulocytosis and anaphylactic shock, which can progress to death. Agranulocytosis Treatment with metamizole may cause agranulocytosis, which can be fatal (see section 4.8). It may occur even after metamizole has previously been used without complications. Metamizole-induced agranulocytosis is an idiosyncratic adverse reaction. It is not dose-dependent and may occur at any time during treatment, even shortly after stopping treatment. Patients should be instructed to stop treatment and seek medical attention immediately if symptoms suggestive of agranulocytosis occur (e.g. fever, chills, sore throat and painful mucosal lesions, particularly in the […]