Algospazmin tab

Metamizolum + Pitofenonum hydrochloridum + Fenpiverinum bromidum

Each tablet contains the active substances: metamizole sodium 500 mg, pitofenone hydrochloride 5 mg and fenpiverinium bromide 0.1 mg. Excipients with known effect: lactose, sodium.

Indication: Symptomatic treatment of mild to moderate pain accompanied by spasm of the smooth muscle of internal organs: renal colic and inflammatory urinary tract disease with pain and dysuria, gastric and intestinal colic, biliary lithiasis, biliary dyskinesia, dysmenorrhoea.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − hypersensitivity to the active substances and/or excipients of the product; − hypersensitivity to other pyrazolone derivatives (e.g. phenazone, propyphenazone) or to pyrazolidines (e.g. phenylbutazone, oxyphenbutazone); − history of agranulocytosis induced by metamizole, other pyrazolones or pyrazolidines, impaired bone marrow function or diseases of the haematopoietic system; − gastrointestinal obstruction and megacolon; − atony of the gallbladder and urinary bladder; − severe renal or hepatic impairment; − glucose-6-phosphate dehydrogenase deficiency; − porphyria; − angle-closure glaucoma; − children under 15 years of age; − pregnancy and breast-feeding.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use During treatment with Algospazmin, potentially life-threatening adverse reactions induced by the metamizole contained in the product may occur: agranulocytosis and anaphylactic shock. Agranulocytosis Treatment with metamizole may cause agranulocytosis, which may 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, including shortly after treatment discontinuation. Patients should be instructed to discontinue treatment and seek medical attention immediately if symptoms suggestive of agranulocytosis occur (e.g. fever, chills, sore throat and painful mucosal lesions)