Drotaverin-BP

Drotaverinum

Each 2 ml ampoule of solution for injection contains drotaverine hydrochloride 40 mg (equivalent to 20 mg/ml). Excipients with known effect: sodium metabisulfite (E 223) 2 mg, ethanol 96% 132 mg per ampoule.

Indication: Smooth-muscle spasm associated with biliary-tract disorders (gallstones, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis) and urinary-tract disorders (renal and ureteral lithiasis, pyelitis, cystitis; bladder-muscle spasm). As adjunctive treatment, when the patient cannot take drotaverine tablets: gastrointestinal spasm (gastric or duodenal ulcer, gastritis, cardia/pylorus sphincter spasm, enteritis, colitis) and dysmenorrhoea.

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 sodium bisulfite (see section 4.4). − Severe hepatic impairment. − Severe renal impairment. − Severe heart failure (low output syndrome). − Children and adolescents.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use − Increased caution is required when administering to patients with arterial hypotension. Because of the risk of collapse, intravenous administration should be performed only with the patient lying down. − Caution is recommended when drotaverine is administered parenterally to pregnant women (see section 4.6). Children and adolescents: see section 4.3. Excipients − This medicinal product contains sodium metabisulfite (E 223). It may rarely cause severe hypersensitivity reactions (including anaphylactic symptoms) and bronchospasm, particularly in susceptible patients with a history of asthma or allergies. In case of hypersensitivity to sodium metabisulfite (E 223), parenteral administration should be avoided (see section 4.3). − This medicinal product contains ethanol (ethyl alcohol) and may be harmful to persons with alcoholism. This should be borne in mind in women […]