Spasmoverin (Drotaverin)

Drotaverinum

One Spasmoverin 40 mg tablet contains drotaverine hydrochloride 40 mg (excipient with known effect: lactose monohydrate 52 mg). One Spasmoverin Forte 80 mg tablet contains drotaverine hydrochloride 80 mg (excipient with known effect: lactose monohydrate 104 mg).

Indication: Smooth-muscle spasm associated with biliary-tract disorders (cholelithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis); smooth-muscle spasm associated with urinary-tract disorders (renal lithiasis, ureteral lithiasis, pyelitis, cystitis and spasms of the bladder musculature). As adjuvant treatment in: smooth-muscle spasm associated with gastrointestinal-tract disorders (gastric or duodenal ulcer, gastritis, spasms of the cardiac and pyloric sphincters, enteritis, colitis, spastic colitis with constipation, irritable-bowel forms with flatulence); headache with a sensation of intracranial tension; gynaecological disorders (dysmenorrhoea).

Contraindications (SmPC sec. 4.3): Hypersensitivity to drotaverine hydrochloride or to any of the excipients listed in sec. 6.1. Severe hepatic impairment. Severe renal impairment. Severe cardiac failure (low-output syndrome). Spasmoverin 40 mg tablets are contraindicated in children under 6 years of age owing to the pharmaceutical form being unsuitable for this age group. Spasmoverin Forte 80 mg tablets are contraindicated in children and adolescents.

Special warnings and precautions (SmPC sec. 4.4): Increased caution is required when administering to patients with arterial hypotension. Children and adolescents: use of drotaverine in children and adolescents has not been evaluated in clinical trials; safety and efficacy have not yet been established and no dosing recommendation can be made. Spasmoverin 40 mg tablets are contraindicated in children under 6 years of age because of the risk of swallowing accidents. Spasmoverin Forte 80 mg tablets are contraindicated in children and adolescents because of the high amount of active substance they contain. Use of drotaverine has been associated with acute porphyria attacks, and its administration to patients with porphyria is therefore unsafe. Excipients: one Spasmoverin 40 mg tablet contains lactose 52 mg; one Spasmoverin […]