Clemastin-BP (inj)

Clemastinum

1 ml solution for injection contains clemastine 1 mg as clemastine fumarate (1 ampoule of 2 ml contains clemastine 2 mg). Excipients with known effect: sorbitol 90 mg and ethanol 96% 140 mg per ampoule (2 ml).

Indication: Prophylaxis and treatment of allergic and pseudoallergic reactions, including those occurring with contrast media, blood transfusions or diagnostic histamine administration; angioneurotic oedema, anaphylactic or anaphylactoid shock (as an adjunctive agent).

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
Hypersensitivity to clemastine or to any of the excipients listed in section 6.1. Porphyria. Children under 1 year of age.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
Antihistamines should be administered with caution to patients with glaucoma, stenosing gastric ulcer, pyloroduodenal obstruction, prostatic hypertrophy with urinary retention, and bladder-neck obstruction. It has a sedative effect, which may be more pronounced in young children. Contains sorbitol. Patients with rare hereditary conditions of fructose intolerance should not use this medicinal product. This medicinal product contains alcohol (96% ethanol) 140 mg/2 ml. May be harmful to people with alcoholism. This should be taken into account in pregnant or breast-feeding women, children, and high-risk groups such as patients with liver disease or epilepsy.