Clemastin-BP (tab)

Clemastinum

Each Clemastin-BP 1 mg tablet contains clemastine fumarate 1.34 mg, equivalent to clemastine 1 mg. Each Clemastin-BP 2 mg tablet contains clemastine fumarate 2.68 mg, equivalent to clemastine 2 mg. Excipient with known effect: lactose monohydrate.

Indication: Allergic rhinitis (including hay fever, perennial and vasomotor rhinitis); allergic dermatoses, including pruritus, atopic eczema and contact dermatitis; urticaria, angioneurotic oedema, drug allergy; insect bites/stings.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to the active substance, other similar antihistamines, or to any of the excipients listed in section 6.1. − Clemastine-BP must not be administered to patients suffering from porphyria. − Clemastine must not be administered to children under 1 year of age. Clemastine-BP tablets are not to be given to children under 6 years of age (for children aged 1 to 6 years, an age-appropriate pharmaceutical form should be used).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Antihistamines should be used with caution in patients with: − narrow-angle glaucoma − stenosing peptic ulcer − pyloroduodenal obstruction − prostatic hypertrophy with urinary retention and bladder neck obstruction − epilepsy or history of convulsions − in elderly patients, who are at increased risk of adverse effects such as paradoxical excitation. Use in confused elderly patients should be avoided. This medicinal product contains lactose It must not be given to patients with rare hereditary conditions of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome.