Alergostop inj Chloropyramin

Chloropyraminum

Each ampoule (1 ml injectable solution) contains the active substance chloropyramine hydrochloride 20 mg.

Indication: Allergic conditions (urticaria, seasonal allergic rhinitis, allergic contact dermatitis, dermographism, allergic conjunctivitis, food and drug allergy, insect-sting allergy, pruritus) and as adjunctive therapy for systemic anaphylactic reactions and angioedema. The possible sedative effect should be considered when administering.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
− Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
− Acute attack of bronchial asthma
− Full-term and premature newborns
− Pregnancy and breast-feeding

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
Because of its sedative and anticholinergic effect, Alergostop should be administered with caution to elderly patients and to patients with hepatic impairment, cardiovascular disease, angle-closure glaucoma, urinary retention or prostatic hypertrophy. Administration of the product late in the evening may intensify the symptoms of gastro-oesophageal reflux disease. When administered concomitantly with ototoxic medicinal products, Alergostop may mask early signs of ototoxicity. Prolonged administration of Alergostop may rarely cause disorders of the haematopoietic system (leukopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia). If fever of unclear origin, laryngitis, ulceration of the oral mucosa, pallor, jaundice, unusual bleeding or difficult haemostasis occur during prolonged administration of the product