Indapamid-BP

Indapamidum

Indapamid-BP film-coated tablets 2.5 mg: each film-coated tablet contains indapamide 2.5 mg. Excipient with known effect: lactose monohydrate 59.25 mg.

Indapamid-BP prolonged-release film-coated tablets 1.5 mg: each prolonged-release film-coated tablet contains indapamide 1.5 mg. Excipients with known effect: lactose monohydrate 81.5 mg and propylene glycol 0.36 mg per tablet.

Indication: Indapamid-BP is indicated for essential hypertension in adults (both pharmaceutical forms — immediate-release 2.5 mg and prolonged-release 1.5 mg).

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to the active substance (indapamide), to other sulfonamides, or to any of the excipients listed in section 6.1. − Severe renal impairment. − Hepatic encephalopathy or severe hepatic impairment. − Hypokalaemia.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Special warnings In hepatic impairment, thiazide diuretics and thiazide-related substances may cause hepatic encephalopathy, particularly in the presence of electrolyte imbalance. If this occurs, diuretic administration must be discontinued immediately. Photosensitivity Cases of photosensitivity reactions have been reported in connection with treatment with thiazide diuretics or thiazide-related substances (see section 4.8). If photosensitivity reactions occur during treatment, it should be stopped. If resuming treatment with indapamide is considered absolutely necessary, it is recommended to protect areas exposed to sunlight or artificial ultraviolet radiation. Choroidal effusion, acute myopia and secondary acute angle-closure glaucoma: Sulfonamides or sulfonamide derivatives may cause […]