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Posology: Telmisartan/Hydrochlorothiazide should be taken in patients whose blood pressure is not adequately controlled by Telmisartan alone. Individual dose titration with each of the two components is recommended before changing to the fixed dose combination.
When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Renal impairment: Periodic monitoring of renal function is advised.
Hepatic impairment: In patients with mild to moderate hepatic impairment the posology should not exceed Telmisartan/Hydrochlorothiazide 40 mg/12.5 mg once daily. Telmisartan/Hydrochlorothiazide is not indicated in patients with severe hepatic impairment. Thiazides should be used with caution in patients with impaired hepatic function.
Elderly: No dose adjustment is necessary.
Pediatric population: The safety and efficacy of Telmisartan/Hydrochlorothiazide in children and adolescents aged below 18 have not been established. No data are available.
Method of administration: Telmisartan/Hydrochlorothiazide tablets are for once-daily oral administration and should be taken with liquid, with or without food. Precautions to be taken before handling or administering the medicinal product.
Telmisartan/Hydrochlorothiazide should be kept in the sealed blister due to the hygroscopic property of the tablets. Tablets should be taken out of the blister shortly before administration.
40 mg/12.5 mg: Telmisartan/Hydrochlorothiazide 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Telmisartan 40 mg.
80 mg/12.5 mg: Telmisartan/Hydrochlorothiazide 80 mg/12.5 mg may be administered once daily in patient whose blood pressure is not adequately controlled by Telmisartan 80 mg or in patients who have been previously stabilized on Telmisartan and Hydrochlorothiazide given separately.
