Telmisartan with hydrochlorothiazide

The fixed-dose combination 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, a direct change from monotherapy to the fixed combination may be considered. 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 may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 80 mg. Tablets are for once-daily oral administration and should be swallowed whole with liquid; may be taken with or without food. Keep in the sealed blister (the tablets are hygroscopic) and take out shortly before administration. Elderly: no dose adjustment is necessary. Hepatic impairment: administer with caution in mild to moderate impairment and the telmisartan posology should not exceed 40 mg once daily; the fixed-dose combination is contraindicated in severe hepatic impairment; thiazides should be used with caution in impaired hepatic function. Paediatric: safety and efficacy have not been established below 18 years — use is not recommended in children and adolescents. Source caveats: (1) SPC section 4.5 (interactions) was not captured in the fetched bundle — clinician to review interactions against the full SPC; (2) comparison symbols appear to have been stripped from the fetched SPC text, so 'creatinine clearance 30 mL/min' should be read as less than 30 mL/min and 'GFR 60 mL/min/1.73 m2' as less than 60 mL/min/1.73 m2 — verify against the SPC.