Cardiovascular

LABORATORIOS LINCOSA S.A., SPAIN; INBIOTECH LTD., BULGARI

VN-23032-22

19/04/2022

Inbiotech Ltd.

Telmisartan; Hydrochlorothiazide

80mg; 12.5mg

Treatment of essential hypertension.
Telsol Plus 80 mg/25 mg fixed dose combination is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone or hydrochlorothiazid alone or telmisartan 80 mg/hydrochlorothiazid 12.5 mg.

Adults
Telsol Plus 80 mg/25 mg 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
Telsol Plus 80 mg/25 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Telmisartan/Hydrochlorothiazide 80 mg/12.5 mg or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Special populations
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. Telsol Plus is not indicated in patients with severe hepatic impairment.
Elderly
No dosage adjustment is necessary.
Paediatric population
The safety and efficacy of Telsol Plus 80 mg/25 mg in children and adolescents aged below 18 have not been established.

36

Tablet

Box of 2 blisters x 14 tablets