TELSOL PLUS (12.5)
Therapeutic area
Cardiovascular
Manufacturer
Inbiotech, Bulgari
Visa Number
VN-23032-22
Issuing date
19/04/2022
Applicant company
INBIOTECH
Active ingredient
Telmisartan; Hydrochlorothiazide
Indication
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.
Dosage
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.
Content
80mg; 12.5mg
Shelf life
24
Dosage Form
Tablet
Package
Box of 2 blisters x 14 tablets
