Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**4.2 POSOLOGY AND METHOD OF ADMINISTRATION** _**Posology**_ _Adults_ **Treatment of essential hypertension** The recommended dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. In cases where the target blood pressure is not achieved, telmisartan dose can be increased to a maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure lowering effect with telmisartan. When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four – eight weeks after the start of treatment. In patients with severe hypertension treatment with telmisartan at doses up to 160 mg alone and in combination with hydrochlorothiazide 12.5 – 25 mg daily was well tolerated and effective. **Reduction of cardiovascular morbidity** The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity. When initiating telmisartan therapy for the reduction of cardiovascular morbidity, monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary. Method of administration TELFOCUS may be taken with or without food. _Renal impairment_ No posology adjustment is required for patients with renal impairment, including those on haemodialysis. Telmisartan is not removed from blood by hemofiltration. _Hepatic impairment_ In patients with mild to moderate hepatic impairment the posology should not exceed 40 mg once daily. _Elderly_ No dosing adjustment is necessary. _Children and adolescents_ TELFOCUS is not recommended for use in children below 18 years due to limited data on safety and efficacy.
ORAL
Medical Information
**4.1 Therapeutic Indications** Treatment of essential hypertension. Reduction of the risk of non-fatal stroke or non-fatal myocardial infarction in patients 55 years or older at high risk of developing major cardiovascular events who cannot tolerate an angiotensin coverting enzyme inhibitor (ACEI). High risk of cardiovascular events includes evidence of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or diabetes mellitus with evidence of end-organ damage.
**4.3 CONTRAINDICATIONS** - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - Second and third trimesters of pregnancy (see section 4.4 and 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Biliary obstructive impairment. - Severe hepatic impairment. The concomitant use of TELFOCUS with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60mg/min/1.73 m2) see sections 4.5 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
C09CA07
telmisartan
Manufacturer Information
APOTHECA MARKETING PTE LTD
AUROBINDO PHARMA LIMITED - UNIT VII
Active Ingredients
Documents
Package Inserts
Telfocus 40 and Telfocus 80 Tablets Package Insert.pdf
Approved: September 1, 2022