Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**4.2 Posology and method of administration** **Posology** **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. When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment. Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide or calcium-channel-blockers such as amlodipine, which have been shown to have an additive blood pressure lowering effect with telmisartan. 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. _Special populations_ Geriatric patients No dose adjustment is necessary for geriatric patients. Paediatric patients The safety and efficacy of MICARDIS for use in patients aged below 18 years have not been established. Renal impairment No posology adjustment is required for patients with renal impairment, including those on haemodialysis. Telmisartan is not removed from blood by hemofiltration and is not dialyzable. Hepatic impairment In patients with mild to moderate hepatic impairment MICARDIS should be administered with caution. For telmisartan, the posology should not exceed 40 mg once daily (see Section 4.3 Contraindications). **Method of Administration** MICARDIS tablets are for once-daily oral administration and should be swallowed whole with liquid. MICARDIS can be taken with or without food. Micardis tablets should not be divided into halves as the tablets have no score line and no studies have been performed on halved tablets. **Handling Instructions** Due to the hygroscopic property of the tablets, they should be taken out of the sealed blister shortly before administration.
ORAL
Medical Information
**4.1 Therapeutic Indications** Treatment of essential hypertension in adults. Reduction of the risk of non-fatal stroke or non-fatal myocardial infarction in adults 55 years or older at high risk of developing major cardiovascular events who cannot tolerate an angiotensin converting 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 - Second and third trimesters of pregnancy - Lactation - Biliary obstructive disorders - Severe hepatic impairment - The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to "list of excipients" – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) the use of the product is contraindicated.
C09CA07
telmisartan
Manufacturer Information
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
BOEHRINGER INGELHEIM PHARMA GMBH & CO KG
Boehringer Ingelheim Shanghai Pharmaceutical Co., Ltd (Primay & Secondary Packaging)
Boehringer Ingelheim Hellas Single member S.A.