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HSA Product

TELMISARTAN SANDOZ TABLETS 80MG

Product approved by Health Sciences Authority (SG)

Basic Information

TELMISARTAN SANDOZ TABLETS 80MG

TABLET

Regulatory Information

SIN14568P

July 8, 2014

Prescription Only

Therapeutic

ORAL

August 10, 2023

June 3, 2025

XC09CA07

Company Information

Active Ingredients

Telmisartan

Strength: 80mg

Detailed Information

Contraindications

**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. - Lactation. - Biliary obstructive disorders. - Severe hepatic impairment. - The concomitant use of telmisartan with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m2). 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.

Indication 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.

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