País: Malta
Idioma: anglès
Font: Medicines Authority
TELMISARTAN
Bristol Laboratories Limited
C09CA07
TELMISARTAN
TABLET
TELMISARTAN 80 milligram(s)
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2016-05-05
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TELMISARTAN 20MG TABLETS TELMISARTAN 40MG TABLETS TELMISARTAN 80MG TABLETS TELMISARTAN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR Telmisartan belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. Telmisartan is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition. High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range. Telmisartan is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a str Llegiu el document complet
Page 1 of 24 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Telmisartan Bristol Laboratories 20 mg tablets Telmisartan Bristol Laboratories 40 mg tablets Telmisartan Bristol Laboratories 80 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg telmisartan. Each tablet contains 40 mg telmisartan. Each tablet contains 80 mg telmisartan. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, round shaped, un-coated tablets about 6.95 mm in diameter with 'C' debossed on one side and '03 ' debossed on the other side. White to off-white, oblong, un-coated tablets about 11.90 mm in length and 5.80mm width with 'C' debossed on one side and '04 ' debossed on the other side. White to off-white, oblong, un-coated tablets about 16.10 mm in length and 7.80mm width with 'C' debossed on one side and '05 ' debossed on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in adults with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or type 2 diabetes mellitus with documented target organ damage Page 2 of 24 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Treatment of essential hypertension _ The usually effective 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, the dose of telmisartan 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 to eight weeks after the start of treatment (see section 5.1). _C Llegiu el document complet