Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
TELMISARTAN
Jubilant Pharmaceuticals nv Axxes Business Park, Guldensporenpark 22 – Block C, 9820 Merelbeke, Belgium
C09CA07
TELMISARTAN 40 mg
TABLET
TELMISARTAN 40 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2013-10-08
PACKAGE LEAFLET: INFORMATION FOR THE USER TELMISARTAN JUBILANT 20 MG TABLETS TELMISARTAN JUBILANT 40 MG TABLETS TELMISARTAN JUBILANT 80 MG 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. WHAT IS IN THIS LEAFLET 1. What Telmisartan Jubilant is and what it is used for 2. What you need to know before you take Telmisartan Jubilant 3. How to take Telmisartan Jubilant 4. Possible side effects 5. How to store Telmisartan Jubilant 6. Contents of the pack and other information 1. WHAT TELMISARTAN JUBILANT IS AND WHAT IT IS USED FOR Telmisartan Jubilant 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 Jubilant blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. TELMISARTAN JUBILANT 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. Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Telmisartan Jubilant 20 mg tablets Telmisartan Jubilant 40 mg tablets Telmisartan Jubilant 80 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 20 mg tablets Each tablet contains 20 mg telmisartan. Excipients with known effect: Each tablet contains 85 mg of mannitol (E421) 40 mg tablets Each tablet contains 40 mg telmisartan. Excipients with known effect: Each tablet contains 170 mg of mannital (E421) 80 mg tablets Each tablet contains 80 mg telmisartan. Excipients with known effect: Each tablet contains 339 mg of mannitol (E421) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 20 mg tablets are white to off-white, round, flat face, beveled edge tablets, approximately 7.16 mm in diameter and approximately 2.60 mm thick, debossed with “B” on one side and plain on the other side. 40 mg tablets are white to off white, capsule shaped tablets, approximately 12.15 mm in length, approximately 3.75 mm thick and approximately 6.10 mm in width, debossed with “H” on one side and plain on other side. 80 mg tablets are white to off white, oval shaped tablets, approximately 16.40 mm in length, approximately 4.70 mm thick and approximately 8.10 mm width, debossed with “D” on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension in adults. Page 1 of 13 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 Olvassa el a teljes dokumentumot