Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Telmisartan
Boehringer Ingelheim International GmbH
C09CA07
telmisartan
Angiotensin II antagonists, plain
Hypertension
HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients 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.
Revision: 27
Authorised
1998-12-16
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE USER MICARDIS 20 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Micardis is and what it is used for 2. What you need to know before you take Micardis 3. How to take Micardis 4. Possible side effects 5. How to store Micardis 6. Contents of the pack and other information 1. WHAT MICARDIS IS AND WHAT IT IS USED FOR Micardis 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. Micardis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. MICARDIS 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. MICARDIS 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 stroke or have high risk diabetes. Your doctor can tell you if you are Pročitajte cijeli dokument
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Micardis 20 mg tablets Micardis 40 mg tablets Micardis 80 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Micardis 20 mg tablets Each tablet contains 20 mg telmisartan. Micardis 40 mg tablets Each tablet contains 40 mg telmisartan. Micardis 80 mg tablets Each tablet contains 80 mg telmisartan. Excipients with known effect Each 20 mg tablet contains 84 mg sorbitol (E420). Each 40 mg tablet contains 169 mg sorbitol (E420). Each 80 mg tablet contains 338 mg sorbitol (E420). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Micardis 20 mg tablets White round tablets of 2.5 mm engraved with the code number '50H' on one side and the company logo on the other side. Micardis 40 mg tablets White oblong tablets of 3.8 mm engraved with the code number '51H' on one side and the company logo on the other side. Micardis 80 mg tablets White oblong tablets of 4.6 mm engraved with the code number '52H' on one side and the company logo on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension in adults. 3 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 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 Pročitajte cijeli dokument