Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
Telmisartan, hydrochlorothiazide
Bayer AG
C09DA07
telmisartan, hydrochlorothiazide
Agents acting on the renin-angiotensin system
Hypertension
Treatment of essential hypertension.PritorPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.PritorPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on PritorPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Revision: 37
Authorised
2002-04-22
59 B. PACKAGE LEAFLET 60 PACKAGE LEAFLET: INFORMATION FOR THE USER PRITORPLUS 40 MG/12.5 MG TABLETS telmisartan/hydrochlorothiazide 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 PritorPlus is and what it is used for 2. What you need to know before you take PritorPlus 3. How to take PritorPlus 4. Possible side effects 5. How to store PritorPlus 6. Contents of the pack and other information 1. WHAT PRITORPLUS IS AND WHAT IT IS USED FOR PritorPlus is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both of these substances help to control high blood pressure. - Telmisartan belongs to a group of medicines called 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. - Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your urine output to increase, leading to a lowering of your blood pressure. 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. PritorPlus is used to treat high blood pressure (essential Lugege kogu dokumenti
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT PritorPlus 40 mg/12.5 mg tablets PritorPlus 80 mg/12.5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PritorPlus 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. PritorPlus 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. Excipients with known effect PritorPlus 40 mg/12.5 mg tablets Each tablet contains 112 mg of lactose monohydrate equivalent to 107 mg lactose anhydrous. Each tablet contains 169 mg sorbitol (E420). PritorPlus 80 mg/12.5 mg tablets Each tablet contains 112 mg of lactose monohydrate equivalent to 107 mg lactose anhydrous. Each tablet contains 338 mg sorbitol (E420). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. PritorPlus 40 mg/12.5 mg tablets Red and white oblong shaped two layer tablet of 5.2 mm engraved with the code number 'H4'. PritorPlus 80 mg/12.5 mg tablets Red and white oblong shaped two layer tablet of 6.2 mm engraved with the code number 'H8'. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. PritorPlus fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide (HCTZ) and 80 mg telmisartan/12.5 mg HCTZ) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The fixed dose combination should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone. Individual dose titration with each of the two components is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. 3 • PritorPlus 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Pritor 40 mg • PritorPlus 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is not ad Lugege kogu dokumenti