Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Telmisartan, hydrochlorothiazide
Krka, d.d., Novo mesto
C09DA07
telmisartan, hydrochlorothiazide
telmisartan and diuretics
Hypertension
Tolucombi fixed-dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Tolucombi 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Revision: 11
Authorised
2013-03-13
57 B. PACKAGE LEAFLET 58 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TOLUCOMBI 40 MG/12.5 MG TABLETS TOLUCOMBI 80 MG/12.5 MG TABLETS TOLUCOMBI 80 MG/25 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 Tolucombi is and what it is used for 2. What you need to know before you take Tolucombi 3. How to take Tolucombi 4. Possible side effects 5. How to store Tolucombi 6. Contents of the pack and other information 1. WHAT TOLUCOMBI IS AND WHAT IT IS USED FOR Tolucombi 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. Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tolucombi 40 mg/12.5 mg tablets Tolucombi 80 mg/12.5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tolucombi 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. Tolucombi 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. Excipient(s) with known effect Each 40 mg/12.5 mg tablet contains 57 mg of lactose (as monohydrate) and 147.04 mg sorbitol (E420). Each 80 mg/12.5 mg tablet contains 114 mg of lactose (as monohydrate) and 294.08 mg sorbitol (E420). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Tolucombi 40 mg/12.5 mg tablets: White to almost white or pinkish white on one side and pink marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 15 mm x 7 mm. Tolucombi 80 mg/12.5 mg tablets White to almost white or pinkish white on one side and pink marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 18 mm x 9 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Tolucombi fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide and 80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Tolucombi 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. - Tolucombi 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 40 mg. - Tolucombi 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is 3 not adequately controlled Lue koko asiakirja