Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
TELMISARTAN, HYDROCHLOROTHIAZIDE
Laboratorios LICONSA, S.A.
C09DA07
TELMISARTAN, HYDROCHLOROTHIAZIDE
80/12.5 mg/mg
Tablets
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics
Authorised
2014-04-04
PACKAGE LEAFLET: INFORMATION FOR THE USER Telmisartan/Hydrochlorothiazide Liconsa 80 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 Telmisartan/Hydrochlorothiazide Liconsa is and what it is used for 2. What you need to know before you take Telmisartan/Hydrochlorothiazide Liconsa. 3. How to take Telmisartan/Hydrochlorothiazide Liconsa 4. Possible side effects 5. How to store Telmisartan/Hydrochlorothiazide Liconsa 6. Contents of the pack and other information 1. WHAT TELMISARTAN/HYDROCHLOROTHIAZIDE LICONSA IS AND WHAT IT IS USED FOR Telmisartan/Hydrochlorothiazide Liconsa is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both 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 Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Telmisartan/Hydrochlorothiazide Liconsa 80 mg/12.5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. Excipients with known effect: Each tablet contains 49.8 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Diameter 10.5 mm approximately. Round bilayer tablet with white and pink colour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Telmisartan/Hydrochlorothiazide Liconsa fixed dose combination (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 _Adults:_ Telmisartan/Hydrochlorothiazide Liconsa 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 Telmisartan/Hydrochlorothiazide Liconsa 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Telmisartan in monotherapy 80 mg _Special populations:_ Patients with renal impairment: Periodic monitoring of renal function is advised (see section 4.4). Patients with hepatic impairment: In patients with mild to moderate hepatic impairment the posology should not exceed Telmisartan/Hydrochlorothiazide Liconsa 40 mg/12.5 mg once daily. Telmisartan/Hydrochlorothiazide Liconsa is not indicated in patients with severe hepatic impairment. Thiazides should be used with caution in Прочетете целия документ