País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Telmisartan; Hydrochlorothiazide
Rowex Ltd
C09DA07
Telmisartan; Hydrochlorothiazide
40 mg/12.5 milligram(s)
Coated tablet
Product subject to prescription which may be renewed (B)
telmisartan and diuretics
Marketed
2013-07-04
PACKAGE LEAFLET: INFORMATION FOR THE USER TELMISARTAN/HYDROCHLOROTHIAZIDE ROWEX 40 MG/12.5 MG COATED TABLETS TELMISARTAN/HYDROCHLOROTHIAZIDE ROWEX 80 MG/12.5 MG COATED TABLETS TELMISARTAN/HYDROCHLOROTHIAZIDE ROWEX 80 MG/25 MG COATED 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 Rowex is and what it is used for 2. What you need to know before you take Telmisartan/hydrochlorothiazide Rowex 3. How to take Telmisartan/hydrochlorothiazide Rowex 4. Possible side effects 5. How to store Telmisartan/hydrochlorothiazide Rowex 6. Contents of the pack and other information 1. WHAT TELMISARTAN/HYDROCHLOROTHIAZIDE ROWEX IS AND WHAT IT IS USED FOR Telmisartan/hydrochlorothiazide Rowex 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 someti Leia o documento completo
Health Products Regulatory Authority 24 June 2019 CRN008L6F Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Telmisartan/hydrochlorothiazide Rowex 40 mg/12.5 mg Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. Excipient(s) with known effect: Contains 153.4 mg lactose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Coated tablet. Red, oval, biconvex coated tablet debossed with 40 on one side and with 12.5 on the other side (12.4 mm x 6.2 mm). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Telmisartan/hydrochlorothiazide Rowex fixed dose combinations (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 Telmisartan/hydrochlorothiazide Rowex 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 Rowex 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 40 mg. Renal impairment Periodic monitoring of renal function is advised (see section 4.4). Hepatic impairment In patients with mild to moderate hepatic impairment the posology should not exceed Telmisartan/hydrochlorothiazide Rowex 40 mg/12.5 mg once daily. Telmisartan/hydrochlorothiazide Rowex is not indicated in patients with severe hepatic impairment. Thiazides should be used with caution in patients with impaired hepatic function (see section 4.4). Elderly No dose adjustment is necessary. Paediatric population The safety and eff Leia o documento completo