国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Irbesartan; Hydrochlorothiazide
Actavis Group PTC ehf
C09DA; C09DA04
Irbesartan; Hydrochlorothiazide
150/12.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics; irbesartan and diuretics
Marketed
2011-02-11
IRPREZIDE 150 MG/12.5 MG FILM-COATED TABLETS IRPREZIDE 300 MG/12.5 MG FILM-COATED TABLETS IRPREZIDE 300 MG/25 MG FILM-COATED TABLETS irbesartan/hydrochlorothiazide PACKAGE LEAFLET: INFORMATION FOR THE USER 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 IRPREZIDE IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRPREZIDE 3 HOW TO TAKE IRPREZIDE 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE IRPREZIDE 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT IRPREZIDE IS AND WHAT IT IS USED FOR Irprezide is a combination of two active substances, irbesartan and hydrochlorothiazide. Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin- II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure. The two active ingredients in Irprezide work together to lower blood pressure further than if either was given alone. Irprezide IS USED IN THE TREATMENT OF HIGH BLOOD PRESSURE (essential hypertension), when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRPREZIDE DO NOT TAK 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Irprezide 150mg/12.5mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Irprezide 150 mg/12.5 mg film-coated tablets. Pink, biconvex, oval-shaped, 6.5 x 12.7 mm film-coated tablet with a H engraved on one side and I on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Irprezide can be taken once daily, with or without food. Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended. When clinically appropriate direct change from monotherapy to the fixed combinations may be considered: Irprezide 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; Irprezide 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irprezide 150 mg/12.5 mg; Irprezide 300 mg/25 mg may be administered in patients insufficiently controlled by Irprezide 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, Irprezide may be administered with another antihypertensive medicinal product (see sections 4.3,4.4, 4.5 and 5.1). Special populations _Renal impairment_: due to the hydrochlorothiazide component, Irprezide is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min). Loop diuretics are preferred to thiazides in this population. No dosage adjustment is necessary in patients with renal impairment whose renal creatini 完全なドキュメントを読む