Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
IRBESARTAN HYDROCHLOROTHIAZIDE
Ranbaxy Ireland Limited
IRBESARTAN HYDROCHLOROTHIAZIDE
300/12.5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
IRBESARTAN/HYDROCHLOROTHIAZIDE 150 MG/12.5 MG FILM-COATED TABLETS IRBESARTAN/HYDROCHLOROTHIAZIDE 300 MG/12.5 MG FILM-COATED TABLETS IRBESARTAN/HYDROCHLOROTHIAZIDE 300 MG/25 MG FILM-COATED TABLETS PACKAGE LEAFLET: INFORMATION FOR THE USER WHAT IS IN THIS LEAFLET 1. WHAT IRBESARTAN/HYDROCHLOROTHIAZIDE TABLETS ARE AND WHAT ARE THEY USED FOR IRBESARTAN/HYDROCHLOROTHIAZIDE TABLETS ARE USED TO TREAT HIGH BLOOD PRESSURE 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRBESARTAN/HYDROCHLOROTHIAZIDE TABLETS DO NOT TAKE IRBESARTAN/HYDROCHLOROTHIAZIDE TABLETS: • ALLERGIC ALLERGIC MORE THAN 3 PREGNANT SEVERE LIVER OR KIDNEY PROBLEMS DIFFICULTY IN PRODUCING URINE PERSISTENTLY HIGH CALCIUM OR LOW POTASSIUM LEVELS IN YOUR BLOOD. CHILDREN AND ADOLESCENTS WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR VOMITING OR DIARRHOEA KIDNEY PROBLEMS KIDNEY TRANSPLANT HEART PROBLEMS LIVER PROBLEMS DIABETES LUPUS ERYTHEMATOSUS PRIMARY ALDOSTERONISM YOU SHOULD ALSO TELL YOUR DOCTOR: LOW-SALT DIET ABNORMAL THIRST, DRY MOUTH, GENERAL WEAKNESS, DROWSINESS, MUSCLE PAIN OR CRAMPS, NAUSEA, VOMITING, ABNORMALLY FAST HEART BEAT SENSITIVITY OF THE SKIN TO THE SUN GOING TO HAVE AN OPERATION BE GIVEN ANAESTHETICS CHANGES IN YOUR VISION OR PAIN IN ONE OR BOTH OF YOUR EYES O T H E R M E D I C I N E S A N D I R B E S A R T A N / HYDROCHLOROTHIAZIDE TABLETS : 1. What Irbesartan/Hydrochlorothiazide tablets are and what are they used for 2. What you need to know before you take Irbesartan/ Hydrochlorothiazide tablets 3. How to take Irbesartan/ Hydrochlorothiazide tablets 4. Possible side effects 5. How to store Irbesartan/ Hydrochlorothiazide tablets 6. Contents of the pack and other information. Irbesartan/Hydrochlo Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Irbesartan/Hydrochlorothiazide 300mg/12.5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Excipient with known effect: Each film-coated tablet contains 97.50 mg of lactose (as lactose monohydrate). For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Yellow coloured, film coated, oval shaped tablets approximately 15.6 x 8.1 mm debossed with ‘IH 3’ on one side and plain 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 Irbesartan/Hydrochlorothiazide Tablets 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: Irbesartan/Hydrochlorothiazide 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; Irbesartan/Hydrochlorothiazide 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide 150 mg/12.5 mg. Irbesartan/Hydrochlorothiazide 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan/Hydrochlorothiazide 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, Citiți documentul complet