Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE
McDermott Laboratories Ltd t/a Gerard Laboratories
C09DA06
CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE
16/12.5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics
Authorised
2012-01-27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CANDESARTAN/HYDROCHLOROTHIAZIDE MYLAN 16 MG/12.5 MG TABLETS (candesartan cilexetil/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 Candesartan/Hydrochlorothiazide Mylan is and what it is used for 2. What you need to know before you take Candesartan/Hydrochlorothiazide Mylan 3. How to take Candesartan/Hydrochlorothiazide Mylan 4. Possible side effects 5. How to store Candesartan/Hydrochlorothiazide Mylan 6. Contents of the pack and other information. 1. WHAT CANDESARTAN/HYDROCHLOROTHIAZIDE MYLAN IS AND WHAT IT IS USED FOR The name of your medicine is Candesartan/Hydrochlorothiazide Mylan. It is used for treating high blood pressure (hypertension). It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. These work together to lower your blood pressure. Candesartan cilexetil belongs to a group of medicines known as angiotensin II receptor antagonists. It makes your blood vessels relax and widen. This helps to lower your blood pressure. Hydrochlorothiazide belongs to a group of medicines known as diuretics (water tablets). It helps your body to get rid of water and salts like sodium in your urine. This helps to lower your blo Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Candesartan/Hydrochlorothiazide Mylan 16 mg/12.5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Candesartan/Hydrochlorothiazide Mylan 16mg/12.5mg tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide. Excipient with known effect Each tablet contains 102.9 mg lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Candesartan/Hydrochlorothiazide Mylan 16 mg/12.5 mg tablets are peach colour, mottled, round, biconvex tablet debossed with “M” on one side and “CH2” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Candesartan/Hydrochlorothiazide Mylan is indicated for: Treatment of essential hypertension in adult patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The recommended dose of Candesartan/Hydrochlorothiazide Mylan 16 mg/12.5 mg tablet is 1 tablet once daily. Dose titration with the individual components (candesartan cilexetil and hydrochlorothiazide) is recommended. When clinically appropriate a direct change from monotherapy to candesartan cilexetil/hydrochlorothiazide may be considered. Dose titration of candesartan cilexetil is recommended when switching from hydrochlorothiazide monotherapy. Candesartan cilexetil/hydrochlorothiazide may be administered in patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy or candesartan cilexetil/hydrochlorothiazide at lower doses. Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment. SPECIAL POPULATIONS _Elderly population_ No dose adjustment is necessary in elderly patients. _Patien Leggi il documento completo