Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE
Takeda UK Limited
C09DA06
CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE
32/25 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics
Authorised
2009-06-19
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER BLOPRESS PLUS 8 MG/12.5 MG_ _TABLETS BLOPRESS PLUS 16 MG/12.5 MG_ _TABLETS BLOPRESS PLUS 32 MG/12.5 MG_ _TABLETS BLOPRESS PLUS 32 MG/25 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Blopress Plus is and what it is used for 2. What you need to know before you take Blopress Plus 3. How to take Blopress Plus 4. Possible side effects 5. How to store Blopress Plus 6. Contents of the pack and other information 1. WHAT BLOPRESS PLUS IS AND WHAT IT IS USED FOR The name of your medicine is Blopress Plus. It is used for treating high blood pressure (hypertension) in adult patients. 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 called 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 called diuretics (water tablets). It helps your body to get rid of water and salts like sodium in your urine. This helps to lower your blood pressure. Your doctor may prescribe Blopress Plus if your blood pressure has not been properly controlled by candesartan cilexetil or hydrochlorothiazide alone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BLOPRESS PLUS DO NOT TAKE BLOPRESS PLUS: - if you are allergic to candesartan cilexetil or hydrochlorothiazide or any of th Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Blopress Plus 32 mg/25 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One Blopress Plus 32mg/25 mg tablet contains 32 mg candesartan cilexetil and 25 mg hydrochlorothiazide. Excipients with known effect: lactose (as monohydrate) Each 32 mg/25 mg tablet contains 137.7 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Blopress Plus 32 mg/25 mg tablets are light pink, oval flat tablets approximately 11 mm by 6.5 mm with debossing 32 C2 on both sides. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Blopress Plus is indicated for the: 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 Blopress Plus is one tablet once daily. Dose titration with the individual components (candesartan cilexetil and hydrochlorothiazide) is recommended. When clinically appropriate a direct change from monotherapy to Blopress Plus may be considered. Dose titration of candesartan cilexetil is recommended when switching from hydrochlorothiazide monotherapy. Blopress Plus may be administered in patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy or Blopress Plus at lower doses. Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment. Special populations _Older people_ No dose adjustment is necessary in elderly patients. _Patients with intravascular volume depletion_ H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Lugege kogu dokumenti