Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
AMLODIPINE BESILATE
Actavis Group PTC ehf
C08CA01
AMLODIPINE BESILATE
10 Milligram
Tablets
Product subject to prescription which may be renewed (B)
amlodipine
Marketed
2008-11-28
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Istolde 5 mg tablets Istolde10 mg tablets Amlodipine 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Istolde is and what it is used for 2. What you need to know before you take Istolde 3. How to take Istolde 4. Possible side effects 5. How to store Istolde 6. Contents of the pack and other information. 1. WHAT ISTOLDE IS AND WHAT IT IS USED FOR Istolde contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists. Istolde is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina. In patients with high blood pressure this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Istolde works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. This medicine does not provide immediate relief of chest pain from angina. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISTOLDE DO NOT TAKE ISTOLDE - if you are allergic to amlodipine, or any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing. - if you have severe low blood pressure (hypotension). - if you have narrowing of the aortic heart valve (aortic stenosis) - if you are in shock (including cardiogenic shock (a condition where your h Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Istolde 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 10 mg tablets: Each tablet contains 10 mg amlodipine (as besilate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Istolde 10 mg tablet: White, uncoated, round, flat, tablet (10 mm) with score line on one side and embossed with AB10 on the other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Chronic stable angina pectoris Vasospastic (Prinzmetal’s) angina 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ For both hypertension and angina the usual initial dose is 5 mg amlodipine once daily which may be increased to a maximum dose of 10 mg depending on the individual patient's response. In hypertensive patients, amlodipine has been used in combination with a thiazide diuretic, alpha blocker, beta blocker, or an angiotensin converting enzyme inhibitor. For angina, Istolde may be used as monotherapy or in combination with other antianginal medicinal products in patients with angina that is refractory to nitrates and/or to adequate doses of beta blockers. No dose adjustment of Istolde is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors. _Special populations_ _Elderly_ Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care (see sections 4.4 and 5.2). _Hepatic impairment_ Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range (see sections 4.4 and 5.2). The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients wi Aqra d-dokument sħiħ