Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
AMLODIPINE BESYLATE
McDowell Pharmaceuticals
C08CA01
AMLODIPINE BESYLATE
5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives
Authorised
2010-02-26
ISTIN® 5mg and 10mg Tablets (Amlodipine) - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 1. What Istin is and what it is used for 2. Before you take Istin 3. How to take Istin 4. Possible side effects 5. How to store Istin 6. Further information Istin contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists. Istin 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 your medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Istin works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Your medicine does not provide immediate relief of chest pain from angina. If you are allergic (hypersensitive) to amlodipine, or any of the other ingredients of your 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), or cardiogenic shock (a condition where your heart is unable Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Istin 5mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Amlodipine Besilate equivalent to 5mg Amlodipine. Excipients: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from the UK_: White to off-white, emerald-shaped tablets engraved AML 5 on one side and Pfizer logo on the other side. The 5 mg tablet can be divided into equal halves. 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 5mg Istin once daily which may be increased to a maximum dose of 10mg depending on the individual patient’s response. In hypertensive patients, Istin has been used in combination with a thiazide diuretic, alpha blocker, beta blocker, or an angiotensin converting enzyme inhibitor. For angina, Istin 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 Istin is required upon concomitant administration of thiazide diuretics, beta blockers and angiotensin-converting enzyme inhibitors. Special populations Elderly Istin 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). HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 02/07/2014_ _CRN 2137224_ _page number: 1_ Hepatic Citiți documentul complet