Nazione: Regno Unito
Lingua: inglese
Fonte: myHealthbox
amlodipine besilate
Pfizer Limited
C08CA01
amlodipine besilate
5mg
Hard capsule
Oral use
14, 28, 30, 56, 90, 98 and 100 capsules
POM - Prescription Only Medicine
Fareva Amboise Zone Industrielle
Calcium channel blockers, selective calcium channel blockers with mainly vascular effects
Hypertension Chronic stable angina pectoris Vasospastic (Prinzmetal’s) angina
Authorised
2015-03-12
Ref: dd AML 2_0 Pfleet no: 2015-0010642 Page 1 of 13 PACKAGE LEAFLET: INFORMATION FOR THE USER AMLODIPINE PFIZER 5 MG AND 10 MG HARD CAPSULES 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 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Amlodipine Pfizer is and what it is used for 2. What you need to know before you take Amlodipine Pfizer 3. How to take Amlodipine Pfizer 4. Possible side effects 5. How to store Amlodipine Pfizer 6. Contents of the pack and other information 1. WHAT AMLODIPINE PFIZER IS AND WHAT IT IS USED FOR Amlodipine Pfizer contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists. Amlodipine Pfizer 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 Amlodipine Pfizer 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 AMLODIPINE PFIZER DO NOT TAKE AMLODIPINE PFIZER If you are allergic (hypersensitive) to amlodipine, or any of the other ingredients of this medicine listed in section 6, or to any other calcium antagonists. This may be Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amlodipine Pfizer 5 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains amlodipine besilate equivalent to 5 mg amlodipine. Excipients: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. Yellow and white capsules with black imprint AML 5 on one side and Pfizer logo on the other. 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 Pfizer once daily which may be increased to a maximum dose of 10 mg depending on the individual patient's response. In hypertensive patients, Amlodipine Pfizer has been used in combination with a thiazide diuretic, alpha blocker, beta blocker, or an angiotensin converting enzyme inhibitor. For angina, Amlodipine Pfizer 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 Amlodipine Pfizer is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors. Special populations _Elderly patients _ Amlodipine Pfizer 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). _Patients with hepatic impairment _ Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and shou Leggi il documento completo