Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Amlodipine
Rowex Ltd
C08CA; C08CA01
Amlodipine
10 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives; amlodipine
Marketed
2007-06-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMLODE 5 MG TABLETS AMLODE 10 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 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 Amlode is and what it is used for 2. What you need to know before you take Amlode 3. How to take Amlode 4. Possible side effects 5. How to store Amlode 6. Contents of the pack and other information 1. WHAT AMLODE IS AND WHAT IT IS USED FOR Amlode belongs to a group of medicines called calcium antagonists. Amlode is used to treat: - high blood pressure (hypertension) - 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 Amlode works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Amlode does not provide immediate relief of chest pain from angina. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLODE DO NOT TAKE AMLODE - if you are allergic to amlodipine, to any other calcium antagonists, or any of the other ingredients of this medicine (listed in section 6). 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 to supply enough blood to the body) - if you suffer from heart failure after a hear Read the complete document
Health Products Regulatory Authority 22 September 2022 CRN00D098 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amlode 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of amlodipine (as besylate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM _Tablet_ White or almost white, oblong tablet with bevelled edges, score line on one side and marked with a 10 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, amlodipine may be used as monotherapy or in combination with other anti-anginal medicinal products in patients with angina that is refractory to nitrates and/or to adequate doses of beta blockers. No dose adjustment of amlodipine is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors. _Paediatric population_ _Children and adolescents with hypertension from 6 years to 17 years of age._ The recommended antihypertensive oral dose in paediatric patients ages 6-17 years is 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks. Doses in excess of 5 mg daily have not been studied in paediatric patients (see sections 5.1 and 5.2). _Children under 6 years old_ No data are available. Special populations _Elderly_ Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommende Read the complete document