Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Amlodipine besilate
Bluefish Pharmaceuticals AB
C08CA; C08CA01
Amlodipine besilate
10 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives; amlodipine
Marketed
2010-05-07
1 PACKAGE LEAFLET: INFORMATION FOR THE USER AMLODIPINE BLUEFISH 5 MG TABLETS AMLODIPINE BLUEFISH 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 Amlodipine Bluefish is and what it is used for 2. What you need to know before you take Amlodipine Bluefish 3. How to take Amlodipine Bluefish 4. Possible side effects 5. How to store Amlodipine Bluefish 6. Contents of the pack and other information 1. WHAT AMLODIPINE BLUEFISH IS AND WHAT IT IS USED FOR Amlodipine Bluefish contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists. Amlodipine Bluefish 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 Amlodipine Bluefish 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLODIPINE BLUEFISH DO NOT TAKE AMLODIPINE BLUEFISH • 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 (hypotensio Read the complete document
Health Products Regulatory Authority 15 September 2022 CRN00D0H0 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amlodipine Bluefish 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of amlodipine (as amlodipine besilate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White or almost white approximately 9.5 mm, flat, round tablet with bevelled edges, imprinted with “C” on one side and “59” on the other side. 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 Bluefish once daily which may be increased to a maximum dose of 10 mg depending on the individual patient's response. In hypertensive patients, Amlodipine Bluefish has been used in combination with a thiazide diuretic, alpha blocker, beta blocker, or an angiotensin converting enzyme inhibitor. For angina, Amlodipine Bluefish 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 Bluefish is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors. Special populations Elderly Amlodipine Bluefish 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 Read the complete document