Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Amlodipine (as amlodipine besilate ph. eur.)
Athlone Laboratories Ltd
C08CA; C08CA01
Amlodipine (as amlodipine besilate ph. eur.)
5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives; amlodipine
Not marketed
2006-08-18
PATIENT INFORMATION LEAFLET 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 YOUR 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 THAT ARE NOT LISTED IN THIS LEAFLET. SEE SECTION 4. WHAT IS IN THIS LEAFLET: 1. What Amlotan Tablets are and what they are used for 2. What you need to know before you take Amlotan Tablets 3. How to take Amlotan Tablets 4. Possible side effects 5. How to store Amlotan Tablets 6. Contents of the pack and other information The name of your medicine is Amlotan5mg Tablets or Amlotan10mg Tablets. We refer to them as Amlotan Tablets or Amlotan throughout this leaflet. Amlotan Tablets contain the active substance amlodipine which belongs to a group of medicines called calcium antagonists. Amlotan Tablets may be used to treat: high blood pressure (hypertension); and 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, these medicines work by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, Amlotan 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. DO NOT TAKE AMLOTAN TABLETS: if you have ever had an allergic reaction to amlodipine or any of the ingredients in the tablet listed in section 6, or to any other calcium antagonist. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue; if you have very low blood pressure (hypotension) so that you Citiți documentul complet
Health Products Regulatory Authority 30 September 2019 CRN008L7Q Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amlotan 5 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg amlodipine (as amlodipine mesilate monohydrate). Excipients: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet The tablets are white to off-white, round biconvex and embossed with “5” on one 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 once daily which may be increased to a maximum dose of 10 mg (as a single dose) 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 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 is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors. _Special populations Elderly patients_ 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). _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 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 t Citiți documentul complet