Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
FELODIPINE
AstraZeneca AB SE-151 85, Södertälje, Sweden
C08CA02
FELODIPINE 5 mg
PROLONGED-RELEASE TABLET
FELODIPINE 5 mg
POM
CALCIUM CHANNEL BLOCKERS
Withdrawn
2006-03-29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PLENDIL 2.5 MG PROLONGED - RELEASE TABLETS PLENDIL 5 MG PROLONGED - RELEASE TABLETS PLENDIL 10 MG PROLONGED - RELEASE TABLETS felodipine 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. • 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Plendil is and what it is used for 2. What you need to know before you take Plendil 3. How to take Plendil 4. Possible side effects 5. How to store Plendil 6. Contents of the pack and other information 1. WHAT PLENDIL IS AND WHAT IT IS USED FOR Plendil contains the active substance felodipine. This belongs to a group of medicines called calcium antagonists. It lowers blood pressure by dilating small blood vessels. It does not negatively affect the heart function. Plendil is used in the treatment of high blood pressure (hypertension) and heart and chest pain brought on by for example exercise and stress (angina pectoris). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PLENDIL DO NOT TAKE PLENDIL • if you are pregnant. You should tell your doctor as soon as possible if you become pregnant while using this medicine. • if you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6). • if you suffer from uncompensated heart failure. • if you have acute myocardial infarction (heart attack). • if you have chest pain of recent onset, or angina pectoris that is lasting for more than 15 minutes or longer or is more severe than usual. • if you have disease of a heart valve or heart muscle, until you have talked to your doctor. WARNINGS AND PRECAUTIONS Pl Perskaitykite visą dokumentą
1 1. NAME OF THE MEDICINAL PRODUCT Plendil 5 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg felodipine. Excipients with known effect: Each tablet contains 28 mg lactose and 5 mg macrogolglycerol hydroxystearate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM The tablet is pink, circular, biconvex, engraved A/Fm on one side and 5 on the other side, with a diameter of 9 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Stable angina pectoris _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Hypertension _ The dose should be adjusted individually. Treatment can be started with 5 mg once daily. Depending on the patient’s response, the dosage can, where applicable, be decreased to 2.5 mg or increased to 10 mg daily. If necessary another antihypertensive agent may be added. The standard maintenance dose is 5 mg once daily. _ _ _Angina pectoris _ The dose should be adjusted individually. Treatment should be initiated with 5 mg once daily and, if needed, increased to 10 mg once daily. _ _ _Elderly population _ Initial treatment with lowest available dose should be considered. _ _ _Renal impairment _ Dose adjustment is not needed in patients with impaired renal function. _ _ _Hepatic impairment _ Patients with impaired hepatic function may have elevated plasma concentrations of felodipine and may respond to lower doses (see section 4.4). _ _ _Paediatric population _ There is limited clinical trial experience of the use of felodipine in hypertensive paediatric patients (see sections 5.1 and 5.2). 2 Method of administration The tablets should be taken in the morning and be swallowed with water. In order to keep the prolonged-release properties, the tablets must not be divided, crushed or chewed. The tablets can be administered without food or following a light meal not rich in fat or carbohydrate. 4.3 CONTRAINDICATIONS • Pregnancy • Hypersensitivity to felodipine or any of the excipients listed in section 6.1 • Dec Perskaitykite visą dokumentą