Country: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Felodipine
Kent Pharma (UK) Ltd
C08CA02
Felodipine
5mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060200; GTIN: 5060003784319
170mm 500mm Neofel PIL Size: 170 x 500mm Package leaflet: Information for the patient NEOFEL XL 2.5, 5 & 10 MG PROLONGED RELEASE TABLETS (FELODIPINE) The name of this medicine is Neofel XL Prolonged Release Tablets (felodipine), which will be referred to as Neofel XL throughout this 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 further questions, please 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 not listed in this leaflet. See section 4. 1. WHAT NEOFEL XL ARE AND WHAT THEY ARE USED FOR The active ingredient in Neofel XL is felodipine which is one of a group of medicines called dihydropyridine calcium antagonists. These work by blocking the entry of calcium into muscle cells. Neofel XL (felodipine) affects the muscle in blood vessels more than other muscles. It causes a relaxation of the muscle and a widening of the blood vessels. As the blood vessels get wider, blood pressure falls and the heart does not need to work so hard to pump blood around the body, reducing the risk of angina. Neofel XL is used to treat high blood pressure (hypertension) and prevent attacks of angina (a painful condition where there is a lack of blood and oxygen to the heart). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEOFEL XL DO NOT TAKE NEOFEL XL: • If you are PREGNANT, planning to become pregnant or you suspect you are pregnant • 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 had a HEART ATTACK (myocardial infarction) within the last 4 weeks • If you SUFFER FROM SEVERE CHEST PAIN DUE TO A LACK OF BLOOD AND Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Neofel XL 5 mg Prolonged Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Neofel XL 5 mg Prolonged Release Tablets contain 5mg of felodipine. 3 PHARMACEUTICAL FORM Light pink, round, biconvex, film coated prolonged-release tablets with imprint 5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In_ _the management of hypertension and prophylaxis of chronic stable angina pectoris. 4.2 POSOLOGY AND 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. 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 Special warnings and precautions for use). Paediatric Population There is limited clinical trial experience of the use of felodipine in hypertensive paediatric patients, see sections 5.1 and 5.2. Neofel XL 5 mg Prolonged Release Tablets can be used in combination with -blockers, ACE inhibitors or diuretics. The effects on blood pressure are likely to be additive and combination therapy will usually enhance the antihypertensive effect. Aqra d-dokument sħiħ