Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
LERCANIDIPINE HCI
Actavis Group PTC ehf
C08CA13
LERCANIDIPINE HCI
20 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
lercanidipine
Marketed
2009-09-11
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LECALPIN 10 MG FILM-COATED TABLETS LECALPIN 20 MG FILM-COATED TABLETS Lercanidipine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Lecalpin is and what it is used for 2. What you need to know before you take Lecalpin 3. How to take Lecalpin 4. Possible side effects 5. How to store Lecalpin 6. Contents of the pack and other information 1. WHAT LECALPIN IS AND WHAT IT IS USED FOR Lecalpin belongs to a group of medicines called calcium channel blockers that block the entry of calcium into the muscle cells of the heart and the blood vessels that carry blood away from the heart (the arteries). It is the entry of calcium into these cells that causes the heart to contract and arteries to narrow. By blocking the entry of calcium, calcium channel blockers decrease contraction of the heart and dilate (widen) the arteries, and the blood pressure is reduced. Lecalpin has been prescribed to you to treat your high blood pressure, also known as hypertension. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LECALPIN DO NOT TAKE LECALPIN - if you are allergic to lercanidipine or any of the other ingredients of this medicine ( listed in section 6). - if you have had allergic reactions to medicines that are closely related to Lecalpin tablets (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine) - if you are suffering from certain heart diseases: - uncontrolled cardiac failure - an obstruction to flow of blood from the heart - unstab Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lecalpin 20 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 20 mg lercanidipine hydrochloride, equivalent to 18.8 mg lercanidipine. Excipient with known effect: Lecalpin 20 mg film-coated tablet: Lactose monohydrate 60 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Pink, round, biconvex 8.5 mm film-coated tablets, scored on one side, marked 'L' on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lecalpin is indicated for the treatment of mild to moderate essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Route of administration: For oral use. The recommended dosage is 10 mg orally once a day at least 15 minutes before meals; the dose may be increased to 20 mg depending on the individual patient's response. Dose titration should be gradual, because it may take about 2 weeks before the maximal antihypertensive effect is apparent. Some individuals, not adequately controlled on a single antihypertensive agent, may benefit from the addition of lercandipine to therapy with a beta - adrenoreceptor blocking drug, a diuretic (hydrochlorothiazide) or an angiotensin converting enzyme inhibitor. Since the dose - response curve is steep with a plateau at doses between 20 - 30 mg, it is unlikely that efficacy will be improved by higher doses; whereas side effects may increase. _Elderly_ Although the pharmacokinetic data and clinical experience suggest that no adjustment of the daily dosage is required, special care should be exercised when initiating treatment in the elderly. _Paediatric population_ Lercanidipine is not recommended for use in children and adolescents below the age of 18 years as there is no clinical H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Lue koko asiakirja