Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lercanidipine hydrochloride
Accord-UK Ltd
C08CA13
Lercanidipine hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060200; GTIN: 5012617019431
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 LERCANIDIPINE HYDROCHLORIDE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE 3 HOW TO TAKE 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT LERCANIDIPINE HYDROCHLORIDE TABLETS ARE AND WHAT THEY ARE USED FOR Lercanidipine 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. Lercanidipine has been prescribed to you to treat your high blood pressure, also known as hypertension. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE LERCANIDIPINE IF YOU: • are ALLERGIC to lercanidipine or any of the other ingredients of this medicine (listed in section 6). • have HAD ALLERGIC REACTIONS to medicines that are closely related to Lercanidipine hydrochloride tablets (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine) • are suffering from certain HEART diseases: • uncontrolled cardiac failure • an obstruction to flow of blood from the heart • unstable angina (angina at rest or progressively increasing) • have had a heart attack le Прочитайте повний документ
OBJECT 1 LERCANIDIPINE HYDROCHLORIDE 10 MG FILM-COATED TABLET Summary of Product Characteristics Updated 21-May-2018 | Accord-UK Ltd 1. Name of the medicinal product Lercanidipine hydrochloride 10 mg film-coated tablet 2. Qualitative and quantitative composition One film-coated tablet contains 10 mg lercanidipine hydrochloride, equivalent to 9.4mg lercanidipine. Excipient with known effect: Lercanidipine hydrochloride 10 mg film-coated tablet: Lactose monohydrate 30 mg For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet Lercanidipine hydrochloride 10 mg film-coated tablet: Yellow, round, biconvex 6.5 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 Lercanidipine hydrochloride 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 r Прочитайте повний документ