البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lercanidipine hydrochloride
Waymade Healthcare Plc
C08CA13
Lercanidipine hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060200
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LERCANIDIPINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS LERCANIDIPINE HYDROCHLORIDE 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. IN THIS LEAFLET: 1. What Lercanidipine Hydrochloride is and what it is used for 2. What you need to know before you take Lercanidipine Hydrochloride 3. How to take Lercanidipine Hydrochloride 4. Possible side effects 5. How to store Lercanidipine Hydrochloride 6. Contents of the pack and other information 1. WHAT LERCANIDIPINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR Lercanidipine Hydrochloride 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. This medicine has been prescribed to you to treat your high blood pressure, also known as hypertension. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LERCANIDIPINE HYDROCHLORIDE DO NOT TAKE LERCANIDIPINE HYDROCHLORIDE • if you are allergic to lercanidipine or to any of the ingredients in this medicine (listed in section 6) • if you have had allergic reactions to medicines that are closely related to lercanidipine (such as amlodipine, nicardipine, اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lercanidipine Hydrochloride 10 mg film-coated tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg lercanidipine hydrochloride, equivalent to 9.4 mg lercanidipine. Excipient with known effect: Each 10 mg film-coated tablet contains 30mg Lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM 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 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 experience. _Renal or hepatic insufficiency _ Special care should be exercised when treatment is commenced اقرأ الوثيقة كاملة