Nazione: Svezia
Lingua: svedese
Fonte: Läkemedelsverket (Medical Products Agency)
lerkanidipinhydroklorid, vattenfri
Orifarm AB
C08CA13
lercanidipine hydrochloride, anhydrous
20 mg
Filmdragerad tablett
laktosmonohydrat Hjälpämne; lerkanidipinhydroklorid, vattenfri 20 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 100 tabletter
Avregistrerad
2016-11-23
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LERKANIDIPIN ACTAVIS 10 MG FILM-COATED TABLETS LERKANIDIPIN ACTAVIS 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 /.../ is and what it is 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 /.../ IS AND WHAT IT IS USED FOR /.../ 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. /.../ 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 /.../ - if you are allergic to lercanidipine or any of the other ingredients of this medicine ( listed in section 6). - if you 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) - if you have had heart attack less than one month ago - if you have severe liver problem - if you have severe kidney problems Leggi il documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Lerkanidipin Actavis 10 mg film-coated tablet Lerkanidipin Actavis 20 mg film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 10 mg lercanidipine hydrochloride, equivalent to 9.4 mg lercanidipine. One film-coated tablet contains 20 mg lercanidipine hydrochloride, equivalent to 18.8 mg lercanidipine. Excipient with known effect: /.../ 10 mg film-coated tablet: Lactose monohydrate 30 mg Excipient with known effect: /.../ 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 /.../ 10 mg film-coated tablet: Yellow, round, biconvex 6.5 mm film-coated tablets, scored on one side, marked 'L' on the other side. /.../ 20 mg 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 /.../ 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-adrenoceptor blocking drug (atenolol), a diuretic (hydrochlorothiazide) or an angiotensin converting enzyme inhibitor (captopril or enalapril). 2 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 Leggi il documento completo