Страна: Нідерланди
мова: голландська
Джерело: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LERCANIDIPINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; LERCANIDIPINE
Teva Nederland B.V.
C08CA13
LERCANIDIPINEHYDROCHLORIDE COMPOSITION corresponding to ; LERCANIDIPINE
Filmomhulde tablet
ALLURAROOD AC ALUMINIUM LAK (E 129) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), ALLURAROOD AC ALUMINIUM LAK (E 129) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Lercanidipine
Hulpstoffen: ALLURAROOD AC ALUMINIUM LAK (E 129); CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);
2011-07-20
Lercanidipine hydrochloride 10 & 20 mg Film-coated Tablets UK/H/4385/001-002/DC 1 PACKAGE LEAFLET: INFORMATION FOR THE USER Lercanidipine HCl 10 mg Teva, filmomhulde tabletten Lercanidipine HCl 20 mg Teva, filmomhulde tabletten Lercanidipine hydrochloride 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 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 of the 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. Whatis and what it is used for 2. What you need to know before you take Прочитайте повний документ3. 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 (dihydropyridine derivatives). is used to treat high blood pressure, also known as hypertension, in adults over the age of 18 years (it is not recommended for children under 18 years old). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE - If you are ALLERGIC (hypersensitive) to lercanidipine or to 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 (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine) - If you are suffering from CERTAIN HEART DISEASES: - untreated heart failure - obstruction to flow of blo
Lercanidipine hydrochloride 10 & 20 mg Film-coated Tablets UK/H/4385/001-002/DC 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lercanidipine HCl 10 mg Teva, filmomhulde tabletten Lercanidipine HCl 20 mg Teva, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 10 mg strength: One tablet contains 10 mg of lercanidipine hydrochloride, which is equivalent to 9.4 mg of lercanidipine. 20 mg strength: One tablet contains 20 mg of lercanidipine hydrochloride, which is equivalent to 18.8 mg of lercanidipine. _Excipients with known effects _ 10 mg strength: One tablet contains 30 mg of lactose monohydrate (equivalent to 28.5 mg of lactose anhydrous) and 0.27 mg of tartrazine aluminium lake (E102). 20 mg strength: One tablet contains 60 mg of lactose monohydrate (equivalent to 57 mg of lactose anhydrous) and 0.711 mg of allura red AC aluminium lake (E129). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film_-_coated tablet. 10 mg strength: Yellow to dark yellow, round convex film-coated tablet debossed with the number "10" on one side and scored on the other. 20 mg strength: Light pink to pink, round convex film-coated tablet debossed with the number "20" on one side and scored on the other The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lercanidipine 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 lercanidipine to therapy with a beta-adrenoceptor blocking agent (atenolol), a diuretic (hydrochlorothiazide) or an angiotensin-converting Прочитайте повний документ