Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LERCANIDIPINEHYDROCHLORIDE HEMIHYDRAAT SAMENSTELLING overeenkomend met ; LERCANIDIPINE
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
C08CA13
LERCANIDIPINEHYDROCHLORIDE HEMIHYDRATE COMPOSITION corresponding to ; LERCANIDIPINE
Filmomhulde tablet
CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Lercanidipine
Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2010-01-05
PACKAGE LEAFLET: INFORMATION FOR THE USER Lercanidipine HCI STADA 10 mg [20 mg], filmomhulde tabletten Active substance: 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 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 Lercanidipin STADA is and what it is used for 2. What you need to know before you take Lercanidipin STADA 3. How to take Lercanidipin STADA 4. Possible side effects 5. How to store Lercanidipin STADA 6. Contents of the pack and other information 1. WHAT LERCANIDIPIN STADA IS AND WHAT IT IS USED FOR Lercanidipin STADA is a selective calcium channel blocker belonging to a group of medicines called dihydropyridines. Selective calcium channel blockers reduce high blood pressure. They work by relaxing and thus widening the blood vessels. LERCANIDIPIN STADA IS USED TO: treat mild to moderate high blood pressure (essential hypertension). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LERCANIDIPIN STADA DO NOT TAKE LERCANIDIPIN STADA if you are allergic to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6) if you have had allergic reactions to medicines closely related to Lercanidipin STADA (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine) if you are pregnant or breast-feeding, or if you might become pregnant (see section 2. Pregnancy and breast-feeding) if you are suffering from certain heart diseases: - uncontrolled cardiac failure - obstruction to flow of blood from the heart - unstable angina (angina at r Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lercanidipine HCl STADA 10 mg, filmomhulde tabletten Lercanidipine HCl STADA 20 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Lercanidipin STADA 10 mg film-coated tablets _ One tablet contains 10 mg of lercanidipine hydrochloride as lercanidipine hydrochloride hemihydrate. This is equivalent to 9.4 mg of lercanidipine. Excipient with known effect: Each film-coated tablet contains 36.55 mg lactose-monohydrate. _Lercanidipin STADA 20 mg film-coated tablets _ One tablet contains 20 mg of lercanidipine hydrochloride as lercanidipine hydrochloride hemihydrate. This is equivalent to 18.8 mg of lercanidipine. Excipient with known effect: Each film-coated tablet contains 73.1 mg lactose-monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film_-_coated tablet _Lercanidipin STADA 10 mg film-coated tablets _ Yellow, round, biconvex film-coated tablets of 6.5 mm with score line. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. _Lercanidipin STADA 20 mg film-coated tablets _ Pink, round, biconvex film-coated tablets of 8.1 mm with score line. The tablets 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 Method of administration: Oral use The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The recommended dosage is 10 mg once a day at least 15 minutes before meals (preferably before breakfast); the dose may be increased to 20 mg depending on the individual patient's response. Lercanidipin STADA 20 mg film-coated tablets The tablets can be divided into equal halves. The remaining tablet half should be stored protected from light. This remaining half should be taken with the next dose. Dose titration should be gradual, because it may take about 2 Lees het volledige document