Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
LERCANIDIPINE HYDROCHLORIDE
Arrow Generics Limited Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom
C08CA13
LERCANIDIPINE HYDROCHLORIDE 10 mg
FILM-COATED TABLET
LERCANIDIPINE HYDROCHLORIDE 10 mg
POM
CALCIUM CHANNEL BLOCKERS
Withdrawn
2011-04-12
1 PACKAGE LEAFLET: INFORMATION FOR THE USER 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 TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. Note that this leaflet is revised on a regular basis with the latest information on your medicine. Please refer to the date at the end of this leaflet. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. 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 which worry you (even side effects not listed in this leaflet), talk to your doctor or pharmacist. WHERE TO FIND INFORMATION IN THIS LEAFLET: 1. What Lercanidipine Tablets are and what they are used for 2. What you need to know about Lercanidipine Tablets 3. How to take Lercanidipine Tablets 4. Possible side effects 5. How to store Lercanidipine Tablets 6. What is in the pack and further information 1. WHAT LERCANIDIPINE TABLETS ARE AND WHAT THEY ARE USED FOR Lercanidipine 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. Lercanidipine is used to treat mild to moderate high blood pressure (essential hypertension). 2. WHAT YOU NEED TO KNOW ABOUT LERCANIDIPINE TABLETS DO NOT TAKE LERCANIDIPINE TABLETS: • if you are allergic (hypersensitive) to lercanidipine or any of the other ingredients of Lercanid Διαβάστε το πλήρες έγγραφο
PAGE 1 OF 9 1 1 NAME OF THE MEDICINAL PRODUCT Lercanidipine hydrochloride 10 mg Film-coated Tablets Lercanidipine hydrochloride 20 mg Film-coated Tablets 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: Each lercanidipine hydrochloride 10 mg film-coated tablet contains 30 mg lactose monohydrate. Each lercanidipine hydrochloride 20 mg film-coated tablet contains 60 mg lactose monohydrate and 0.012 mg Sunset Yellow (E110). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). _ _ <10 mg> Yellow, round shaped coated tablet, with bisect on one side and ‘LC’ over ‘ ’ on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. <20 mg> Pink, round shaped coated tablet, with bisect on one side and ‘LC’ over ‘ ’ on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS {Lercanidipine hydrochloride <10 mg><20 mg> Film-coated Tablets} are indicated for the treatment of mild to moderate essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dosage is 10 mg once a day to be taken orally at least 15 minutes before a meal; the dose may be increased to 20 mg depending on the individual patient's response. Dose titration should be gradual; it may take 2 weeks before the maximal antihypertensive effect is apparent. Some individuals, not adequately controlled on a Διαβάστε το πλήρες έγγραφο