Страна: Кіпр
мова: грецька
Джерело: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
PRAVASTATIN SODIUM
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
C10AA03
PRAVASTATIN
40MG
FILM COATED TABLETS
PRAVASTATIN SODIUM (8000001179) 40MG
ORAL USE
Εθνική Διαδικασία
PRAVASTATIN
Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S)(PVC/PVDC ALU) (340001118) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται
COMPARATIVE TABLE ENGLISH VS GREEK PIL PACKAGE LEAFLET: INFORMATION FOR THE USER LIPREN 10 MG FILM-COATED TABLETS LIPREN 20 MG FILM-COATED TABLETS LIPREN 40 MG FILM-COATED TABLETS Pravastatin sodium 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 or nurse. 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Lipren is and what it is used for 2. What you need to know before you take Lipren 3. How to take Lipren 4. Possible side effects 5. How to store Lipren 6. Contents of the pack and other information ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΤΟΝ ΧΡΉΣΤΗ LIPREN 10 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΔΙΣΚΊΑ LIPREN 20 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΔΙΣΚΊΑ LIPREN 40 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΔΙΣΚΊΑ Νατριούχος πραβαστατίνη ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ ΠΡΙΝ ΑΡΧΊΣΕΤΕ ΝΑ ΠΑΊΡΝΕΤΕ ΑΥΤΌ ΤΟ ΦΆΡΜΑΚΟ, ΔΙΌΤΙ ΠΕΡΙΛΑΜΒΆΝΕΙ ΣΗΜΑΝΤΙΚΈΣ ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΣΑΣ. Φυλάξτε αυτό το φύλλο οδηγιών χρήσης. Ίσως χρειαστεί να το διαβάσετε ξανά. Εάν έχετε περαιτέρω απορίες, ρωτήστε το γιατρό, ή το φαρμακοποιό σας, ή το νοσοκόμο σας. Η συνταγή για αυτό το φάρμακο χορηγήθηκε αποκλεισ Прочитайте повний документ
1. NAME OF THE MEDICINAL PRODUCT Lipren 10 mg Film-coated tablets Lipren 20 mg Film-coated tablets Lipren 40 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg, 20 mg or 40 mg pravastatin sodium. Excipient(s) with known effect: each 10 mg film-coated tablet contains 52.15 mg of lactose monohydrate. Excipient(s) with known effect: each 20 mg film-coated tablet contains 104.60 mg of lactose monohydrate. Excipient(s) with known effect: each 40 mg film-coated tablet contains 207.36 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Lipren 10 mg film-coated tablets: Pink-peach, indented capsule shape tablet, with "10" on one side. Lipren 20 mg film-coated tablets: Yellow, indented capsule shape tablet, with "20" on one side. Lipren 40 mg film-coated tablets: Yellow, indented capsule shape tablet, with "40" on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERCHOLESTEROLAEMIA Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. 1 SUMMARY OF PRODUCT CHARACTERISTICS PRIMARY PREVENTION Reduction of cardiovascular mortality and morbidity in patients with moderate or severe hypercholesterolaemia and at high risk of a first cardiovascular event, as an adjunct to diet (see section 5.1). SECONDARY PREVENTION Reduction of cardiovascular mortality and morbidity in patients with a history of myocardial infarction (MI) or unstable angina pectoris and with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors (see section 5.1). POST TRANSPLANTATION Reduction of post transplantation hyperlipidaemia in patients receiving immunosuppressive therapy following solid organ transplantation. (see sections 4.2, 4.5 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prior to initiating Lipren, secondary causes of hypercholest Прочитайте повний документ