LIPREN 10MG FILM COATED TABLETS

Country: Cyprus

Language: Greek

Source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Active ingredient:

PRAVASTATIN SODIUM

Available from:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

ATC code:

C10AA03

INN (International Name):

PRAVASTATIN

Dosage:

10MG

Pharmaceutical form:

FILM COATED TABLETS

Composition:

PRAVASTATIN SODIUM (8000001179) 10MG

Administration route:

ORAL USE

Prescription type:

Εθνική Διαδικασία

Therapeutic area:

PRAVASTATIN

Product summary:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S)(PVC/PVDC ALU) (340000918) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Patient Information leaflet

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�

Summary of Product characteristics

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