FORAVATE 5MG FILM COATED TABLETS

Land: Cypern

Språk: grekiska

Källa: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Aktiva substanser:

FINASTERIDE

Tillgänglig från:

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

ATC-kod:

G04CB01

INN (International namn):

FINASTERIDE

Dos:

5MG

Läkemedelsform:

FILM COATED TABLETS

Sammansättning:

FINASTERIDE (8000001325) 5MG

Administreringssätt:

ORAL USE

Receptbelagda typ:

Εθνική Διαδικασία

Terapiområde:

FINASTERIDE

Produktsammanfattning:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (300026604) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Bipacksedel

COMPARATIVE TABLE OF PIL-EN VS PIL-GR
PACKAGE LEAFLET: INFORMATION FOR THE USER
FORAVATE 5 MG FILM-COATED TABLETS
finasteride
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 Foravate is and what it is used for
2. What you need to know before you take Foravate
3. How to take Foravate
4. Possible side effects
5. How to store Foravate
6. Contents of the pack and other information1. What T is and what
1.
WHAT FORAVATE IS AND WHAT IT IS USED FOR
Foravate contains a medicine called finasteride. This belongs to a
group of medicines called “5-alpha reductase inhibitors”.
ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ
ΤΟΝ ΧΡΉΣΤΗ
FORAVATE 5 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ
ΔΙΣΚΊΑ
φιναστερίδη
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
τον γιατρό σας ή τον
φαρμακοποιό.

Η συνταγή γι’ αυτό το φάρμακο
χορηγήθηκε αποκλειστικά για
σας. Δεν πρέπει να δώσετε το φάρμακο σε
άλλους. Μ�

Produktens egenskaper

1.
NAME OF THE MEDICINAL PRODUCT
Foravate 5 mg
Finasteride 5 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of 'Foravate' contains 5 mg of Finasteride.
Excipient(s) with known effect: 90.962 mg of lactose monohydrate per
film-coated tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Round biconvex, blue, 7 mm, marked “F5” on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
'Foravate' is indicated for the treatment and control of benign
prostatic hyperplasia (BPH) in
patients with an enlarged prostate to:

cause regression of the enlarged prostate, improve urinary flow and
improve the symptoms
associated with BPH

reduce the incidence of acute urinary retention and the need for
surgery including transurethral
resection of the prostate (TURP) and prostatectomy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended adult dose is one 5 mg tablet daily, with or without
food.
‘Foravate’ can be administered alone or in combination with the
alpha-blocker doxazosin (see
section 5.1 ‘Pharmacodynamic properties’).
1
SUMMARY OF PRODUCT CHARACTERISTICS
Although early improvement in symptoms may be seen, treatment for at
least six months may be
necessary to assess whether a beneficial response has been achieved.
Thereafter, treatment should
be continued long term.
No dosage adjustment is required in the elderly or in patients with
varying degrees of renal
insufficiency (creatinine clearance as low as 9ml/min).
There are no data available in patients with hepatic insufficiency.
‘Foravate’ is contra-indicated in children.
4.3 CONTRAINDICATIONS
'Foravate' is not indicated for use in women or children.
'Foravate' is contraindicated in the following:

Hypersensitivity to any component of this product.

Pregnancy - Use in women when they are or may potentially be pregnant
(see 4.6 Pregnancy and
lactation, Exposure to finasteride - risk to male foetus).
4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE