VALEX 1MG FILM COATED TABLETS

Země: Kypr

Jazyk: řečtina

Zdroj: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Aktivní složka:

ANASTROZOLE

Dostupné s:

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

ATC kód:

L02BG03

INN (Mezinárodní Name):

ANASTROZOLE

Dávkování:

1MG

Léková forma:

FILM COATED TABLETS

Složení:

ANASTROZOLE (8000001587) 1MG

Podání:

ORAL USE

Druh předpisu:

Εθνική Διαδικασία

Terapeutické oblasti:

ANASTROZOLE

Přehled produktů:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 10 TABS IN BLISTER(S) (300032901) 10 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 20 TABS IN BLISTER(S) (300032902) 20 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (300032903) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) (300032904) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 50 TABS IN BLISTER(S) (300032905) 50 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 56 TABS IN BLISTER(S) (300032906) 56 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Informace pro uživatele

COMPARATIVE TABLE PIL-EN VS PIL-GR
PACKAGE LEAFLET: INFORMATION FOR THE USER
VALEX 1 MG FILM-COATED TABLETS
anastrozole
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, 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See
section 4.
WHAT IS IN THIS LEAFLET
1. What Valex is and what it is used for
2. What you need to know before you take Valex
3. How to take Valex
4. Possible side effects
5. How to store Valex
6. Contents of the pack and other information
1.
WHAT VALEX IS AND WHAT IT IS USED FOR
Valex contains a substance called anastrozole. This belongs to a group
of
ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ
ΤΟΝ ΧΡΉΣΤΗ
VALEX 1 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ
ΔΙΣΚΊΑ
αναστροζόλη
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, τον φαρμακοποιό ή
τον νοσοκόμο σας.
-
Η συνταγή γι’ αυτό το φάρμακο
χορηγήθηκε αποκλειστικά για σας. Δεν
πρέπει να δώσετε το φάρμακο σε άλλους.
Μπορεί να τους προκαλέσει
βλάβη, ακόμα και

Charakteristika produktu

1.
NAME OF THE MEDICINAL PRODUCT
Valex 1 mg Film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg anastrozole.
Excipient(s) with known effects: each film-coated tablet contains
92.750 mg of lactose
monohydrate (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex film-coated tablets with A1 embossed on one
side and no score line.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Treatment of hormone receptor – positive advanced breast cancer in
postmenopausal
women.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Valex for adults including the elderly is one
1 mg tablet once a
day.
Special populations
_Paediatric population_
Anastrozole is not recommended for use in children and adolescents due
to insufficient data
on safety and efficacy (see sections 4.4 and 5.1).
_Renal impairment_
1
SUMMARY OF PRODUCT CHARACTERISTICS
No dose change is recommended in patients with mild or moderate renal
impairment. In
patients with severe renal impairment, administration of Valex should
be performed with
caution (see section 4.4 and 5.2).
_Hepatic impairment_
No dose change is recommended in patients with mild hepatic disease.
Caution is advised in
patients with moderate to severe hepatic impairment (see section 4.4).
Method of administration
Valex should be taken orally.
4.3 CONTRAINDICATIONS
Valex is contraindicated in:

Pregnant or breast-feeding women.

Patients with known hypersensitivity to anastrozole or to any of the
excipients as
referenced in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
General
Valex should not be used in premenopausal women. The menopause should
be defined
biochemically (luteinizing-hormone [LH], follicle stimulating hormone
[FSH], and/or
estradiol levels) in any patient where there is doubt about menopausal
status. There are no
data to support the use of Anastrozole with LHRH analogues.
Co-administration of tamoxifen o