TOMEL 25MG FILM COATED TABLETS

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

QUETIAPINE FUMARATE

Διαθέσιμο από:

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

Φαρμακολογική κατηγορία (ATC):

N05AH04

INN (Διεθνής Όνομα):

QUETIAPINE

Δοσολογία:

25MG

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

QUETIAPINE FUMARATE (8000001571) 28,783MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

QUETIAPINE

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 30 TABS IN BLISTER(S) (300006303) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 60 TABS IN BLISTER(S) (300006304) 60 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή

Φύλλο οδηγιών χρήσης

COMPARATIVE TABLE OF PIL-EN VS PIL-GR
Package leaflet: Information for the user
Tomel 25 mg film-coated tablets
Tomel 100 mg film-coated tablets
Tomel 150 mg film-coated tablets
Tomel 200 mg film-coated tablets
Tomel 300 mg film-coated tablets
quetiapine
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 Tomel is and what it is used for
2. What you need to know before you take Tomel
3. How to take Tomel
4. Possible side effects
5. How to store Tomel
6. Contents of the pack and other information
1.
What Tomel is and what it is used for
Φύλλο οδηγιών χρήσης: Πληροφορίες για
τον χρήστη
Tomel 25 mg επικαλυμμένα με λεπτό υμένιο
δισκία
Tomel 100 mg επικαλυμμένα με λεπτό υμένιο
δισκία
Tomel 150 mg επικαλυμμένα με λεπτό υμένιο
δισκία
Tomel 200 mg επικαλυμμένα με λεπτό υμένιο
δισκία
Tomel 300 mg επικαλυμμένα με λεπτό υμένιο
δισκία
κουετιαπίνη
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 απορ�

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
Tomel 25 mg Film-coated tablets
Tomel 100 mg Film-coated tablets
Tomel 150 mg Film-coated tablets
Tomel 200 mg Film-coated tablets
Tomel 300 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For 25mg strength:
Each tablet contains 25 mg quetiapine (as quetiapine fumarate).
Excipient(s) with known effect: Each tablet contains 1.000 mg lactose
monohydrate.
For 100mg strength:
Each tablet contains 100 mg quetiapine (as quetiapine fumarate).
Excipient(s) with known effect: Each tablet contains 4.000 mg lactose
monohydrate.
For 150mg strength:
Each tablet contains 150 mg quetiapine (as quetiapine fumarate).
Excipient(s) with known effect: Each tablet contains 6.000 mg lactose
monohydrate.
For 200mg strength:
Each tablet contains 200 mg quetiapine (as quetiapine fumarate).
Excipient(s) with known effect: Each tablet contains 8.000 mg lactose
monohydrate.
For 300mg strength:
Each tablet contains 300 mg quetiapine (as quetiapine fumarate).
Excipient(s) with known effect: Each tablet contains 12.000 mg lactose
monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
1
SUMMARY OF PRODUCT CHARACTERISTICS
For 25 mg strength:
Peach coloured, round, biconvex film-coated tablets.
For 100 mg strength:
Yellow coloured, round, biconvex film-coated tablets with breakline on
one side*.
For 150 mg strength:
Pale yellow coloured, round, biconvex film-coated tablets.
For 200 mg strength:
White, round, biconvex film-coated tablets.
For 300 mg strength:
White, capsule shaped, film-coated tablets with breakline on one
side*.
The tablet can be divided in to equal halves*.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tomel is indicated for:

treatment of schizophrenia.

treatment of bipolar disorder:

For the treatment of moderate to severe manic episodes in bipolar
disorder

For the treatment of major depressive episodes in bipolar disorder

For the prevention of recurrence of manic or depressed episodes in
patients with b