SEIZAL 25MG TABLETS

מדינה: קפריסין

שפה: יוונית

מקור: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

מרכיב פעיל:

LAMOTRIGINE

זמין מ:

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

קוד ATC:

N03AX09

INN (שם בינלאומי):

LAMOTRIGINE

כמות:

25MG

טופס פרצבטיות:

TABLETS

הרכב:

LAMOTRIGINE (0084057841) 25MG

מסלול נתינה (של תרופות):

ORAL USE

סוג מרשם:

Εθνική Διαδικασία

איזור תרפויטי:

LAMOTRIGINE

leaflet_short:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) (340000308) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

עלון מידע

COMPARATIVE TABLE ENGLISH VS GREEK PIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEIZAL 25 MG TABLETS
SEIZAL 50 MG TABLETS
SEIZAL 100 MG TABLETS
SEIZAL 200 MG TABLETS
lamotrigine
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 Seizal is and what it is used for
2.
What you need to know before you take Seizal
3.
How to take Seizal
4.
Possible side effects
5.
How to store Seizal
6.
Contents of the pack and other information
1.
WHAT SEIZAL IS AND WHAT IT IS USED FOR
Seizal belongs to a group of medicines called _anti-epileptics_. It is
used to
treat two conditions – EPILEPSY and BIPOLAR DISORDER.
ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ
ΤΟΝ ΧΡΉΣΤΗ
SEIZAL 25 MG ΔΙΣΚΊΑ
SEIZAL 50 MG ΔΙΣΚΊΑ
SEIZAL 100 MG ΔΙΣΚΊΑ
SEIZAL 200 MG ΔΙΣΚΊΑ
λαμοτριγίνη
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 ή τον φαρµακοποιό
σας.

Η συνταγή για αυτό το φάρµακο
χορηγήθηκε αποκλειστικά για σας. ∆εν
πρέπει να �

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Seizal 25 mg Τablets
Seizal 50 mg Τablets
Seizal 100 mg Τablets
Seizal 200 mg Τablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of lamotrigine.
Excipient
(s) with known effect
:
Each tablet contains 4.0 mg lactose monohydrate.
Each tablet contains 50 mg of lamotrigine.
Excipient
(s) with known effect
:
Each tablet contains 8.0 mg lactose monohydrate.
Each tablet contains 100 mg of lamotrigine.
Excipient
(s) with known effect
:
Each tablet contains 16.0 mg lactose monohydrate.
Each tablet contains 200 mg of lamotrigine.
Excipient
(s) with known effect
:
Each tablet contains 32.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
For 25 mg, 50 mg, 100 mg, 200 mg tablets strength:
White to off-white, round, flat face, bevelled edge tablet, plain on
both sides.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epilepsy
_Adults and adolescents aged 13 years and above_

Adjunctive or monotherapy treatment of partial seizures and
generalised seizures, including
tonic-clonic seizures.

Seizures associated with Lennox-Gastaut syndrome. Seizal is given as
adjunctive therapy but
may be the initial antiepileptic drug (AED) to start with in
Lennox-Gastaut syndrome.
1
SUMMARY OF PRODUCT CHARACTERISTICS
_Children and adolescents aged 2 to 12 years_

Adjunctive treatment of partial seizures and generalised seizures,
including tonic-clonic
seizures and the seizures associated with Lennox-Gastaut syndrome.

Monotherapy of typical absence seizures.
Bipolar disorder
_Adults aged 18 years and above_

Prevention of depressive episodes in patients with bipolar I disorder
who experience
predominantly depressive episodes (see section 5.1).
Seizal is not indicated for the acute treatment of manic or depressive
episodes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Seizal tablets should be swallowed whole, and should not be chewed or
crushed.
If the calculated dose of lamot