SEIZAL 100MG TABLET, DISPERSIBLE

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

LAMOTRIGINE

Διαθέσιμο από:

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

Φαρμακολογική κατηγορία (ATC):

N03AX09

INN (Διεθνής Όνομα):

LAMOTRIGINE

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

TABLET, DISPERSIBLE

Σύνθεση:

LAMOTRIGINE (0084057841) 100MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

LAMOTRIGINE

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) (320020505) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 60 TABS IN BLISTER(S) (320020509) 60 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Φύλλο οδηγιών χρήσης

PATIENT INFORMATION LEAFLET
SEIZAL 5 MG DISPERSIBLE TABLETS
SEIZAL 25 MG DISPERSIBLE TABLETS
SEIZAL 50 MG DISPERSIBLE TABLETS
SEIZAL 100 MG DISPERSIBLE TABLETS
SEIZAL 200 MG DISPERSIBLE TABLETS
Lamotrigine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms 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.
IN THIS LEAFLET:
1. What Seizal is and what it is used for
2. Before you take Seizal
3. How to take Seizal
4. Possible side effects
5. How to store Seizal
6. Further 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.
SEIZAL TREATS EPILEPSY by blocking the signals in the brain that
trigger epileptic seizures (fits).
• For adults and children aged 13 years and over, Seizal can be used
on its own or with other
medicines, to treat epilepsy. Seizal can also be used with other
medicines to treat the seizures that
occur with a condition called Lennox-Gastaut syndrome.
• For children aged between 2 and 12 years, Seizal can be used with
other medicines, to treat those
conditions. It can be used on its own to treat a type of epilepsy
called typical absence seizures.
SEIZAL ALSO TREATS BIPOLAR DISORDER
People with bipolar disorder (sometimes called _manic depression_)
have extreme mood swings, with
periods of mania (excitement or euphoria) alternating with periods of
depression (deep sadness or
despair). For adults aged 18 years and over, Seizal can be used on its
own or with other medicines, to
prevent the periods of depression that occur in bipolar disorder. It
is not yet known how Seizal works
in the br

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
Seizal 5 mg Dispersible tablets
Seizal 25 mg Dispersible tablets
Seizal 50 mg Dispersible tablets
Seizal 100 mg Dispersible tablets
Seizal 200 mg Dispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For 5 mg strength:
Each dispersible tablet contains 5 mg lamotrigine
For 25 mg strength:
Each dispersible tablet contains 25 mg lamotrigine
For 50 mg strength:
Each dispersible tablet contains 50 mg lamotrigine
For 100 mg strength:
Each dispersible tablet contains 100 mg lamotrigine
For 200 mg strength:
Each dispersible tablet contains 200 mg lamotrigine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
For 5 mg dispersible tablets strength:
White to off-white, oblong shape, engraved with “L” and “5” on
one side, scored on the other side.
For 25 mg dispersible tablets strength:
White to off-white, modified square shape, engraved with “L” and
“25” on one side, plain on the
other side.
For 50 mg dispersible tablets strength:
White to off-white, modified square shape, engraved with “L” and
“50” on one side, plain on the
other side.
For 100 mg dispersible tablets strength:
White to off-white, modified square shape, engraved with “L” and
“100” on one side, plain on the
other side.
For 200 mg dispersible tablets strength:
1
SUMMARY OF PRODUCT CHARACTERISTICS
White to off-white, modified square shape, engraved with “L” and
“200” on one side, plain on the
other side.
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.
_Children and adolescents aged 2 to 12 years_
- Adjunctive treatment of partial seizures and generalised seizures,
including tonic
clonic seizures
and the s