PIRALEPS 100MG FILM COATED TABLETS

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

TOPIRAMATE

Διαθέσιμο από:

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

Φαρμακολογική κατηγορία (ATC):

N03AX11

INN (Διεθνής Όνομα):

TOPIRAMATE

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

TOPIRAMATE (0097240794) 100MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

TOPIRAMATE

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) ALU/ALU (300051701) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 60 TABS IN BLISTER(S) ALU/ALU (300051702) 60 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 100 TABS IN BLISTER(S) ALU/ALU (300051703) 100 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 200 TABS IN BLISTER(S) ALU/ALU (300051704) 200 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) PVC/PVDC-ALU (300051705) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 60 TABS IN BLISTER(S) PVC/PVDC-ALU (300051706) 60 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 100 TABS IN BLISTER(S) PVC/PVDC-ALU (300051707) 100 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 200 TABS IN BLISTER(S) PVC/PVDC-ALU (300051708) 200 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
PIRALEPS 25 MG FILM-COATED TABLETS
PIRALEPS 50 MG FILM-COATED TABLETS
PIRALEPS 100 MG FILM-COATED TABLETS
PIRALEPS 200 MG FILM-COATED TABLETS
Topiramate
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. 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 Piraleps is and what it is used for
2. What you need to know before you take Piraleps
3. How to take Piraleps
4. Possible side effects
5. How to store Piraleps
6. Contents of the pack and other information
1.
WHAT PIRALEPS IS AND WHAT IT IS USED FOR
Piraleps belongs to a group of medicines called “anti-epileptic
medicines.” It is used:

alone to treat seizures in adults and children over age 6

with other medicines to treat seizures in adults and children age 2
years and above

to prevent migraine headaches in adults
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIRALEPS
DO NOT TAKE PIRALEPS

if you are allergic to topiramate or any of the other ingredients of
this medicine (listed in
section 6).

for migraine prevention: if you are pregnant or if you are a woman of
childbearing
potential unless you are using effective contraception (see section
‘pregnancy and
breastfeeding’ for further information). You should talk to your
doctor about the best kind
of contraception to use while you are taking Piraleps.
If you are not sure if the above applies to you, talk to your doctor
or pharmacist before using
Piraleps.
WARNINGS AND PRECAUTIONS
1
Talk to your doctor or pharmacist before taking Piraleps if you:

have kidney problems, especially k

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Piraleps 25 mg Film-coated tablets
Piraleps 50 mg Film-coated tablets
Piraleps 100 mg Film-coated tablets
Piraleps 200 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mg tablet contains 25 mg of Topiramate.
Each 50 mg tablet contains 50 mg of Topiramate.
Each 100 mg tablet contains 100 mg Topiramate.
Each 200 mg tablet contains 200 mg Topiramate.
Excipients with known effect
25 mg tablet contains 47. 960 mg lactose monohydrate;
50 mg tablet contains 95.920 mg lactose monohydrate;
100 mg tablet contains 191.840 mg lactose monohydrate;
200 mg tablet contains 124.505 mg lactose monohydrate;
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
For 25 mg strength:
White, round, embossed film-coated tablets with ‘T’ logo engrave
on one
side and ‘25’ on the other side.
For 50 mg strength:
Orange, round, embossed film-coated tablets with ‘T’ logo engraved
on one
side and ‘50’ on the other side.
For 100 mg strength: Yellow, round, embossed film-coated tablets with
‘T’ logo engraved on one
side and ‘100’ on the other side.
For 200 mg strength:
Pink, round, embossed tablets with ‘T’ logo engraved on one side
and
‘200’
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1
Monotherapy in adults, adolescents and children over 6 years of age
with partial seizures with or
without secondary generalised seizures, and primary generalised
tonic-clonic seizures.
Adjunctive therapy in children aged 2 years and above, adolescents and
adults with partial onset
seizures with or without secondary generalization or primary
generalized tonic-clonic seizures and for
the treatment of seizures associated with Lennox-Gastaut syndrome.
Topiramate is indicated in adults for the prophylaxis of migraine
headache after careful evaluation of
possible alternative treatment options. Topiramate is not intended for
acute treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATIO