Topiramate 25mg Film-coated Tablets

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

TOPIRAMATE

Saatavilla:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC-koodi:

N03AX11

INN (Kansainvälinen yleisnimi):

TOPIRAMATE 25 mg

Lääkemuoto:

FILM-COATED TABLET

Koostumus:

TOPIRAMATE 25 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTIEPILEPTICS

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-07-03

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER TOPIRAMATE 25 MG FILM-COATED TABLETS
TOPIRAMATE 50 MG FILM-COATED TABLETS
TOPIRAMATE 100 MG FILM-COATED TABLETS
TOPIRAMATE 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 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 Topiramate is and what it is used for
2.
What you need to know before you take Topiramate
3.
How to take Topiramate
4.
Possible side effects
5.
How to store Topiramate
6.
Contents of the pack and other information
1.
WHAT TOPIRAMATE IS AND WHAT IT IS USED FOR
Topiramate 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 aged 2
years and above.
•
to prevent migraine headaches in adults
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATE
DO NOT TAKE TOPIRAMATE
•
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
breast-feeding” for
further information).
You should talk to your doctor about the best kind of contraception to
use
while you are taking
Topiramate
.
If you are not sure if the above applies to you, talk to your doctor
or pharmacist before using
Topiramate.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Topiramate if you:
•

Valmisteyhteenveto

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Topiramate 25 mg film-coated tablets
Topiramate 50 mg film-coated tablets
Topiramate 100 mg film-coated tablets
Topiramate 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg topiramate.
Each film-coated tablet contains 50 mg topiramate.
Each film-coated tablet contains 100 mg topiramate.
Each film-coated tablet contains 200 mg topiramate.
Excepient with known effect: lactose monohydrate.
25 mg tablet contains 21.15 mg lactose monohydrate;
50 mg tablet contains 42.30 mg lactose monohydrate;
100 mg tablet contains 84.60 mg lactose monohydrate;
200 mg tablet contains 61.70 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-ccoated tablet
Topiramate 25 mg film-coated tablets:
White, circular, biconvex film-coated tablets debossed with ‘E’ on
one side and ‘22’ on the other
side.
Topiramate 50 mg film-coated tablets:
Light yellow coloured, circular, biconvex film-coated tablets debossed
with ‘E’ on one side and ‘33’
on the other side.
Topiramate 100 mg film-coated tablets:
Dark yellow coloured, circular, biconvex bevelled edged film-coated
tablets debossed with ‘E’ on
one side and ‘23’ on the other side.
Topiramate 200 mg film-coated tablets:
Pink coloured, circular, biconvex, bevelled edged film-coated tablets
debossed with ‘E’ on one side
and ‘24’ on the other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
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.
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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 f