Talopam 200mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TOPIRAMATE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

N03AX11

INN (International Name):

TOPIRAMATE 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TOPIRAMATE 200 mg

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Withdrawn

Authorization date:

2010-06-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TALOPAM 25 MG FILM-COATED TABLETS
TALOPAM 50 MG FILM-COATED TABLETS
TALOPAM 100 MG FILM-COATED TABLETS
TALOPAM 200 MG FILM-COATED TABLETS
Topiramate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-   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 symptoms are the same as yours.
-   If any of the side effects gets serious, or if you notice any
side effects not listed in this  

leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.   What Talopam is and what it is used for
2.   Before you take Talopam 
3.   How to take Talopam 
4.   Possible side effects
5.   How to store Talopam 
6.   Further information.
1.   WHAT TALOPAM IS AND WHAT IT IS USED FOR
Talopam is a medicine to treat epilepsy. Talopam is used for the
treatment of epilepsy in 
patients where seizures start in a limited part of the brain (known as
partial seizures) and/or 
with generalised tonic-clonic seizures (grand mal).
Talopam can be used alone or in addition to a treatment with other
anti-epileptic drugs.
Talopam is also used to prevent frequently recurring migraine
headaches in adults when 
earlier treatment with other medicinal products was not effective.
2.   BEFORE YOU TAKE TALOPAM 
DO NOT TAKE TALOPAM 
-   if you are allergic (hypersensitive) to topiramate, soya,
peanuts or any of the other  

ingredients of Talopam
-   for the indication prophylaxis of migraine if you are pregnant
or if you are a woman  

with child bearing potential and you are not using an effective method
of  

contraception (see pregnancy).
TAKE SPECIAL CARE WITH TALOPAM 
Check with your doctor or pharmacist before using this medicine if you
have ever had:
-   problems with your liver.  Your doctor may want to give you a
lower do

Summary of Product characteristics

Page 1 of 15 
SUMMARY OF PRODUCT CHARACTERISTICS  

1. NAME OF THE MEDICINAL PRODUCT   
Talopam 25 mg film-coated tablets  
Talopam 50 mg film-coated tablets  
Talopam 100 mg film-coated tablets  
Talopam 200 mg film-coated tablets  

2. QUALITATIVE AND QUANTITATIVE COMPOSITION  
Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate.  

Topiramate 50 mg, 100 mg and 200 mg Film-coated Tablets contain the following excipient: 
Lecithin (contains soya oil). 

For a full list of excipients, see section 6.1.  

3. PHARMACEUTICAL FORM  
Film-coated tablet.  

Talopam 25 mg: film-coated tablet, white, round, biconvex, 6 mm diameter with V1 marked on it. 
Talopam 50 mg: film-coated tablet, light yellow, round, biconvex, 8 mm diameter with V3 marked on it. 
Talopam 100 mg: film-coated tablet, yellow, round, biconvex, 10 mm diameter with V4 marked on it. 
Talopam 200 mg: film-coated tablet, salmon-coloured, oval, biconvex, 9.2-18.3 mm in size with V5 marked on 
it. 

4. CLINICAL PARTICULARS  

4.1 THERAPEUTIC INDICATIONS  
Adults and adolescents aged 12 years and older: Monotherapy of epileptic patients with partial onset seizures 
and/or generalised tonic-clonic seizures.  
Adults and adolescents aged 12 years and older: Adjunctive therapy for epileptic patients with partial onset 
seizures and/or generalised tonic-clonic seizures.  
Adults: Second line treatment for migraine prophylaxis.  

4.2 POSOLOGY AND METHOD OF ADMINISTRATION  
It is recommended that the dose should be titrated gradually to the therapeutic level in order to avoid dose 
dependent undesirable effects.  
Estimation of plasma levels is not necessary for optimisation of Topiramate therapy.  
For doses not realisable/practicable with t