Topiramate 100 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TOPIRAMATE

Available from:

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

ATC code:

N03AX11

INN (International Name):

TOPIRAMATE 100 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TOPIRAMATE 100 mg

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Authorised

Authorization date:

2014-07-03

Patient Information leaflet

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

Topiramate belongs to a group of medicines called “antiepileptic 
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

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 you are able to 
become pregnant but you are not using effective contraception 
(see section “Pregnancy, breast-feeding and fertility” for
further 
information).
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:
•
have kidney problems, especially kidney stones, or are getting 
kidney dialysis
•
have a history of blood and body fluid abnormality (metabolic 
acidosis). 
•
have liver problems
•
have eye problems, especially glaucoma
•
have a growth problem
•
are on a high fat diet (ketogenic diet)
•
are pregnant or could become pregnant (see section 
“Pregnancy, breast

Summary of Product characteristics

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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