Topiramate Capsules Hard 25mg

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

topiramate 25 mg

MAH:

Arrow Generics Limited

ATC_code:

N03AX11

INN:

topiramate

pharmaceutical_form:

hard capsule

authorization_status:

Authorised

authorization_date:

2014-06-29

PIL

1 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

TOPIRAMATE 15MG, 25MG 
CAPSULES, HARD 
(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 get serious, or if
you notice any side effects not listed in 
this leaflet, please tell your doctor or pharmacist. 

IN THIS LEAFLET: 
1.       What Topiramate Capsules is and what it is used for 
2. Before 
you 
take 
Topiramate 
Capsules 
3. 
How to take Topiramate Capsules 
4. 
Possible side effects 
5. 
How to store Topiramate Capsules 
6 Further 
information

1.   WHAT TOPIRAMATE CAPSULES IS AND WHAT IT IS USED FOR 

Topiramate Capsules 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
over age 2 
• to 
prevent 
migraine headaches in adults 

2.   BEFORE YOU TAKE TOPIRAMATE CAPSULES 

Do not take Topiramate Capsules: 

•  if you are allergic (hypersensitive) to topiramate or
any of the other ingredients of 
Topiramate Capsules (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 and 
breastfeeding’ for further information). 

If you are not sure if the above applies to you, talk to your
doctor or pharmacist before 
using Topiramate Capsules. 

TAKE SPECIAL CARE WITH TOPIRAMATE CAPSULES: 
Check with your doctor or pharmacist
before taking Topir

SPC

1 

SUMMARY OF PRODUCT CHARACTERISTICS 

1 NAME 
OF 
THE 
MEDICINAL 
PRODUCT 

Topiramate 15mg Capsules, hard 
Topiramate 25mg Capsules, hard 

2 QUALITATIVE 
AND 
QUANTITATIVE 
COMPOSITION 

Each capsule contains 15mg/25mg  of topiramate. 
Each capsule also contains 41.4mg / 69mg of sucrose.  For
a full list of excipients, see section 6.1 

3 PHARMACEUTICAL 
FORM 

Capsule, hard (capsule). 
White opaque body and white opaque cap.  The body has ‘15’
/ ‘25’ printed in black and the cap 
has 
‘>’ over ‘Ti’ printed in black. 

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. 

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 
ADMINISTRATION 

General 
It is recommended that therapy be initiated at a low dose
followed by titration to an effective 
dose. Dose and titration rate should be guided by clinical
response. 

Topiramate is available in film-coated tablet and a hard
capsule formulations. It is recommended 
that film-coated tablets not be broken. The hard
capsule formulation is provided for those 
patients who cannot swallow tablets, e.g. paediatric and the
elderly. 

Topiramate Capsules may be swallowed whole or may be
administered by carefully ope