TOPAMAX 25mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Topiramate

Available from:

Janssen-Cilag Ltd

ATC code:

N03AX; N03AX11

INN (International Name):

Topiramate

Dosage:

25 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antiepileptics; topiramate

Authorization status:

Marketed

Authorization date:

1997-06-13

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPAMAX 25 MG FILM-COATED TABLETS
TOPAMAX 50 MG FILM-COATED TABLETS
TOPAMAX 100 MG FILM-COATED TABLETS
TOPAMAX 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 Topamax is and what it is used for
2.
What you need to know before you take Topamax
3.
How to take Topamax
4.
Possible side effects
5.
How to store Topamax
6.
Contents of the pack and other information
1.
WHAT TOPAMAX IS AND WHAT IT IS USED FOR
Topamax 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 TOPAMAX
DO NOT TAKE TOPAMAX
-
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 Topamax.
If you are not sure if the above applies to you, talk to your doctor
or pharmacist before using
Topamax.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Topamax if you:
-
have kidney problems, especially kidney stones, or are getting

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TOPAMAX 25mg Film-coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 25 mg of topiramate.
Excipients with known effect: also includes lactose monohydrate:
25 mg tablet contains 30.85 mg lactose monohydrate;
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Description of the product
White, round tablets, 6 mm in diameter, “TOP” on one side and
“25” on the other.
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
Posology
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.
It is not necessary to monitor topiramate plasma concentrations to
optimize therapy with Topamax. On rare occasions,
the addition of topiramate to phenytoin may require an adjustment of
the dose of phenytoin to achieve optimal clinical
outcome. Addition or withdrawal of phenytoin and carbamazepine to
adjunctive therapy with Topamax may require
adjustment of the dose of Topamax.
In patients with or without a history of seizures or epilepsy,
antiepileptic drugs (AEDs) including topiramate should be
gradually withdrawn to minimize the potential for seizures or
increased seizure frequency. In clinical trials, daily
dosages w