Topamax 50 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Topiramate

Available from:

Imbat Limited

ATC code:

N03AX; N03AX11

INN (International Name):

Topiramate

Dosage:

50 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:

Authorised

Authorization date:

2014-02-21

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPAMAX
® 50MG FILM-COATED TABLETS
(topiramate)
Your medicine is available using the above name but will be
referred to as 'Topamax' throughout this 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 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 breast-feeding’ 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,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Topamax 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 50 mg of topiramate.
Excipients with known effect: also includes lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Portugal, Romania & Spain_
Light yellow, round tablet marked ‘TOP’ on one side and ‘50’
on the other.
4 CLINICAL PARTICULARS
As per PA0748/012/002
5 PHARMACOLOGICAL PROPERTIES
As per PA 0748/012/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
CORE TABLET:
Lactose monohydrate
Pregelatinised maize starch
Microcrystalline cellulose
Sodium starch glycolate (Type A)
Magnesiums Stearate
FILM-COATING:
OPADRY Yellow
1
Carnauba wax
1
OPADRY contains:
Hypromellose
Macrogol
Polysorbate 80
Titanium dioxide (E171)
Iron oxide yellow (E172)
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister and outer carton of the product as marketed in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
o
C. Store the tablets in the original package to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Over-labelled outer carton containing bl