Topamax 100 mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Topiramate

Available from:

PCO Manufacturing Ltd.

ATC code:

N03AX; N03AX11

INN (International Name):

Topiramate

Dosage:

100 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:

2007-03-16

Patient Information leaflet

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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 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 apply 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 k

Summary of Product characteristics

Health Products Regulatory Authority
17 January 2020
CRN009FTF
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Topamax 100 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 100 mg of Topiramate
Excipients with known effect: also contains lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-Coated Tablet.
_Product imported from Greece,France, Spain, The Netherlands and
Lithuania:_
Yellow, embossed, round tablets imprinted with “TOP”on one side
and “100”on the other.
4 CLINICAL PARTICULARS
As per PA22612/013/003
5 PHARMACOLOGICAL PROPERTIES
As per PA22612/013/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core Tablet
Lactose monohydrate
Pregelatinised Maize starch
Microcrystalline cellulose
Sodium starch glycolate (Type A)
Magnesium stearate
Film Coating
OPADRY Yellow
1
Carnauba Wax
1
OPADRY Yellow contains:
Hypromellose
Macrogol
Polysorbate 80
And as colourant, titanium dioxide (E171) and Iron oxide yellow (E172)
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
Health Products Regulatory Authority
17 January 2020
CRN009FTF
Page 2 of 2
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Store the tablets in the original package
(blister or bottle) in order to protect from moisture. Keep the
bottle tightly closed to protect the tablets from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Opaque plastic containers containing 60 tablets or Al-PVC/ALU-ALU
blisterpacks containing 28 or 60 tablets. Not all pack sizes
may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/196/003
9 DATE OF FIRST AUTHORISATION/RENEWA