Topamax 200 mg Film-coated Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Topiramate

Disponible depuis:

IMED Healthcare Ltd.

Code ATC:

N03AX11

DCI (Dénomination commune internationale):

Topiramate

Dosage:

200 milligram(s)

forme pharmaceutique:

Film-coated tablet

Domaine thérapeutique:

topiramate

Date de l'autorisation:

2021-04-16

Notice patient

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 kidney problems, especially kidney stones, or are getting kid

Résumé des caractéristiques du produit

Health Products Regulatory Authority
21 June 2022
CRN00CXZ7
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Topamax 200 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of topiramate.
Excipients with known effect: lactose monohydrate:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Product imported from _Greece_
Salmon-coloured, round tablets, 10 mm in diameter, "TOP" on one side
and "200" on the other.
4 CLINICAL PARTICULARS
As per PA22612/013/004
5 PHARMACOLOGICAL PROPERTIES
As per PA22612/013/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
CORE TABLET:
Lactose Monohydrate
Pregelatinized Maize Starch
Microcrystalline Cellulose
Sodium Starch Glycolate (Type A)
Magnesium Stearate
FILM-COATING:
OPADRY Pink
1
Carnauba Wax
1
OPADRY Pink contains:
Hypromellose
Macrogol
Polysorbate 80
Titanium dioxide (E171)
Iron oxide red (E172)
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
21 June 2022
CRN00CXZ7
Page 2 of 2
6.3 SHELF LIFE
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 in the original package and keep the bottle tightly closed in
order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Opaque plastic bottle with tamper-evident closure containing 60
tablets.
In each bottle there is a desiccant canister which should not be
swallowed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/136/004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16
th
April 2021
10 DATE OF REVISION OF THE TEXT
June 2022