TOPAMAX 25mg Film-coated Tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Topiramate

Mevcut itibaren:

Primecrown 2010 Limited

ATC kodu:

N03AX; N03AX11

INN (International Adı):

Topiramate

Doz:

25 milligram(s)

Farmasötik formu:

Tablet

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Other antiepileptics; topiramate

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2006-09-22

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPAMAX
®
25MG FILM-COATED TABLETS
TOPAMAX
®
50MG FILM-COATED TABLETS
TOPAMAX
®
100MG 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
kidney dialysis
-
ha

Ürün özellikleri

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.
Excipient(s) 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 and Spain:_
White, round tablets, 6 mm in diameter, “TOP” on one side and
“25” on the other.
4 CLINICAL PARTICULARS
As per PA0748/012/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0748/012/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Portugal_
CORE TABLET:
Lactose Monohydrate
Pregelatinised Maize Starch
Microcrystalline Cellulose
Sodium Starch Glycolate (Type A)
Magnesium Stearate
FILM-COATING
OPADRY White
1
Carnauba wax
1
OPADRY White contains:
Hypromellose
Macrogol
Polysorbate 80
And as colourants, titanium dioxide E171
_Product imported from Spain_
Lactose monohydrate
Pregelatinised maize starch
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Microcrystalline cellulose (E460)
Sodium starch glycolate
Magnesium stearate
Coating:
Carnauba wax
Hypromellose
Titanium dioxide (E171)
Polyethylene glycol
Polysorbate 80
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the co