Topamax 50mg film-coated tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Topiramate

Tersedia dari:

IMED Healthcare Ltd.

Kode ATC:

N03AX; N03AX11

INN (Nama Internasional):

Topiramate

Dosis:

50 milligram(s)

Bentuk farmasi:

Film-coated tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Other antiepileptics; topiramate

Status otorisasi:

Authorised

Tanggal Otorisasi:

2016-03-11

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPAMAX 50 MG FILM-COATED TABLETS
TOPAMAX 100 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
kidney dialysis
- have a history of blood and body fluid abnormality (m

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Topamax 50mg 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 Slovakia_
Description of the product
Light yellow, round tablets, 7 mm in diameter, “TOP” on one side
and “50” on the other.
4 CLINICAL PARTICULARS
As per PA0748/012/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0748/012/002
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 Yellow1
Carnauba Wax
1OPADRY Yellow contains:
Hypromellose
Macrogol
Polysorbate 80
And as colourants, titanium dioxide E171 and iron oxide yellow E172
6.2 INCOMPATIBILITIES
Not applicable.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_2_
_/_
_0_
_5_
_/_
_2_
_0_
_1_
_8_
_C_
_R_
_N_
_ _
_2_
_2_
_0_
_6_
_3_
_2_
_0_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
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 the tablets in the original package to
protect from moisture.
6.5 NATURE AND CONTEN