TOPAMAX Capsules 25mg

Држава: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

TOPIRAMATE

Доступно од:

Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium

АТЦ код:

N03AX11

INN (Међународно име):

TOPIRAMATE 25 mg

Фармацеутски облик:

HARD CAPSULE

Састав:

TOPIRAMATE 25 mg

Тип рецептора:

POM

Терапеутска област:

ANTIEPILEPTICS

Статус ауторизације:

Authorised

Датум одобрења:

2008-02-05

Информативни летак

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PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPAMAX 15 MG HARD CAPSULES
TOPAMAX 25 MG HARD CAPSULES
TOPAMAX 50 MG HARD CAPSULES
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:
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have kidney problems, especially kidney stones, or are getting kidney
dialysis

Карактеристике производа

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Topamax 15 mg capsules, hard
Topamax 25 mg capsules, hard
Topamax 50 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 15 mg of topiramate.
One capsule contains 25 mg of topiramate.
One capsule contains 50 mg of topiramate.
Excipients
with
known
effect:
Also includes sugar spheres containing not less than 62.5% and not
more than 91.5% of sucrose:
One 15 mg capsule contains between 28.1 and 41.2 mg sucrose
One 25 mg capsule contains between 46.8 and 68.6 mg sucrose
One 50 mg capsule contains between 93.7 and 137.2 mg sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
15 mg: Small white to off-white spheres in Size 2 hard gelatin
capsules with white opaque body
marked '15 mg’ and clear cap marked 'TOP'.
25 mg: Small white to off-white spheres in Size 1 hard gelatin
capsules with white opaque body
marked '25 mg’ and clear cap marked 'TOP'.
50 mg: Small white to off-white spheres in Size 0 hard gelatin
capsules with white opaque body
marked '50 mg’ and clear cap marked 'TOP'.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Monotherapy in adults, adolescents and children over 6 years of age
with partial seizures with
or without secondary generalised seizures, and primary generalised
tonic-clonic seizures.
Adjunctive therapy in children aged 2 years and above, adolescents and
adults with partial onset
seizures with or without secondary generalisation or primary
generalised tonic-clonic seizures
and for the treatment of seizures associated with Lennox-Gastaut
syndrome.
Topiramate is indicated in adults for the prophylaxis of migraine
headache after careful
evaluation of possible alternative treatment options. Topiramate is
not intended for acute
treatment.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
It is recommended that therapy be initiated at a low dose followed by
titration to an effective
dose. Dose and titration rate should be gu