Topamax Sprinkle 25 mg Hard Capsules

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Topiramate

Dostupné s:

Janssen-Cilag Ltd

ATC kód:

N03AX; N03AX11

INN (Mezinárodní Name):

Topiramate

Dávkování:

25 milligram(s)

Léková forma:

Capsule, hard

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Other antiepileptics; topiramate

Stav Autorizace:

Marketed

Datum autorizace:

1999-06-25

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPAMAX SPRINKLE 15 MG HARD CAPSULES
TOPAMAX SPRINKLE 25 MG HARD CAPSULES
TOPAMAX SPRINKLE 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 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

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Topamax Sprinkle 25 mg Hard Capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 25 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 25 mg capsule contains between 46.8 and 68.6 mg sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
Description of the product
Small white to off-white spheres in Size 1 hard gelatin capsules with
white opaque body marked '25 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 generalization or primary generalized 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.
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 guided by clinical response.
It is not necessary to monitor topiramate plasma concentrations to
optimize therapy with Topamax. On rare occasions,
the addition of topiramate to phenytoin may require an adjustment of
the dose of phenytoin to achieve optimal clinical
outcome. Addition or withdrawal of phenytoin and carbamazepine to
adjunctive therapy with Topamax may require
adjustment of the dose of Topamax.
In patients with or without a history of seizures or epilepsy,
antiepileptic drugs (AEDs) including topiramate should be
gradually withdra