TOPAMAX 200mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TOPIRAMATE

Available from:

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

ATC code:

N03AX11

INN (International Name):

TOPIRAMATE 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TOPIRAMATE 200 mg

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Authorised

Authorization date:

2006-12-20

Patient Information leaflet

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PACKAGE LEAFLET
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
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.
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WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Topamax if you:
-
have kidney problems, esp

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Topamax 25 mg film-coated tablets
Topamax 50 mg film-coated tablets
Topamax 100 mg film-coated tablets
Topamax 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 25 mg of topiramate.
One tablet contains 50 mg of topiramate.
One tablet contains 100 mg of topiramate.
One tablet contains 200 mg of topiramate.
Excipients with known effect: also includes lactose monohydrate:
One 25 mg tablet contains 30.85 mg lactose monohydrate
One 50 mg tablet contains 61.70 mg lactose monohydrate
One 100 mg tablet contains 123.40 mg lactose monohydrate
One 200 mg tablet contains 43.50 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
25 mg: White round tablets, 6 mm in diameter, “TOP” on one side,
“25” on the other side.
50 mg: Light yellow round tablets, 7 mm in diameter, “TOP” on one
side, “50” on the other
side.
100 mg: Yellow round tablets, 9 mm in diameter, “TOP” on one side,
“100” on the other side.
200 mg: Salmon round tablets, 10 mm in diameter, “TOP” on one
side, “200” on the other
side.
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
titrati