TOPAMAX 200mg film-coated Tablets

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

TOPIRAMATE

זמין מ:

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

קוד ATC:

N03AX11

INN (שם בינלאומי):

TOPIRAMATE 200 mg

טופס פרצבטיות:

FILM-COATED TABLET

הרכב:

TOPIRAMATE 200 mg

סוג מרשם:

POM

איזור תרפויטי:

ANTIEPILEPTICS

מצב אישור:

Authorised

תאריך אישור:

2006-12-20

עלון מידע

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PACKAGE LEAFLET
_ _
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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
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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).
Migraine prevention
-
You must not use Topamax if you are pregnant.
-
If you are a woman who is able to become pregnant, you must not take
Topamax, unless you
use highly effective contraception (birth control) during your
treatment. See below under
‘Pregnancy and breast-feeding – Important advice for

מאפייני מוצר

Page 1 of 27
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 27
This medicinal product is subject to additional monitoring. This will
allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse reactions. See section 4.8 for how to report adverse
reactions.
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.
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Topiramate is indicated in adults for the prophylax