Talopam 50mg film-coated Tablets

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

TOPIRAMATE

זמין מ:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

קוד ATC:

N03AX11

INN (שם בינלאומי):

TOPIRAMATE 50 mg

טופס פרצבטיות:

FILM-COATED TABLET

הרכב:

TOPIRAMATE 50 mg

סוג מרשם:

POM

איזור תרפויטי:

ANTIEPILEPTICS

מצב אישור:

Withdrawn

תאריך אישור:

2010-06-21

עלון מידע

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
TALOPAM 25 AND 50MG 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Talopam is and what it is used for
2.
What you need to know before you take Talopam
3.
How to take Talopam
4.
Possible side effects
5.
How to store Talopam
6.
Contents of the pack and other information
1.
WHAT TALOPAM IS AND WHAT IT IS USED FOR
Talopam belongs to a group of medicines called “antiepileptic
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 over age
2
-
to prevent migraine headaches in adults
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TALOPAM
DO NOT TAKE TALOPAM
-
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 you are able to become
pregnant but you are not
using effective contraception (see section ‘pregnancy and
breastfeeding’ for further
information).
If you are not sure if the above applies to you, talk to your doctor
or pharmacist before using
Talopam.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Talopam if you:
-
have kidney problems, especially kidney stones, or are getting kidney
dialysis
-
have a history of blood and body fluid abnormality (metabolic
acidosis)
-
have liver problems
-
have eye problems, especially glaucoma
-
have a growth problem
-
are on a high f

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Talopam 25 mg film-coated tablets
Talopam 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg, 50 mg of topiramate.
Excipient with known effect:
Talopam 50 mg film-coated tablets contain the following excipient:
lecithin (contains soya oil).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Talopam 25 mg: film-coated tablet, white, round, biconvex, 6 mm
diameter with V1 marked on it.
Talopam 50 mg: film-coated tablet, light yellow, round, biconvex, 8 mm
diameter with V3 marked on
it.
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
General
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 Talopam. 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 Talopam may require
adjustment of the dose of Talopam.
In patients with or without a history of seizures or epilepsy,
antiepileptic drugs includin