Topiramate Capsules Hard 25mg

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

TOPIRAMATE

Διαθέσιμο από:

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

Φαρμακολογική κατηγορία (ATC):

N03AX11

INN (Διεθνής Όνομα):

TOPIRAMATE 25 mg

Φαρμακοτεχνική μορφή:

HARD CAPSULE

Σύνθεση:

TOPIRAMATE 25 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

ANTIEPILEPTICS

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2014-06-29

Φύλλο οδηγιών χρήσης

Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPIRAMATE 15MG, 25MG
CAPSULES, HARD
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 of the 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 Topiramate is and what it is used for
2.
What you need to know before you take Topiramate
3.
How to take Topiramate
4.
Possible side effects
5.
How to store Topiramate
6.
Contents of the pack and other information
1.
WHAT TOPIRAMATE IS AND WHAT IT IS USED FOR
Topiramate 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 TOPIRAMATE
Do not take Topiramate
-
if you are allergic (hypersensitive) 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).
Page 2 of 10
If you are not sure if the above applies to you, talk to your doctor
or pharmacist before using
Topiramate.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Topiramate 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, especia

Αρχείο Π.Χ.Π.

Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Topiramate 15 mg/25 mg Capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 15 mg/25 mg of topiramate.
Each capsule also contains 41.4 mg / 69 mg of sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard (capsule).
White opaque body and white opaque cap. The body has ‘15’ /
‘25’ printed in black and the cap has
‘>’ over ‘Ti’ printed in black.
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.
Topiramate is available in film-coated tablet and a hard capsule
formulations. It is recommended that
film-coated tablets not be broken. The hard capsule formulation is
provided for those patients who cannot
swallow tablets, e.g. paediatric and the elderly.
Topiramate may be swallowed whole or may be administered by carefully
opening the capsule and
sprinkling the entire contents on a small amount (teaspoon) of soft
food. This medicinal product/food
mixture is to be swallowed immediately and not chewed. It must not be
stored for future use.
It is not necessary to monitor topiramate plasma concentrations to
opti