Topamax Sprinkle 25 mg Hard Capsules

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Topiramate

Διαθέσιμο από:

Janssen Sciences Ireland UC

Φαρμακολογική κατηγορία (ATC):

N03AX; N03AX11

INN (Διεθνής Όνομα):

Topiramate

Δοσολογία:

25 milligram(s)

Φαρμακοτεχνική μορφή:

Capsule, hard

Θεραπευτική περιοχή:

Other antiepileptics; topiramate

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1999-06-25

Φύλλο οδηγιών χρήσης

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 using effective contraception (see section ‘pregnancy
and breast-feeding’ 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 apply 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 his

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
05 October 2022
CRN00CS6D
Page 1 of 19
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.
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 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.
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
optimise 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)