Topiramate 100mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Topiramate

제공처:

Ennogen Healthcare Ltd

ATC 코드:

N03AX11

INN (International Name):

Topiramate

복용량:

100mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04080100; GTIN: 05060254924403

환자 정보 전단

TOPIRAMATE ACCORD HEALTHCARE
25MG, 50MG, 100MG AND 200MG
FILM-COATED TABLETS
(Topiramate)
_Continued on next page_
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.
•
The full name of this medicine is Topiramate Accord
Healthcare 25mg, 50mg, 100mg and 200mg
Film-coated Tablets but within the leaflet it will be
referred to as Topiramate tablets.
WHAT IS IN THIS LEAFLET:
1 WHAT TOPIRAMATE TABLETS ARE AND WHAT THEY
ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TOPIRAMATE TABLETS
3 HOW TO TAKE TOPIRAMATE TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE TOPIRAMATE TABLETS
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT TOPIRAMATE TABLETS ARE AND WHAT THEY
ARE 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 aged 2 years and above
•
to prevent migraine headaches in adults.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TOPIRAMATE TABLETS
DO NOT TAKE TOPIRAMATE TABLETS
•
if you are ALLERGIC to topiramate or any of the other
ingredients of this medicine (listed in section 6).
•
for migraine prevention DO NOT TAKE IF YOU ARE PREGNANT
or if you are a woman of childbearing potential unless you
are USING EFFECTIVE CONTRACEPTION (see ‘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 Topiramate tablets.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR

제품 특성 요약

1
NAME OF THE MEDICINAL PRODUCT
Topiramate Torrent 100mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg of Topiramate.
Excipient(s) with known effect: Also contains 0.53mg soya lecithin
(E322).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-Coated Tablets
Topiramate 100mg Film-Coated Tablets are yellow, round, biconvex
tablets with
10mm diameter and engraved with the marking “V4”.
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
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 topiramate. 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
topiramate may require adjustment of the dose of topiramate.
In patients with or without a history of seizures or epilepsy,
antiepileptic drugs
(AEDs)
including
topiramate
should
be
gradually
withdrawn
to
minimize
the
potential for seizures or increased seizure frequency. In clinical
trials, daily dosages
were decreased in weekly intervals by 50-