Topiramate 25mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Topiramate

Dostopno od:

Ennogen Healthcare Ltd

Koda artikla:

N03AX11

INN (mednarodno ime):

Topiramate

Odmerek:

25mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04080100; GTIN: 05060254924380

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
Topiramate Glenmark 25mg film-coated tablets
Topiramate Glenmark 50mg film-coated tablets
Topiramate Glenmark 100mg film-coated tablets
Topiramate Glenmark 200mg film-coated tablets
Topiramate
SAME SIZE ARTWORK
LEAFLET SIZE: 180 mm x 490 mm
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
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 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 if you are pregnant or if you are a
woman of childbearing potential unless you are using
effective
contraception
(see
section
'pregnancy
and
breastfeeding' for further information). You should talk to
your doctor about the best kind of contraception to use
while you are t

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Topiramate Accord Healthcare 25mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg of Topiramate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
Topiramate 25mg Film-coated Tablets are white, round, biconvex tablets
with
6mm diameter and engraved with the marking “V1”.
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 50-100 mg in adults with epilepsy and