Topiramate 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Topiramate

Available from:

Ennogen Healthcare Ltd

ATC code:

N03AX11

INN (International Name):

Topiramate

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 05060254924397

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPAMAX
® 50MG 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 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 name of your medicine is Topamax 50mg Tablets, but will be
referred to as Topamax throughout the remainder of this leaflet.

Topamax is also available in other strengths.
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 applies to you, talk to your doctor
or
pharmacist before using Topamax.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Topiramate Glenmark 50mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of topiramate.
Excipients: lactose 57.0 mg/film-coated tablet and sunset yellow lake
0.05 mg/film-
coated tablet
For the full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
Topiramate 50mg film-coated Tablets are round, yellow, film-coated
tablets,
with ‘G’ engraved on one side and ‘50’ on the other.
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
optimise
Topiramate film-coated tablets therapy. 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
including topiramate should be gradually withdrawn to minimize the
potential
for seizures or increased seizure frequ