Topiramate 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Topiramate

Available from:

Milpharm 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: 8901175023394

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 Accord Healthcare 50mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg of Topiramate.
Excipient: Also contains 0.27mg soya lecithin (E322).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
Topiramate
50mg
Film-coated
Tablets
are
light
yellow,
round,
biconvex
tablets with 8mm diameter and engraved with the marking “V3”.
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