Topiramate 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Topiramate

Available from:

Sigma Pharmaceuticals Plc

ATC code:

N03AX11

INN (International Name):

Topiramate

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPIRAMATE TORRENT 25,50,100 AND 200MG FILM-COATED TABLETS
Topiramate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist or
nurse.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their signs of illness are th same
as yours.
•
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Topiramate film-coated tablets are and what they are used for
2.
What you need to know before you take Topiramate film-coated tablets
3.
How to take Topiramate film-coated tablets
4.
Possible side effects
5.
How to store Topiramate film-coated tablets
6.
Contents of the pack and other information 1. WHAT TOPIRAMATE FILM-COATED 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 over age
2
-
to prevent migraine headaches in adults 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATE FILM-COATED
TABLETS
DO NOT TAKE TOPIRAMATE FILM-COATED TABLETS
-
if you are allergic to topiramate or any of the other ingredients of
Topiramate film-coated tablets (listed in section 6).
-
for migraine prevention if you are pregnant or you are able to become
pregnant but you are not using effective contraception (see
section ‘pregnancy and breastfeeding’ for further information).
If you are not sure if the above applies to you, talk to your doctor
or pharmacist before using Topiramate film-coated tablets.
WARNINGS AND PRECAUTIONS
Check with your doctor or pharmacist before taking Topiramate
film-coated tablets if you:
-
have kidney problems, especially kidney stones, or are getting kidney
dialy

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Topiramate Accord Healthcare 100mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg of Topiramate.
Excipient: 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