Topiramate 100mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Topiramate

Fáanlegur frá:

Glenmark Pharmaceuticals Europe Ltd

ATC númer:

N03AX11

INN (Alþjóðlegt nafn):

Topiramate

Skammtar:

100mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04080100; GTIN: 5060204160097

Upplýsingar fylgiseðill

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

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Topiramate Glenmark 100mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of topiramate.
Excipient:lactose 114.0 mg/film-coated tablet
For the full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
Topiramate 100mg film-coated Tablets Are round, yellow, film-coated
tablets
with ‘G’ engraved on one side and ‘100’ on other side.
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 frequency. In clinical trials, daily
dosages
were dec