Topiramate Capsules Hard 50mg

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

TOPIRAMATE

제공처:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC 코드:

N03AX11

INN (International Name):

TOPIRAMATE 50 mg

약제 형태:

HARD CAPSULE

구성:

TOPIRAMATE 50 mg

처방전 유형:

POM

치료 영역:

ANTIEPILEPTICS

승인 상태:

Withdrawn

승인 날짜:

2014-06-29

환자 정보 전단

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPIRAMATE CAPSULES, HARD
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.
WHAT IS IN THIS LEAFLET:
1.
What Topiramate is and what it is used for
2.
What you need to know before you take Topiramate
3.
How to take Topiramate
4.
Possible side effects
5.
How to store Topiramate
6.
Contents of the pack and other information
1.
WHAT TOPIRAMATE IS AND WHAT IT IS 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
Do not take Topiramate:
-
if you are allergic (hypersensitive) to topiramate or any of the other
ingredients of this medicine (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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Topiramate if you:
-
have kidney problems, especially kidney stones, or are getting kidney
dialysis
-
have a history of blood and body fluid abnormality (metabolic
acidosis)
-
have liver problems
-
have eye problems, especially glaucoma
-
have a growth problem
-
are o

제품 특성 요약

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Topiramate 50 mg Capsules, hard
Topiramate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg of topiramate.
Each capsule also contains 138 mg of sucrose.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule, hard (capsule).
White opaque body and white opaque cap. The body has ‘50’ printed
in black and the cap has ‘>’ over ‘Ti’ printed in
black.
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
General
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.
Topiramate is available in film-coated tablet and a hard capsule
formulations. It is recommended that film-
coated tablets not be broken. The hard capsule formulation is provided
for those patients who cannot
swallow tablets, e.g. paediatric and the elderly.
Topiramate may be swallowed whole or may be administered by carefully
opening the capsule and
sprinkling the entire contents on a small amount (teaspoon) of soft
food. This medicinal product/food
mixture is to be swallowed immediately and not chewed. It must not be
stored for future use.
It is not necessary to monitor topiramate plasma concentrations to
optimize therapy with topiram