Topiramate Milpharm 200mg film-coated tablets

国: イギリス

言語: 英語

ソース: myHealthbox

有効成分:

topiramate

から入手可能:

Milpharm Limited

ATCコード:

N03AX11

INN（国際名）:

topiramate

投薬量:

200mg

医薬品形態:

Film-coated tablets

投与経路:

Oral use

パッケージ内のユニット:

60 film-coated tablets

処方タイプ:

POM - Prescription Only Medicine

製:

APL Swift Services (Malta) Limited

治療群:

antiepileptics, other antiepileptics, antimigraine preparations

適応症:

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.

認証ステータス:

Authorised

承認日:

2014-06-19

情報リーフレット

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 Milpharm is and what it is used for
2.
What you need to know before you take Topiramate Milpharm 
3.
How to take Topiramate Milpharm 
4.
Possible side effects
5.
How to store Topiramate Milpharm 
6.
Contents of the pack and other information

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

DO NOT TAKE TOPIRAMATE MILPHARM
•
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 you are able to 
become pregnant but you are not using effective contraception 
(see section “Pregnancy, breast-feeding and fertility” for
further 
information).
If you are not sure if the above applies to you, talk to your doctor
or 
pharmacist before using Topiramate Milpharm.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Topiramate 
Milpharm 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 on a high fat diet (ketogenic diet)
•
are

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS 
1 
NAME OF THE MEDICINAL PRODUCT 

Topiramate Milpharm 200 mg film-coated tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 200 mg topiramate. 

Excepient with known effect: lactose monohydrate. 
200 mg tablet contains 61.70 mg lactose monohydrate. 

For the full list of excipients, see section 6.1.  

3 PHARMACEUTICAL 
FORM 

Film-coated tablet 

Pink coloured, circular, biconvex, bevelled edged film-coated
tablets debossed 
with ‘E’ on one side and ‘24’ on the 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 

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. 

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 Milpharm
may require 
adjustment of the dose of Topiramate Milpharm.�