Neurostil 300 mg capsules, hard

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Gabapentin

から入手可能:

Teva Pharma B.V.

ATCコード:

N03AX; N03AX12

INN（国際名）:

Gabapentin

投薬量:

300 milligram(s)

医薬品形態:

Capsule, hard

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

Other antiepileptics; gabapentin

認証ステータス:

Marketed

承認日:

2008-09-26

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEUROSTIL 100 MG CAPSULES, HARD
NEUROSTIL 300 MG CAPSULES, HARD
NEUROSTIL 400 MG CAPSULES, HARD
gabapentin
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
NEUROSTIL
is and what it is used for
2.
What you need to know before you take
NEUROSTIL
3.
How to take
NEUROSTIL
4.
Possible side effects
_5. _
How to store
NEUROSTIL
6.
Contents of the pack and other information
1.
WHAT NEUROSTIL IS AND WHAT IT IS USED FOR
Neurostil belongs to a group of medicines used to treat epilepsy and
peripheral neuropathic pain (long
lasting pain caused by damage to the nerves).
The active substance in Neurostil is gabapentin.
Neurostil is used to treat
-
Various forms of epilepsy (seizures that are initially limited to
certain parts of the brain, whether
the seizure spreads to other parts of the brain or not). The doctor
treating you or your child 6
years of age and older will prescribe Neurostil to help treat epilepsy
when the current treatment
is not fully controlling the condition. You or your child 6 years of
age and older should take
Neurostil in addition to the current treatment unless told otherwise.
Neurostil can also be used
on its own to treat adults and children over 12 years of age.
-
Peripheral neuropathic pain (long lasting pain caused by damage to the
nerves). A variety of
different diseases can cause peripheral neuropathic pain (primarily
occurring in the legs and/or
arms), such as diabetes or shingles. Pain sensations may be described
as hot, burning, throb

製品の特徴

HealthProductsRegulatoryAuthority
28February2023
CRN00DCY2
Page1of13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neurostil300mgcapsules,hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachcapsulecontains300mggabapentin.
Excipientwithknowneffect:Eachcapsulecontains0.54mgsunsetyellowFCF(E110).
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Hardgelatinecapsulewithanorangecapandbody,filledwithawhitetooff-whitepowderwithsmallagglomerates.
Thecapsulecapandbodyareeachimprintedwiththenumbers’93‘and’39‘.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epilepsy
Gabapentinisindicatedasadjunctivetherapyinthetreatmentofpartialseizureswithandwithoutsecondarygeneralizationin
adultsandchildrenaged6yearsandabove(seesection5.1).
Gabapentinisindicatedasmonotherapyinthetreatmentofpartialseizureswithandwithoutsecondarygeneralizationin
adultsandadolescentsaged12yearsandabove.
Treatment of peripheral neuropathic pain
Gabapentinisindicatedforthetreatmentofperipheralneuropathicpainsuchaspainfuldiabeticneuropathyandpost-herpetic
neuralgiainadults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ForallindicationsatitrationschemefortheinitiationoftherapyisdescribedinTable1,whichisrecommendedforadultsand
adolescentsaged12yearsandabove.Dosinginstructionsforchildrenunder12yearsofageareprovidedunderaseparate
sub-headinglaterinthissection.
Table1
​
​
DOSINGCHART-INITIALTITRATION
​
​
Day1
Day2
Day3
300mgoncea