Gabapentine Glenmark 400 mg harde capsules

Kraj: Holandia

Język: niderlandzki

Źródło: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Składnik aktywny:

GABAPENTINE 400 mg/stuk

Dostępny od:

Glenmark Arzneimittel GmbH Industriestrasse 31 82194 GROBENZELL (DUITSLAND)

Kod ATC:

N03AX12

INN (International Nazwa):

GABAPENTINE 400 mg/stuk

Forma farmaceutyczna:

Capsule, hard

Skład:

AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 1-WATER ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 1-WATER ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,

Droga podania:

Oraal gebruik

Dziedzina terapeutyczna:

Gabapentin

Podsumowanie produktu:

Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); KALIUMHYDROXIDE (E 525); LACTOSE 1-WATER; MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); TALK (E 553 B); TITAANDIOXIDE (E 171); ZWARTE INKT;

Data autoryzacji:

2018-04-25

Ulotka dla pacjenta

NL/H/3976/001-003/IAin/016
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gabapentine Glenmark 100 mg harde capsules
Gabapentine Glenmark 300 mg harde capsules
Gabapentine Glenmark 400 mg harde capsules
G
abapentin
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 [Name to be completed nationally] are and what they are used for
2.
What you need to know before you take [Name to be completed
nationally]
3.
How to take [Name to be completed nationally]
4.
Possible side effects
5.
How to store [Name to be completed nationally]
6.
Contents of the pack and other information
1.
WHAT X ARE AND WHAT THEY ARE USED FOR
[Name to be completed nationally] 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 [Name to be completed nationally] is
gabapentin.
[NAME TO BE COMPLETED NATIONALLY] ARE 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 [Name to be completed nationally] 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
[Name to be completed nationally] in addition to the current treatment
unless told otherwise. [Name to
be completed nationally] can also be used on its own to treat adults
and children over

Charakterystyka produktu

NL/H/3976/001-003/IA/019
1
SUMMARY OF PRODUCT CHARACTERISTICS
NL/H/3976/001-003/IA/019
2
1.
NAME OF THE MEDICINAL PRODUCT
Gabapentine Glenmark 100 mg harde capsules
Gabapentine Glenmark 300 mg harde capsules
Gabapentine Glenmark 400 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg hard capsule contains 100 mg of gabapentin.
Each 300 mg hard capsule contains 300 mg of gabapentin.
Each 400 mg hard capsule contains 400 mg of gabapentin.
Excipients with known effect
Each 100 mg hard capsule contains 6.5 mg lactose (as monohydrate).
Each 300 mg hard capsule contains 19.50 mg lactose (as monohydrate).
Each 400 mg hard capsule contains 26.00 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
100 mg: Size
‘3’
Hard Gelatin Capsule with white opaque cap and white opaque Body,
imprinted with
Glenmark logo
“G”
on Cap and ‘456’ on body with black ink, filled with white to
off-white powder.
300 mg: Size
‘1’
Hard Gelatin Capsule with Light Yellow to Yellow cap and Light Yellow
to Yellow
Body, imprinted with Glenmark logo
“G”
on Cap and ‘457’ on body with black ink, filled with white
to off-white powder.
400 mg: Size
‘0’
Hard Gelatin Capsule with Light Orange to Orange cap and Light Orange
to Orange
body, imprinted with Glenmark logo
“G”
on Cap and ‘458’ on body with black ink, filled with white
to off-white powder.
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