Gabapentine Sandoz capsule 300 mg, capsules, hard

País: Países Bajos

Idioma: neerlandés

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

Ingredientes activos:

GABAPENTINE 300 mg/stuk

Disponible desde:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Código ATC:

N03AX12

Designación común internacional (DCI):

GABAPENTINE 300 mg/stuk

formulario farmacéutico:

Capsule, hard

Composición:

GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD, GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD,

Vía de administración:

Oraal gebruik

Área terapéutica:

Gabapentin

Resumen del producto:

Hulpstoffen: GELATINE (E 441); IJZEROXIDE GEEL (E 172); MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); ZETMEEL, GEPREGELATINEERD;

Fecha de autorización:

1900-01-01

Información para el usuario

Sandoz B.V.
Page 1 / 11
Gabapentine Sandoz capsule 100/300/400 mg, capsules hard
RVG 33677-33678-33679
v18
1.3.1.3 Package Leaflet
januari 2023
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
GABAPENTINE SANDOZ CAPSULE 100 MG, CAPSULES, HARD
GABAPENTINE SANDOZ CAPSULE 300 MG, CAPSULES, HARD
GABAPENTINE SANDOZ CAPSULE 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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Content of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] 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 [Nationally completed name] is gabapentin.
[NATIONALLY COMPLETED NAME] 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 [Nationally completed name] 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
[Nationally completed name] in addition to the current treatment
unless told otherwise. [Nation

Ficha técnica

Sandoz B.V.
Pagina 1 van 19
Gabapentine Sandoz capsule 100/300/400 mg, capsules, hard
RVG 33677-33678-33679
v17A
1.3.1.1 SmPC
April 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gabapentine Sandoz capsule 100 mg, capsules, hard
Gabapentine Sandoz capsule 300 mg, capsules, hard
Gabapentine Sandoz capsule 400 mg, capsules, hard
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains 100 mg of gabapentin.
_ _
Each capsule, hard contains 300 mg of gabapentin.
_ _
Each capsule, hard contains 400 mg of gabapentin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
_100mg capsule, hard: _
hard gelatin capsule (size 3), with white opaque body and cap.
_300mg capsule, hard: _
hard gelatin capsule (size 1), with yellow opaque body and cap.
_400mg capsule, hard: _
hard gelatin capsule (size 0), with brown opaque body and cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epilepsy
[Nationally completed name] 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).
[Nationally completed name] 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
Sandoz B.V.
Pagina 2 van 19
Gabapentine Sandoz capsule 100/300/400 mg, capsules, hard
RVG 33677-33678-33679
v17A
1.3.1.1 SmPC
April 2023
[Nationally completed name] 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.
Tab