Gabagamma capsules hard

Land: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

gabapentin

Fáanlegur frá:

Medis International a.s.

ATC númer:

N03AX12

INN (Alþjóðlegt nafn):

gabapentin

Skammtar:

300mg

Lyfjaform:

capsules hard

Einingar í pakka:

(20/2x10/) and (50/5x10/), in blister

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2021-06-29

Vara einkenni

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gabagamma 100 mg hard capsules
Gabagamma 300 mg hard capsules
Gabagamma 400 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg hard capsule contains 100 mg gabapentin.
Each 300 mg hard capsule contains 300 mg gabapentin.
Each 400 mg hard capsule contains 400 mg gabapentin.
Excipient with known effect
Each 100 mg hard capsule contains 22,5 mg lactose anhydrous.
Each 300 mg hard capsule contains 67,5 mg lactose anhydrous.
Each 400 mg hard capsule contains 90 mg lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Gabagamma 100 mg hard capsules: hard gelatine capsule with white
opaque body and cap.
Gabagamma 300 mg hard capsules: hard gelatine capsule with yellow
opaque body and cap.
Gabagamma 400 mg hard capsules: hard gelatine capsule with orange
opaque body and cap.
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.
2
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 day
300 mg two times a day
300 mg three times a day
Discontinuation of gabapentin
In accordance with c