Gabapentin 400mg capsules

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Gabapentin

Disponível em:

Wockhardt UK Ltd

Código ATC:

N02BF01

DCI (Denominação Comum Internacional):

Gabapentin

Dosagem:

400mg

Forma farmacêutica:

Oral capsule

Via de administração:

Oral

Classe:

Schedule 3 (CD No Register Exempt Safe Custody)

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 04080100; GTIN: 5012727911991

Folheto informativo - Bula

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amends
PACKAGE LEAFLET: INFORMATION FOR THE USER
GABAPENTIN WOCKHARDT 100MG, 300MG AND 400MG CAPSULES
Gabapentin
(Referred to as Gabapentin Capsules in the remainder of the leaflet)
ART WORK CHECK BOX
PRODUCT :
Gabapentin 100mg, 300mg and 400mg Capsules
CUSTOMER :
Wockhardt UK
FP CODE:
—
PLANT LOCATION :
UK
DIMENSIONS :
(w)150 x (h)400mm
PHARMACODE :
Dummy
TEXT FONT SIZE :
9pt. (5% condensed)
FILE NAME :
Gabapentin_Leaflet_107104-5.ai
SOFTWARE :
Adobe Illustrator CS5
TYPEFACES :
Myriad Pro Regular / Bold
ARTWORK (DETAILS)
7th August, 2017
RECEIVED ON :
PROOF REVISION :
R 1st PDF sent on
- 8TH AUG. 2017
R 2nd PDF sent on - 9TH AUG. 2017
Keyline
(non-printing)
Text
free area
Process
Black
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 Gabapentin Capsules are and what they
are used for
2. What you need to know before you take
Gabapentin Capsules
3. How to take Gabapentin Capsules
4. Possible side effects
5. How to store Gabapentin Capsules
6. Contents of the pack and other information
1. WHAT GABAPENTIN CAPSULES ARE AND
WHAT THEY ARE USED FOR
Gabapentin Capsules belong to a group of
medicines used to treat epilepsy and peripheral
neuropathic pain (long lasting pain caused by
damage to the nerves).
GABAPENTIN CAPSULES ARE USED TO TREAT
• Various forms of epilepsy (seizures that are
initially limited to certain parts of the brain,
whether the seizure spre

Características técnicas

OBJECT 1
GABAPENTIN WOCKHARDT 400MG HARD CAPSULES
Summary of Product Characteristics Updated 13-Sep-2017 | Wockhardt UK
Ltd
1. Name of the medicinal product
Gabapentin Wockhardt 400mg Hard Capsules
2. Qualitative and quantitative composition
Each 400mg hard capsule contains 400mg of gabapentin.
For a full list of excipients, see section 6 .1.
3. Pharmaceutical form
Capsule, hard.
A two-piece, orange opaque hard gelatin capsule marked GA400 with
black ink, containing a 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 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
300mg once a day
300mg two times a day
300mg three times a day
Discontinuation of gabapentin
In accordance with current clinical practice, if gabapentin has to be
discontinued it is recommended this
should be done gradually over a minimum of 1 week independent of the
indication.
EPILEPSY
Epilepsy typically requires long term therapy. Dosage is determined by
the treating physician according
to individual tolerance and efficacy.
_Adults and Adolescents _
In clinical trials, the effective dosing range was 900 to 3600 mg/day.
Therapy may b