Gabapentin 400mg capsules

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Gabapentin

可用日期:

Zentiva Pharma UK Ltd

ATC代码:

N02BF01

INN（国际名称）:

Gabapentin

剂量:

400mg

药物剂型:

Oral capsule

给药途径:

Oral

类:

Schedule 3 (CD No Register Exempt Safe Custody)

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04080100; GTIN: 5000283630920

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
GABAPENTIN ZENTIVA 100MG, 300MG & 400MG CAPSULES
(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 gabapentin is and what it is used for
2. What you need to know before you take gabapentin
3. How to take gabapentin
4. Possible side effects
5. How to store gabapentin
6. Contents of the pack and other information
1. WHAT GABAPENTIN IS AND WHAT IT IS USED FOR
This medicine is called Gabapentin Zentiva and it contains the active
substance Gabapentin (called gabapentin throughout this
leaflet).
Gabapentin 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)._ Your doctor will prescribe
gabapentin if your current treatment is no longer fully controlling
your
epilepsy. You should take gabapentin in addition to your current
treatment. If your doctor considers that it is necessary, gabapentin
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
this type of pain (primarily occurring in the legs and/or arms), such
as diabetes (high blood sugar) or shingles (disease caused by
the varicella virus). These pains may be felt as hot, burning,
throbbing, shooting, stabbing, sharp, cramping, aching, tingling,
numbness, pins and needles etc. 2. WHAT YOU NEED TO KNOW BEFORE Y

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gabapentin Medreich 400mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 400mg hard capsule contains 400mg of gabapentin.
Excipient with known effect:
Each 400mg hard capsule contains 67.333 mg of lactose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
‘Capsule, hard’.
Size ‘0’ orange/orange hard gelatin capsule marked ‘MG 400’
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EPILEPSY
Gabapentin is indicated as adjunctive therapy in the treatment of
partial
seizures with and without secondary generalisation 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 generalisation 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 be initiated by titrating the dose as described in Table 1