Gabapentin 400mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gabapentin

Available from:

Rivopharm (UK) Ltd

ATC code:

N02BF01

INN (International Name):

Gabapentin

Dosage:

400mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

Schedule 3 (CD No Register Exempt Safe Custody)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5060388650094

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GABAPENTIN 100 MG CAPSULES, HARD
GABAPENTIN 300 MG CAPSULES, HARD
GABAPENTIN 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. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist. See section 4.
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, hard (called Gabapentin capsules in the rest of
this leaflet) 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 spreads to other parts of the brain or not). Your
doctor will
prescribe Gabapentin capsules for you to help treat your epilepsy when
your current
treatment is not fully controlling your condition. You should take
Gabapentin capsules
in addition to your current treatment unless told otherwise.
Gabapentin capsules 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 peripheral neuropathic pain (primarily
occurring in the legs
and/or arms), such as diabetes or shingles. Pain se

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gabapentin 400 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 400mg capsule contains 400 mg gabapentin.
Excipients:
Each 400 mg capsule contains 67.33 mg lactose (as monohydrate).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsules (capsules):
Orange hard capsule, imprinted with “400” and containing a white
crystalline
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
300 mg once a day
300 mg two times a day
300 mg 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 T