Gabapentin 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gabapentin

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

N02BF01

INN (International Name):

Gabapentin

Dosage:

100mg

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

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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
Gabapentin is used as an anticonvulsant for the treatment of various
types of epilepsy. It is used to reduce
the risk of an epileptic fit or to stop one that is in progress.
Anticonvulsant drugs stop the excessive electrical activity in your
brain which is causing epileptic fits.
You should take gabapentin in addition to your current treatment
unless your doctor tells you otherwise. It
can also be used on its own to treat adults and children over 12 years
of age.
Gabapentin belongs to a group of medicines used to treat chronic (long
lasting) pain caused by damage to
the nerves. This pain is known as peripheral neuropathic pain.
Peripheral neuropathic pain is caused by a
variety of diseases such as diabetes, shingles, trauma or diseases of
the nervous system. Pain sensations
may be described as hot, burning, throbbing, shooting, stabbing,
sharp, cramping, aching, tingling, pins
and needles etc.
Your doctor will have explained the reason for prescribing gabapentin
capsules to you.
DO NOT TAKE GABAPENTIN IF:
-
you have had an allergic reaction or are allergic to gabapentin or
similar medicines or to any of
the ingredients ( listed in section 6)
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMA

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gabapentin Medreich 100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100mg hard capsule contains 100mg of gabapentin.
Excipient with known effect:
Each 100mg hard capsule contains 16.83 mg of lactose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
‘Capsule, hard’.
Size ‘3’ white/white hard gelatin capsule marked ‘MG 100’
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 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 or