Gabapentin 100mg capsules

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Gabapentin

Beschikbaar vanaf:

Creo Pharma Ltd

ATC-code:

N02BF01

INN (Algemene Internationale Benaming):

Gabapentin

Dosering:

100mg

farmaceutische vorm:

Oral capsule

Toedieningsweg:

Oral

klasse:

Schedule 3 (CD No Register Exempt Safe Custody)

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 04080100; GTIN: 5060222600407

Bijsluiter

Gabapentin Capsules belongs to a group of
medicines used to treat epilepsy and peripheral
neuropathic pain (long lasting pain caused by
damage to the nerves).
The active substance in Gabapentin Capsules is
gabapentin.
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
sensations may be described as hot, burning,
throbbing, shooting, stabbing, sharp, cramping,
aching, tingling, numbness, pins and needles etc.
DO NOT TAKE GABAPENTIN CAPSULES
• if you are allergic to gabapentin or any of the
other ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Gabapentin Capsules
• if you suffer from kidney problems your doctor
may prescribe a different dosing schedule.
• if you are on haemodialysis (to remove waste
products because of kidney failure), tell your
doctor if you develop muscle pain and/or
weakness.
• if you develop signs such as persistent stomach
pain, feeling sick and being sick contact your
doctor immediately as these may be symptoms
of acute pancreatitis (an inflamed pancreas).
• if you have nervous system disorders, respiratory
disorders, or you are more than 65 years old,
your doctor may prescribe you a different
dosing regimen.
Cases of abuse and dependence have been
reported for gabapentin from the post

Productkenmerken

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