Gabapentin 800mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gabapentin

Available from:

Sun Pharma UK Ltd

ATC code:

N02BF01

INN (International Name):

Gabapentin

Dosage:

800mg

Pharmaceutical form:

Oral tablet

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

Gabapentin 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 is gabapentin.
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). The doctor treating you or your child
6 years of age and older will prescribe
Gabapentin to help treat epilepsy when the
current treatment is not fully controlling the
condition. You or your child 6 years of age and
older should take Gabapentin in addition to the
current treatment unless told otherwise.
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 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
•
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
•
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-m

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gabapentin 800mg tablets
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 Table 1 or by
administering 300 mg three times a day (TID) on Day 1. Thereafter,
based on
individual patient response and tolerability, the dose can be further
increased
in 300 mg/day increments every 2-3 days up to a maximum dose of 3600
mg/day. Slower titration of gabapentin dosage may be appropriate for
individual patients. The minimum time to reach a dose of 1800 mg/day
is one
week, to reach 2400 mg/day is a total of 2 weeks, and to reach 3600
mg/day is
a total of 3 weeks. Dosages up to 4800 mg/day have been well tolerated
in
long-term open-label clinical studies. The total daily dose should be
divided
in three single doses, the maximum time interval between the doses
should not
exceed 12 hours to prevent breakthrough convulsions.
_Children aged 6 years and above: _
The starting dose should range from 10 to 15 mg/kg/day and the
effective dose
is reached by upward titration over a period of approximately three
days. The
effective dose of gabapen