Gabapentin 800mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gabapentin

Available from:

Milpharm 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; GTIN: 8901175008056

Patient Information leaflet

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 Milpharm Tablets is and what it is used for
2. What you need to know before you take Gabapentin
Milpharm Tablets
3. How to take Gabapentin Milpharm Tablets
4. Possible side effects
5. How to store Gabapentin Milpharm Tablets
6. Contents of the pack and other information 1. WHAT GABAPENTIN MILPHARM TABLETS IS AND WHAT IT IS
USED FOR
Gabapentin Milpharm Tablets 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 Milpharm Tablets is
gabapentin.
Gabapentin Milpharm 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 Milpharm Tablets for you to help treat your
epilepsy when your current treatment is not fully controlling
your condition. You should take Gabapentin Milpharm
Tablets in addition to your current treatment unless told
otherwise. Gabapentin Milpharm Tablets 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,

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