Gabapentin 800mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gabapentin

Available from:

Brown & Burk 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; GTIN: 5060124640167

Patient Information leaflet

other neurological or psychiatric problems.
MEDICINES
CONTAINING
'OPIOIDS'
(STRONG
PAINKILLERS) SUCH AS MORPHINE
If
you
are
taking
any
medicines
containing
opioids (such as morphine), please tell your
doctor or pharmacist as opioids may increase the
effect of Gabapentin Brown & Burk. In addition,
combination of Gabapentin Brown and Burk with
opioids may cause symptoms like sleepiness
and/or decrease in breathing.
ANTACIDS FOR INDIGESTION
If
Gabapentin
Brown
&
Burk
and
antacids
containing aluminium and magnesium are taken
at the same time, absorption of Gabapentin
Brown & Burk from the stomach may be reduced.
It is therefore recommended that Gabapentin
Brown & Burk is taken at the earliest two hours
after taking an antacid.
GABAPENTIN BROWN & BURK:
•
is
not
expected
to
interact
with
other
antiepileptic drugs or the oral contraceptive
pill;
•
may interfere with some laboratory tests, if
you require a urine test tell your doctor or
hospital what you are taking;
GABAPENTIN BROWN & BURK WITH FOOD AND DRINK
Gabapentin Brown & Burk can be taken with or
without food.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
_Pregnancy_
Gabapentin Brown & Burk should not be taken
during pregnancy, unless you are told otherwise
by your doctor. Effective contraception must be
used by women of child-bearing potential.
There have been no studies specifically looking
at the use of Gabapentin in pregnant women, but
other medications used to treat seizures have
reported
an
increased
risk
of
harm
to
the
developing baby, particularly when more than
one seizure medication is taken at the same time.
Therefore, whenever possible, you should try to
take
only
one
seizure
medication
during
pregnancy and only under the advice of your
doctor.
Contact your doctor immediately if you become
pregnant, think you might be pregnant or are
planning
to
become
pregnant
while
taking
Gabapentin Brown

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Gabapentin Brown & Burk 800mg Film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 800 mg film-coated tablet contains 800 mg gabapentin.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
White to off white, oval, biconvex tablets, engraved ‘800’ on one
side and plain on the other.
Length: 19.20 mm. Width: 10.00 mm.
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 Table 1 or by administering 300 mg thre