Gabapentin 300mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gabapentin

Available from:

Wockhardt UK Ltd

ATC code:

N02BF01

INN (International Name):

Gabapentin

Dosage:

300mg

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; GTIN: 5012727911984

Patient Information leaflet

OTHER MEDICINES AND GABAPENTIN
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. In particular, tell your
doctor (or pharmacist) if you are taking or have been recently taking
any medicines for convulsions, sleeping disorders,
depression, anxiety, or any other neurological or psychiatric
problems.
Medicines containing opioids 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. In addition, combination of
Gabapentin with opioids may cause symptoms like sleepiness
and/or decrease in breathing.
Antacids for indigestion
If Gabapentin and antacids containing aluminum and magnesium are taken
at the same time, absorption of Gabapentin from the
stomach may be reduced. It is therefore recommended that Gabapentin is
taken at the earliest two hours after taking an antacid.
GABAPENTIN:
•
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 CAPSULES WITH FOOD
Gabapentin 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 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 medica-
tion is taken at the same time. Therefore, whenever possible, you
should try to take only one seizure medication during
pregnancy and only under the advic

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gabapentin Noumed 300mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 300mg hard capsule contains 300mg of gabapentin.
Excipient with known effect:
Each 300mg hard capsule contains 50.50 mg of lactose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
‘Capsule, hard’.
Size ‘1’ yellow/yellow hard gelatin capsule marked ‘MG 300’
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