Gabapentin 600mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gabapentin

Available from:

Teva UK Ltd

ATC code:

N02BF01

INN (International Name):

Gabapentin

Dosage:

600mg

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: 5017007014751

Patient Information leaflet

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 aluminium 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
anti-epileptic drugs or the oral contraceptive pill.
•
Gabapentin may interfere with some laboratory tests;
if you require a urine test tell your doctor or hospital
what you are taking.
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 medication is
taken at the same time. Therefore, whenever possible
and only under the advice of your doctor, you should try
to take only one seizure medication during pregnancy.
Contact your doctor immediately if you become pregnant,
think you might be pregnant or are planning to become
pregnant while taking Gabapentin.
Do not suddenly discontinue taking this medicine as this
may lead to a breakthrough seizure, which could have
serious consequences for you and your baby.
Breast-feeding
Gabapentin, the active substance of Gabapentin Tablets,
is passed on through human milk.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gabapentin Teva 600 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gabapentin Teva 600 mg Film-coated Tablets
Each film-coated tablet contains 600 mg gabapentin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
Gabapentin 600 mg film-coated tablets
White to off-white, oval shaped, bevelled edged, film-coated tablet.
On one side engraved “7173”, and on the other side engraved
“93”.
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.
For lower dosages, which cannot be applied with these strengths, other
strengths and
dosage forms are available.
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 accordin