Gabapentin 800mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Gabapentin

제공처:

Teva UK Ltd

ATC 코드:

N02BF01

INN (국제 이름):

Gabapentin

복용량:

800mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

Schedule 3 (CD No Register Exempt Safe Custody)

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04080100; GTIN: 5017007014805

환자 정보 전단

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.

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gabapentin Teva 800 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gabapentin Teva 800 mg Film-coated Tablets
Each film-coated tablet contains 800 mg gabapentin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Gabapentin Teva 800 mg film-coated tablets
White to off-white, oval shaped, bevelled edged, film-coated tablet.
On one side engraved “7174”, 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 according to