Gabapentin 600mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Gabapentin

Предлага се от:

Actavis UK Ltd

АТС код:

N02BF01

INN (Международно Name):

Gabapentin

дозиране:

600mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

Schedule 3 (CD No Register Exempt Safe Custody)

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04080100; GTIN: 5012617018366

Листовка

Gabapentin 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 ingredient in Gabapentin is gabapentin.
Gabapentin 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 for you to help treat your epilepsy
when your current treatment is not fully controlling
your condition. You should take Gabapentin in
addition to your current treatment unless told
otherwise. Gabapentin 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, sharp, cramping,
aching, tingling, numbness, pins and needles etc.
DO NOT TAKE GABAPENTIN
•
if you are allergic to gabapentin, soya or any
of the other ingredients of this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Gabapentin
•
if you suffer from kidney problems your doctor
may prescribe a different dosing schedule
•
if you are on haemodialysis (to remove waste
products because of kidney failure), tell your
doctor if you develop muscle pain and/or
weakness
•
if you develop signs such as persistent stomach
pain, feeling sick and being sick contact your
doctor immediately as these may be symptoms
of acute pancreatitis (an inflamed pancreas).
•
if you have nervous system disorders, respiratory
disorders, or you are more than 65 years old,
your doctor may prescribe you a different
dosing regimen.
Cases of abuse and dependence have been
reported for gabapentin from the post-marketing
experience. Talk to your doctor if you have a
history of a

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gabapentin 600mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of gabapentin.
Excipients with known effect:
Each film-coated tablet contains 0.04 mmol (0.96 mg) of sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, film-coated tablet, oblong, biconvex, scored on both sides. The
tablets can be
divided into equal doses.
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. Dose 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 in