Gabapentin 600mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Gabapentin

Dostopno od:

Mawdsley-Brooks & Company Ltd

Koda artikla:

N02BF01

INN (mednarodno ime):

Gabapentin

Odmerek:

600mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

Schedule 3 (CD No Register Exempt Safe Custody)

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04080100

Navodilo za uporabo

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 substance 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). The doctor treating you or your child
6 years of age and older will prescribe
Gabapentin to help treat epilepsy when the
current treatment is not fully controlling the
condition. You or your child 6 years of age and
older should take Gabapentin in addition to the
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 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-m

Lastnosti izdelka

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 56 mg hydrogenated castor oil.
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. 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