Vultin 600mg Tablet

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

GABAPENTIN

Beschikbaar vanaf:

MEDISPEC (M) SDN.BHD

INN (Algemene Internationale Benaming):

GABAPENTIN

Eenheden in pakket:

100tablet Tablets

Geproduceerd door:

UNISON LABORATORIES CO.LTD

Bijsluiter

VULTIN 600MG TABLET
Gabapentin (600mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Vultin 600_
is used for
2.
How
_Vultin 600_
works
3.
Before you use
_Vultin 600_
4.
How to use
_Vultin 600_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Vultin 600_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _VULTIN 600_
IS USED FOR
_Vultin 600 _
is used:
•
As an additional therapy in the
treatment of partial seizure (occurs in
a limited area of the brain) with or
without secondary generalization
(affect the whole brain) in adults and
children aged 3years and above.
•
To treat neuropathic pain (pain
caused by nerve damage) which
includes diabetic neuropathy (nerve
damage from diabetes), post-herpetic
neuralgia (nerve pain at the site of a
previous attack of shingles) and
trigeminal neuralgia (facial pain) in
adults age 18 years and above.
HOW _VULTIN 600_
WORKS
This medicine belongs to a group of
medicines called anti-convulsants. It is
said to work by controlling brain
chemicals which send signals to nerves
to help control seizures or neuropathic
pain.
BEFORE YOU USE _VULTIN 600_
-
_When you must not use it _
Do not take this medicine if:
•
You are allergic to
_Vultin 600_
or any
of its excipients
•
Your child has epilepsy and is under
3 years old
•
Your child has neuropathic pain and
is younger than 18 years old.
_ _
-
_Before you start to use it _
Tell your doctor or pharmacist if:
•
You have allergies to any other
medicines or any other anticonvulsant
medicines, food, preservatives or
dyes.
•
You have absence seizures (a short
period of “blanking out” or staring
into space).
•
You are pregnant or plan to become
pregnant while you are taking
gabapentin.
•
You are breastfeeding or plan to
breastfeed. Gabapentin is excreted
in breast milk.
•
You have kidney problems, nervous
system disorders, respiratory
disorders or you are more than 65
years old, your doctor may
prescribe a different dos

Productkenmerken

FRONT
28.5 cm.
17.0 cm.


ANTIEPILEPTIC/ NEUROPATHIC PAIN
Each film coated tablet contains:
GABAPENTIN 600 MG
PRODUCT DESCRIPTION:
White, oval, biconvex, film coated tablet with engraved GBP 600 on one
side and scored on the other
MECHANISM OF ACTION:
_PHARMACOLOGY_
Gabapentin is structurally related to the neurotransmitter GABA;
however, Gabapentin and its metabolites do not bind to GABA (A) or
GABA (B)
receptors or influence the degradation or uptake of GABA. The
analgesic action of Gabapentin has been demonstrated in animal models
of analgesia
where Gabapentin prevented allodynia and hyperalgesia. Pain related
responses in neuropathic pain models and in peripheral inflammation
models
were prevented or decreased by Gabapentin. Immediate pain-related
behaviors were not altered.
The mechanism by which Gabapentin exerts its analgesic effects is
unknown. It has been suggested the mechanism of action may be by
Gabapentin
preventing thrombospondin from binding to alpha-2 delta-1 (a receptor
involved in excitatory synapse formation). The anticonvulsant action
of
Gabapentin has been demonstrated in animal test systems; however, the
mechanism by which Gabapentin prevents seizure activity is unknown.
_PHARMACOKINETICS_
Absorption
Gabapentin bioavailability is not dose-proportional. That is, as the
dose is increased, bioavailability decreases.
Gabapentin is absorbed from the gastrointestinal tract by means of a
saturable mechanism. After multiple dosing peak plasma concentrations
usually occur within 2 to 3 hours of a dose and a steady state within
1 to 2 days.
Absolute bioavailability of Gabapentin capsules is approximately 60%.
Distribution
Gabapentin is distributed into breast milk.
It is widely distributed throughout the body but binding to plasma
proteins is minimal. It has a volume of distribution equal to 57.7
liters.
Metabolism
Gabapentin is excreted unchanged in the urine, and is not appreciably
metabolized.
Excretion
The elimination half-life of Gabapentin is independent of dose and