GAPENTIN gabapentin 300mg capsule blister pack (new formulation)

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

gabapentin, Quantity: 300 mg

Saadav alates:

Arrotex Pharmaceuticals Pty Ltd

INN (Rahvusvaheline Nimetus):

Gabapentin

Ravimvorm:

Capsule

Koostis:

Excipient Ingredients: maize starch; iron oxide yellow; titanium dioxide; purified talc; lactose monohydrate; Gelatin; propylene glycol; indigo carmine; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution

Manustamisviis:

Oral

Ühikuid pakis:

100 capsules

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

GAPENTIN is indicated for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic medicines. GAPENTIN is indicated for the treatment of neuropathic pain.

Toote kokkuvõte:

Visual Identification: Size 0 yellow capsule printed with "G 300" in blue ink. Contains white crystalline powder; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2005-07-04

Infovoldik

GAPENTIN capsules - Consumer Medicine Information
Page 1 of 5
GAPENTIN
capsules
gabapentin
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GAPENTIN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking GAPENTIN
against the benefits they expect it
will have for you.
ASK YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT GAPENTIN IS USED
FOR
GAPENTIN capsules contain
gabapentin as the active ingredient.
GAPENTIN belongs to a group of
medicines called anticonvulsants
and is used to control epilepsy. It is
also used in addition to current anti-
epileptic therapy when the current
treatment is no longer working as
well. Epilepsy is a condition where
you have repeated seizures (fits).
There are many different types of
seizures, ranging from mild to
severe.
This medicine is also used to treat
neuropathic pain, a type of pain
caused by damage to the nerves
_HOW GAPENTIN WORKS _
Anticonvulsants such as GAPENTIN
are thought to work by controlling
brain chemicals which send signals
to nerves so that seizures are
treated.
Gapentin also has pain relieving
effects
Your doctor may have prescribed
Gapentin in addition to other
medicines that you may be taking.
This may be necessary if your
current treatment is no longer
working as well.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
GAPENTIN HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
Gapentin may lead to dependence
on this medicine.
This medicine is available only with
a doctor’s prescription.
_USE IN CHILDREN _
It is not recommended for use in
children under the age of 3 years to
control epilepsy, as its safety and
effectiveness in that age group
have not been established. Also,
the safety and effectiveness of
GAPENTIN for

Toote omadused

1
AUSTRALIAN PRODUCT INFORMATION – GAPENTIN (GABAPENTIN)
CAPSULES
WARNINGS
ABUSE POTENTIAL OR DEPENDENCE
GAPENTIN is a potential drug of abuse and dependence. GAPENTIN poses
risks of abuse and
dependence which can lead to overdose and death especially when used
concomitantly with
opioids and other CNS depressants. Assess the patient’s risk of
abuse or dependence before
prescribing and monitor the patient regularly during treatment,
particularly amongst patients
with current or past abuse or dependence of opioids and/or
benzodiazepines (see Section 4.4
Special warnings and precautions for use).
1
NAME OF THE MEDICINE
Gabapentin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
GAPENTIN 100 mg capsules contain 100mg of gabapentin.
GAPENTIN 300 mg capsules contain 300mg of gabapentin.
GAPENTIN 400 mg capsules contain 400mg of gabapentin.
EXCIPIENTS WITH KNOWN EFFECT:
GAPENTIN capsules: sugar as lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
GAPENTIN 100 mg capsules are size 3 white capsule printed with “G
100” in blue ink containing a
white crystalline powder.
GAPENTIN 300 mg capsules are size 0 yellow capsule printed with “G
300” in blue ink containing a
white crystalline powder.
GAPENTIN 400 mg capsules are size 0 orange capsule printed with “G
400” in blue ink containing a
white crystalline powder.
2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
GAPENTIN is indicated for the treatment of partial seizures, including
secondarily generalised tonic-
clonic seizures, initially as add-on therapy in adults and children
age 3 years and above who have not
achieved adequate control with standard anti-epileptic medicines.
GAPENTIN is indicated for the treatment of neuropathic pain.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
EPILEPSY DOSAGE FOR ADULTS AND CHILDREN OVER 12 YEARS OF AGE:
Initiation of treatment should be as add-on therapy. Gabapentin can be
given orally with or without
food.
In controlled clinical trials, the effective dose rang