NUPENTIN TABS gabapentin 800 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gabapentin

Available from:

Alphapharm Pty Ltd

INN (International Name):

Gabapentin

Authorization status:

Registered

Patient Information leaflet

NUPENTIN
_gabapentin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nupentin.
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 Nupentin
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NUPENTIN IS USED
FOR
_WHAT NUPENTIN DOES_
Nupentin is used to control epilepsy.
Epilepsy is a condition where you
have repeated seizures (fits). There
are many different types of seizures,
ranging from mild to severe.
Nupentin is also used to treat
neuropathic pain, a type of pain
caused by damage to the nerves.
This medicine belongs to a group of
medicines called anticonvulsants.
_HOW NUPENTIN WORKS_
This medicine is thought to work by
controlling brain chemicals which
send signals to nerves to help control
seizures or neuropathic pain.
Nupentin also has pain relieving
effects.
Your doctor may have prescribed
Nupentin in addition to other
medicines that you may be taking.
This may be necessary if your current
treatment is no longer working as
well.
Your doctor may have prescribed
Nupentin for another reason.
Nupentin may lead to dependence on
this medicine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY NUPENTIN HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN_
There is not enough information to
recommend the use of this medicine
in children:
•
under the age of 3 years to control
epilepsy, or
•
under the age of 18 years to treat
neuropathic pain.
BEFORE YOU TAKE
NUPENTIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE NUPENTIN IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
gabapentin, the active ingredient
in Nupentin
•
any of the ingredients listed at the
end of this leaflet.
Some of the sympt

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
NUPENTIN
_Gabapentin capsule _
1
NAME OF THE MEDICINE
Gabapentin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gabapentin is a white to off-white crystalline solid. It is freely
soluble in water and both basic and acidic
aqueous solutions.
Each NUPENTIN capsule contains gabapentin 100 mg, 300 mg or 400 mg as
the active ingredient.
NUPENTIN also contains: lactose monohydrate and sulfites (present in
trace amounts).
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
NUPENTIN 100:
Each 100 mg capsule contains gabapentin as the active ingredient,
presented as a size 3
capsule with white body and white cap, “GP100” printed in black
ink on the body and “G” on the cap.
NUPENTIN 300:
Each 300 mg capsule contains gabapentin as the active ingredient,
presented as a
size 1 capsule with yellow body and yellow cap, “GP300” printed in
black ink on the body and “G” on the
cap.
NUPENTIN 400:
Each 400 mg capsule contains gabapentin as the active ingredient,
presented as a
size 0 capsule with orange body and orange cap, “GP400” printed in
black ink on the body and “G” on the
cap.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gabapentin 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 drugs.
Gabapentin is indicated for the treatment of neuropathic pain.
4.2
DOSE AND METHOD OF ADMINISTRATION
EPILEPSY DOSAGE FOR ADULTS AND CHILDREN OLDER THAN 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 range was 900 mg/day
to 1800 mg/day given in divided
doses (three times a day).
Therapy may be initiated by administering 300 mg of Nupentin three
times a day on Day 1, or by titrating the
dose as described below.
Titration to an ef