GAPENTIN gabapentin 600 mg tablet blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

gabapentin, Quantity: 600 mg

Saadav alates:

Arrotex Pharmaceuticals Pty Ltd

INN (Rahvusvaheline Nimetus):

Gabapentin

Ravimvorm:

Tablet, film coated

Koostis:

Excipient Ingredients: hyprolose; magnesium stearate; copovidone; poloxamer; maize starch; purified talc

Manustamisviis:

Oral

Ühikuid pakis:

100s

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 who have not achieved adequate control with standard antiepileptic drugs. GAPENTIN is indicated for the treatment of neuropathic pain.

Toote kokkuvõte:

Visual Identification: White to off white, oval shaped, film coated tablets plain on both sides.; Container Type: Blister Pack; Container Material: PVC/PVDC/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:

2010-06-03

Infovoldik

GAPENTIN
CONSUMER MEDICINE INFORMATION
- 1 -
GAPENTIN 600MG & 800MG
Gabapentin Tablets
CONSUMER MEDICINE INFORMATION
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 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 GAPENTIN IS USED
FOR
_WHAT GAPENTIN DOES _
Gapentin 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.
Gapentin is also used to treat
neuropathic pain, a type of pain
caused by damage to the nerves.
Gapentin belongs to a group of
medicines called anticonvulsants.
_HOW GAPENTIN WORKS _
This medicine is thought to work
by controlling brain chemicals
which send signals to nerves to
help control seizures or
neuropathic pain.
Gapentin also has pain relieving
effects.
Ask your doctor if you have any
questions about why Gapentin has
been prescribed for you.
Your doctor may have prescribed it
in addition to your current therapy
when your current treatment is no
longer working as well.
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 _
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
GAPENTIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE GAPENTIN IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
gabapentin, the active
ingredient in Gapentin
•
any of the ingredients listed at
the end of this leaflet.
Some

Toote omadused

1
AUSTRALIAN PRODUCT INFORMATION – GAPENTIN (GABAPENTIN)
TABLETS
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 600 mg tablets contain 600mg of gabapentin.
GAPENTIN 800 mg tablets contain 800mg of gabapentin.
EXCIPIENTS:
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
GAPENTIN 600 mg tablets white to off white, oval shaped, film coated
tablets plain on both sides.
GAPENTIN 800 mg tablets are white to off white, capsule shaped, film
coated tablets plain on both
sides.
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 who have not
achieved adequate control with
standard antiepileptic drugs.
GAPENTIN is indicated for the treatment of neuropathic pain.
4.2
D
OSE AND METHOD OF ADMINISTRATION
NOTE: GAPENTIN IS AVAILABLE AS 600MG AND 800 MG UNSCORED TABLETS AND
SHOULD NOT BE BROKEN INTO
HALF TO ACHIEVE GABAPENTIN DOSAGES OF 300MG OR 400 MG.
GAPENTIN 600 MG UNSCORED TABLETS AND GAPENTIN 800 MG UNSCORED TABLETS
CANNOT BE USED FOR
INITIATION OF TREATMENT, DOSE TITRATION OR TO ACHIEVE LOWER DAILY DOSE
REGIMENS. GAPENTIN CAN ONLY
BE USED IN STABILISED PATIENTS.
DOSAGE
EPILEPSY DOSAGE FOR ADULTS AND CHILDREN OLDER THAN 12 YEARS OF AGE
GAPENTIN can be only used in stabilised patients. Alternative brands
of gabapentin must be used for
initiation of treatment. G