PHARMACOR GABAPENTIN 600 gabapentin 600 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gabapentin, Quantity: 600 mg

Available from:

Pharmacor Pty Ltd

INN (International Name):

Gabapentin

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

100s

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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. Treatment of neuropathic pain.

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2010-06-03

Patient Information leaflet

Pharmacor Gabapentin (V 04)
1
PHARMACOR GABAPENTIN
_Gabapentin_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PHARMACOR
GABAPENTIN.
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
PHARMACOR GABAPENTIN 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 PHARMACOR
GABAPENTIN IS USED FOR
_WHAT _
_PHARMACOR _
_GABAPENTIN DOES _
PHARMACOR GABAPENTIN 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.
PHARMACOR GABAPENTIN is also
used to treat neuropathic pain, a type
of pain caused by damage to the
nerves.
PHARMACOR GABAPENTIN belongs to
a group of medicines called
anticonvulsants.
_HOW PHARMACOR _
_GABAPENTIN WORKS _
This medicine is thought to work by
controlling brain chemicals, which
send signals to nerves to help control
seizures or neuropathic pain.
PHARMACOR GABAPENTIN also has
pain relieving effects.
Your doctor may have prescribed
PHARMACOR GABAPENTIN 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
PHARMACOR GABAPENTIN for
another reason.
PHARMACOR GABAPENTIN may lead
to dependence on this medicine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PHARMACOR
GABAPENTIN 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
PHARMACOR GABAPENTIN
_WHE

Summary of Product characteristics

Pharmacor Gabapentin (V 06)
1
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR GABAPENTIN (GABAPENTIN) TABLETS
1
NAME OF THE MEDICINE
Gabapentin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Each tablet contains 600mg or 800mg gabapentin.
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
600 mg Tablets:
White to off white, oval shaped, film-coated tablets plain on both
sides
800 mg Tablets:
White to off white, capsule shaped, film-coated tablets plain on both
sides
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
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.
•
Treatment of neuropathic pain.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Note : Pharmacor Gabapentin 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.
WARNINGS
Abuse Potential or Dependence
Pharmacor Gabapentin is a potential drug of abuse and dependence.
Pharmacor Gabapentin 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).
Pharmacor Gabapentin (V 06)
2
Pharmacor Gabapentin 600 unscored tablets and Pharmacor Gabapentin 800
unscored Tablets
cannot be used for initiation of treatment, dose titration or to
achieve lower daily dose regimens.
Pharmacor Gabapentin can only be used in stabilised patients.
Adults and Children Older than 12 Years of Age with Epilepsy
Pharmacor Gabapentin can be only used in stabilised patients.
Alternative brands of gabapentin
must be used for initiation of treatment