GABAPENTIN SANDOZ gabapentin 300mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gabapentin, Quantity: 300 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Gabapentin

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: maize starch; colloidal anhydrous silica; purified talc; pregelatinised maize starch; titanium dioxide; purified water; iron oxide yellow; Gelatin; sodium lauryl sulfate

Administration route:

Oral

Units in package:

100 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Gabapentin Sandoz 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 antiepileptic medicines..,Gabapentin Sandoz is indicated for the treatment of neuropathic pain.

Product summary:

Visual Identification: Size 1 capsules with yellow body; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2010-02-22

Patient Information leaflet

GABAPENTIN SANDOZ
®
1 GABAPENTIN SANDOZ
®
_gabapentin capsules _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Gabapentin Sandoz.
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 risk of you taking this medicine
against the benefits they expect it
will 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 GABAPENTIN
SANDOZ IS USED
FOR
_WHAT GABAPENTIN SANDOZ _
_DOES_
This medicine 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.
This medicine 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 GABAPENTIN SANDOZ _
_WORKS_
This medicine is thought to work by
controlling brain chemicals which
send signals to nerves to help control
seizures or neuropathic pain.
Gabapentin Sandoz also has pain
relieving effects.
Your doctor may have prescribed
Gabapentin Sandoz 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
Gabapentin Sandoz for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY GABAPENTIN
SANDOZ 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 for the
treatment of neuropathic pain.
BEFORE YOU TAKE
GABAPENTIN
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
gabapenti

Summary of Product characteristics

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Page 1 of 21
AUSTRALIAN PRODUCT INFORMATION
GABAPENTIN SANDOZ
® (GABAPENTIN) CAPSULES
1
NAME OF THE MEDICINE
Gabapentin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Gabapentin Sandoz 100 mg capsule contains 100 mg of gabapentin.
Each Gabapentin Sandoz 300 mg capsule contains 300 mg of gabapentin.
Each Gabapentin Sandoz 400 mg capsule contains 400 mg of gabapentin.
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Gabapentin Sandoz 100 mg* capsules: Size 3 hard gelatin capsules with
white body and cap.
_ _
Gabapentin Sandoz 300 mg capsules: Size 1 hard gelatin capsules with
yellow body and cap.
_ _
Gabapentin Sandoz 400 mg capsules: Size 0 hard gelatin capsules with
brown body and cap.
_* Gabapentin Sandoz 100mg capsules are not marketed in Australia. _
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Gabapentin Sandoz 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
antiepileptic medicines.
Gabapentin Sandoz is indicated for the treatment of neuropathic pain.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_EPILEPSY _
_Adults and children over 12 years of age _
Initiation of treatment should be as add-on therapy.
WARNINGS
ABUSE POTENTIAL OR DEPENDENCE
Gabapentin Sandoz is a potential drug of abuse and dependence.
Gabapentin Sandoz 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).
210416-gabapentin sandoz-pi
Page 2 of 21
In controlled clinical trials, the effective dose range was 90