GABAPENTIN APOTEX gabapentin 100 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gabapentin, Quantity: 100 mg

Available from:

Apotex Pty Ltd

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; purified talc; Gelatin; purified water; sodium lauryl sulfate; titanium dioxide

Administration route:

Oral

Units in package:

50, 10, 30, 20, 100, 500, 300, 150, 1000

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: White/White coloured size '3' hard gelatine capsules, filled with white to off-white blend.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-09-20

Patient Information leaflet

GABAPENTIN APOTEX – Consumer Medicine Information Page 1 of 5
WARNING: Before taking Gabapentin, tell your doctor if you have a
history of drug abuse. Gabapentin poses risks of
abuse and dependence. Using Gabapentin with other medicines that can
make you feel drowsy such as sleeping tablets and
other pain relievers (e.g., benzodiazepines and opioids),
antihistamines, antidepressants, antipsychotics, cannabis,
and alcohol may result in severe drowsiness, decreased awareness,
breathing problems, coma and death. If you have any
concern about taking this medicine, speak to your doctor.
GABAPENTIN APOTEX
CAPSULES
_Contains the active ingredient gabapentin _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about gabapentin. It does not
contain all the available information. It
does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was last
updated on the date listed on the last
page. More recent information on this
medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up to
date leaflet from www.apotex.com.au.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using this medicine against the
benefits they expect it will have for
you.
Pharmaceutical companies cannot give
you medical advice or an individual
diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS USED FOR
The name of your medicine is
Gabapentin APOTEX capsules. It
contains the active ingredient,
gabapentin.
•
control epilepsy, a condition that
causes repeated seizures (fits).
There are many different types of
seizures, ranging from mild to
severe
•
treat neuropathic pain (pain due to
nerves being damaged or affected).
Ask your do

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – GABAPENTIN
APOTEX (GABAPENTIN)
WARNINGS
ABUSE POTENTIAL OR DEPENDENCE
Gabapentin is a potential drug of abuse and dependence. 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).
1
NAME OF THE MEDICINE
Gabapentin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg, 300 mg or 400 mg of gabapentin.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
100 MG CAPSULES:
White/White coloured size ‘3’ hard gelatin capsules, filled with
white to off-white blend.
300 MG CAPSULES:
Yellow/Yellow coloured size ‘0’ with cap ‘M’ and body
‘300’ printed with black ink hard gelatin
capsules, filled with white to off-white blend.
400 MG CAPSULES: Orange/Orange coloured size ‘0el’ with cap
‘M’ and body ‘400’ printed
with black ink hard gelatin capsules, filled with white to off-white
blend.
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 antiepileptic
drugs.
Gabapentin is indicated for the treatment of neuropathic pain.
2
4.2
DOSE 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 range was 900mg/day
to 1800mg/day given in
divided dose