APO-PREGABALIN pregabalin 300 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pregabalin

Available from:

Apotex Pty Ltd

INN (International Name):

Pregabalin

Authorization status:

Registered

Patient Information leaflet

APO-PREGABALIN
_Contains the active ingredient pregabalin_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about pregabalin. 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 APO-
Pregabalin. It contains the active
ingredient pregabalin.
It is used to:
•
treat neuropathic pain, which is
pain caused by an abnormality of,
or damage to, the nerves
•
control epilepsy. Epilepsy is a
condition where you have
repeated seizures (fits). There are
many different types of seizures,
ranging from mild to severe.
Pregabalin may be used alone, or in
combination with other medicines, to
treat your condition.
Your doctor may prescribe
pregabalin in addition to your current
therapy when your current treatment
is no longer working as well as
before.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Pregabalin belongs to a group of
medicines called a

Summary of Product characteristics

Product Information – Australia
APO-Pregabalin capsules
Page 1
APO-PREGABALIN CAPSULES
NAME OF THE MEDICINE
Pregabalin.
Chemical Name:
(S)-3-(aminomethyl)-5-methylhexanoic acid
Structural Formula:
Molecular Formula:
C
8
H
17
NO
2
Molecular Weight:
159.23
CAS Registry Number:
148553-50-8
DESCRIPTION
Pregabalin is an analogue of the neurotransmitter gamma-aminobutyric
acid (GABA). It has analgesic and
anticonvulsant activity. Pregabalin is a white to off-white solid. It
is freely soluble in water and basic and
acidic aqueous solutions.
Each capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225
mg or 300 mg of pregabalin,
as the active ingredient.
In addition, each capsule contains the following inactive ingredients:
lactose monohydrate, maize starch,
purified talc, gelatin, purified water, titanium dioxide, sodium
lauryl sulfate and TekPrint SW 9008 black ink.
The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain
iron oxide red.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
_In vitro_ studies show that pregabalin binds to an auxiliary subunit
(α2δ protein) of voltage-gated calcium
channels in the central nervous system, potently displacing
[3H]-gabapentin. Two lines of evidence indicate
that binding of pregabalin to the α2δ site is required for analgesic
and anticonvulsant activity in animal
models: (1) Studies with the inactive _R_-enantiomer and other
structural derivatives of pregabalin and (2)
Studies of pregabalin in mutant mice with defective drug binding to
the α2δ protein. In addition, pregabalin
reduces the release of several neurotransmitters, including glutamate,
noradrenaline and substance P. The
significance of these effects for the clinical pharmacology of
pregabalin is not known.
Pregabalin does not show affinity for receptor sites or alter
responses associated with the action of several
common drugs for treating seizures or pain. Pregabalin does not
interact with either GABA
A
or GABA
B
receptors; it is not converted metabolically into GABA or a GABA
agonist; it is not an inh