PREGABALIN INTAS Pregabalin 150 mg capsules bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pregabalin, Quantity: 150 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Pregabalin

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: pregelatinised maize starch; purified talc; sodium lauryl sulfate; Gelatin; purified water; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

56 capsules in HDPE bottle, 20 capsules in HDPE bottle, 500 capsules in HDPE bottle, 200 capsules in HDPE bottle, 14 capsules in HDPE bottle, 60 capsules in HDPE bottle, 30 capsules in HDPE bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PREGABALIN INTAS (pregabalin) is indicated for the treatment of neuropathic pain in adults.,PREGABALIN INTAS (pregabalin) is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Product summary:

Visual Identification: White opaque/White opaque, size 2 hard gelatin capsules imprinted with PG on cap and 150 on body containing white to off white powder.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-03-23

Patient Information leaflet

PREGABALIN INTAS
CONSUMER MEDICINE INFORMATION
Version: 2.0
PREGABALIN INTAS
(PREGABALIN CAPSULES 25 MG, 75 MG, 150 MG AND 300 MG)
_Pregabalin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Pregabalin Intas.
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
Pregabalin Intas against the
benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING PREGABALIN INTAS ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT PREGABALIN INTAS
IS USED FOR
Pregabalin Intas is used to treat
neuropathic pain, which is pain
caused by an abnormality of, or
damage to, the nerves.
Pregabalin Intas is also 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.
Pregabalin Intas belongs to a
group of medicines called
anticonvulsants. These medicines
are thought to work by
controlling brain chemicals
which send signals to nerves so
that seizures do not happen.
Pregabalin Intas also has pain
relieving effects.
Pregabalin Intas
_ _
may be used
alone, or in combination with
other medicines, to treat your
condition.
Your doctor may prescribe
Pregabalin Intas
_ _
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
PREGABALIN INTAS_ _HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another reason.
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 18 years.
BEFORE YOU TAKE
PREGABALIN INTAS
_WHEN YOU MUST NOT USE IT _
DO NOT USE PREGABALIN INTAS_ _IF
YOU HAVE AN ALLERGY TO:
•
pregabalin, the active

Summary of Product characteristics

Pregabalin Intas (Pregabalin Capsules 25 mg, 75 mg, 150 mg and 300 mg)
Version 2.0
PRODUCT INFORMATION
PREGABALIN INTAS
(PREGABALIN CAPSULES 25 MG, 75 MG, 150 MG AND 300 MG)
NAME OF THE MEDICINE
Pregabalin Intas (Pregabalin Capsules 25 mg, 75 mg, 150 mg and 300
mg).
Pregabalin Intas contains the active ingredient pregabalin. Pregabalin
is an analogue of the
neurotransmitter gamma-aminobutyric acid (GABA). It has analgesic and
anticonvulsant
activity.
The structural formula of pregabalin is shown below:
Chemical name:
(
_S_
)-3-(aminomethyl)-5-methylhexanoic acid
Molecular formula:
C
8
H
17
NO
2
Molecular weight:
159.23
CAS number:
148553-50-8.
DESCRIPTION
Pregabalin is a white to off-white solid. It is freely soluble in
water and basic and acidic
aqueous solutions.
Pregabalin Intas capsules contain 25 mg, 75 mg, 150 mg or 300 mg of
pregabalin and the
following inactive ingredients: pregelatinised maize starch, purified
talc, gelatin, sodium
lauryl sulfate, titanium dioxide. The capsules also have a trace of
TekPrint SW-9008 black
ink.
PHARMACOLOGY
MECHANISM OF ACTION
_In vitro _
studies show that pregabalin binds to an auxiliary subunit (α
2
-δ protein) of voltage-
gated calcium channels in the central nervous system, potently
displacing [
3
H]-gabapentin.
Two lines of evidence indicate that binding of pregabalin to the α
2
-δ site is required for
-2016-
Page 1 of 22
Pregabalin Intas (Pregabalin Capsules 25 mg, 75 mg, 150 mg and 300 mg)
Version 2.0
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 α
2
-δ 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 se