LYRACCORD Pregabalin 75 mg capsules bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pregabalin, Quantity: 75 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Pregabalin

Pharmaceutical form:

Capsule, hard

Composition:

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

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Red opaque/White opaque, size 4 hard gelatin capsules imprinted with PG on cap and 75 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

LYRACCORD
CONSUMER MEDICINE INFORMATION
Version: 2.0
LYRACCORD
(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
Lyraccord.
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
Lyraccord against the benefits
this medicine is expected to have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING LYRACCORD ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT LYRACCORD IS
USED FOR
Lyraccord is used to treat
neuropathic pain, which is pain
caused by an abnormality of, or
damage to, the nerves.
Lyraccord 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.
Lyraccord 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.
Lyraccord also has pain relieving
effects.
Lyraccord
_ _
may be used alone, or
in combination with other
medicines, to treat your
condition.
Your doctor may prescribe
Lyraccord
_ _
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
LYRACCORD_ _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
LYRACCORD
_WHEN YOU MUST NOT USE IT _
DO NOT USE LYRACCORD_ _IF YOU
HAVE AN ALLERGY TO:
•
pregabalin, the active
ingredient in Lyraccord or
•
any of the ingredients listed at
the end of this leaflet.
Some of the sym

Summary of Product characteristics

Lyraccord (Pregabalin Capsules 25 mg, 75 mg, 150 mg and 300 mg)
Version 2.0
PRODUCT INFORMATION
LYRACCORD
(PREGABALIN CAPSULES 25 MG, 75 MG, 150 MG AND 300 MG)
NAME OF THE MEDICINE
Lyraccord (Pregabalin Capsules 25 mg, 75 mg, 150 mg and 300 mg).
Lyraccord
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.
Lyraccord 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
analgesic and anticonvulsant activity in animal models: (1) Studies
with the inactive
_R_
-
-2016-
Page 1 of 22
Lyraccord (Pregabalin Capsules 25 mg, 75 mg, 150 mg and 300 mg)
Version 2.0
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 several common drugs for treating seizures o