NEUROCCORD 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:

Pharmacor Pty Ltd

INN (International Name):

Pregabalin

Pharmaceutical form:

Capsule, hard

Composition:

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

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

NEUROCCORD (pregabalin) is indicated for the treatment of neuropathic pain in adults.,NEUROCCORD (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

NEUROCCORD
_Pregabalin _
CONSUMER MEDICINE INFORMATION
Neuroccord (V – 05)
Page 1 of 5
WARNING: BEFORE TAKING NEUROCCORD, TELL YOUR DOCTOR IF YOU HAVE A
HISTORY OF DRUG ABUSE. NEUROCCORD POSES RISKS OF
MISUSE, ABUSE AND DEPENDENCE. USING NEUROCCORD 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.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Neuroccord.
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 Neuroccord
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING NEUROCCORD ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT NEUROCCORD IS USED
FOR
Neuroccord is used to treat
neuropathic pain, which is pain
caused by an abnormality of, or
damage to, the nerves.
Neuroccord 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.
Neuroccord 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.
Neuroccord also has pain relieving
effects.
Neuroccord may be used alone, or in
combination with other medicines,
to treat your condition.
Your doctor may prescribe
Neuroccord 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 NEUROCCORD
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may h

Summary of Product characteristics

Neuroccord (V 07)
Page
1
of
23
AUSTRALIAN PRODUCT INFORMATION
NEUROCCORD
(pregabalin) Capsules
1
NAME OF THE MEDICINE
Pregabalin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Neuroccord (Pregabalin Capsules 25 mg, 75 mg, 150 mg and 300 mg).
Neuroccord capsules contain 25 mg, 75 mg, 150 mg or 300 mg of
pregabalin.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Neuroccord capsules 25 mg (AUST R No. 235847): White opaque/White
opaque, size “4” hard gelatin capsules
imprinted with ‘PG’ on cap and ‘25’ on body containing white
to off white powder.
Neuroccord capsules 25 mg (AUST R No. 235872): White opaque/White
opaque, size “4” hard gelatin capsules
imprinted with ‘PG’ on cap and ‘25’ on body containing white
to off white powder.
Neuroccord capsules 75 mg (AUST R No. 235849): Red opaque/White
opaque, size “4” hard gelatin capsules
imprinted with ‘PG’ on cap and ‘75’ on body containing white
to off white powder.
Neuroccord capsules 75 mg (AUST R No. 235854): Red opaque/White
opaque, size “4” hard gelatin capsules
imprinted with ‘PG’ on cap and ‘75’ on body containing white
to off white powder.
Neuroccord capsules 150 mg (AUST R No. 235837): White opaque/White
opaque, size “2” hard gelatin
capsules imprinted with ‘PG’ on cap and ‘150’ on body
containing white to off white powder.
Neuroccord capsules 150 mg (AUST R No. 235841): White opaque/White
opaque, size “2” hard gelatin
capsules imprinted with ‘PG’ on cap and ‘150’ on body
containing white to off white powder.
Neuroccord capsules 300 mg (AUST R No. 235864): Red opaque/White
opaque, size “0” hard gelatin capsules
imprinted with ‘PG’ on cap and ‘300’ on body containing white
to off white powder.
WARNINGS
Misuse, abuse potential or dependence
NEUROCCORD is a potential drug of misuse, abuse, and dependence.
NEUROCCORD poses risks of
misuse, abuse and dependence which can lead to overdose and death
especially when used
concomitantly with opioids