LYZALON Pregabalin 25 mg capsules bottle pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

pregabalin, Quantity: 25 mg

Beschikbaar vanaf:

Accord Healthcare Pty Ltd

INN (Algemene Internationale Benaming):

Pregabalin

farmaceutische vorm:

Capsule, hard

Samenstelling:

Excipient Ingredients: Gelatin; 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

Toedieningsweg:

Oral

Eenheden in pakket:

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

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

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

Product samenvatting:

Visual Identification: White opaque/White opaque, size 4 hard gelatin capsules imprinted with PG on cap and 25 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

Autorisatie-status:

Licence status A

Autorisatie datum:

2016-03-23

Bijsluiter

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

Productkenmerken

1
v4
AUSTRALIAN PRODUCT INFORMATION – LYZALON (PREGABALIN) CAPSULES
WARNINGS
MISUSE, ABUSE POTENTIAL OR DEPENDENCE
LYZALON is a potential drug of misuse, abuse, and dependence. LYZALON
poses risks of
misuse, 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
misuse, abuse or dependence before prescribing and monitor the patient
regularly during
treatment, particularly amongst patients with current or past misuse,
abuse or dependence
of opioids and/or benzodiazepines (see SECTION 4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR
USE).
1
NAME OF THE MEDICINE
Pregabalin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LYZALON (Pregabalin Capsules 25 mg, 75 mg, 150 mg and 300 mg).
LYZALON contains the active ingredient pregabalin.
EXCIPIENTS:
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
LYZALON capsules 25 mg are white opaque/White opaque, size “4”
hard gelatin capsules imprinted
with ‘PG’ on cap and ‘25’ on body containing white to off
white powder.
LYZALON capsules 75 mg are red opaque/White opaque, size “4” hard
gelatin capsules imprinted
with ‘PG’ on cap and ‘75’ on body containing white to off
white powder.
LYZALON capsules 150 mg are white opaque/White opaque, size “2”
hard gelatin capsules imprinted
with ‘PG’ on cap and ‘150’ on body containing white to off
white powder.
LYZALON capsules 300 mg are red opaque/White opaque, size “0” hard
gelatin capsules imprinted
with ‘PG’ on cap and ‘300’ on body containing white to off
white powder.
2
v4
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
LYZALON (pregabalin) is indicated for the treatment of neuropathic
pain in adults.
LYZALON (pregabalin) is indicated as adjunctive therapy in adults with
partial seizures with or
without secondary generalisation.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The dose range is 150 to 600 mg per day given in two divided doses.
LYZALON