Proladone 30mg

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxycodone, Quantity: 30 mg

Available from:

Phebra Pty Ltd

Pharmaceutical form:

Suppository, compressed

Composition:

Excipient Ingredients: Hard fat; povidone; pectin; maize starch; lactose monohydrate; magnesium stearate

Administration route:

Rectal

Units in package:

12 suppositories

Class:

Medicine Registered

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

INDICATIONS AS AT 15 DEC 1993 : Semisynthetic narcotic analgesic. Relief of post operative pain following a wide range of major operative procedures such as major orthopaedic, abdominal. gynaecological and thoracic surgery and for the relief of pain in malignant disease.

Product summary:

Visual Identification: Wax coated, off white, oval suppository; Container Type: Strip Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-09

Patient Information leaflet

Proladone
Page 1 of 5
_Version 06 _
_ _
PROLADONE
_oxycodone 30 mg suppository _
CONSUMER MEDICINE INFORMATION
WARNINGS
_LIMITATIONS OF USE_
Proladone suppositories should only be given when your doctor decides
that other treatment options are not ab
le to
effectively manage your pain or you cannot tolerate them.
_HAZARDOUS AND HARMFUL USE_
Proladone suppositories poses risks of abuse, misuse and addiction
which can lead to overdose and death. Your doctor will
monitor you regularly during treatment.
_LIFE THREATENING RESPIRATORY DEPRESSION_
Proladone suppositories can cause life-threatening or fatal breathing
problems (slow, shallow, unusual or no breathing).even
when used as recommended. These problems can occur at any time during
use, but the risk is higher when first starting
Proladone suppositories and after a dose increase, if you are older,
or have an existing problem with your lungs. Your doctor
will monitor you and change the dose as appropriate.
_USE OF OTHER MEDICINES WHILE BEING GIVEN PROLADONE SUPPOSITORIES_
USING PROLADONE SUPPOSITORIES WITH OTHER MEDICINES THAT CAN MAKE YOU
FEEL DROWSY SUCH AS SLEEPING TABLETS (E.G.
BENZODIAZEPINES),
OTHER
PAIN
RELIEVERS,
ANTIHISTAMINES,
ANTIDEPRESSANTS,
ANTIPSYCHOTICS,
GABAPENTINOIDS
(E.G.
GABAPENTIN AND PREGABALIN), CANNABIS AND ALCOHOL MAY RESULT IN SEVERE
DROWSINESS, DECREASED AWARENESS, BREATHING
PROBLEMS, COMA AND DEATH.
Your doctor will minimise the dose and duration of use; and monitor
you for signs and
symptoms of breathing difficulties and sedation. You must not drink
alcohol while using Proladone suppositories.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Proladone.
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 using Proladone against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again

Summary of Product characteristics

PRODUCT INFORMATION
Australian Product Information – Proladone
Page 1 of 9
PROLADONE
(OXYCODONE) 30 MG SUPPOSITORY
WARNINGS
_LIMITATIONS OF USE_
Because of the risks associated with the use of opioids, Proladone
suppositories should only be used in
patients for whom other treatment options, including non-opioid
analgesics, are ineffective, not tolerated or
otherwise inadequate to provide appropriate management of pain (see
section 4.4 Special Warnings and
Precautions for Use).
_HAZARDOUS AND HARMFUL USE_
Proladone suppositories poses risks of hazardous and harmful use which
can lead to overdose and death.
Assess the patient's risk of hazardous and harmful use before
prescribing and monitor the patient regularly
during treatment (see section 4.4. Special Warnings and Precautions
for Use).
_LIFE THREATENING RESPIRATORY DEPRESSION_
Serious, life-threatening or fatal respiratory depression may occur
with the use of Proladone suppositories. Be
aware of situations which increase the risk of respiratory depression,
modify dosing in patients at risk and
monitor patients closely, especially on initiation or following a dose
increase (see
section 4.4 Special Warnings
and Precautions for Use).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING _
_ALCOHOL_
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic antidepressants,
antipsychotics, cannabis or other central nervous system (CNS)
depressants, including alcohol, may result in
profound sedation, respiratory depression, coma, and death. Limit
dosages and durations to the minimum
required; and monitor patients for signs and symptoms of respiratory
depression and sedation. Caution
patients not to drink alcohol while taking Proladone suppositories.
1
NAME OF THE MEDICINE
Oxycodone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Proladone suppositories contain oxycodone 30 mg per suppository as the
active ingredient.
Proladone suppositories also contain lactose monohydrate.
For the full list of