OXYCODONE VIATRIS oxycodone hydrochloride 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxycodone hydrochloride, Quantity: 5 mg

Available from:

Viatris Pty Ltd

INN (International Name):

oxycodone hydrochloride

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose; microcrystalline cellulose; stearic acid

Administration route:

Oral

Units in package:

20 tablets, 6, 8, 500 tablets, 10

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

OXYCODONE VIATRIS is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Product summary:

Visual Identification: A white, round, biconvex 10 mm tablet, one side embossed 'O 5' with a break bar on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-04-08

Patient Information leaflet

OXYCODONE VIATRIS
_oxycodone hydrochloride_
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
OXYCODONE VIATRIS SHOULD ONLY BE USED WHEN YOUR DOCTOR DECIDES THAT
OTHER TREATMENT OPTIONS ARE NOT ABLE TO
EFFECTIVELY MANAGE YOUR PAIN OR YOU CANNOT TOLERATE THEM.
HAZARDOUS AND HARMFUL USE
OXYCODONE VIATRIS 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
OXYCODONE VIATRIS 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 OXYCODONE VIATRIS 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 USING OXYCODONE VIATRIS
USING OXYCODONE VIATRIS 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. GABAPEN-
TIN 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 OXYCODONE
VIATRIS.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OXYCODONE
VIATRIS. 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
OXYCODONE VIATRIS against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT OXYCODONE
VIATRIS

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
OXYCODONE VIATRIS
_oxycodone hydrochloride tablets _
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, OXYCODONE
VIATRIS 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
OXYCODONE VIATRIS 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
OXYCODONE
VIATRIS. 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 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 OXYCODONE VIATRIS.
1
NAME OF THE MEDICINE
Oxycodone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each OXYCODONE VIATRIS tablet contains 5 mg of oxycodone hydrochloride
as the active ingredient.
Excipients of known effect: sugars as lactose.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
OXYCODONE V