OXYNDONE oxycodone hydrochloride 5mg film coated tablet blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

oxycodone hydrochloride, Quantity: 5 mg

זמין מ:

Arrotex Pharmaceuticals Pty Ltd

טופס פרצבטיות:

Tablet, film coated

הרכב:

Excipient Ingredients: lactose monohydrate; sodium starch glycollate type A; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; lecithin; brilliant scarlet 4R aluminium lake; indigo carmine aluminium lake

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

20, 6, 10, 8

סוג מרשם:

(S8) Controlled Drug

סממני תרפויטית:

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.

leaflet_short:

Visual Identification: Dark blue, round, vaulted and biconvex film coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius

מצב אישור:

Registered

תאריך אישור:

2019-05-29

עלון מידע

OXYNDONE
_oxycodone hydrochloride _
CONSUMER MEDICINE INFORMATION (CMI)
WARNING
LIMITATIONS OF USE
Oxyndone 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
Oxyndone 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
Oxyndone 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 Oxyndone 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 OXYNDONE
Using Oxyndone 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
Oxyndone.
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Oxyndone. 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 up the risks of you
taking oxycodone 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 want to read
it again later.
WHAT OXYNDONE IS USED FOR
This medicine is used for the
short term management of severe
pain.
This

מאפייני מוצר

AUSTRALIAN PRODUCT INFORMATION - OXYNDONE
(OXYCODONE HYDROCHLORIDE) TABLETS
WARNINGS
_ _
_LIMITATIONS OF USE _
BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, OXYNDONE
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 _
OXYNDONE 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
OXYNDONE. 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 OXYNDONE.
1
NAME OF THE MEDICINE
Oxycodone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg oxycodone hydrochloride.
List of excipients with known effect: Contains sugars (as lactose) and
soy bean products.
For the full list of excipients, see section
6.1 LIST OF EXCIPIENTS
.
3
P