JURNISTA hydromorphone hydrochloride 32 mg prolonged release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydromorphone hydrochloride, Quantity: 32 mg

Available from:

Janssen-Cilag Pty Ltd

INN (International Name):

hydromorphone hydrochloride

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: polyethylene oxide; povidone; magnesium stearate; butylated hydroxytoluene; sodium chloride; iron oxide black; cellulose acetate; iron oxide yellow; hypromellose; lactose; macrogol 3350; lactose monohydrate; titanium dioxide; triacetin; macrogol 400; propylene glycol; isopropyl alcohol; purified water

Administration route:

Oral

Units in package:

Blister packs of 10 tablets, Blister packs of 50 tablets, Blister packs of 28 tablets, Blister packs of 14 tablets, Blister pack

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

JURNISTA is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. JURNISTA is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. JURNISTA is not indicated as an as-needed (PRN) analgesia. Not for use in opioid na?ve patients.

Product summary:

Visual Identification: White, round, biconvex tablet with 'HM32' printed in black on one side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-07-29

Patient Information leaflet

JURNISTA
®
1
JURNISTA
®
_Hydromorphone hydrochloride _
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
JURNISTA 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
JURNISTA 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
JURNISTA 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 JURNISTA 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 JURNISTA
USING JURNISTA 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 JURNISTA.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about JURNISTA
prolonged-release tablets. 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 JURNISTA
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING JURNISTA, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT JURNISTA IS
TAKEN FOR
JURNISTA is taken to relieve
modera

Summary of Product characteristics

CCDS v10 200417
1
JURNISTA (201012)API
AUSTRALIAN
PRODUCT
INFORMATION
JURNISTA
®
HYDROMORPHONE HYDROCHLORIDE
P
ROLONGED
-
RELEASE
T
ABLETS
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, JURNISTA
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
JURNISTA 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 JURNISTA.
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 JURNISTA.
1. NAME OF THE MEDICINE
Hydromorphone hydrochloride
CCDS v10 200417
2
JURNISTA(201012)API
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
JURNISTA is available as prolonged-release tablets containing 4, 8,
16, 32 and 64 mg
hydromorphone hydrochloride.
Excipient(s) with known effect: Lactose
Fo