Consumer Medicine Information
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 moderate to severe pain, which requires strong painkillers.
JURNISTA is only for patients with chronic, around the clock pain that is moderate
to severe and expected to be long lasting. JURNISTA should not usually be the first
medicine prescribed for your pain.
JURNISTA prolonged-release tablets contain a medicine called hydromorphone hydrochloride.
This strong pain reliever belongs to a group of medicines known as opioid analgesics.
Hydromorphone hydrochloride relieves pain by blocking the nerves that recognise pain
messages from the body.
Your doctor may have prescribed JURNISTA for another reason. Ask your doctor if you
have any questions about why this medicine has been prescribed for you.
Before you take JURNISTA
When you must not take it
Do not take JURNISTA if you:
have an allergy to hydromorphone hydrochloride or any of the ingredients. See Product
Description at the end of this leaflet for a list of ingredients.
have been diagnosed with serious narrowing of the stomach and/or intestine (bowel)
have pain resulting from very recent surgery or sudden pain which is long lasting
have had surgery which may have left you with 'blind loop' in your intestine
have seriously impaired liver function
have serious breathing difficulties, with slow or shallow breathing
have severe acute asthma
get sudden severe abdominal pain and the cause hasn't been diagnosed
are taking a type of antidepressants called Monoamine Oxidase (MAO) inhibitors, or
have taken them within the last 14 days
are taking other morphine-related painkillers (buprenorphine, nalbuphine or pentazocine).
Do not take JURNISTA if the packaging is torn or shows signs of tampering.
Do not take JURNISTA beyond the expiry date (month and year) printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as well.
Do not give JURNISTA to babies or children, women during pregnancy, labour, delivery,
breastfeeding or patients who are in a coma.
JURNISTA should not be used during childbirth as the medicine can slow the breathing
of the newborn child. Prolonged use of JURNISTA during pregnancy can cause withdrawal
symptoms in your newborn baby that could be life-threatening if not recognised and
Before you start to take it
You must tell your doctor if you:
are pregnant or planning to become pregnant
are breastfeeding or wish to breastfeed
have or have ever had liver or kidney disease
have or have ever had lung disease or difficulty in breathing
have a history of sleep apnoea or if anyone notices you stop breathing from time to
time whilst sleeping
have or have ever had heart disorders
have or ever had headaches or head injuries
have or ever had chronic constipation or any disease of your intestine including obstruction
or inflammatory bowel disease
have or ever had inflammation of the pancreas (pancreatitis) or disease of the bile
you or your family have a history of substance dependence or abuse of drugs, alcohol
or any opioid painkillers
had a severe reaction, such as confusion and shaking, to stopping alcohol (sometimes
called delirium tremens)
have or ever had symptoms of CNS depression such as severe drowsiness, low body temperature
and sometimes coma
have or ever had fits or seizures
have an under-active thyroid (hypothyroidism) or problems with your adrenal gland
have an enlarged prostate
have difficulty in passing urine
have a major mental disorder following an infection (toxic psychosis)
have abnormal curvature of the spine (kyphoscoliosis)
are planning to have a surgery
are sensitive to sulfite
You must tell your doctor if you have not used any opioid analgesics in the past,
unless you are being treated for cancer pain. This is because you may be more likely
to experience some of the side effects.
If you have not told your doctor or pharmacist about any of the above, tell them before
you start taking or are given JURNISTA.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including medicines
you can buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, tell your doctor or pharmacist if you are taking any of the following:
other morphine-related painkillers (buprenorphine, nalbuphine or pentazocine).
medicines used as antidepressants. In particular, antidepressants belonging to a group
called monoamine oxidase inhibitors (MAOIs) should be stopped for 14 days before JURNISTA
is taken. These include moclobemide, phenelzine sulfate and tranylcypromine sulfate.
medicines used as sedatives, sleeping tablets, tranquillisers or muscle relaxants.
JURNISTA can increase the effect of drugs that are sedating or slow down your ability
to react. A change in dose may be required if JURNISTA is taken with these medicines.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
Effect on driving and operating machinery
JURNISTA can make you drowsy. Do not drive, operate machinery or do hazardous work
until you are sure you are not affected. Take special care if your dose or type of
medication is changed.
Effect of alcohol
Avoid alcohol when taking JURNISTA since their combined effect may cause drowsiness.
Warning: If your doctor has told you that you have intolerance to some sugars, including
lactose, contact your doctor before taking JURNISTA.
Tolerance and Dependence
JURNISTA contains an opioid analgesic called hydromorphone hydrochloride. As with
all opioid analgesics, over time your body becomes used to taking hydromorphone. Your
doctor may, therefore, prescribe a higher dose of JURNISTA after some time to continue
to give you pain relief. Also, if you suddenly stop taking JURNISTA you may experience
some symptoms of withdrawal.
How to take the tablet
JURNISTA is available in five different strengths. Your doctor will decide which strength
is suitable to control your pain.
The usual starting dose of JURNISTA is 8mg taken at the same time each day. However,
your doctor may prescribe a different dose of JURNISTA to start with if you are changing
from a different morphine-related painkiller.
The lowest effective dose should be used for the shortest period of time.
JURNISTA should be swallowed whole, with a glass of water.
JURNISTA may be taken with or without food.
DO NOT crush or chew the tablets. If you do, there is a danger you could overdose,
because the medicine will be released into your body too quickly.
Do not take JURNISTA more than once every 24 hours. If you have insufficient pain
relief from JURNISTA you should contact your doctor for advice. Taking another JURNISTA
tablet some time after a first tablet on the same day could result in too much medicine
being released into your body.
Ask your doctor or pharmacist for help if you do not understand the instructions provided
with this medicine.
JURNISTA should not be given to children and adolescents under 18 years of age.
If you forget to take it
If you forget to take a tablet, take the next dose immediately and start a new 24-hour
regimen. If you are not sure what to do, check with your doctor or pharmacist. DO
NOT take extra tablets or double dose to make up for the forgotten tablets.
If you have trouble remembering when to take the tablet, ask your pharmacist for some
If you take too much (overdose)
The most important sign of overdose is difficulty in breathing. Other signs of overdose
are feeling very drowsy, an increased heart rate, clammy skin, small pupils, low blood
pressure and coma. Someone who's taken a serious overdose may stop breathing, have
a heart attack and die.
Immediately telephone your doctor or the Poisons Information Centre for advice, or
go to the Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent
Poisons Information Centre telephone numbers:
Australia: 13 11 26
New Zealand: 0800 764 766 or 0800 POISON
Keep these telephone numbers handy.
INFORMATION FOR THE DOCTOR
In case of overdose: administer an opioid antagonist and transfer patient to hospital.
Please refer to full Product Information for details on appropriate management of
While you are taking JURNISTA
Things you must do
Always follow your doctor's instructions carefully.
Tell your doctor if you become pregnant while taking JURNISTA.
If your pain continues or returns, see your doctor. You may need additional medicines
to control the pain or a change in the strength of the JURNISTA tablet.
If you are about to start taking a new medicine, tell your doctor and pharmacist that
you are taking JURNISTA.
DO NOT be alarmed if you notice what appears to be the JURNISTA tablet in your stool;
this is simply the non-dissolvable shell of the tablet.
Things you must not do
DO NOT use JURNISTA to treat any other complaint unless your doctor says so.
DO NOT give the tablets to anyone else, even if their symptoms seem similar to yours.
DO NOT stop taking JURNISTA unless your doctor advises you to do so.
If you have been taking JURNISTA for a long period of time but stop taking it suddenly
without your doctor's advice, you may experience withdrawal symptoms such as:
anxiety or irritability
vomiting or feeling sick
diarrhoea or stomach pain
the pupils of your eyes increasing in size
blushing or sweating
crying for no reason
pains in your joints
Seek your doctor's advice if you experience any of these symptoms.
Do not crush and intravenously inject JURNISTA. Animal studies have shown that some
of the non-active components of JURNISTA can cause serious damage to organs such as
the heart, kidneys, and blood cells and even death, when injected intravenously. When
taken by mouth as instructed by your doctor these non-active components of JURNISTA
are not absorbed into the body and are well tolerated.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some side effects. Do not
be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you experience any of the following:
nausea, vomiting, cramps, diarrhoea, fever, stomach pain or discomfort, constipation,
dry mouth, indigestion, difficulty in swallowing, excessive gas in the stomach or
bowel, passage of stools containing blood, piles, abnormal faeces, belching, torn
rectum, inflammation of the small intestine, bowel obstruction, painful defecation
loss of appetite, weight decrease, dehydration, fluid retention, increased appetite,
high uric acid levels in the blood, which may cause gout
nervousness, confusion, hallucinations, euphoria, depression, trouble sleeping, anxiety,
abnormal dreams, restlessness, altered mood, decreased sexual drive, panic attack,
listless, paranoia, aggression, crying, erectile dysfunction
sleep apnoea (stopping breathing from time to time whilst sleeping)
trouble in urinating, pain when passing urine, urinary hesitation, frequent day time
sleepiness, headache, dizziness, increased or decreased feeling, pins and needles,
shaking, memory impairment, disturbance in attention, taste disorder, speech disorder,
, balance disorder, abnormal coordination, uncontrollable twitching, cognitive disorder,
convulsion, unusually increased reflexes, buzzing or whistling in the ears
blurred vision, double vision, dry eyes, contraction of the pupil
itching, excessive sweating, rash, redness of the skin, skin burning sensation, sneezing
muscle spasms, back pain, joint pain, pain in extremity, aching muscles
weakness, pain, , chills, drug withdrawal symptoms, feeling unwell or abnormal, difficulty
in walking, influenza-like illness.
Tell your doctor immediately if you experience any of the following, as you may need
urgent medical care:
fainting, decreased level of consciousness, cognitive disorder
fast or irregular heart rate, extra heart beats
flushing, high or low blood pressure
shortness or difficulty in breathing, lack of oxygen, respiratory depression, fast
swelling of the face, lips, mouth, tongue or throat, fever or high temperature, chest
After taking JURNISTA
Store JURNISTA securely, where other people cannot access it. It may harm people who
may take this medicine by accident, or intentionally when it has not been prescribed
Keep JURNISTA tablets in the blister pack and box until it is time to take them.
Keep the tablets in a cool dry place where temperature is below 25°C.
Keep your medicines where children cannot reach them. A locked cupboard at least one-and-a-half
metres (1.5 m) above the ground is a good place to store medicines.
Do not store JURNISTA tablets or any other medicine, in the bathroom or near a sink.
Do not leave medicines in the car or on window sills. Heat and dampness can destroy
If your doctor tells you to stop taking JURNISTA, or the tablets have passed their
expiry date, return the tablets to your pharmacist.
What it looks like
JURNISTA 4 mg prolonged-release tablets are pale beige and have "HM 4" printed in
black ink on one side
JURNISTA 8 mg prolonged-release tablets are red and have "HM 8" printed in black ink
on one side
JURNISTA 16 mg prolonged-release tablets are yellow and have "HM 16" printed in black
ink on one side
JURNISTA 32 mg prolonged-release tablets are white and have "HM 32" printed in black
ink on one side
JURNISTA 64 mg prolonged-release tablets are blue and have "HM 64" printed in black
ink on one side.
JURNISTA is provided in blister packs of 14 tablets. Blister packs of 7, 10, 20, 28,
30, 35, 40, 50, 60 and 100 tablets are currently not marketed.
JURNISTA 4 mg (AUST R 155995)
JURNISTA 8 mg (AUST R 141508)
JURNISTA 16 mg (AUST R 141533)
JURNISTA 32 mg (AUST R 141534)
JURNISTA 64 mg (AUST R 141535)
Each JURNISTA tablet contains 4 mg, 8 mg, 16 mg, 32 mg or 64 mg of hydromorphone hydrochloride
as the active ingredient.
Each tablet also contains the following other ingredients:
Coated tablet core:
polyethylene oxide, povidone, magnesium stearate, butylhydroxytoluene (E321), sodium
chloride, hypromellose, iron oxide black (E172), lactose, cellulose acetate, macrogol
3350 and iron oxide yellow (E172) (32 mg tablet only).
lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, iron
oxide red (E172) (4 mg & 8 mg tablet)/iron oxide black (4 mg tablet)/iron oxide yellow
(E172) (4 mg & 16 mg tablet)/indigo carmine lake (E132) (64 mg tablet).
hypromellose and macrogol 400.
iron oxide black (E172), propylene glycol and hypromellose.
Janssen-Cilag Pty Ltd
1-5 Khartoum Road
Macquarie Park NSW 2113 Australia
Telephone: 1800 226 334
NZ Office: Auckland New Zealand
Telephone: 0800 800 806
This leaflet was prepared in November 2019