Jurnista

Hydromorphone hydrochloride

Consumer Medicine Information

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.

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 is not used to treat pain on an as-needed basis.

JURNISTA should not 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.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Addiction

You can become addicted to JURNISTA even if you take it exactly as prescribed. JURNISTA may become habit forming causing mental and physical dependence. If abused it may become less able to reduce pain.

Dependence

As with all other opioid containing products, your body may become used to you taking JURNISTA. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking JURNISTA suddenly, so it is important to take it exactly as directed by your doctor.

Tolerance

Tolerance to JURNISTA may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect.

Withdrawal

Continue taking your medicine for as long as your doctor tells you. If you stop having this medicine suddenly, your pain may worsen and you may experience some or all of the following withdrawal symptoms:

nervousness, restlessness, agitation, trouble sleeping or anxiety

body aches, weakness or stomach cramps

loss of appetite, nausea, vomiting or diarrhoea

increased heart rate, breathing rate or pupil size

watery eyes, runny nose, chills or yawning

increased sweating.

JURNISTA given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.

Increased sensitivity to pain

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor about your treatment.

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).

have not used any opioid analgesics in the past. This is because you may be more likely to experience some of the side effects

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 treated.

You must tell your doctor if you:

are pregnant or planning to become pregnant

are breastfeeding or wish to breastfeed

have not used any opioid analgesics in the past

have or have ever had any problems with your liver or kidney

have or have ever had any problems with your lungs 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 duct

you or your family have a history of substance dependence or abuse of drugs, alcohol or any opioid painkillers or mental illness

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

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking or are given JURNISTA.

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:

medicines that slow down your central nervous system, (for example:

medicines that makes you sleepy, reduce anxiety such as sedatives, hypnotics, sleeping tablets, tranquillisers (benzodiazepines),

other opioid medicines

medicines used for surgery (anaesthetics) and, muscle relaxants ,

antihistamines or allergy medicine that makes you drowsy ,

gabapentinoid medicines used to treat epilepsy or nerve pain such as gabapentin and pregabalin

alcohol, cannabis or some illegal drugs.

Taking these medicines with JURNISTA may make you even more drowsy, slow down your ability to react, have decrease awareness, breathing difficulties with slow or shallow breathing, coma and death. A change in dose by your doctor may be required if JURNISTA is used with these medicines.

medicines used as antidepressants. In particular, antidepressants belonging to a group called monoamine oxidase inhibitors (MAOIs), such asmoclobemide, phenelzine sulfate and tranylcypromine sulfate. JURNISTA should not be used together with MAOIs as this may cause severe serotonin syndrome which is a potentially life-threatening condition. Signs and symptoms can include confusion, restlessness, fever, heavy sweating, fast or irregular heart rate, diarrhoea, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles, seizures and unconsciousness. Do not use JURNISTA if you have taken an MAOI in the last 14 days.

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

You must not drink alcohol while taking JURNISTA since their combined effect may cause severe drowsiness, decreased awareness, breathing problems, coma and death.

Warning: If your doctor has told you that you have intolerance to some sugars, including lactose, contact your doctor before taking JURNISTA.

Adults

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.

JURNISTA is only designed to work properly if swallowed whole. The tablets may release all their contents at once if broken, chewed, crushed or dissolved, which can be dangerous and cause serious problems, such as an overdose which may be fatal. Unless stated otherwise, they should be swallowed whole.

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.

Children

JURNISTA should not be given to children and adolescents under 18 years of age.

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 hints.

If you or someone else receive too much (overdose), and experience one or more of the symptoms below, call triple zero (000) for an ambulance.

Keep the person awake by talking to them or gently shaking them every now and then. You should follow the above steps even if someone other than you have accidentally used JURNISTA that was prescribed for you. If someone takes an overdose they may experience one or more of the following symptoms:

Slow, unusual or difficult breathing

Drowsiness, dizziness or unconsciousness

Slow or weak heartbeat

Nausea or vomiting

Convulsions or fits

If you think you or someone else may have used too much JURNISTA, you should immediately:

phone the Poisons Information Centre (by calling 13 11 26), or

contact your doctor, or

go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

When seeking medical attention, take this leaflet and remaining medicine with you to show the doctor. Also tell them about any other medicines or alcohol which have been taken.

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 overdose.

Always follow your doctor’s instructions carefully.

Tell your doctor if you become pregnant while taking JURNISTA.

If you are about to start taking a new medicine, tell your doctor and pharmacist that you are 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 there is a change in the pain you are feeling e.g if

You feel your pain is no longer relieved by the tablets

you feel an increase in pain

there is a change in how you feel the pain (for example, you feel pain in another part of your body)

you feel pain when something touches your body that you wouldn’t expect to hurt you.

Do not change the dose yourself. Your doctor may decide to change your dose or treatment.

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.

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 urination

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 breathing

swelling of the face, lips, mouth, tongue or throat, fever or high temperature, chest discomfort

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 for them.

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 some medicines.

If the medicine is damaged, you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

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).

Colour overcoat:

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).

Clear overcoat:

hypromellose and macrogol 400.

Printing ink:

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 October 2020.

OROS^® formulation is a trademark of ALZA Corporation.