Read all of this leaflet carefully before you start

using this medicine because it contains important

information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, pharmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Palladone injection is and what it is used for

2.    What you need to know before you use Palladone injection

3.    How to use Palladone injection

4.    Possible side effects

5.    How to store Palladone injection

6.    Contents of the pack and other information

1. What Palladone injection is and what it is used for_

You have been prescribed Palladone injection to relieve severe pain.

It contains the active substance hydromorphone hydrochloride, which is a potent analgesic (strong “painkiller”) of the opioid group.

2. What you need to know before you use Palladone injection

Do not use Palladone injection if you:

•    are allergic to hydromorphone or to any of the other ingredients of this medicine (listed in section 6);

•    have breathing problems (respiratory depression);

•    suffer from a severe lung disease associated with obstruction of the airways (severe chronic obstructive pulmonary disease or severe COPD);

•    have a heart problem after long-term lung disease (cor pulmonale);

•    have severe pain in your abdomen;

•    have a condition where the small bowel does not work properly (paralytic ileus);

•    are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks.

Palladone injection must not be used if the patient is in a

coma.

Warnings and precautions

Talk to your doctor or pharmacist before using Palladone

injection if you:

•    have a dependence on strong painkillers;

•    have a head injury (due to the risk of increased brain pressure);

•    suffer from seizures, fits or convulsions;

•    have an addiction to alcohol;

•    have previously suffered from withdrawal symptoms such as agitation, anxiety, nervousness, difficulty in sleeping, being unusually overactive, shaking and gastrointestinal problems upon stopping taking alcohol or drugs;

•    suffer from a mental disorder as a result of an intoxication (toxic psychosis);

•    have low blood pressure associated with low circulating blood volume (hypotension with hypovolaemia);

•    are feeling light-headed or faint;

•    have problems with your gall bladder;

•    have inflammation of the pancreas (pancreatitis);

•    have any bowel problems (such as obstructive or inflammatory bowel disease);

•    have prostate problems (such as difficulties in passing urine);

•    have poor adrenal gland function (e.g. Addison’s disease).

•    have an under-active thyroid gland (hypothyroidism);

•    have a chronic obstructive airway disease (such as COPD) or reduced pulmonary function;

•    suffer from a debilitated general condition or are elderly;

•    suffer from severe kidney problems (including ureteric colic);

•    suffer from severe liver problems.

If this information applies to you or formerly applied to you, please speak to your doctor.

Palladone injection is not recommended for children under 12 years of age.

The major risk of opioid excess is difficulty in breathing (respiratory depression).

Patients may develop tolerance with long-term use of this medicine. This means you may require higher doses to achieve the desired pain control.

Long-term use of this medicine may lead to physical dependence. If treatment is stopped abruptly, withdrawal symptoms such as agitation, anxiety, nervousness, difficulty in sleeping, involuntary muscle contractions, shaking, and gastro-intestinal problems may occur. If you no longer require therapy with hydromorphone, your doctor will taper the daily dose gradually to prevent these symptoms.

The active substance hydromorphone hydrochloride has an abuse profile similar to other strong opioids. There is potential for development of psychological dependence. Therefore, this medicine should be used with particular care in patients with a history of alcohol and drug abuse. An increase in sensitivity to pain (hyperalgesia) that will not respond to a further dose increase of this medicine may occur in particular in high doses. Your doctor will decide whether a dose reduction or change in analgesic (opioid) is required in such a situation.

Please tell your doctor if you experience small bowel problems (paralytic ileus) during treatment with this medicine. He or she will take appropriate measures.

If you are going to have an operation, please tell the doctor at the hospital that you are using this medicine as they may need to adjust the amount of injection you are given.

The use of this medicine may produce positive results in doping controls.

Other medicines and Palladone injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

When taken with some other medicines or alcohol, the side effects of Palladone injection (such as drowsiness, breathing problems, constipation, dry mouth, difficulty in passing urine) or the other medicine may be altered.

Tell your doctor if you:

•    are taking medicines to treat anxiety (for example tranquillisers);

•    have been given an anaesthetic (for example a barbiturate);

•    are taking medicines to help you sleep (hypnotics or sedatives);

•    are taking medicines to treat psychiatric or mental disorders (neuroleptics or psychotropics);

•    are taking medicines to treat depression (antidepressants);

•    are taking medicines used to stop you feeling sick or being sick (antiemetics);

•    are taking medicines used to prevent or relieve the symptoms of an allergy (antihistamines);

•    are taking medicines to treat Parkinson’s disease;

•    are taking other strong analgesics or ‘painkillers’, or have recently taken another painkiller from the opioid class.

Do not take this medicine if you are taking a specific type of medicine known as a monoamine oxidase inhibitor, or you have taken this type of medicine in the last two weeks.

Palladone injection with food, drink and alcohol

Drinking alcohol during your treatment with this medicine may make you drowsy. If you are affected you should avoid drinking alcohol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

You should not use this medicine during pregnancy and labour unless you have been specifically told by your doctor. If you use this medicine during labour, uterine contractility may be impaired. In addition slow and shallow breathing (respiratory depression) may occur in the newborn infant.

If you use this medicine for a long time during pregnancy, withdrawal symptoms may be observed in the newborn infant.

Breast-feeding

This medicine should not be used while breast-feeding because the active substance can get into breast milk. Driving and using machines

This medicine may make you drowsy and thus impair your ability to drive and use machines. This applies particularly:

•    at the beginning of treatment;

•    if your dose is increased;

•    if you have switched to this medicine from a different opioid.

•    if you drink alcohol or use medicines which influence your brain function.

You should consult your doctor before driving or using machinery.

This medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive while you have this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’).

•    This defence applies when:

•    The medicine has been prescribed to treat a medical or dental problem; and

•    You have taken it according to the instructions given by the prescriber and in the information provided with the medicine.

•    Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Palladone injection contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially “sodium-free”.

3. How to use Palladone injection

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

A doctor or nurse will usually prepare and administer the injection for you.

Your doctor will decide how much Palladone injection you require based on:

•    the severity of your pain;

•    the dose of painkiller you have previously been given;

•    your age and weight.

Your doctor will increase the amount of this medicine you are given until your pain is relieved. If you find that you are still in pain whilst undergoing treatment with this medicine discuss this with your doctor.

You should not use Palladone 10 mg, [20 mg, 50 mg] injection as initial opioid therapy. This higher strength may only be used as individual doses if you have no longer sufficiently responded to lower doses of hydromorphone preparations (Palladone 2 mg) or comparably strong analgesics as part of long term pain therapy.

The usual starting doses of Palladone injection are as follows:

Use in adults and adolescents (older than 12 years of ^ag^e)

•    As a single injection into a vein, the usual dose is

1 to 1.5 mg given slowly over 2 to 3 minutes. This can be repeated every 3 to 4 hours.

•    As a single injection through a fine needle into the tissue under the skin, the usual dose is 1 to 2 mg. This can be repeated every 3 to 4 hours.

•    As an infusion into a vein or through a fine needle into the tissue under the skin, the usual starting dose is 0.15 to 0.45 mg/hour (or 0.004 mg/kg bodyweight/hour).

•    If given by patient controlled analgesia (PCA), the usual recommended bolus dose is 0.2 mg with a stop interval of 5 to 10 minutes.

Use in children (under 12 years of age)

Palladone injection is not recommended for children under 12 years of age.

If you use more Palladone injection than you should

Call your doctor, hospital or an ambulance straight away as the patient may need emergency treatment in hospital. In severe cases an overdose may lead to unconsciousness or even death. The following symptoms may occur after an overdose:

•    pin point pupils;

•    slowing of heartbeat;

•    respiratory problems;

•    low blood pressure;

•    unconsciousness leading to coma.

If you have used too much Palladone injection under no circumstances should you put yourself in a situation that requires you to be alert e.g. driving a car.

When seeking medical attention make sure that you take this leaflet and any remaining ampoules with you to show to the doctor.

If you forget to use Palladone injection

Please use Palladone injection as soon as you notice that you forgot a dose. Never double the dose.

If you forget to use Palladone injection or use a smaller dose than prescribed, this will lead to unsatisfactory and/ or insufficient pain relief.

If you stop using Palladone injection You should not suddenly stop using this medicine unless your doctor tells you to. If you want to stop using this medicine discuss this with your doctor first. If you do stop using this medicine suddenly after extended treatment, you may experience withdrawal symptoms such as agitation, anxiety, nervousness, difficulty in sleeping, involuntary muscle contractions, shaking, and gastro-intestinal problems. Your doctor will tell you how to stop your treatment, usually by reducing the dose gradually so you do not experience unpleasant effects.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

This medicine can cause allergic reactions (hypersensitivity reactions). The incidence of serious allergic reactions (anaphylactic reactions) is not known. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face, lips, mouth or throat, or any rash or itching especially those covering your whole body.

Difficulty in breathing (respiratory depression) is the chief hazard of an opioid overdose.

Most people will have constipation when using this medicine. Increasing the amount of fibre (fruit, vegetables, wholemeal bread, pasta, brown rice) and fluids you eat and drink may help reduce the problem, but if necessary your doctor may prescribe a laxative.

You may feel sick or vomit (be sick) when you use this medicine, this should normally wear off after a few days however your doctor can prescribe an anti-vomiting medicine if it continues to be a problem.

Very common side effects (may affect more than 1 in 10 people)

•    dizziness, feel more sleepy than normal

•    constipation, feel sick

Common side effects (may affect up to 1 in 10 people)

•    confusion, anxiety, sleeplessness

•    headache

•    dry mouth, vomiting (be sick)

•    itchy skin, sweating

•    urgency in passing urine

•    a feeling of unusual weakness

•    loss of appetite

•    abdominal pain or discomfort

•    skin reactions at the injection site Uncommon side effects (may affect up to 1 in 100 people)

•    feeling of extreme happiness, hallucinations

•    shaking, muscle spasms, tingling in the hands or feet

•    blurred vision

•    low blood pressure

•    indigestion

•    rash

•    decreased sexual drive, impotence

•    withdrawal symptoms such as agitation, anxiety, nervousness, difficulty in sleeping, being unusually overactive, shaking and gastrointestinal problems

•    tiredness, generally feeling unwell

•    swelling of hands, ankles or feet

•    agitation, depression, nightmares

•    shortness of breath

•    diarrhoea, changes in taste

•    difficulty in passing urine

•    a worsening in liver function tests (seen in a blood test)

Rare side effects (may affect up to 1 in 1,000 people)

•    sedation, lack of energy

•    slow, fast or irregular heartbeat

•    difficulty in breathing or wheezing

•    a worsening in pancreas function tests (seen in a blood test)

Very rare side effects (may affect up to 1 in 10,000 people)

•    irritation and hardening of the skin at the injection site (particularly after repeated subcutaneous administration)

Side effects with unknown frequency (frequency cannot be estimated from the available data)

•    drug dependence, drug tolerance

•    unpleasant or uncomfortable mood

•    reduction in size of the pupils in the eye

•    an increase in sensitivity to pain (hyperalgesia; see “Warnings and precautions” in section 2)

•    seizures, fits or convulsions

•    uncontrolled muscle movements

•    facial flushing (redness of the face)

•    a condition where the small bowel (part of your gut) does not work properly (paralytic ileus)

•    itching rash (hives)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Palladone injection

Keep this medicine out of the sight and reach of children. Keep the ampoules in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton and the ampoule label after “EXP”. The expiry date refers to the last day of that month. Instructions for stability of the medicinal product after preparation

After opening, this medicine should be used immediately. The physical and chemical in-use stability has been demonstrated for a dilution of Palladone injection with solutions for infusion/injection of sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%) or water for injections for 24 hours at 25°C.

From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless opening/ dilution has taken place in controlled and validated aseptic conditions.

The medicine is to be visually inspected prior to use.

Only clear solutions free from particles should be used. Do not use opened ampoules and previously diluted solutions.

Instructions for stability after use or dilution:

Once the ampoule is opened the injection should be used immediately. Any unused portion should be discarded immediately.

Do not throw away any medicines via wastewater or household waste. Ask you pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Palladone injection contains:

Palladone 2 mg/ml injection:

•    The active substance is hydromorphone hydrochloride. Each ampoule contains 2 mg hydromorphone hydrochloride (corresponding to 1.77 mg hydromorphone) in 1 ml solution.

Palladone 10 mg/ml injection:

•    The active substance is hydromorphone hydrochloride. Each ampoule contains 10 mg hydromorphone hydrochloride (corresponding to 8.87 mg hydromorphone) in 1 ml solution.

Palladone 20 mg/ml injection:

•    The active substance is hydromorphone hydrochloride. Each ampoule contains 20 mg hydromorphone hydrochloride (corresponding to 17.7 mg hydromorphone) in 1 ml solution.

Palladone 50 mg/ml injection:

•    The active substance is hydromorphone hydrochloride. Each ampoule contains 50 mg hydromorphone hydrochloride (corresponding to 44.33 mg hydromorphone) in 1 ml solution.

The other ingredients are:

•    Citric acid anhydrous

•    Sodium citrate

•    Sodium chloride

•    Sodium hydroxide

•    Hydrochloric acid

•    Water for injections

What Palladone injection looks like and contents of the pack

Palladone injection is a clear, colourless to pale yellow, pH 4.0 solution for injection or infusion supplied in clear glass ampoules, available in packs of 5 x 1 ml ampoules.

Marketing Authorisation Holder

Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.

Manufacturer

Bard Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.

This leaflet is also available in large print, Braille or as an audio CD.

To request a copy, please call the RNIB Medicine Information line (free of charge) on :

0800 198 5000

You will need to give details of the product name and reference number.

These are as follows:

Product name: Palladone solution for injection or infusion Reference number: 16950/0163

This leaflet was last revised in October 2015 ® Palladone and the NAPP logo are registered trade marks.

© 2012-2015 Napp Pharmaceuticals Limited

(napp