Palladone 10 mg/ml solution for injection or infusion

• 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.

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

• are allergic to hydromorphone or to any of the other ingredients of this medicine (listed in section 6);
• have breathing problems, such as severe chronic obstructive airways disease, respiratory depression or severe asthma. Symptoms may include breathlessness, coughing or breathing more slowly and weakly than expected;
• 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.

Talk to your doctor or pharmacist before using Palladone injection if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs;
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs;
• feel you need to take more of Palladone to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever;
• have a head injury (due to the risk of increased brain pressure);
• suffer from seizures, fits or convulsions;
• 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;
• suffer from constipation.
• or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• are a smoker.
• have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

This medicine may cause breathing problems or worsen already existing problems while sleeping. These problems may include pauses in breathing during sleep, being awoken by shortness of breath, difficulty staying asleep or excessive daytime drowsiness. If you or someone else observes these symptoms contact your doctor. Your doctor may want to lower your dose.

This medicine contains hydromorphone which is an opioid medicine. Repeated use of opioid painkillers may result in the drug being less effective (you become accustomed to it). Repeated use of Palladone injection may lead to dependence and abuse which may result in life threatening overdose. If you have concern that you may become dependent on Palladone injection, it is important that you consult your doctor.

Using this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely.

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

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your doctor will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

You may experience hormonal changes whilst using this medicine. Your doctor may want to monitor these changes.

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).

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.

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 (benzodiazepines, 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.

Concomitant use of Palladone injection and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. The concomitant use of opioids and drugs used to treat epilepsy, nerve pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression and may be life-threatening.

However if your doctor does prescribe Palladone injection together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Sleep-related breathing disorders

Palladone injection can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

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.

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

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

Do not use Palladone injection if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby. If you use Palladone injection during pregnancy your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated, such as high-pitched cry, jitteriness, fits, poor feeding and diarrhoea.

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.

Breast-feeding

Do not use Palladone injection while you are breastfeeding as hydromorphone passes into breast milk and will affect your baby.

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.

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

A doctor or nurse will usually administer Palladone injection for you.

This medicine is intended for injection or infusion into a vein (intravenous = IV) or through a fine needle under the skin (subcutaneous = SC).

This medicine should only be used as long as necessary. Your doctor should have discussed with you how long your treatment with Palladone will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

If you get long term treatment, your doctor should verify regularly whether you still need this medicine. Do not stop the treatment without talking to your doctor (see “If you stop using Palladone injection”).

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, a brain disorder (known as toxic leukoencephalopathy), pneumonia caused by inhaling vomit or foreign matter (symptoms may include breathlessness, cough and fever) 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.
• breathlessness, cough and fever

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.

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.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

If you notice any of the following signs whilst using Palladone injection it could be a sign that you have become addicted.

• You need to use the medicine for longer than advised by your prescriber;
• You feel you need to use more than the recommended dose;
• You are using the medicine for reasons other than prescribed;
• When you stop using the medicine you feel unwell, and you feel better once using the medicine again.

If you notice any of these signs it is important you talk to your doctor.

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)

• dependence and addiction (see section ‘How do I know if I am addicted?’)
• 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)
• withdrawal symptoms in babies born to mothers who have used hydromorphone (see “Pregnancy and breastfeeding” in section 2).
• sleep apnoea (breathing pauses during sleep).

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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.

The other ingredients are:

• Citric acid anhydrous
• Sodium citrate
• Sodium chloride
• Sodium hydroxide
• Hydrochloric acid
• Water for injections

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.

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