Active ingredient
- hydromorphone hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 16950/0053.
Palladone SR capsules
Package leaflet: Information for the user
Palladone® SR 2 mg, 4 mg, 8 mg, 16 mg and 24 mg prolonged-release capsules
Hydromorphone hydrochloride
This medicine contains hydromorphone which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
In this leaflet:
1. What Palladone SR capsules are and what they are used for
2. What you need to know before you take Palladone SR capsules
3. How to take Palladone SR capsules
4. Possible side effects
5. How to store Palladone SR capsules
6. Contents of the pack and other information
1. What Palladone SR capsules are and what they are used for
This medicine has been prescribed for you for the relief of severe pain. It contains hydromorphone, which belongs to a class of medicines called opioids, which are ‘pain relievers’. The medicine has been prescribed for you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your doctor should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
2. What you need to know before you take Palladone SR capsules
Do not take Palladone SR capsules if you:
If you are going to have an operation, please tell the doctor at the hospital that you are taking these capsules.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
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.
Taking this medicine regularly, particularly for a long time, can lead to addiction. Your doctor 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 doctor 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 while taking these capsules. Your doctor may want to monitor these changes.
Other medicines and Palladone SR capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you take these capsules with some other medicines, the effect of the capsules or the other medicine may be changed.
These capsules must not be used together with a type of medicine known as a monoamine oxidase inhibitor, or if you have taken this type of medicine in the last two weeks (see section 2 ‘Do not take…’).
Tell your doctor or pharmacist if you are taking:
Also tell your doctor if you have recently been given an anaesthetic.
Concomitant use of Palladone SR capsules 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.
However if your doctor does prescribe Palladone SR capsules 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.
Palladone SR capsules with alcohol
Drinking alcohol whilst taking Palladone SR capsules may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol whilst you are taking Palladone SR capsules.
Pregnancy and breastfeeding
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 take Palladone SR capsules 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 take Palladone SR capsules 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.
Breast-feeding
Do not take Palladone SR capsules while you are breastfeeding as hydromorphone passes into breast milk and will affect your baby.
Driving and using machines
These capsules may cause a number of side effects such as drowsiness, which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually most noticeable when you first start taking the capsules, or when changing to a higher dose. If you are affected you should not drive or use machinery.
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
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.
3. How to take Palladone SR capsules
Always take the capsules exactly as your doctor has told you. The label on your medicine will tell you how many capsules to take and how often.
Adults and children over 12 years of age
The usual starting dose is one 4 mg capsule every 12 hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these capsules, discuss this with your doctor.
Children under 12 years of age
Children under 12 years of age should not take the capsules.
Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.
Your doctor should have discussed with you how long the course of Palladone SR capsules will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
Swallow your capsules whole with a glass of water. If you prefer, you can open the capsules and sprinkle the contents on to cold soft food, such as yoghurt. You must only take the capsules by mouth. Do not crush or chew the capsule or the capsule contents.
Palladone SR capsules are designed to work properly over 12 hours. If the capsule contents are crushed, dissolved or chewed, the entire 12-hour dose may be absorbed rapidly into your body. The capsule contents should never be injected. This can be dangerous, causing serious problems such as an overdose, which may be fatal.
You should take your capsules every 12 hours. For instance, if you take a capsule at 8 o’clock in the morning, you should take your next capsule at 8 o’clock in the evening.
If you take more Palladone SR capsules than you should or if someone accidentally swallows your capsules
Call your doctor or hospital straight away as you may need emergency treatment in hospital. People who have taken an overdose may feel very sleepy, sick, dizzy or get pneumonia from inhaling vomit or foreign matter (symptoms may include breathlessness, cough and fever). They may also have breathing difficulties leading to unconsciousness, or even death.
When seeking medical attention make sure that you take this leaflet and any remaining capsules with you to show the doctor.
If you forget to take Palladone SR capsules
If you remember within 4 hours of the time your capsule was due, take your capsule straight away. Take your next capsule at your normal time. If you are more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for a forgotten capsule.
If you stop taking Palladone SR capsules
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, these capsules can cause side effects, although not everybody gets them.
This medicine can cause allergic reactions. The incidence of serious allergic reactions is not known. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, mouth or throat, or any rash or itching especially those covering your whole body.
The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression).
Drug withdrawal
When you stop taking Palladone SR capsules you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.
How do I know if I am addicted?
If you notice any of the following signs whilst taking Palladone SR capsules it could be a sign that you have become addicted.
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)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Side effects with unknown frequency (frequency cannot be estimated from the available data)
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 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.
5. How to store Palladone SR capsules
Keep this medicine out of the sight and reach of children.
Do not use any capsules after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.
Do not store your capsules above 25°C. Store in the original package.
Do not take your capsules if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.
Do not throw away any medicines via wastewater or household waste. Ask your 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 SR capsules contain
The active ingredient is hydromorphone hydrochloride. Each capsule contains 2 mg, 4 mg, 8 mg, 16 mg or 24 mg of hydromorphone hydrochloride.
The other ingredients are:
The capsules also contain the following colourants:
2 mg capsule – Quinoline yellow (E104)
4 mg capsule – Erythrosine (E127) and indigo carmine (E132)
8 mg capsule – Erythrosine (E127)
16 mg capsule – Iron oxide (E172)
24 mg capsule – Indigo carmine (E132)
What Palladone SR capsules look like and the contents of the pack
The capsules have a hard gelatin shell containing spherical pellets. The capsules are marked HCR followed by the strength (e.g. 2, 4 etc.) and are coloured as follows: 2 mg – yellow/ white, 4 mg – pale blue/clear, 8 mg – pink/clear, 16 mg – brown/clear, 24 mg – dark blue/clear.
In each box there are 56 capsules.
Marketing Authorisation Holder and Manufacturer
The capsules are made by
for the marketing authorisation holder
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 SR prolonged-release capsules
Reference number: 16950/0051
This leaflet was last revised in July 2020.
® Palladone, NAPP and the NAPP logo are registered trade marks.
© 2011-2020 Napp Pharmaceuticals Limited.
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