Palladone SR 2 mg, 4 mg, 8 mg, 16 mg and 24 mg prolonged-release capsules
Hydromorphone hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1. What Palladone SR capsules are and what they are used for
2. 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. Further information
What Palladone SR capsules are and what they are used for
These capsules have been prescribed for you to relieve severe pain over a period of 12 hours. They contain the active ingredient hydromorphone which belongs to a group of medicines called strong analgesics or ‘painkillers’.
Before you take Palladone SR capsules
Do not take Palladone SR capsules if you:
- are allergic (hypersensitive) to hydromorphone or any of the other ingredients of the capsules (see section 6 ‘Further Information’);
- have a condition where you breathe more slowly or weakly than expected (respiratory depression);
- have a severe pain in your abdomen;
- have liver problems;
- 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 tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks;
- have a severe headache or feel sick due to a head injury or increased pressure in your skull (for instance due to brain disease). This is because the capsules may make symptoms worse or hide the extent of a head injury;
- suffer from seizures, fits or convulsions;
- are addicted to alcohol;
- are under 12 years of age.
If you are going to have an operation, please tell the doctor at the hospital that you are taking these capsules.
Take special care with Palladone SR capsules
Before treatment with these capsules tell your doctor or pharmacist if you:
- have breathing problems, such as severely impaired pulmonary function, chronic obstructive airways disease or reduced respiratory reserve. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness and coughing;
- have a mental disorder as a result of an infection (toxic psychosis);
- have inflammation of the pancreas (which causes severe pain in the abdomen and back);
- have an under-active thyroid gland (hypothyroidism);
- have low blood pressure (hypotension);
- have kidney problems;
- have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick);
- have prostate problems;
- are suffering from shock (this may make you suddenly feel very light-headed, faint, cold or clammy and look pale);
- are addicted to drugs or have ever been addicted to either alcohol or drugs;
- have withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping alcohol or drugs.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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:
- medicines to help you sleep (for example tranquillisers, hypnotics or sedatives);
- medicines known as barbiturates to either treat fits or to help you sleep;
- medicines to stop you feeling or being sick;
- medicines to treat depression;
- medicines to treat psychiatric or mental disorders (such as neuroleptics);
- other strong analgesics or ‘painkillers’.
Also tell your doctor if you have recently been given an anaesthetic.
Taking Palladone SR capsules with alcohol
Drinking alcohol during your treatment with these capsules may make you sleepy. If you are affected you should avoid drinking alcohol.
Pregnancy and breastfeeding
Do not take these capsules if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
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.
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 capsulesthan you should or if someone accidentally swallows your capsules
Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. 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
You should not stop taking these capsules unless your doctor tells you to. If you want to stop taking your capsules, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant side effects. Withdrawal symptoms such as agitation, anxiety, shaking or sweating may occur if you suddenly stop taking these capsules.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Palladone-SR capsules Side Effects
Like all medicines, these capsules can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are uncommon. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, 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).
As with all strong painkillers, there is a risk you may become addicted or reliant on these capsules.
Common side effects (Probably affecting more than 1 in 100 people taking these capsules)
- Constipation (your doctor can prescribe a laxative to overcome this problem).
- Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe
an anti-sickness medicine if it continues to be a problem). - Drowsiness (this is most likely when you first start taking your capsules or when your dose is increased,
but it should wear off after a few days). - Low blood pressure.
- Dry mouth.
- A feeling of unusual weakness, confusion or dizziness.
- Rash or itchy skin.
- Sweating.
- Difficulty in passing urine.
Uncommon side effects (Probably affecting fewer than 1 in 100 people taking these capsules)
- A condition where the small bowel (part of your gut) does not work properly (paralytic ileus), abdominal
pain or discomfort. - Swelling of the hands, ankles or feet.
- A feeling of extreme happiness, mood changes or agitation.
- Hallucinations.
- Blurred vision or a reduction in size of the pupils in the eye.
- Uncontrolled muscle movements.
- Headache.
- Shaking.
- An increase in sensitivity to pain.
- Seizures, fits or convulsions.
- A need to take increasingly higher doses to obtain the same level of pain relief (tolerance).
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
How to store Palladone SR capsules
Keep out of the reach and sight of children.
Do not use any capsules after the expiry date which is stated on the blister and carton. EXP 08 2010 means that you should not take the capsules after the last day of that month i.e. August 2010.
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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further 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:
- Microcrystalline cellulose
- Hypromellose
- Ethylcellulose
- Colloidal anhydrous silica
- Dibutyl sebacate
- Gelatin
- Sodium dodecyl sulphate
- Shellac
- Propylene glycol
- Titanium dioxide (E171)
- Iron oxide (E172)
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 May 2009.
Palladone and the NAPP device (logo) are Registered Trade Marks.
© 2009 Napp Pharmaceuticals Limited
P0067-A R2V2 UK AW 05-03-09
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