Read all of this leaflet carefully

before you start taking 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 or pharmacist.

•    This medicine has been prescribed for you. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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’.

2. What you need to know before you take Palladone SR capsules

Do not take Palladone SR capsules if

you:

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

•    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 tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks;

•    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.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine 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 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;

•    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 lightheaded, faint, cold or clammy and look pale);

•    are 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;

•    have an increase in sensitivity to pain. Your doctor will decide whether you need a change in dose or a change in strong analgesic (‘painkiller’).

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:

•    medicines to help you sleep or stay calm (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.

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.

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.

•    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.

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.

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.

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).

As with all strong painkillers, there is a risk you may become addicted or reliant on these capsules.

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, constipation, feel sick.

•    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).

Common side effects (may affect up to

1 in 10 people)

•    Loss of appetite.

•    Confusion, anxiety, difficulty sleeping.

•    Headache.

•    Being sick, abdominal pain, dry mouth.

•    A feeling of unusual weakness.

•    Itchy skin, sweating.

Uncommon side effects (may affect up

to 1 in 100 people)

•    Agitation, depression, hallucinations, nightmares.

•    A feeling of extreme happiness.

•    Muscle spasms, shaking, tingling in the hands or feet.

•    Blurred vision.

•    Low blood pressure.

•    Shortness of breath.

•    Diarrhoea, changes in taste.

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

•    Rash.

•    Difficulty in passing urine.

•    Impotence.

•    Withdrawal symptoms (see section 3: ‘If you stop taking Palladone-SR capsules’).

•    Tiredness, generally feeling unwell.

•    Swelling of the hands, ankles or feet.

Rare side effects (may affect up to 1 in

1,000 people)

•    Sedation, lack of energy.

•    Fast heartbeat.

•    A condition where you breathe more slowly and weakly than expected.

Side effects with unknown frequency

(frequency cannot be estimated from the

available data)

•    Allergic reactions.

•    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 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^oC. 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:

•    Microcrystalline cellulose

•    Hypromellose

•    Ethylcellulose

•    Colloidal anhydrous silica

•    Dibutyl sebacate

•    Gelatin

•    Sodium laurilsulfate

•    Shellac

•    Propylene glycol

•    T itanium 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 Bard Pharmaceuticals Limited for the marketing authorisation holder Napp Pharmaceuticals Limited, both at Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.