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The product codes for this leaflet are: PL 16950/0049, PL 16950/0050

 

Palladone capsules

Company Details

Napp Pharmaceuticals Limited


Cambridge Science ParkMilton RoadCambridgeCambridgeshireCB4 0GW
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Package Leaflet: Information for the user

Palladone® 1.3 mg and 2.6 mg 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 capsules are and what they are used for
2. Before you take Palladone capsules
3. How to take Palladone capsules
4. Possible side effects
5. How to store Palladone capsules
6. Further information

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1. What Palladone capsules are and what they are used for

These capsules have been prescribed for you to relieve severe pain. They contain the active ingredient hydromorphone which belongs to a group of medicines called strong analgesics or ‘painkillers’.

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2. Before you take Palladone capsules

Do not take Palladone 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.

Take special care with Palladone 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.

If you are going to have an operation, please tell the doctor at the hospital that you are taking these capsules.

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 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 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.

Important information about some of the ingredients of Palladone capsules

These capsules contain lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these capsules.

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3. How to take Palladone 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 capsule every 4 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.

The capsule contents should never be injected as this may lead to serious side effects, which may be fatal.

If you take more Palladone capsules than 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 capsules

If you miss a dose you should take it as soon as you remember and then carry on as before. Do not take two doses within 4 hours. Do not take a double dose to make up for a forgotten capsule.

If you stop taking Palladone 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.

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4. Possible 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.

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5. How to store Palladone 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.

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.

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6. Further information

What Palladone capsules contain

The active ingredient is hydromorphone hydrochloride. Each capsule contains 1.3 mg or 2.6 mg of hydromorphone hydrochloride.

The other ingredients are:

  • Microcrystalline cellulose
  • Lactose
  • Gelatin
  • Sodium dodecyl sulphate
  • Erythrosine (E127)
  • Shellac
  • Propylene glycol
  • Titanium dioxide (E171)
  • Iron oxide (E172)

What Palladone capsules look like and the contents of the pack

The capsules have a hard gelatin shell containing spherical pellets. The capsules are marked HNR followed by the strength (e.g. 1.3) and are coloured as follows: 1.3 mg - orange/clear, 2.6 mg - red/clear.

In each box there are 56 capsules.

Marketing Authorisation Holder and Manufacturer

The capsules are made by

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

for the marketing authorisation holder

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

Reference number: 16950/0049

This leaflet was last revised in May 2009.

Palladone ® capsules are protected by UK Patent No 2264640.

® Palladone and the NAPP device (logo) are Registered Trade Marks.

© 2009 Napp Pharmaceuticals Limited

P0071-A R2V2UK AW 05-03-09


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