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    1) What OxyNorm capsules are and what they are used for


    These capsules have been prescribed for you by your doctor to relieve

    moderate to severe pain. They contain the active ingredient oxycodone which

    belongs to a group of medicines called strong analgesics or ‘painkillers’.

    2) What you need to know before you take OxyNorm capsules


    Do not take OxyNorm capsules if you:

    • are allergic to oxycodone, or any of the other ingredients of the capsules

    (listed in section 6);

    • have breathing problems, such as severe chronic obstructive lung

    disease, severe bronchial asthma or severe respiratory depression. Your

    doctor will have told you if you have any of these conditions. Symptoms

    may include breathlessness, coughing or breathing more slowly or weakly

    than expected;

    • have a condition where the small bowel does not work properly (paralytic

    ileus), your stomach empties more slowly than it should (delayed gastric

    emptying) or you have severe pain in your abdomen;

    • have a heart problem after long-term lung disease (cor pulmonale);

    • have moderate to severe liver problems. If you have other long-term liver

    problems you should only take these capsules if recommended by your

    doctor;

    • have ongoing problems with constipation;

    • are under 18 years of age.

    Warnings and precautions

    Talk to your doctor or pharmacist before taking these capsules if you:

    • are elderly or weakened;

    • have an under-active thyroid gland (hypothyroidism), as you may need a

    lower dose;

    • have myxoedema (a thyroid disorder with dryness, coldness and swelling

    [‘puffiness’] of the skin affecting the face and limbs;

    • have a head injury, severe headache or feel sick as this may indicate that

    the pressure in your skull is increased;

    • have low blood pressure (hypotension);

    • have low blood volume (hypovolaemia); this can happen with severe

    external or internal bleeding, severe burns, excessive sweating, severe

    diarrhoea or vomiting;

    • 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 problems with your gall bladder or bile duct;

    • have inflammatory bowel disease;

    • have an enlarged prostate gland, which causes difficulty in passing urine

    (in men);

    • 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), e.g. Addison’s disease;

    • have breathing problems such as severe pulmonary disease. Your doctor

    will have told you if you have this condition. Symptoms may include

    breathlessness and coughing;

    • have kidney or liver problems;

    • have previously suffered from withdrawal symptoms such as agitation,

    anxiety, shaking or sweating, upon stopping taking alcohol or drugs;

    • are or have ever been addicted to alcohol or drugs or have a known

    opioid dependence;

    • have an increased sensitivity to pain;

    • need to take increasingly higher doses of OxyNorm to gain the same level

    of pain relief (tolerance).

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

    you are taking these tablets.

    Other medicines and OxyNorm capsules

    Please tell your doctor or pharmacist if you are taking, have recently taken or

    might take any other medicines, including medicines obtained without a

    prescription. If you take these capsules with some other medicines, the effect

    of these capsules or the other medicine may be changed.

    Tell your doctor or pharmacist if you are taking:

    • a type of medicine known as a monoamine oxidase inhibitor or you have

    taken this type of medicine in the last two weeks;

    • medicines to help you sleep or stay calm (for example tranquillisers,

    hypnotics or sedatives);

    • medicines to treat depression (such as paroxetine);

    • medicines to treat psychiatric or mental disorders (such as

    phenothiazines or neuroleptic drugs);

    • other strong analgesics (‘painkillers’);

    • muscle relaxants;

    • medicines to treat high blood pressure;

    • quinidine (a medicine to treat a fast heart beat);

    • cimetidine (a medicine for stomach ulcers, indigestion or heartburn);

    • antifungal medicines (such as ketoconazole, voriconazole, itraconazole

    and posaconazole);

    • antibiotics (such as clarithromycin, erythromycin or telithromycin);

    • medicines known as ‘protease inhibitors’ to treat HIV (e.g. boceprevir,

    ritonavir, indinavir, nelfinavir or saquinavir);

    • rifampicin (to treat tuberculosis);

    • carbamazepine (a medicine to treat sezures, fits or convulsions and

    certain pain conditions);

    • phenytoin (a medicine to treat seizures, fits or convulsions);

    • a herbal remedy called St. John’s Wort (also known as Hypericum

    perforatum);

    • antihistamines;

    • medicines to treat Parkinson’s disease.

    Also tell your doctor if you have recently been given an anaesthetic.

    Taking OxyNorm capsules with food, drink and alcohol

    Drinking alcohol during your treatment with these capsules may make you

    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 while you’re taking OxyNorm capsules.

    You should avoid drinking grapefruit juice during your treatment with this

    medicine.

    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 may 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.

    OxyNorm 5 mg capsules contain sunset yellow (E110)

    The 5 mg capsules contain sunset yellow (E110) which may cause allergic

    reactions.

    3) How to take OxyNorm capsules

    Always take these 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 (over 18 years of age)

    The usual starting dose is one 5 mg capsule every 4 to 6 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

    Children and adolescents under 18 years of age should not take the capsules.

    Patients with kidney or liver problems

    Please tell your doctor if you suffer from kidney or liver problems as they may

    prescribe a lower dose depending on your condition.

    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 water.

    Do not chew or crush them.

    You must only take the capsules by mouth. The capsules contents should

    never be injected as this may lead to serious side effects, which may be fatal.

    Rare side effects

    (May affect up to 1 in 1,000 people)

    • Low blood pressure.

    • A feeling of ‘faintness’ especially on standing up.

    • Hives (nettle rash).

    If you take more OxyNorm 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 to the

    doctor.

    If you forget to take OxyNorm capsules

    If you miss a dose you should take the next dose as soon as you remember

    then carry on as before. Do not take two doses within 4 hours. Do not take a

    double dose to make up for forgotten capsules.

    If you stop taking OxyNorm capsules

    You should not suddenly 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 effects. Withdrawal symptoms such as

    agitation, anxiety, palpitations, 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.

    4) Possible side effects

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

    Frequency not known

    (Frequency cannot be estimated from the available data)

    • An increased sensitivity to pain.

    • Aggression.

    • Tooth decay.

    • Absence of menstrual periods.

    • A blockage in the flow of bile from the liver (cholestasis). This can cause

    itchy skin, yellow skin, very dark urine and very pale stools.

    • Long term use of OxyNorm capsules during pregnancy may cause lifethreatening withdrawal symptoms in the newborn. Symptoms to look for in

    the baby include irritability, hyperactivity and abnormal sleep pattern, high

    pitched cry, shaking, being sick, diarrhoea and not putting on weight.

    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 OxyNorm capsules


    • Keep out of the sight and reach of children. Accidental overdose by a

    child is dangerous and may be fatal.

    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 rare. 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). Tell your doctor

    immediately if this happens to you.

    Do not use any capsules after the expiry date which is stated on the

    blister and carton. EXP 08 2016 means that you should not take the

    tablets after the last day of that month i.e. August 2016.

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