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OXYNORM 10 MG CAPSULES

Active substance(s): OXYCODONE HYDROCHLORIDE

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Package leaflet: Information for the user

OxyNorm® 10 mg capsules
(oxycodone hydrochloride)
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 only. 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.
OxyNorm is available in other strengths and forms
In this leaflet:
1. What OxyNorm capsules are and what they are used for
2. What you need to know before you take OxyNorm capsules
3. How to take OxyNorm capsules
4. Possible side effects
5. How to store OxyNorm capsules
6. Contents of the pack and other information
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 longterm 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 seizures, 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.
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
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.
As with all strong painkillers, there is a risk that you may become
addicted or reliant on these capsules.
Very common side effects
(May affect more than 1 in 10 people)
• 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 start taking your capsules
or when your dose is increased, but it should wear off after a few
days).
• Dizziness.
• Headache.
• Itchy skin.
Common side effects
(May affect up to 1 in 10 people)
• Dry mouth, loss of appetite, indigestion, abdominal pain or
discomfort, diarrhoea.
• Confusion, depression, a feeling of unusual weakness, shaking,
lack of energy, tiredness, anxiety, nervousness, difficulty in
sleeping, abnormal thoughts or dreams.
• Difficulty in breathing or wheezing, shortness of breath, decreased
cough reflex.
• Rash.
• Sweating.
Uncommon side effects
(May affect up to 1 in 100 people)
• Difficulty in swallowing, belching, hiccups, wind, a condition where
the bowel does not work properly (ileus), inflammation of the
stomach, changes in taste.










A feeling of dizziness or ‘spinning’, hallucinations, mood changes,
unpleasant or uncomfortable mood, a feeling of extreme
happiness, restlessness, agitation, generally feeling unwell, loss of
memory, difficulty in speaking, reduced sensitivity to pain or touch,
tingling or numbness, seizures, fits or convulsions, blurred vision,
fainting, unusual muscle stiffness or slackness, involuntary muscle
contractions.
Difficulty in passing urine, impotence, decreased sexual drive, low
levels of sex hormones in the blood (‘hypogonadism’, seen in a
blood test).
Fast, irregular heart beat, flushing of the skin.
Dehydration, thirst, chills, swelling of the hands, ankles or feet.
Dry skin, severe flaking or peeling of the skin.
Redness of the face, reduction in size of the pupils in the eye,
muscle spasm, high temperature.
A need to take increasingly higher doses of the capsules to obtain
the same level of pain relief (tolerance).
Colicky abdominal pain or discomfort.
A worsening of liver function tests (seen in a blood test).

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).
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
life-threatening 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.
Do not use any capsules after the expiry date which is stated on the
blister and carton. EXP 08 2020 means that you should not take the
capsules after the last day of that month i.e. August 2020.
Do not store your capsules above 30°C.
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.
6. Contents of the pack and other information
What OxyNorm capsules contain
The active substance is oxycodone hydrochloride.
Each capsule contains 10 mg of oxycodone hydrochloride.
The other ingredients are:
Microcrystalline Cellulose
Magnesium stearate
Titanium dioxide (E171)
Red and yellow iron oxide (E172)
Indigo carmine (E132)
Sodium laurilsulphate
Gelatin
Shellac
Propylene glycol
Black iron oxide
What OxyNorm capsules look like and the contents of the pack
The capsules white/beige and are marked ONR on cap and 10 on the
body.
In each box there are 28, 56 or 98 capsules.
Manufacturer:
Bard Pharmaceuticals Limited, Cambridge Science Park,
Milton Road, Cambridge, CB4 0GW.
Procured within the EU
Product Licence holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride G75 0TD.
PL 19065/0396
This leaflet was last revised 06.04.2016 E0396/6
CD POM
® OxyNorm is a registered trade mark Mundipharma AG

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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