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Package leaflet: Information for the user

OxyNorm® 5 mg, 10 mg and 20 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.
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

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’.

• have myxoedema (a thyroid disorder
with dryness, coldness and swelling
[‘puffiness’] of the skin affecting the face
Do not take OxyNorm capsules if you:
and limbs;
• are allergic to oxycodone, or any of the • have a head injury, severe headache or feel
other ingredients of the capsules (listed
sick as this may indicate that the pressure
in section 6);
in your skull is increased;
• have breathing problems, such as severe • have low blood pressure (hypotension);
chronic obstructive lung disease, severe • have low blood volume (hypovolaemia);
bronchial asthma or severe respiratory
this can happen with severe external or
depression. Your doctor will have told
internal bleeding, severe burns, excessive
you if you have any of these conditions. sweating, severe diarrhoea or vomiting;
Symptoms may include breathlessness, • have a mental disorder as a result of an
coughing or breathing more slowly or
infection (toxic psychosis);
weakly than expected;
• have inflammation of the pancreas (which
• have a condition where the small bowel
causes severe pain in the abdomen and
does not work properly (paralytic ileus), back);
your stomach empties more slowly than • have problems with your gall bladder or
it should (delayed gastric emptying) or
bile duct;
you have severe pain in your abdomen; • have inflammatory bowel disease;
• have a heart problem after long-term
• have an enlarged prostate gland, which
lung disease (cor pulmonale);
causes difficulty in passing urine (in men);
• have moderate to severe liver problems. • have poor adrenal gland function (your
If you have other long-term liver
adrenal gland is not working properly
problems you should only take these
which may cause symptoms including
capsules if recommended by your
weakness, weight loss, dizziness, feeling
or being sick), e.g. Addison’s disease;
• have ongoing problems with
• have breathing problems such as severe
pulmonary disease. Your doctor will
• are under 18 years of age.
have told you if you have this condition.
Symptoms may include breathlessness and
Warnings and precautions
Talk to your doctor or pharmacist before • have kidney or liver problems;
taking these capsules if you:
• have previously suffered from withdrawal
• are elderly or weakened;
symptoms such as agitation, anxiety,
• have an under-active thyroid gland
shaking or sweating, upon stopping taking
(hypothyroidism), as you may need a
alcohol or drugs;
lower dose;
2. What you need to know before you
take OxyNorm capsules

• 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
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
• 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
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;
• 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
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
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
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
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
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
• Dehydration, thirst, chills, swelling of the
hands, ankles or feet.
• Dry skin, severe flaking or peeling of the
• Redness of the face, reduction in size of
the pupils in the eye, muscle spasm, high
• 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

• 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:
By reporting side effects you can help
provide more information on the safety of
this medicine.
5. How to store OxyNorm capsules
Keep this medicine 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 30oC.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away of medicines
you no longer use. These measures will help
to protect the environment.

6. Contents of the pack and other
What OxyNorm capsules contain
The active substance is oxycodone
hydrochloride. Each capsules contains 5 mg,
10 mg or 20 mg of oxycodone hydrochloride.
The other ingredients are:
• Cellulose, microcrystalline
• Magnesium stearate
• Titanium dioxide (E171)
• Iron oxide (E172)
• Indigo carmine (E132)

• Sodium laurilsulphate
• Gelatin
• Shellac
• Propylene glycol
In addition the 5 mg capsules contain sunset
yellow (E110).
What OxyNorm capsules look like and the
contents of the pack
The capsules are marked ONR and the
strength (5, 10 or 20). The capsule colours
are: 5 mg – orange/beige, 10 mg – white/
beige, 20 mg – pink/beige.
In each box there are 56 capsules.

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
These are as follows:
Product name: OxyNorm Capsules
Reference number: 16950/0106
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.
This leaflet was last revised in November 2015.
® OxyNorm, NAPP and the NAPP logo are registered trade marks.
© 2009-2015 Napp Pharmaceuticals Ltd.

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