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OXYNORM 10MG

Active substance: OXYCODONE HYDROCHLORIDE

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4893-5

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Package leaflet: Information for the user

2. Before you take OxyNorm
capsules


Do not take OxyNorm capsules if you:
• are allergic (hypersensitive) to
oxycodone, or any of the other
ingredients of the capsules (see section
6 ‘Further Information’);
• have breathing problems, such as
OxyNorm® 5 mg, 10 mg and 20 mg capsules
chronic obstructive lung disease,
chronic bronchial asthma or respiratory
Oxycodone hydrochloride
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;
Read all of this leaflet carefully before you start taking this medicine.
• have a head injury that causes a severe
• Keep this leaflet. You may need to read it again.
headache or makes you feel sick. This
• If you have any further questions, ask your doctor or pharmacist.
is because the capsules may make these
• This medicine has been prescribed for you. Do not pass it on to others. It may
symptoms worse or hide the extent of
harm them, even if their symptoms are the same as yours.
the head injury;
• If any of the side effects become serious, or if you notice any side effects not
• have a condition where the small bowel
listed in this leaflet, please tell your doctor or pharmacist.
does not work properly (paralytic
ileus), your stomach empties more
In this leaflet:
1. What OxyNorm capsules are
slowly than it should (delayed gastric
1. What OxyNorm capsules are and
and what they are used for
emptying) or you have severe pain in

what they are used for
your abdomen;
These capsules have been prescribed
2. Before you take OxyNorm capsules
• have a heart problem after long-term
for you by your doctor to relieve
3. How to take OxyNorm capsules
lung disease (cor pulmonale);
moderate to severe pain. They contain
4. Possible side effects
• have severe kidney problems or
the active ingredient oxycodone which
5. How to store OxyNorm capsules
moderate to severe liver problems. If
belongs to a group of medicines called
6. Further information
you have other long-term kidney or
strong analgesics or ‘painkillers’.
liver problems you should only take
these capsules if recommended by your
doctor;
• have ongoing problems with
constipation;

OXYNORM CAPS PIL UK 4893-5 V4.indd 2

• 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;
• are under 18 years of age.
Take special care with OxyNorm capsules
Before treatment with these capsules tell
your doctor or pharmacist 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 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.
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 these 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 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).
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.
Important information about some of
the ingredients of OxyNorm capsules
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.

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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.

OXYNORM CAPS PIL UK 4893-5 V4.indd 3

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, anxiety, nervousness,
difficulty in sleeping, abnormal thoughts or
dreams.
• Difficulty in breathing or wheezing,
shortness of breath, decreased cough reflex.
• Rash.
• Sweating, chills.
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, tooth decay.

• A blockage in the flow of bile from the liver.
This can cause itchy skin, yellow skin, very
dark urine and very pale stools.
• 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, absence of menstrual
periods.
• Fast, irregular heart beat, low blood pressure,
a feeling of ‘faintness’ especially on standing
up, flushing of the skin.
• Dehydration, thirst, swelling of the hands,
ankles or feet.
• Dry skin, severe flaking or peeling of the
skin, hives (nettle rash).
• 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).
Frequency unknown
(Frequency cannot be estimated from the
available data)
• An increased sensitivity to pain.
• Aggression.

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 reach and sight 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.
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. Further information
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
number.
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 April 2015.
® OxyNorm, NAPP and the NAPP device (logo) are Registered Trade Marks.
© 2009-2014 Napp Pharmaceuticals Ltd

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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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