OXYNORM 5MG

Active substance: OXYCODONE HYDROCHLORIDE

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2. Before you take OxyNorm
capsules

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.
• 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 OxyNorm capsules are and
what they are used for
2. Before you take OxyNorm capsules
3. How to take OxyNorm capsules
4. Possible side effects
5. How to store OxyNorm capsules
6. Further information

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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’.



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 chronic obstructive airways
disease, chronic bronchial asthma or
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 head injury that causes a
severe headache or makes you feel
sick. This is because the capsules
may make these symptoms worse or
hide the extent of the head injury;
• 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 severe kidney problems or
moderate to severe liver problems. If
you have other long-term kidney or
liver problems you should only take
these capsules if recommended by your
doctor;
• have ongoing problems with
constipation;
• 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:
• have an under-active thyroid gland
(hypothyroidism), as you may need a
lower dose;
• 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 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) or problems with
your gall bladder;

• have inflammatory bowel disease;
• have prostate 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 breathing problems such as
severe pulmonary disease. Your
doctor will have told you if you
have this condition. Symptoms
may include breathlessness and
coughing;
• are or ever have been addicted to
alcohol or drugs;
• have previously suffered from
withdrawal symptoms such as
agitation, anxiety, shaking or
sweating, upon stopping taking
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 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 (for
example tranquillisers, hypnotics or
sedatives);
• medicines to treat depression;
• medicines to treat psychiatric
or mental disorders (such as
phenothiazines or neuroleptic drugs);
• other strong analgesics or
‘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);
• antibiotics (such as erythromycin).
Also tell your doctor if you have
recently been given an anaesthetic.
Taking OxyNorm 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
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.
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.

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Children
Children and adolescents under 18 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 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.

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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).
As with all strong painkillers, there is a risk
that 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
start taking your capsules or when your
dose is increased, but it should wear off
after a few days).
• Dry mouth, loss of appetite, indigestion,
abdominal pain or discomfort, diarrhoea.
• Headache, confusion, a feeling of unusual
weakness, dizziness, anxiety, nervousness,
twitching, difficulty in sleeping, abnormal
thoughts or dreams.
• Difficulty in breathing or wheezing,
shortness of breath, decreased cough reflex.
• Rash, itchy skin.
• Sweating, chills.

happiness, restlessness, agitation, generally
feeling unwell, loss of memory, shaking,
difficulties with speech, reduced sensitivity
to pain or touch, tingling or numbness,
seizures, fits or convulsions, blurred vision.
• Difficulty in passing urine, impotence,
decreased sexual drive, absence of
menstrual periods.
• Fast, irregular heart beat, low blood
pressure, flushing of the skin.
• Dehydration, thirst, 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
to obtain the same level of pain relief
(tolerance).
Uncommonly, these capsules may affect the
results of blood tests to check that your liver
is working properly.

Uncommon side effects
(Probably affecting fewer than 1 in 100
people taking these capsules)
• Difficulty in swallowing, belching, hiccups,
wind, gastrointestinal disorders (e.g. upset
stomach), changes in taste.
• A feeling of dizziness or ‘spinning’,
a feeling of ‘faintness’ especially on
standing up, hallucinations, mood
changes, depression, a feeling of extreme

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 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 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.

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 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
This leaflet was last revised in January 2014.

® OxyNorm 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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