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OXYNORM 50 MG / ML SOLUTION FOR INJECTION OR INFUSION

Active substance: OXYCODONE HYDROCHLORIDE

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196022 022002-I

550x148mm (LSN-CON-42) (L) V2

Package leaflet: Information for the user
OxyNorm 50 mg/ml, solution for injection or infusion
Oxycodone hydrochloride
®

Read all of this leaflet carefully before you start using 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 injection is and what it is used for
2. Before you use OxyNorm injection
3. How to use OxyNorm injection
4. Possible side effects
5. How to store OxyNorm injection
6. Further information
1. What OxyNorm injection is and what it is used for
This injection has been prescribed for you by your doctor to
relieve moderate to severe pain. It contains the active ingredient
oxycodone which belongs to a group of medicines called strong
analgesics or ‘painkillers’. The other ingredients are listed in section
6 of this leaflet.

OXYNORM INJ 10MG-ML 50MG-ML PIL UK 196022 022002-I V2.indd 2

2. Before you use OxyNorm injection
Do not use OxyNorm injection if you:
• are allergic (hypersensitive) to oxycodone, or any of the other
ingredients of OxyNorm injection;
• have breathing problems, such as chronic obstructive lung
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 injection 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) 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 use OxyNorm injection 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 injection
Before treatment with OxyNorm injection, 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 of OxyNorm injection;
• 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 this medicine.
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 use OxyNorm injection with some
other medicines, the effect of OxyNorm injection or the other
medicines may be changed.
This injection 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 use…”).
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;
• 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).
Using OxyNorm injection with food, drink and alcohol
Drinking alcohol during your treatment with OxyNorm injection
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 injection.
You should avoid drinking grapefruit juice during your treatment
with this medicine.
Pregnancy and breastfeeding
Do not use OxyNorm injection if you are pregnant or
breastfeeding.
Ask your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines
You may feel sleepy when you first start using OxyNorm injection,
or when increasing 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 injection
This injection contains less than 1 mmol sodium (23 mg) per 1 ml,
i.e. it is essentially “sodium-free”.

Information for Health Professionals
OxyNorm® 50 mg/ml, solution for injection or infusion
Oxycodone hydrochloride
This leaflet provides technical information for the healthcare
professional about OxyNorm 50 mg/ml, solution for injection
or infusion.
Posology and method of administration
Route of administration:
Subcutaneous injection or infusion.
Intravenous injection or infusion.
Posology:
The dose should be adjusted according to the severity of pain,
the total condition of the patient and previous or concurrent
medication.
Adults over 18 years:
The following starting doses are recommended. A gradual
increase in dose may be required if analgesia is inadequate or
if pain severity increases.
i.v. (Bolus): Dilute in 0.9% saline, 5% dextrose or water for
injections.
Administer a bolus dose of 1 to 10 mg slowly over 1-2
minutes in opioid naïve patients. Doses should not be
administered more frequently than every 4 hours.
i.v. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for
injections. A starting dose of 2 mg/hour is recommended for
opioid naïve patients.

i.v. (PCA): Dilute in 0.9% saline, 5% dextrose or water for
injections. Bolus doses of 0.03 mg/kg should be administered
with a minimum lock-out time of 5 minutes for opioid naïve
patients.
s.c. (Bolus): Use the 10 mg/ml or the 50 mg/ml strength and
dilute in 0.9% saline, 5% dextrose or water for injections if
required. A starting dose of 5 mg is recommended, repeated at
4‑hourly intervals as required for opioid naïve patients.
s.c. (Infusion): Dilute in 0.9% saline, 5% dextrose or water
for injections if required. A starting dose of 7.5 mg/day is
recommended in opioid naïve patients, titrating gradually
according to symptom control. Cancer patients transferring
from oral oxycodone may require much higher doses (see
below).
Transferring patients between oral and parenteral oxycodone:
The dose should be based on the following ratio: 2 mg of oral
oxycodone is equivalent to 1 mg of parenteral oxycodone. It
must be emphasised that this is a guide to the dose required.
Inter-patient variability requires that each patient is carefully
titrated to the appropriate dose.
Elderly patients:
Elderly patients should be treated with caution. The lowest
dose should be administered with careful titration to pain
control.

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196022 022002-I

550x148mm (LSN-CON-42) (L) V2

Patients with renal and hepatic impairment:
The dose initiation should follow a conservative approach in
these patients. The recommended adult starting dose should be
reduced by 50% (for example a total daily dose of 10 mg orally
in opioid naive patients), and each patient should be titrated to
adequate pain control according to their clinical situation.
Children under 18 years:
There are no data on the use of OxyNorm injection in patients
under 18 years of age.
Use in non-malignant pain:
Opioids are not first-line therapy for chronic non-malignant
pain, nor are they recommended as the only treatment. Types of
chronic pain which have been shown to be alleviated by strong
opioids include chronic osteoarthritic pain and intervertebral
disc disease. The need for continued treatment in non-malignant
pain should be assessed at regular intervals.
Duration of treatment:
Oxycodone should not be used for longer than necessary.
Discontinuation of treatment:
When a patient no longer requires therapy with oxycodone,
it may be advisable to taper the dose gradually to prevent
symptoms of withdrawal.

Instructions for use/handling
The injection should be given immediately after opening the
ampoule. Once opened any unused portion should be discarded.
Chemical and physical in-use stability has been demonstrated
for 24 hours at room temperature.
From a microbiological point of view, the product should be
used immediately. If not used immediately, in-use storage times
and conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2 to 8°C, unless
reconstitution / dilution (etc) has taken place in controlled and
validated aseptic conditions.
OxyNorm injection, undiluted or diluted to 1 mg/ml with
0.9% w/v saline, 5% w/v dextrose or water for injections,
is physically and chemically stable when in contact with
representative brands of polypropylene or polycarbonate
syringes, polyethylene or PVC tubing and PVC or EVA
infusion bags, over a 24 hour period at room temperature.
The injection, whether undiluted or diluted to 1 mg/ml in
the infusion fluids used in these studies and contained in the
various assemblies, does not need to be protected from light.
Inappropriate handling of the undiluted solution after opening
of the original ampoule, or of the diluted solutions may
compromise the sterility of the product.
This leaflet was last revised in April 2015.
® OxyNorm, NAPP and the NAPP device (logo) are
Registered Trade Marks.
© 2009-2015 Napp Pharmaceuticals
Limited

OXYNORM INJ 10MG-ML 50MG-ML PIL UK 196022 022002-I V2.indd 3

3. How to use OxyNorm injection
A doctor or nurse will usually prepare and administer the
injection for you. The injection should be used immediately after
opening. The dose and how often the injection is given may be
adjusted according to the severity of your pain.
Adults (over 18 years of age)
The usual starting dose is dependent upon how the injection is
administered. The usual starting doses are as follows:
• As a single injection into a vein, the usual dose is 1 to 10 mg
given slowly over 1 to 2 minutes. This can be repeated every
4 hours.
• As an infusion into a vein, the usual starting dose is 2 mg/
hour.
• As a single injection through a fine needle into the tissue
under the skin, the usual starting dose is 5 mg repeated at
4-hourly intervals if needed.
• As an infusion through a fine needle into the tissue under the
skin, the usual starting dose is 7.5 mg/day.
• If given by patient controlled analgesia (PCA), the dose is
worked out according to your weight (0.03 mg per kg of body
weight). Your doctor or nurse will set a suitable frequency.
Children
Children and adolescents under 18 years of age should not be
given the injection.
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.

The dose recommended by the doctor should not be
exceeded. Check with the doctor or pharmacist if you are
unsure.
If you find that you are still in pain whilst being given
OxyNorm injection discuss this with your doctor.
If you use more OxyNorm injection than you should, or if
someone else uses your injection
Call your doctor or hospital straight away. People who
have been given an overdose may feel very sleepy and
sick. 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 injection
with you to show to the doctor.
If you stop using OxyNorm injection
You should not suddenly stop using this injection unless your
doctor tells you to. If you want to stop using your injection,
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.
If you have any further questions on the use of OxyNorm
injection, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, OxyNorm injection 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 OxyNorm injection.
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 medicine 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 (cholestasis).
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
in the hands or feet, seizures, fits or convulsions, blurred
vision, fainting, unusual muscle stiffness or slackness,
involuntary muscle contractions.
• Difficulty 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 this medicine 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 injection
Keep out of the reach and sight of children. Accidental overdose by a
child is dangerous and may be fatal.
Do not use OxyNorm injection after the expiry date which is stated
on the ampoule label and carton. EXP 08 2020 means that you should
not use the injection after the last day of that month i.e. August 2020.
There are no special precautions for storage prior to use however
once the ampoule is opened the injection should be used immediately.
Any unused portion should be discarded immediately.
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 injection contains
The active ingredient is oxycodone
hydrochloride.
The other ingredients are:
• Citric acid monohydrate
• Sodium citrate
• Sodium chloride
• Hydrochloric acid, dilute
• Sodium hydroxide
• Water for injections

What OxyNorm injection looks like and the
contents of the pack
OxyNorm injection is a clear, colourless solution
supplied in clear glass ampoules. The 50 mg/ml
strength is available as 1 ml of solution (containing
50 mg of oxycodone hydrochloride).
Marketing Authorisation Holder and
Manufacturer
OxyNorm injection is 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 solution for injection or
infusion
Reference number: 16950/0155
This leaflet was last revised in April 2015.
® OxyNorm, NAPP and the NAPP device (logo) are Registered Trade
Marks.
© 2009-2015 Napp Pharmaceuticals Limited

30/06/2015 14:31

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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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