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OXYNORM 50 MG / ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): OXYCODONE HYDROCHLORIDE

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196022 022003-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 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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
In this leaflet:
1. What OxyNorm injection is and what it is used for
2. What you need to know before you use OxyNorm injection
3. How to use OxyNorm injection
4. Possible side effects
5. How to store OxyNorm injection
6. Contents of the pack and other 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 50MG-ML PIL UK 196022 022003-I V2.indd 2

2. What you need to know before you use OxyNorm
injection
Do not use OxyNorm injection if you:
• are allergic to oxycodone, or any of the other ingredients of
OxyNorm injection (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) 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 long
term liver problems you should only use OxyNorm injection if
recommended by your doctor;
• have ongoing problems with constipation;
• are under 18 years of age.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before treatment with
OxyNorm injection 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 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 this medicine.
Other medicines and OxyNorm injection
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 use OxyNorm injection with
some other medicines, the effect of OxyNorm injection or the other
medicines 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;
• 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
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.
OxyNorm injection contains less than 1 mmol sodium (23 mg) per 1
ml, i.e. it is essentially “sodium-free”.
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.

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
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 022003-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.
Paediatric population:
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.
Route of administration:
Subcutaneous injection or infusion.
Intravenous injection or infusion.
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.

OXYNORM INJ 50MG-ML PIL UK 196022 022003-I V2.indd 3

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 November 2015.
® OxyNorm, NAPP and the NAPP logo are registered trade
marks.
© 2009-2015 Napp
Pharmaceuticals Limited.

• 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,
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 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, 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 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).
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 injection 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 injection
Keep this medicine out of the sightand reach 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.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.
6. Contents of the pack and other 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 November 2015.
® OxyNorm, NAPP and the NAPP logo are
registered trade marks.
© 2009-2015 Napp Pharmaceuticals Limited.

08/01/2016 10:21

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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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