Skip to Content

UK Edition. Click here for US version.



PDF options:  View Fullscreen   Download PDF

PDF Transcript

196016 016003-I

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

Package leaflet: Information for the user
OxyNorm® 10 mg/ml,
solution for injection or infusion
Oxycodone hydrochloride

• have moderate to severe liver problems.
If you have other long-term liver
problems you should only use this
injection if recommended by your doctor;
• have ongoing problems with
• are under 18 years of age.
Read all of this leaflet carefully before you start using this medicine
Warnings and precautions
because it contains important information for you.
Talk to your doctor, pharmacist or nurse
• Keep this leaflet. You may need to read it again.
before treatment with OxyNorm injection
• If you have any further questions, ask your doctor or pharmacist.
if you:
• This medicine has been prescribed for you only. Do not pass it on to others. It
• are elderly or weakened;
may harm them, even if their signs of illness are the same as yours.
• have an under-active thyroid gland
• If you get any side effects, talk to your doctor, pharmacist or nurse. This
(hypothyroidism), as you may need a
includes any possible side effects not listed in this leaflet. See section 4.
lower dose;
In this leaflet:
• have myxoedema (a thyroid disorder
2. What you need to know before
1. What OxyNorm injection is and
with dryness, coldness and swelling
you use OxyNorm injection
what it is used for
[‘puffiness’] of the skin affecting the face
2. What you need to know before
Do not use OxyNorm injection if you:
and limbs;
you use OxyNorm injection
• are allergic (hypersensitive) to
• have a head injury, severe headache or
3. How to use OxyNorm injection
oxycodone, or any of the other
feel sick as this may indicate that the
4. Possible side effects
ingredients of the injection (listed in
pressure in your skull is increased;
5. How to store OxyNorm injection
section 6);
• have low blood pressure (hypotension);
6. Contents of the pack and other
• have breathing problems, such as
• have low blood volume (hypovolaemia);
severe chronic obstructive lung
this can happen with severe external or
disease, severe bronchial asthma or
internal bleeding, severe burns, excessive
1. What OxyNorm injection is
severe respiratory depression. Your
sweating, severe diarrhoea or vomiting;
and what it is used for
doctor will have told you if you have
• have a mental disorder as a result of an
any of these conditions. Symptoms
This injection has been prescribed
infection (toxic psychosis);
may include breathlessness, coughing • have inflammation of the pancreas
for you by your doctor to relieve
or breathing more slowly or weakly
moderate to severe pain. It contains
(which causes severe pain in the
than expected;
the active ingredient oxycodone
abdomen and back);
• have a condition where the small bowel • have problems with your gall bladder or
which belongs to a group of
does not work properly (paralytic
medicines called strong analgesics
bile duct;
ileus) or you have severe pain in your • have inflammatory bowel disease;
or ‘painkillers’.
• have an enlarged prostate gland, which
• have a heart problem after long-term
causes difficulty in passing urine (in
lung disease (cor pulmonale);

OXYNORM INJ 10MG-ML PIL UK 196016 016003-I V2.indd 2

• 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
• 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
• 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
this injection with some other medicines, the
effect of this injection or the other medicines
may be changed.
Tell your doctor or pharmacist if you are
• 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
• medicines to treat depression (such as
• medicines to treat psychiatric or mental
disorders (such as phenothiazines or
• other strong analgesics (‘painkillers’);
• muscle relaxants;
• medicines to treat high blood pressure.
• quinidine (a medicine to treat a fast heart
• 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 treat seizures,
fits or convulsions and certain pain
• 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.
Also tell your doctor if you have recently
been given an anaesthetic.

Using OxyNorm injection with food, drink
and alcohol
Drinking alcohol during your treatment
with this 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 this injection if you are pregnant
or breastfeeding.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
This injection may cause a number of side
effects such as drowsiness which could
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 using the injection, 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
• 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
Details regarding a new driving offence
concerning driving after drugs have been
taken in the UK may be found here:
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
• 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.

Information for Health Professionals
OxyNorm® 10 mg/ml,
solution for injection or infusion
Oxycodone hydrochloride
This leaflet provides technical information
for the healthcare professional about
OxyNorm 10 mg/ml, solution for
injection or infusion.
Posology and method of administration
The dose should be adjusted according
to the severity of pain, the total condition
of the patient and previous or concurrent
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): 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
Patients with renal and hepatic impairment:
The dose initiation should follow a
conservative approach in these patients. The
recommended adult starting dose should

08/01/2016 10:21

196016 016003-I

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

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.
Instructions for use/handling
Each ampoule is for single use in a single
patient. The injection should be given
immediately after opening the ampoule and
any unused portion should be discarded.
Chemical and physical in-use stability has

OXYNORM INJ 10MG-ML PIL UK 196016 016003-I V2.indd 3

been demonstrated for 24 hours at room
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
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 device
logo are registered trade marks.
© 2009-2015 Napp

• 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 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
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 this injection discuss this with
your doctor.
If you use more OxyNorm injection than
you should, or if someone else uses your
Call your doctor or hospital straight away.
People who have been given 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
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. Withdrawal symptoms
such as agitation, anxiety, palpitations,
shaking or sweating may occur if you
suddenly stop using this injection.
If you have any further questions on the use
of this injection, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this injection can cause
side effects, although not everybody gets
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
this 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
• 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
• 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
• 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
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
• 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:
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 sight and reach
of children. Accidental overdose by a child is
dangerous and may be fatal.
Do not use this 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
What OxyNorm injection contains
The active ingredient is oxycodone
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
This injection is a clear, colourless
solution supplied in clear glass
ampoules. The 10 mg/ml strength
is available as either 1 ml or 2 ml
of solution (containing 10 mg or
20 mg of oxycodone hydrochloride
Marketing Authorisation Holder
and Manufacturer
This 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: 16950/0128
This leaflet was last revised in November 2015.
® OxyNorm, NAPP and the NAPP logo are registered trade
© 2009-2015 Napp Pharmaceuticals Limited.

08/01/2016 10:21

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.