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OXYCODONE HYDROCHLORIDE 10MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): OXYCODONE HYDROCHLORIDE

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Package leaflet: Information for the user
®

OXYNORM 10mg/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.
®
The name of your medicine is OXYNORM 10mg/ml solution for injection or infusion
but will be referred to as Oxynorm injection throughout this leaflet.
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’.
2. What you need to know
before you use Oxynorm
injection
Do not use Oxynorm injection if you:
are allergic (hypersensitive) to
oxycodone, or any of the other
ingredients of the 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
this 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;
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 injection 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
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 (such as
phenothiazines or neuroleptics);
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 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.
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.

This leaflet provides technical information
for the healthcare professional about
Oxynorm 10mg/ml, solution for injection
or infusion.
Posology and method of
administration

Pregnancy and breast-feeding
Do not use this injection if you are
pregnant or breast-feeding.
Ask your doctor or pharmacist for advice
before taking any medicine.

Posology:
The dose should be adjusted according to
the severity of pain, the total condition of
the patient and previous or concurrent
medication.

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 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).

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.

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
1mmol sodium (23mg) per 1ml, i.e. it is
essentially ‘sodium-free’.

Information for Health Professionals

OXYNORM® 10mg/ml solution for injection or infusion
(oxycodone hydrochloride)

i.v. (Bolus): Dilute in 0.9% saline, 5%
dextrose or water for injections.
Administer a bolus dose of 1 to 10mg
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 2mg/hour is recommended for
opioid naïve patients.
i.v. (PCA): Dilute in 0.9% saline, 5%
dextrose or water for injections. Bolus
doses of 0.03mg/kg should be
administered with a minimum lock-out
time of 5 minutes for opioid naïve
patients.
s.c. (Bolus): A starting dose of 5mg 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 7.5mg/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: 2mg of oral oxycodone is
equivalent to 1mg of parenteral
oxycodone. It must be emphasised that
this is a guide to the dose required. Interpatient 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.
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 10mg 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
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
1mg/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 1mg/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.
Manufactured by: Hamol Limited, 1 Thane
Road, Nottingham, NG90 2DB, UK.
Procured from within the EU and
repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
®

OXYNORM 10mg/ml solution for
injection

Leaflet date: 20.04.2016

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 10mg 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 2mg/hour.
As a single injection through a fine
needle into the tissue under the skin,
the usual starting dose is 5mg
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 7.5mg/day.
If given by patient controlled analgesia
(PCA), the dose is worked out
according to your weight (0.03mg 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 this 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, 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 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 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
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).

5. How to store Oxynorm injection

Keep out of the sight and 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
carton and ampoule labels after ‘EXP’.
The expiry date refers to the last day
of the month.
There are no special precautions for
storage prior to use however once the
ampoule is opened the Oxynorm
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.
If the solution becomes discoloured or
show any other signs of deterioration,
consult your doctor or pharmacist who
will tell you what to do.
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 and water for injections.

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 lifethreatening 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.

What Oxynorm injection looks like and
the contents of the pack
Oxynorm injection is a clear, colourless
solution for injection or infusion, supplied
in clear glass ampoules.
Oxynorm injection is available as either
1ml of solution containing 9mg of
oxycodone equivalent to 10mg
oxycodone hydrochloride or 2ml of
solution containing 18mg of oxycodone
equivalent to 20mg of oxycodone
hydrochloride.
The 1ml ampoule has a yellow ring
around the neck of the glass.
The 2ml ampoule has a reddish brown
ring around the neck of the glass.

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.

Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.

Manufactured by: Hamol Limited,
1 Thane Road, Nottingham,
NG90 2DB, UK.

®

OXYNORM 10mg/ml solution for
injection or infusion
POM
PL 18799/2760
Leaflet date: 20.04.2016

CD

Oxynorm is a registered
trademark of Mundipharma AG.

Package leaflet: Information for the user

OXYCODONE HYDROCHLORIDE 10mg/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.
The name of your medicine is OXYCODONE HYDROCHLORIDE 10mg/ml solution
for injection or infusion but will be referred to as Oxycodone injection throughout this
leaflet.
In this leaflet:
1. What Oxycodone injection is and what
it is used for
2. What you need to know before you
use Oxycodone injection
3. How to use Oxycodone injection
4. Possible side effects
5. How to store Oxycodone injection
6. Contents of the pack and other
information
1. What Oxycodone 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’.
2. What you need to know
before you use Oxycodone
injection
Do not use Oxycodone injection if you:
are allergic (hypersensitive) to
oxycodone, or any of the other
ingredients of the 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
this 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 Oxycodone
injection 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 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 Oxycodone injection 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 Oxycodone
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
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 (such as
phenothiazines or neuroleptics);
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 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.
Also tell your doctor if you have recently
been given an anaesthetic.

Using Oxycodone 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
Oxycodone injection.
You should avoid drinking grapefruit juice
during your treatment with this medicine.
Pregnancy and breast-feeding
Do not use this injection if you are
pregnant or breast-feeding.
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 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.
Oxycodone injection contains less
than 1mmol sodium (23mg) per 1ml,
i.e. it is essentially ‘sodium-free’.

Information for Health Professionals

OXYCODONE HYDROCHLORIDE 10mg/ml solution for injection
or infusion
This leaflet provides technical information
for the healthcare professional about
Oxycodone hydrochloride10mg/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 10mg
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 2mg/hour is recommended for
opioid naïve patients.
i.v. (PCA): Dilute in 0.9% saline, 5%
dextrose or water for injections. Bolus
doses of 0.03mg/kg should be
administered with a minimum lock-out
time of 5 minutes for opioid naïve
patients.
s.c. (Bolus): A starting dose of 5mg 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 7.5mg/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: 2mg of oral oxycodone is
equivalent to 1mg of parenteral
oxycodone. It must be emphasised that
this is a guide to the dose required. Interpatient 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.
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 10mg 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
Oxycodone 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
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.

Oxycodone injection, undiluted or diluted
to 1mg/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 1mg/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.
Manufactured by: Hamol Limited, 1 Thane
Road, Nottingham, NG90 2DB, UK.
Procured from within the EU and
repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.

OXYCODONE HYDROCHLORIDE
10mg/ml solution for injection
Leaflet date: 20.04.2016

3. How to use Oxycodone
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 10mg 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 2mg/hour.
As a single injection through a fine
needle into the tissue under the skin,
the usual starting dose is 5mg
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 7.5mg/day.
If given by patient controlled analgesia
(PCA), the dose is worked out
according to your weight (0.03mg 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 this injection discuss this with
your doctor.
If you use more Oxycodone 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, 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 Oxycodone 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 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 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
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).

5. How to store Oxycodone
injection

Keep out of the sight and reach of
children.
Accidental overdose by a child is
dangerous and may be fatal.
Do not use Oxycodone injection after
the expiry date which is stated on the
carton and ampoule label after ‘EXP’.
The expiry date refers to the last day
of the month.
There are no special precautions for
storage prior to use however once the
ampoule is opened the Oxycodone
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.
If the solution becomes discoloured or
show any other signs of deterioration,
consult your doctor or pharmacist who
will tell you what to do.
6. Contents of the pack and
other information
What Oxycodone injection contains
The active ingredient is oxycodone
hydrochloride.
The other ingredients are citric acid
monohydrate, sodium citrate, sodium
chloride and water for injections.

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 Oxycodone injection
during pregnancy may cause lifethreatening 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.

What Oxycodone injection looks like
and the contents of the pack
Oxycodone injection is a clear, colourless
solution for injection or infusion, supplied
in clear glass ampoules.
Oxycodone injection is available as either
1ml of solution containing 9mg of
oxycodone equivalent to 10mg
oxycodone hydrochloride or 2ml of
solution containing 18mg of oxycodone
equivalent to 20mg of oxycodone
hydrochloride.
The 1ml ampoule has a yellow ring
around the neck of the glass.
The 2ml ampoule has a reddish brown
ring around the neck of the glass.

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.

Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.

Manufactured by: Hamol Limited,
1 Thane Road, Nottingham,
NG90 2DB, UK.

OXYCODONE HYDROCHLORIDE
10mg/ml solution for injection or
infusion
PL 18799/2760
Leaflet date: 20.04.2016
POM

CD

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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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