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OXYNORM 10 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): OXYCODONE HYDROCHLORIDE

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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
constipation;
are under 18 years of age.

Read all of this leaflet carefully before you start using this medicine



because it contains important information for you.

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);

• 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.
Your medicine is called OxyNorm 10 mg/ml solution for injection or infusion, but will
be referred to as OxyNorm injection. Another strength, 50 mg/ml is also available.
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 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
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.
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 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.
• 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
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): 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.
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.

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 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
10.06.2016
®

OxyNorm is a registered
trade mark of Mundipharma AG



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 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).
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 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 2016 means that you
should not use the injection
after the last day of that month
i.e. August 2016.

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.

If the solution becomes discoloured or
shows any other signs of
deterioration, you should seek the
advice of your pharmacist who will tell
you what to do.
6. Further information
What OxyNorm injection contains
The active ingredient is oxycodone
hydrochloride.
Each ampoule contains 20 mg
oxycodone hydrochloride in 2 ml.
Also contains:
• Citric acid monohydrate
• Sodium citrate (E331)
• Sodium chloride
• Hydrochloric acid, dilute (E507)
• Sodium hydroxide (E524)
• 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 supplied in packs of 5 ampoules, with
each ampoule containing 2 ml of solution
(containing 20 mg of oxycodone hydrochloride).
Manufacturer
This injection is made by Hamol Ltd,
Nottingham Site, 1 Thane Road, Nottingham,
NG90 2DB, UK.
Procured from within the EU. Product Licence
Holder: S.C.A.C. Ltd., Throsk, Stirling, FK7 7NP,
UK and repackaged by Cross Healthcare Ltd.,
Throsk, Stirling, FK7 7NP, UK.
PL 30984/0224
OxyNorm® 10 mg/ml solution for injection or
infusion

CD

POM

This leaflet was last revised in 10.06.2016
OxyNorm® is a registered trademark of
Mundipharma AG

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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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