OXYNORM 50 MG / ML SOLUTION FOR INJECTION OR INFUSION

Active substance: OXYCODONE HYDROCHLORIDE

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OxyNorm® 50 mg/ml, solution for injection or infusion
Oxycodone hydrochloride

Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What OxyNorm injection is and what it is used for
2. Before you use OxyNorm injection
3. How to use OxyNorm injection
4. Possible side effects
5. How to store OxyNorm injection
6. Further information

1. What OxyNorm injection is and what it is used for
This injection has been prescribed for you by your doctor to relieve moderate
to severe pain. It contains the active ingredient oxycodone which belongs
to a group of medicines called strong analgesics or ‘painkillers’. The other
ingredients are listed in section 6 of this leaflet.
2. Before you use OxyNorm injection
Do not use OxyNorm injection:
• if you are allergic (hypersensitive) to oxycodone, or any of the other
ingredients of OxyNorm injection;
• if you have breathing problems, such as respiratory depression, chronic
obstructive airways disease, chronic bronchial asthma or severe pulmonary
disease, unless otherwise recommended by your doctor;
• if you have a head injury that causes a severe headache or makes you feel
sick. This is because the injection may make these symptoms worse or hide
the extent of the head injury;
• if you have a condition where the small bowel does not work properly
(paralytic ileus) or you have severe pain in your abdomen;

• if you have a heart problem after long-term lung disease (cor pulmonale);
• if you have severe kidney problems or moderate to severe liver problems.
If you have other long term kidney or liver problems you should only use
OxyNorm injection if recommended by your doctor;
• if you have ongoing problems with constipation;
• if you are taking a type of medicine known as a monoamine oxidase
inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid,
moclobemide and linezolid), or you have taken this type of medicine in the
last two weeks.
Children and adolescents under 18 years old should not use the injection.
Take special care with OxyNorm injection
Before treatment with OxyNorm injection tell your doctor or pharmacist:
• if you have an under-active thyroid gland (hypothyroidism), as you may
need a lower dose of OxyNorm injection;
• if you have a severe headache or feel sick as this may indicate that the
pressure in your skull is increased;
• if you have low blood pressure (hypotension);
• if you have a mental disorder as a result of an infection (toxic psychosis);
• if you have inflammation of the pancreas (pancreatitis) or problems with
your gall bladder;
• if you have inflammatory bowel disease;
• if you have prostate problems;
• if you have poor adrenal gland function;
• if you are or have ever been addicted to alcohol or drugs;
• if you have previously suffered from withdrawal symptoms such as
agitation, anxiety, shaking or sweating upon stopping taking alcohol or
drugs.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
If you use OxyNorm injection with some other medicines, the effect of
OxyNorm injection or the other medicines may be changed.
Tell your doctor or pharmacist:
• if you are taking medicines to help you sleep (for example tranquillisers,
hypnotics or sedatives);
• if you have recently been given an anaesthetic;
• if you are taking medicines to treat depression;
• if you are taking medicines to treat psychiatric or mental disorders;
• if you are taking other strong analgesics or ‘painkillers’;
• if you are taking muscle relaxants;
• if you are taking medicines to treat high blood pressure;
• if you are taking a type of medicine known as a monoamine oxidase
inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid,
moclobemide and linezolid), or you have taken this type of medicine in the
last two weeks.
Using OxyNorm injection with alcohol
Drinking alcohol during your treatment with OxyNorm injection may make
you sleepy. If you are affected you should avoid drinking alcohol.
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.

Important information about some of the ingredients of OxyNorm
injection
This injection contains less than 1 mmol sodium (23 mg) per 1 ml, i.e. it is
essentially “sodium-free”.
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.
The usual starting dose for adults over 18 years old is dependent upon how the
injection is administered. The usual starting doses are as follows:
• As a single injection into a vein, the usual dose is 1 to 10 mg given slowly
over 1 to 2 minutes. This can be repeated every 4 hours.
• As an infusion into a vein, the usual starting dose is 2 mg/hour.
• As a single injection through a fine needle into the tissue under the skin, the
usual starting dose is 5 mg repeated at 4-hourly intervals if needed.
• As an infusion through a fine needle into the tissue under the skin, the usual
starting dose is 7.5 mg/day.
• If given by patient controlled analgesia (PCA), the dose is worked out
according to your weight (0.03 mg per kg of body weight). Your doctor or
nurse will set a suitable frequency.
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.

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Package leaflet: Information for the user

Information for Health Professionals
OxyNorm® 50 mg/ml, solution for injection or infusion
Oxycodone hydrochloride

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

i.v. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for
injections. A starting dose of 2 mg/hour is recommended for opioid
naïve patients.
i.v. (PCA): Dilute in 0.9% saline, 5% dextrose or water for injections.
Bolus doses of 0.03 mg/kg should be administered with a minimum
lock-out time of 5 minutes for opioid naïve patients.
s.c. (Bolus): Use the 10 mg/ml or the 50 mg/ml strength and dilute in
0.9% saline, 5% dextrose or water for injections if required. A starting
dose of 5 mg is recommended, repeated at 4‑hourly intervals as required
for opioid naïve patients.
s.c. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for
injections if required. A starting dose of 7.5 mg/day is recommended in
opioid naïve patients, titrating gradually according to symptom control.
Cancer patients transferring from oral oxycodone may require much
higher doses (see below).

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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.
As with all strong painkillers, there is a risk that you may become addicted or
reliant on OxyNorm injection.

Common side effects
(Probably affecting more than 1 in 100 people using OxyNorm injection)
Most people will have constipation when they use OxyNorm injection. Your
doctor can prescribe a laxative to overcome this problem.
You may feel sick or vomit (be sick) when using this injection, this should
normally wear off after a few days however your doctor can prescribe an
anti-vomiting medicine if it continues to be a problem.
You may find that you feel more sleepy than normal when you start using
your injection or when your dose is increased. This should wear off after a
few days.
The following side effects have also been commonly reported in patients
treated with OxyNorm injection:
• Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort,
diarrhoea.
• Headache, confusion, a feeling of unusual weakness, dizziness, a feeling
of ‘faintness’ especially on standing up, anxiety, nervousness, twitching,
difficulty in sleeping, abnormal thoughts or dreams.
• Difficulty in breathing or wheezing, shortness of breath, decreased cough
reflex.
• Rash, itchy skin.
• Sweating, chills.

Uncommon side effects
(Probably affecting fewer than 1 in 100 people using OxyNorm injection)
• Difficulty in swallowing, belching, hiccups, wind, gastrointestinal disorders
(e.g. upset stomach), changes in taste.
• A feeling of dizziness or ‘spinning’, hallucinations, mood changes,
depression, a feeling of extreme happiness, restlessness, agitation, generally
feeling unwell, loss of memory, shaking, difficulties with speech, reduced
sensitivity to pain or touch, tingling in the hands or feet, seizures, fits or
convulsions, blurred vision.
• Difficulty passing urine, impotence, decreased sexual drive, absence of
menstrual periods.
• Fast, irregular heart beat, low blood pressure, flushing of the skin.
• Dehydration, thirst, 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, high
temperature.
• Withdrawal symptoms such as agitation, anxiety, shaking or sweating upon
stopping using OxyNorm injection.
If you need to have blood tests remind your doctor that you are using
OxyNorm injection. This is important because OxyNorm injection may
change the way your liver works and this could affect the results of some
blood tests.
If any of the side effects become serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5. How to store OxyNorm injection
Keep out of the reach and sight of children. Accidental overdose by a child is
dangerous and may be fatal.
Do not use OxyNorm injection after the expiry date which is stated on the
ampoule label and carton. EXP 08 2010 means that you should not use the
injection after the last day of that month i.e. August 2010.
There are no special precautions for storage prior to use however once the
ampoule is opened the injection should be used immediately. Any unused
portion should be discarded immediately.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
6. Further information
What OxyNorm injection contains
The active ingredient is oxycodone hydrochloride.
The other ingredients are:
• Citric acid monohydrate
• Sodium citrate
• Sodium chloride
• Hydrochloric acid, dilute
• Sodium hydroxide
• Water for injections
What OxyNorm injection looks like and the contents of the pack
OxyNorm injection is a clear, colourless solution supplied in clear glass
ampoules. The 50 mg/ml strength is available as 1 ml of solution (containing
50 mg of oxycodone hydrochloride).

Marketing Authorisation Holder and Manufacturer
OxyNorm injection is made by Hamol Ltd,
1 Thane Road, Nottingham NG90 2DB, UK.
The marketing authorisation holder is Napp Pharmaceuticals Limited,
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 approved in March 2009.

® OxyNorm, NAPP and the NAPP device (logo) and are
Registered Trade Marks.
© 2009 Napp Pharmaceuticals Limited

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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.

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:
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:
Patients with mild to moderate renal impairment and/or mild hepatic
impairment should be treated with caution. The lowest dose should be
given with careful titration to pain control.
Children under 18 years:
There are no data on the use of OxyNorm injection in patients under
18 years of age.
Use in non-malignant pain:
Opioids are not first-line therapy for chronic non-malignant pain, nor
are they recommended as the only treatment. Types of chronic pain
which have been shown to be alleviated by strong opioids include
chronic osteoarthritic pain and intervertebral disc disease. The need for
continued treatment in non-malignant pain should be assessed at regular
intervals.
Cessation of Therapy:
When a patient no longer requires therapy with oxycodone, it may
be advisable to taper the dose gradually to prevent symptoms of
withdrawal.

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

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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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