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OXYCODONE HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): OXYCODONE HYDROCHLORIDE

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Information for Healthcare Professionals
Oxycodone Hydrochloride 50 mg/ml Solution for Injection or
Infusion
Please refer to the Summary of Product Characteristics (SmPC) for
further details on this product.
Qualitative and Quantitative Composition
Each ml contains oxycodone hydrochloride 50 mg (equivalent to
45 mg of oxycodone base). This medicinal product contains less
than 1 mmol sodium (23 mg) per dose.
For the full list of excipients, see Section 6.1.
Pharmaceutical Form
Solution for injection or infusion (injection or infusion). A clear,
colourless solution practically free of particles.
Therapeutic indications
For the treatment of moderate to severe pain in patients with cancer
and post-operative pain. For the treatment of severe pain requiring
the use of a strong opioid.
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 one
to two minutes in opioid naive patients. Doses should not be
administered more frequently than every four 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
naive 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 five minutes for opioid naive patients.
s.c. (Bolus): Dilute in 0.9% saline, 5% dextrose or water for
injections. A starting dose of 5 mg is recommended, repeated at
four-hourly intervals as required for opioid naive 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. Interpatient 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 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.

16/09/2016
Date

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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.
1. What Oxycodone Injection is and what it
• quinidine (a medicine to treat a fast heartbeat);
is used for
• cimetidine (a medicine for stomach ulcers,
indigestion or heartburn);
This injection has been prescribed for you by your
doctor to relieve moderate to severe pain. It contains • antifungal medicines (such as ketoconazole,
voriconazole, itraconazole and posaconazole);
the active ingredient oxycodone which belongs
• antibiotics (such as clarithromycin, erythromycin or
to a group of medicines called strong analgesics
telithromycin);
or ‘painkillers’. The other ingredients are listed in
• medicines known as ‘protease inhibitors’ to treat
section 6 of this leaflet.
HIV (e.g. boceprevir, ritonavir, indinavir, nelfinavir
2. What you need to know before you use
or saquinavir);
Oxycodone Injection
• rifampicin (to treat tuberculosis);
• carbamazepine (a medicine treat seizures, fits or
Do not use Oxycodone Injection if you:
convulsions and certain pain conditions);
• are allergic (hypersensitive) to oxycodone, or any
• phenytoin (a medicine to treat seizures, fits or
of the other ingredients of the injection (listed in
convulsions);
section 6);
• a herbal remedy called St. John’s Wort (also known
• have breathing problems, such as severe chronic
as Hypericum perforatum);
obstructive lung disease, severe bronchial asthma
• antihistamines;
or severe respiratory depression. Your doctor will
• medicines to treat Parkinson’s disease.
have told you if you have any of these conditions.
Oxycodone Injection with food, drink and alcohol
Symptoms may include breathlessness, coughing
or breathing more slowly or weakly than expected; Drinking alcohol during your treatment with
Oxycodone Injection may make you sleepy or
• have a condition where the small bowel does not
increase the risk of serious side effects such as
work properly (paralytic ileus) or you have severe
shallow breathing with a risk of stopping breathing,
pain in your abdomen;
• have a heart problem after long-term lung disease and loss of consciousness. It is recommended not to
drink alcohol while you’re taking Oxycodone injection.
(cor pulmonale);
• have moderate to severe liver problems. If you have You should avoid drinking grapefruit juice during your
other long-term liver problems you should only use treatment with this medicine.
this injection if recommended by your doctor;
Pregnancy and breast-feeding
• have ongoing problems with constipation;
Do not use Oxycodone Injection if you are pregnant
• are under 18 years of age.
or breast-feeding.
Warnings and precautions
If you are pregnant or breast-feeding, think you may
Talk to your doctor, pharmacist or nurse before
be pregnant or are planning to have a baby, ask your
treatment with Oxycodone injection if you:
doctor, pharmacist or nurse for advice before using
• are elderly or weakened;
this medicine.
• have an under-active thyroid gland
Driving and using machines
(hypothyroidism), as you may need a lower dose;
• have myxoedema (a thyroid disorder with dryness, You may feel sleepy when you first start using
Oxycodone Injection, or when increasing to a higher
coldness and swelling (‘puffiness’) of the skin
dose. If you are affected you should not drive or use
affecting the face and limbs;
• have a head injury, severe headache or feel sick as machinery.
this may indicate that the pressure in your skull is
This medicine can affect your ability to drive.
increased;
Do not drive whilst taking this medicine until you
• have low blood pressure (hypotension);
know how this medicine affects you.
• have low blood volume (hypovolaemia); this can
It may be an offence to drive if your ability to drive
happen with severe external or internal bleeding,
safely is affected.
severe burns, excessive sweating, severe
There is further information for patients who are
diarrhoea or vomiting;
intending to drive in Great Britain - go to
• have a mental disorder as a result of an infection
http://www.gov.uk/drug-driving-law
(toxic psychosis);
Talk to your doctor or pharmacist if you are not sure
• have inflammation of the pancreas (which causes
whether it is safe for you to drive while taking this
severe pain in the abdomen and back);
medicine.
• have problems with your gall bladder or bile duct;
• have inflammatory bowel disease;
Oxycodone Injection contains sodium
• have an enlarged prostate gland, which causes
This injection contains less than 1 mmol sodium
difficulty in passing urine (in men);
(23 mg) per 1 ml, i.e. it is essentially “sodium-free”.
• have poor adrenal gland function (your adrenal
3. How to use Oxycodone Injection
gland is not working properly which may cause
symptoms including weakness, weight loss,
A doctor or nurse will usually prepare and administer
dizziness, feeling or being sick), e.g. Addison’s
the injection for you. The injection should be used
disease;
immediately after opening.
• have breathing problems such as severe
The dose and how often the injection is given may be
pulmonary disease. Your doctor will have told you
adjusted according to the severity of your pain.
if you have this condition. Symptoms may include
The recommended starting dose for adults over
breathlessness and coughing;
18 years old is dependent upon how the injection is
• have kidney or liver problems;
administered. The recommended starting doses are
• have previously suffered from withdrawal
as follows:
symptoms such as agitation, anxiety, shaking or
• As a single injection into a vein, the recommended
sweating upon stopping taking alcohol or drugs;
dose is 1 to 10 mg given slowly over 1 to 2 minutes.
• are or have ever been addicted to alcohol or drugs
This can be repeated every 4 hours.
or have a known opioid dependence;
• As an infusion into a vein, the recommended
• have an increased sensitivity to pain;
starting dose is 2 mg/hour.
• need to take increasingly higher doses of
• As a single injection through a fine needle into the
Oxycodone to gain the same level of pain relief
tissue under the skin, the usual starting dose is
(tolerance).
5 mg repeated at 4-hourly intervals if needed.
If you are going to have an operation, please tell the
• As an infusion through a fine needle into the tissue
doctor at the hospital that you are taking this medicine.
under the skin, the usual starting dose is 7.5 mg/day.
• If given by patient controlled analgesia (PCA), the
Other medicines and Oxycodone Injection
dose is worked out according to your weight
Tell your doctor, pharmacist or nurse if you are using,
(0.03 mg per kg of body weight). Your doctor or
have recently used or might use any other medicines.
nurse will set a suitable frequency.
If you use Oxycodone Injection with some other
medicines, the effect of Oxycodone Injection or the

Measure bar should be 150mm at 100% scale

The name of your medicine is Oxycodone
Hydrochloride 50 mg/ml Solution for Injection
or Infusion. In the rest of this leaflet it is called
Oxycodone Injection.
What is 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

Colours Used

Package leaflet: Information for the user
Oxycodone Hydrochloride 50 mg/ml
Solution for Injection or Infusion
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, pharmacist or nurse.
− 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.

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.
Pharmaceutical Particulars
Excipients: Citric acid monohydrate, sodium citrate, sodium
chloride, hydrochloric acid (for pH adjustment), sodium hydroxide
(for pH adjustment) and water for injections.
Incompatibilities
This medicinal product must not be mixed with other medicinal
products except those mentioned below (special precautions for
disposal/handling).
Cyclizine at concentrations of 3 mg/ml or less, when mixed with
oxycodone injection, either undiluted or diluted with water for
injections, shows no sign of precipitation over a period of 24 hours
storage at room temperature. Precipitation has been shown to occur
in mixtures with oxycodone injection at cyclizine concentrations
greater than 3 mg/ml or when diluted with 0.9% saline. It is
recommended that Water for Injections be used as a diluent when
cyclizine and oxycodone hydrochloride are co-administered, as
cyclizine will precipitate in the presence of 0.9% saline.
Prochlorperazine is chemically incompatible with Oxycodone injection.
Shelf life and special precautions for storage/handling
Unopened: 24 months.
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.

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, hydrochloric acid
(dilute), sodium hydroxide (dilute) and water for
injections.
What Oxycodone Injection looks like and
contents of the pack
Oxycodone Injection is a clear, colourless solution
practically free of particles supplied in clear glass
ampoules. The 50 mg/ml strength is available as
1 ml of solution, containing 50 mg of oxycodone
hydrochloride (equivalent to 45mg of oxycodone
base). It is available in packs of 5 ampoules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham,
LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK
Other formats:
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:
0800 198 5000 (UK only).
Please be ready to give the following information:
Product name
Reference number
Oxycodone Hydrochloride
50 mg/ml Solution for
PL 29831/0367
Injection or Infusion
This is a service provided by the Royal National
Institute of Blind People.
For patients in the Republic of Ireland, please call
UK +44 1978 669272.
This medicinal product is authorised in the
Member States of the EEA under the following
names:
UK and Ireland: Oxycodone Hydrochloride 50 mg/ml
Solution for Injection or Infusion.
This leaflet was last revised in 09/2016.

105940/5

Do not store above 25°C. Keep the ampoule in the outer carton in
order to protect from light.
Nature and contents of container
Type I neutral glass ampoules: 1 ml. Pack size: 5 ampoules.
Special precautions for disposal
Oxycodone injection has been shown to be compatible with the
following drugs:
Hyoscine butylbromide
Hyoscine hydrobromide
Dexamethasone sodium phosphate
Haloperidol
Midazolam hydrochloride
Metoclopramide hydrochloride
Levomepromazine hydrochloride
Oxycodone 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.
Inappropriate handling of the undiluted solution after opening of the
original ampoule, or of the diluted solutions may compromise the
sterility of the product.
Any unused medicinal product or waste material should be
disposed of in accordance with local requirements.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
Marketing Authorisation Number
PL 29831/0367
PA 1339/25/2
Date of Revision of the Text: 09/2016

105940/5

16/09/2016
Date

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Artwork No.

686782

3

English
Language

Proof No.

UK
Market

matt.pirie-scott

6pt (Main Body) / 7pt (Variables)
Min. Point Size

Proof By

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

460 x 150mm
Clearly mark any amendments on one proof and return to MPS

Size

105940/5
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Oxycodone injection 50mg/ml leaflet
Description

Pharma
Code

257

Text Free Area (non-printing)

Keylines (non-printing)

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Customer

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artwork.leicester@multipkg.com

5. How to store Oxycodone 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 Oxycodone Injection after the expiry
date which is stated on the ampoule label and carton
after EXP. The expiry date refers to the last day of
that month.
Do not store above 25°C. Keep the ampoule in the
outer carton in order to protect from light. 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.
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.

Measure bar should be 150mm at 100% scale

4. Possible side effects
Like all medicines, Oxycodone 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 Oxycodone
Injection.
Other side effects
Very common: 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: 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: 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: may affect up to 1 in 1,000 people
• Low blood pressure.
• A feeling of ‘faintness’ especially on standing up.
• Hives (nettle rash).

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 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, or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the national reporting
systems listed below:
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland:
HPRA Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.



Use in 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, pharmacist or
nurse if you are unsure.
If you find that you are still in pain whilst being given
Oxycodone 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 and sick. They may also have breathing
difficulties leading to unconsciousness or even death
and may need emergency treatment in hospital.
When seeking medical attention make sure that you
take this leaflet and any remaining injection with you
to show to the doctor.
If you stop using 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.
If you have any further questions on the use of
Oxycodone Injection, ask your doctor or pharmacist.

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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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