Patient leaflet - Oxycodone Molteni 50 mg/ml solution for injection or infusion
1. What Oxycodone is and what it is used for
The full name of your injection is
Oxycodone injection. In this leaflet the
shorter name ‘Oxycodone’ is used. It
contains the active ingredient oxycodone
hydrochloride. This belongs to a group
of medicines called pain-killers (or
‘analgesics’).
Oxycodone is used for moderate to severe
pain.
2. What you need to know before you use Oxycodone
Do not use Oxycodone if:
you are allergic to oxycodone
hydrochloride or any of the other
ingredients of the injection (listed in
you have breathing problems, such
as ‘severe chronic obstructive lung
disease’, ‘severe bronchial asthma’ or
‘severe respiratory depression’ where
you feel breathless, with coughing or
breathing more slowly or weakly
you have a problem where you have
severe pain in your tummy or part of your
gut does not work properly (‘paralytic
ileus of your small bowel’)
you have a heart problem caused by
long-term lung disease (‘cor pulmonale’)
you have moderate to severe liver
problems
- you are often constipated
- you are under 18 years of age.
Do not use Oxycodone if any of the above
apply to you. If you are not sure, talk to
your doctor, pharmacist or nurse before
using Oxycodone.
Warning and precautions
Talk to your doctor, pharmacist or nurse before using this injection if:
- you are elderly or weakened
- you have an under-active thyroid gland (‘hypo-thyroidism’) – you may need a lower dose
- you have myxoedema (a thyroid disorder with dryness, coldness and swelling [‘puffiness’] of the skin affecting the face and limbs;
- you have a head injury, a severe headache or feel sick – this may be a sign of high pressure in your skull
you have low blood volume
(hypovolaemia); this can happen with severe external or internal bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting;you have low blood pressure (‘hypo-tension’)
- you have a mental problem caused by an infection (‘toxic psychosis’)
- you have problems with your gall bladder or bile duct
- you have inflammation of the pancreas (which causes severe pain in the abdomen and back)
- you have inflammatory bowel disease
- you have prostate problems
- you feel weak or dizzy, feel sick or be sick or have weight loss – these may be signs that your adrenal gland is not working properly
- you have breathing problems such as in ‘severe lung disease’ where you feel breathless with coughing
you have previously suffered from withdrawal symptoms such as feeling agitated or anxious, shaking or sweating when stopping taking alcohol or drugs
- you have kidney problems
- you have liver problems
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Oxycodone. Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system. Tolerance, dependence and addiction
This medicine contains oxycodone, which is an opioid. It can cause dependence and/or addiction.
This medicine contains oxycodone which is an opioid medicine. Repeated use of opioid painkillers can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Oxycodone may lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use. Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it. You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain.
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Common: may affect up to 1 in 10 people
dry mouth, loss of appetite, indigestion,
tummy pain or discomfort, diarrhoea
confusion, depression, feeling weak,
shaking, lack of energy, tiredness,
anxious or nervous, difficulty sleeping,
unusual thoughts or dreams
difficulty breathing or wheezing, feeling
short of breath, not being able to cough
properly
- rash
- sweating.
Uncommon: may affect up to 1 in 100
people
- allergic reactions
- difficulty breathing
- fast, uneven heart beat, flushing
- spinning feeling
seeing or hearing things that are not
real (hallucination), mood changes, ,
unpleasant or uncomfortable mood,
feeling of extreme happiness, feeling
restless, agitated or generally unwell,
loss of memory
difficulty speaking, reduced sensitivity to
pain or touch , tingling or numbness in
the hands or feet, fits, visual impairment,
fainting, unusual muscle stiffness
or slackness, involuntary muscle
contractions
dry skin, severe flaking or peeling of the
skin
dehydration, feeling thirsty, chills,
swelling of the hands, ankles or feet
redness of the face, smaller pupils in the
eye, muscle spasm, high temperature
difficulty swallowing, burping, hiccups,
wind, a condition where the bowel
does not work properly (ileus), stomach
problems, changes in the way things taste,
difficulty passing urine, problems getting
an erection, decreased sexual drive,
low levels of sex hormones in the blood
(‘hypogonadism’, seen in a blood test)
needing to take higher doses of the
medicine than normal to get the same
amount of pain relief (tolerance) – as with
all strong pain-killers, there is a risk that
you may become addicted or tolerant to
this injection withdrawal symptoms (see
section 2 “Warnings and precautions”)
- changes to liver test results, biliary colic.
Rare side effects: may affect up to 1 in
1000 people
- low blood pressure,
- feeling faint especially when standing up
- hives (nettle rash).
Frequency not known: frequency cannot
be estimated from the available data
- an increased sensitivity to pain
- aggression
- tooth decay
- lack 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
a problem affecting a valve in the
intestines that may cause severe upper
abdominal pain (sphincter of Oddi
dysfunction)
Long term use of Oxycodone 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
slow and shallow breathing (respiratory
depression) or withdrawal symptoms in
the newborn baby.
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before using this injection.
Breast-feeding
Do not breast-feed while using
Oxycodone. This is because the medicine
may pass into breast milk.
Driving and using machines
You may feel sleepy or have other side
effects like feeling weak, dizzy or faint
while using Oxycodone. These are more
likely at the start of treatment or when
changing to a higher dose. If this happens,
do not drive or use any tools or machines.
Oxycodone contains sodium
Oxycodone 50 mg/ml – 1 ml ampoule
contains less than 1 mmol sodium (23 mg)
per ampoule, that is to say essentially
‘sodium-free’.
3. How to use Oxycodone
Before starting treatment and regularly
during treatment, your doctor will discuss
with you what you may expect from using
Oxycodone, when and how long you need
to take it, when to contact your doctor,
and when you need to stop it (see also if
you stop using Oxycodone).
Oxycodone is normally given by a doctor
or nurse. The injection should be used
straight away after opening.
Having this medicine
The injection can be given in 3 ways;
- into a vein over 1 to 2 minutes
- through a needle under the skin
- as a ‘drip’ (infusion).
How much to use
Your doctor will work out the right dose for
you. The dose and how often the injection
is given may be changed depending on
your level of pain.
The usual starting dose depends on how
the injection is given – your doctor will work
this out. The usual starting doses are:
single injection into a vein – usually 1 to
10 mg given slowly over 1 to 2 minutes.
Doses will be given at least 4 hours apart
single injection through a fine needle
into the tissue under the skin – the
recommended starting dose is 5 mg
usually given every 4 hours.
As a ‘drip’ (also called an infusion):
an infusion into a vein – usual starting
dose is 2 mg each hour
an infusion through a fine needle into
the tissue under the skin – usual starting
dose is 7.5 mg per day
an infusion controlled by you (‘patient
controlled analgesia’ or ‘PCA’) – the dose
depends on your weight (0.03 mg per kg of
body weight). Your doctor or nurse will work
out how often you need the medicine.
If you are still in pain whilst using Oxycodone
talk to your doctor, pharmacist or nurse.
Children and young people
Do not use this injection if you are under
18 years of age.
People with kidney or liver problems
Talk to your doctor, pharmacist or nurse
if you have any kidney or liver problems.
This is because they may give you a
different medicine or a lower dose of
Oxycodone.
If you use more Oxycodone than you should, or if someone else uses your injection
Do not use more Oxycodone than the doctor tells you to. Check with your doctor or pharmacist if you are not sure. If you think you have had too much of the medicine (‘overdose’), talk to your doctor or go to hospital straight away. Take the medicine pack with you. Do not drive or do anything that needs you to be alert. The following effects may happen if you use too much of this medicine:
- smaller pupils in the eye
- slower or weaker breathing than normal (respiratory depression)
- feeling sleepy or fainting
- low muscle tone (hypotonia)
- slower pulse rate
- low blood pressure
- a brain disorder (known as toxic leukoencephalopathy).
In some serious cases, an overdose may make you pass out (become ‘unconscious’) or could cause death. If you stop using Oxycodone
Do not suddenly stop using this injection unless your doctor tells you to.
If you want to stop using your injection, talk to your doctor first. They will tell you how to do this. This is usually by reducing the dose slowly, so you do not get side effects. The following may happen if you suddenly stop using this injection:
- feeling agitated or anxious
- palpitations
- shaking
- sweating.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this injection can cause side effects, although not everybody gets them.
Serious side effects
Stop using Oxycodone and tell your doctor straight away if you notice any of the following serious side effects:
- allergic reactions – the signs may include suddenly feeling wheezy, difficulty breathing, swelling of the eyelids, face or lips, rash or itching – these may cover your whole body
- breathing problems – the signs may include breathing more slowly or weakly. Stop using Oxycodone and tell your doctor straight away if you notice any of the serious side effects above.
Other side effects
Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Very common: may affect more than 1 in 10 people
- constipation – your doctor can give you medicines to help with this
- feeling or being sick – this should normally wear off after a few days. If it does not wear off, your doctor can give you medicines to help with this
- feeling sleepy – this is most likely when you start using your injection or when your dose is increased, but it should wear off after a few days
- headache
- dizziness
itchy skin
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Pag 2
The risk of becoming dependent or
addicted varies from person to person.
You may have a greater risk of becoming
dependent or addicted on Oxycodone if:
You or anyone in your family have ever
abused or been dependent on alcohol,
prescription medicines or illegal drugs
(“addiction”)
- You are a smoker
You have ever had problems with your
mood (depression, anxiety or a personality
disorder) or have been treated by a
psychiatrist for other mental illnesses.
If you notice any of the following signs
whilst taking Oxycodone, it could be a
sign that you have become dependent or
addicted.
You need to take the medicine for longer
than advised by your doctor
You need to take more than the
recommended dose
You are using the medicine for reasons
other than prescribed, for instance, ‘to
stay calm’ or ‘help you sleep’
You have made repeated, unsuccessful
attempts to quit or control the use of the
medicine
When you stop taking the medicine you
feel unwell, and you feel better once
taking the medicine again (‘withdrawal
effects’)
If you notice any of these signs, speak to
your doctor to discuss the best treatment
pathway for you, including when it is
appropriate to stop and how to stop
safely (See section 3, If you stop using
Oxycodone).
Sleep-related breathing disorders
Oxycodone can cause sleep-related
breathing disorders such as sleep apnoea
(breathing pauses during sleep) and sleep
related hypoxemia (low oxygen level in
the blood). The symptoms can include
breathing pauses during sleep, night
awakening due to shortness of breath,
difficulties to maintain sleep or excessive
drowsiness during the day. If you or
another person observe these symptoms,
contact your doctor. A dose reduction may
be considered by your doctor.
Children and young people
Do not use this injection if you are under
18 years of age.
Other medicines and Oxycodone
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including herbal
medicines. This is because Oxycodone
can affect the way some other medicines
work. Also some other medicines can
affect the way Oxycodone works.
Concomitant use of Oxycodone
and sedative medicines such as
benzodiazepines or related drugs
increases the risk of drowsiness,
difficulties in breathing (respiratory
depression), coma and may be
life-threatening. Because of this,
concomitant use should only be
considered when other treatment options
are not possible. However if your doctor
does prescribe Oxycodone together
with sedative medicines the dose and
duration of concomitant treatment should
be limited by your doctor. Please tell
your doctor about all sedative medicines
you are taking, and follow your doctor’s
dose recommendation closely. It could
be helpful to inform friends or relatives
to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
The risk of side effects increases, if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
Do not use this medicine and tell your doctor or pharmacist if you are taking
a type of medicine known as a
‘monoamine oxidase inhibitor’, such as tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid. Tell your doctor or pharmacist if you are taking any of the following:
- 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, such as tranquillisers, hypnotics or sedatives including benzodiazepines
- medicines for depression
- medicines for mental health problems, such as phenothiazines or neuroleptics
- other strong pain-killers or ‘analgesics’
- medicines which relax your muscles
- medicines for high blood pressure
- medicines for infections, such as clarithromycin, erythromycin or telithromycin
- medicines for fungal infections, such as ketoconazole, voriconazole, itraconazole or posaconazole
- a type of medicine for HIV called ‘protease inhibitors’, such as boceprevir, ritonavir, indinavir, nelfinavir or saquinavir
- rifampicin (to treat tuberculosis);
- carbamazepine (a medicine to treat sezures, fits or convulsions and certain pain conditions);
- phenytoin (a medicine to treat seizures, fits or convulsions);
- cimetidine, used for stomach ulcers, indigestion or heartburn
- quinidine, used for a fast heart beat
- anaesthetics, used before an operation or medical procedure
- a herbal remedy called St. John’s Wort (also known as Hypericum perforatum)
- antihistamines
- medicines to treat Parkinson’s disease If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Oxycodone.
Oxycodone with food, drink and alcohol
- Do not drink grapefruit juice while you are being treated with Oxycodone.
- Do not drink alcohol while you are being treated with Oxycodone. This is because it may make you feel sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. Pregnancy and breast-feeding Pregnancy
Do not use this injection if you are pregnant unless your doctor has said it is okay. It should also not be used during labour. This is because it may cause
- s.c. (Bolus): Dilute in 0.9% saline, 5% dextrose or water for injections. A starting dose of 5 mg is recommended 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:
Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control.
Patients with renal or 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 naïve patients), and each patient should be titrated to adequate pain control according to their clinical situation. Pediatric 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.
Method of administration
Subcutaneous injection or infusion.
Intravenous injection or infusion.
Treatment goals and discontinuation
Before initiating treatment with Oxycodone, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4 of the summary of product characteristics).
Duration of treatment:
Oxycodone should not be used for longer than necessary.
✂
- Sleep apnoea (breathing pauses during sleep).
Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above. 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 Oxycodone
Keep this injection out of sight and reach of children. Store this medicine in a locked safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been prescribed for them. Do not use this injection after the expiry date, which is stated on the ampoule label and carton after ‘Exp.’
This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from light. Once the ampoule is opened the injection should be used immediately. Any unused medicine should be discarded immediately.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Oxycodone 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 Oxycodone looks like and the contents of the pack
This 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
L. Molteni & C. dei F.lli Alitti
Società di Esercizio SpA -
Strada Statale 67, Fraz. Granatieri - 50018 Scandicci (Firenze) – Italy
Tel: +3905573611
Fax: +39055720057
e-mail: info@moltenifarma.it
This medicinal product is authorised in the Member States of the EEA under the following names:
Oxycodone Medac France Ossicodone Molteni Italy Oxycodone Molteni Poland
This leaflet was last revised in 02/2025
Information for Health Professionals
Oxycodone 50 mg/ml, solution for injection or infusion
Oxycodone hydrochloride
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 for opioid-naïve patients. The initial dose should be adjusted to previous or concurrent medication (especially if the patient has been treated with other opioids before), the total condition of the patient, and the severity of pain. 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.
Instruction 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 15 – 25°C 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 50 mg/ml injection, undiluted or diluted to 3 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 50 mg/ml injection, whether undiluted or diluted to 3 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. Please refer to the summary of product characteristics for other information. This leaflet was last revised in 02/2025
✂ Package leaflet: Information for the user
Oxycodone 50 mg/ml, solution for injection or infusion
Oxycodone hydrochloride
020F106018/R7
020F106018/R7