Oxycodone Molteni 50 Mg/Ml Solution For Injection Or Infusion
Oxycodone HCl 10-50 mg/ml ampoule injection/infusion or sterile concentrate - L.Molteni & C. dei F.lli Alitti Societa
di Esercizio SpA
Package leaflet: Information for the user
Oxycodone Molteni 50 mg/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, 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 effect not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Oxycodone is and what it is used for
2. What you need to know before you use Oxycodone
3. How to use Oxycodone
4. Possible side effects
5. How to store Oxycodone
6. Contents of the pack and other information
1. What Oxycodone is and what it is used for
The full name of your injection is Oxycodone Molteni 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 painkillers (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 section 6)
• you have breathing problems, such as ‘chronic obstructive lung disease’, ‘asthma’ or ‘respiratory depression’ where you feel breathless, with coughing or breathing more slowly or weakly
• you have had a head injury that causes a severe headache or makes you feel sick - this is because the injection may make these worse or hide how bad the head injury is
• 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 severe kidney problems
• you have moderate to severe liver problems
• you are often constipated
• you are taking a type of medicine known as a ‘monoamine oxidase inhibitor’ (MAOI), such as tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid, or you have taken this type of medicine in the last two weeks
• 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 have an under-active thyroid gland (‘hypo-thyroidism’) - you may need a lower dose
• you have a severe headache or feel sick - this may be a sign of high pressure in your skull
• 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 pain in the tummy and back - these may be signs of an inflamed pancreas
• 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 ever been addicted to alcohol or drugs
• 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 that are not severe
• you have liver problems that are not moderate or severe.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Oxycodone.
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.
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:
• medicines to help you sleep, such as tranquillisers, hypnotics or sedatives
• 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
• 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).
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.
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 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
This injection contains less than 1 mmol sodium (23 mg) per 1 ml, this means it is essentially ‘sodium free’.
3. How to use 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. 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.
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
Common: may affect up to 1 in 10 people
• dry mouth, loss of appetite, indigestion, tummy pain or discomfort, diarrhoea
• confusion, depression, feeling weak, , anxious or nervous, twitching, difficulty sleeping, unusual thoughts or dreams
• difficulty breathing or wheezing, feeling short of breath, not being able to cough properly
• rash,.
• sweating or chills.
Uncommon: may affect up to 1 in 100 people
• fast, uneven heart beat, low blood pressure, flushing
• spinning feeling or feeling faint especially when standing up
• seeing or hearing things that are not real (hallucination), mood changes, depression, feeling of extreme happiness, feeling restless, agitated or generally unwell, loss of memory
• shaking, difficulty speaking, changes to the way things feel, unable to feel pain, tingling in the hands or feet, fits, blurred vision, involuntary muscle contractions
• dry skin, severe flaking or peeling of the skin
• dehydration, feeling thirsty, 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, stomach problems, changes in the way things taste, tooth decay
• 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
• difficulty passing urine, problems getting an erection, decreased sexual drive, lack of menstrual periods
• 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
• changes to liver test results.
Frequency unknown: frequency cannot be estimated from the available data
• an increased sensitivity to pain
• aggression
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.
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 Societa 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 Molteni 50 mg/ml, solution injectable or pour perfusion France
Ossicodone Molteni Italy
Oxycodone Molteni Poland
This leaflet was last revised in January/2016
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Information for Health Professionals
This leaflet provides technical information for the healthcare professional about Oxycodone Molteni 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 18years:
The following starting doses are recommended for opioid-naive 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-naive 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-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 5 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 at 4-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 naive 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:
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.
Cessation 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.
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.
This leaflet was last revised in January/2016
rev. 2 - 1.3.1.120.7.1 - COMMON-pl-50mg 7