Oxycodone Molteni

Package leaflet: Information for the patient

Oxycode Molteni 50 mg/ml, injectable or infusion solution

Oxycodone hydrochloride
Generic medicine
Please read all of this leaflet carefully before using this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Oxycode is and what it is used for
2. What you need to know before you are given Oxycode
3. How you will be given Oxycode
4. Possible side effects
5. How to store Oxycode
6. Contents of the pack and other information

1. What Oxycode is and what it is used for

The full name of the medicine is Oxycode Molteni injectable solution. In this leaflet,
the abbreviated name 'Oxycode' is used. It contains the active substance oxycodone hydrochloride. This
belongs to a group of medicines called painkillers (or 'analgesics').
Oxycode is used for moderate to severe pain.

2. What you should know before being given Oxycodone

Do not take Oxycodone if:

• you are allergic to oxycodone hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• you have breathing problems, such as 'severe chronic bronchial obstruction', 'severe asthma' or 'severe respiratory depression' causing shortness of breath, cough or slower and weaker breathing;
• you have severe abdominal pain or a part of your intestine is not functioning properly ('paralytic ileus');
• you have heart problems caused by long-term lung disease ('pulmonary heart');
• you have moderate to severe liver problems;
• you frequently suffer from constipation;
• you are under 18 years of age.

If any of the above warnings apply to you, do not use Oxycodone. If you are unsure, speak with your
doctor, pharmacist or nurse before being administered Oxycodone.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using this medicine if:

• you are elderly or debilitated;
• you have reduced thyroid function ('hypothyroidism') – you may need a lower dose;
• you suffer from myxoedema (a thyroid disorder characterized by dry, cold and swollen skin affecting the face and legs);
• you have a head injury, severe headache or malaise – this could indicate increased pressure in the head;
• you have reduced blood volume ('hypovolemia'); this may occur following severe internal or external bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting; you have low blood pressure ('hypotension');
• you have mental disorders resulting from intoxication ('toxic psychosis');
• you have gallbladder or bile duct disorders;
• you suffer from inflammation of the pancreas (which may cause severe abdominal or back pain);
• you have inflammatory bowel disorders;
• you have prostate problems;
• you feel weak or experience dizziness, nausea or vomiting, or have lost weight – these may be symptoms of adrenal gland dysfunction;
• you have breathing problems, such as 'severe lung disease' causing shortness of breath and cough;
• you have previously experienced withdrawal symptoms such as restlessness or anxiety, tremors or sweating when stopping alcohol or medication;
• you have kidney problems;
• you have liver problems. If any of the above warnings apply to you (or you are unsure), talk to your doctor before being administered this medicine.

Tolerance, dependence and abuse
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers
may reduce the effectiveness of the medicine (you become accustomed to the medicine, a phenomenon known as tolerance).
Repeated use of Oxycodone may also lead to dependence, abuse, and addiction, which can result in
potentially fatal overdose. The risk of these adverse effects may increase with higher doses
and longer duration of use.
Dependence or abuse may make you feel that you no longer have control over how much medicine you take or how often you take it. You may feel compelled to continue taking the
medicine, even when it no longer helps relieve pain.
The risk of becoming dependent or addicted varies from person to person. Your risk of becoming dependent or addicted to Oxycodone may be higher if:

• you or a family member has ever abused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction");
• you are a smoker;
• you have had mood disorders (depression, anxiety or personality disorders) or have been treated by a psychiatrist for other mental illnesses. If any of the following signs occur while you are taking Oxycodone, this may indicate that you have become dependent or addicted:
• you need to take the medicine for longer than prescribed by your doctor;
• you need to take a higher dose than recommended;
• you are using the medicine for reasons other than prescribed, for example "to stay calm" or "to help sleep";
• you have repeatedly tried, but failed, to stop or control the use of the medicine;
• you feel unwell when you stop taking the medicine, and feel better after resuming it ("withdrawal effects"). If any of these signs occur, speak to your doctor to discuss the best treatment approach for you, including when and how to safely stop treatment (see section 3 "If you stop treatment with Oxycodone").

Sleep-related breathing disorders
Oxycodone may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxaemia (low blood oxygen levels). Symptoms
may include pauses in breathing during sleep, waking up at night due to breathlessness,
difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes
these symptoms, speak to your doctor. Your doctor may consider reducing your dose.
Children and adolescents
Do not use this medicine if you are under 18 years of age.
For athletes: using this medicine without therapeutic need constitutes doping and may
result in a positive anti-doping test.
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 may alter the effect of other
medicines. Other medicines may also alter the effect of Oxycodone.
Concomitant use of Oxycodone Molteni and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Oxycodone Molteni together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and follow your doctor's dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
The risk of adverse effects increases when taking 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 muscle contractions, including muscles controlling eye movements, restlessness, excessive sweating, tremor, exaggerated reflexes, increased muscle tension and body temperature above 38°C. Contact your doctor if you experience these symptoms.
Do not take this medicine and inform your doctor or pharmacist if you are taking:

• medicines called 'monoamine oxidase inhibitors', such as tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid.

Inform your doctor or pharmacist if you are taking:

• certain types of antidepressants called monoamine oxidase inhibitors or if you have taken these medicines within the last two weeks;
• medicines for sleep, such as tranquilisers, hypnotics or sedatives, including benzodiazepines;
• medicines for depression;
• medicines for mental disorders, such as phenothiazines or neuroleptics;
• other strong painkillers or 'analgesics';
• medicines that relax 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 (for the treatment of tuberculosis);
• carbamazepine (a medicine for the treatment of seizures, epilepsy, convulsions and certain types of pain);
• phenytoin (a medicine for the treatment of seizures, epilepsy, convulsions);
• cimetidine, used for stomach ulcers, indigestion or heartburn;
• quinidine, used for tachycardia (rapid heartbeat);
• anaesthetics, used before surgery or medical procedures;
• a herbal remedy called St John's wort (also known as Hypericum perforatum);
• antihistamines;
• medicines for the treatment of Parkinson's disease.

If any of the above conditions apply to you (or you are unsure), talk to your doctor or pharmacist before
being administered this medicine.
Oxycodone with food, drinks and alcohol

• Do not drink grapefruit juice during treatment with Oxycodone.
• Do not drink alcohol during treatment with Oxycodone. This is because it may cause drowsiness or increase the risk of serious adverse effects such as shortness of breath, respiratory depression and loss of consciousness.

Pregnancy and breastfeeding
Pregnancy
This medicine should not be used during pregnancy unless specifically advised by your doctor, and should not be administered during childbirth, as it may cause slow and shallow breathing (respiratory depression) or withdrawal symptoms in the newborn.
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before being administered this medicine.
Breastfeeding
Do not breastfeed while taking Oxycodone. This is because the medicine may pass into breast milk.
Driving and using machines
While taking Oxycodone, you may experience adverse effects such as drowsiness, weakness,
dizziness or loss of consciousness. These are more common at the beginning of treatment or when increasing to a higher dose. If you experience such symptoms, do not drive or operate tools or machinery.
Oxycodone contains sodium
Oxycodone contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially 'sodium-free'.

3. How to take Oxycode

Before starting treatment and regularly during treatment, your doctor will discuss with you what you can expect from using Oxycode, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also “If you stop treatment with Oxycode”).
Oxycode will be administered to you by a doctor or nurse. The injection must be given immediately after opening the vial.
Administration of the medicine
The injection can be given in 3 ways:

• intravenously over a period of 1 to 2 minutes;
• subcutaneously using a fine needle;
• by infusion (also called ‘drip’ or ‘flebo’).

How much medicine will be given to you
Your doctor will calculate the correct dose. The dose and frequency of administration may be adjusted depending on the intensity of your pain. Usually, the initial dose depends on the type of injection and will be determined by your doctor. Generally, the initial doses are:

• single intravenous injection, usually 1 to 10 mg, administered slowly over 1–2 minutes. Doses should be given at intervals of at least 4 hours;
• single subcutaneous injection using a fine needle, the recommended initial dose is 5 mg, generally administered every 4 hours.
  By infusion (also called ‘flebo’):
• intravenous infusion, usually the initial dose is 2 mg per hour;
• subcutaneous infusion using a fine needle, usually the initial dose is 7.5 mg per day;
• patient-controlled analgesia (‘PCA’), the dose depends on your body weight (0.03 mg per kg of body weight). The frequency of drug administration will be determined by your doctor or nurse.
  If pain persists while you are taking Oxycode, contact your doctor, pharmacist, or nurse.

Use in children and adolescents
This medicine must not be used in individuals under 18 years of age.

Patients with kidney or liver problems
Talk to your doctor, pharmacist, or nurse if you have kidney or liver problems. This is because you may need to be given a different medicine or a lower dose of oxycodone.

If you are given more oxycodone than you should, or if the medicine is used by someone else
Do not use a dose of oxycodone higher than that prescribed by your doctor. If in doubt, check with your doctor or pharmacist. If you think you have been given too much medicine (‘overdose’), inform your doctor immediately and go immediately to hospital. Take the medicine packaging with you. Do not drive or operate machinery or do anything that requires you to be alert.
In case of overdose, the following symptoms may occur:

• pinpoint pupils;
• slower or weaker breathing than normal (respiratory depression);
• drowsiness or loss of consciousness;
• loss of muscle tone (hypotonia);
• slowed pulse rate;
• low blood pressure;
• a brain disorder (known as toxic leukoencephalopathy).
  In severe cases, an overdose can lead to fainting (‘loss of consciousness’) or death.

If you stop treatment with Oxycode
Do not stop using this medicine abruptly unless your doctor has told you to do so. If you wish to stop taking this medicine, discuss it first with your doctor. Your doctor will advise you on the correct way to do this. Usually, the dose should be gradually reduced to avoid unwanted effects. The following symptoms may occur if you stop using this medicine abruptly:

• anxiety or restlessness;
• palpitations;
• tremor;
• sweating.

If you need further information about the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this injection can cause side effects, although not everyone experiences them.
Serious side effects
Stop taking oxycodone and contact your doctor immediately if any of the following serious side effects occur:

• Allergic reactions – symptoms may include sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching – these may affect the whole body;
• Breathing problems (symptoms may include slow and weak breathing).

If any of the above-mentioned serious side effects occur, stop taking oxycodone and contact your doctor immediately.
Other side effects
Contact your doctor, pharmacist or nurse if any of the following side effects occur:
Very common: may affect more than 1 in 10 people

• Constipation – your doctor may prescribe a medicine to help with this problem;
• Nausea or vomiting – these usually disappear within a few days. If they do not, your doctor may prescribe medications to help;
• Drowsiness – this is more likely at the beginning of treatment or when the dose is increased, but should disappear after a few days;
• Headache;
• Dizziness;
• Itching.

Common: may affect up to 1 in 10 people

• Dry mouth, loss of appetite, indigestion, stomach pain or discomfort, diarrhoea;

• Confusion, depression, weakness, tremors, lack of energy, fatigue, anxiety or nervousness, difficulty falling asleep, unusual thoughts or dreams;

• Wheezing or difficulty breathing, shortness of breath, inability to cough normally;

• Rash;

• Sweating.
  Uncommon: may affect up to 1 in 100 people

• Allergic reactions;

• Breathing difficulties;

• Fast or irregular heartbeat, flushing;

• Dizziness;

• Seeing or hearing things that are not real (hallucinations), mood swings, unpleasant mood or discomfort, feelings of euphoria, restlessness, agitation or general malaise, memory loss;

• Difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness in hands and feet, seizures, changes in vision, fainting, unusual muscle stiffness or relaxation, involuntary muscle contractions;

• Dry skin, severe peeling or flaking of the skin;

• Dehydration, feeling thirsty, chills, sweating of hands, ankles or feet;

• Flushing of the face, constricted pupils, muscle spasms, high body temperature;

• Difficulty swallowing, belching, hiccups, bloating, a condition in which the bowel does not function properly (ileus), stomach problems, changes in taste;

• Difficulty urinating, erection problems, decreased sex drive, low levels of sex hormones in the blood (hypogonadism, detectable by blood tests);

• Need to take higher doses of the medicine than normal to achieve the same level of pain relief (tolerance): as with all strong opioid painkillers, there is a risk of becoming dependent on or tolerant to this medicine, withdrawal symptoms (see section 2 “Warnings and precautions”);

• Changes in liver function test results, gallbladder colic.

Rare side effects

• Low blood pressure;
• Feeling faint, especially when standing up;
• Hives (urticaria).

Frequency not known: frequency cannot be estimated from the available data

• Increased sensitivity to pain;
• Aggression;
• Dental caries;
• Absence of menstrual periods;
• Blockage of bile flow from the liver (cholestasis). This may cause itching of the skin, yellowish skin, dark urine and very pale stools;
• Long-term use of Ossicodone Molteni during pregnancy may cause potentially life-threatening neonatal withdrawal syndrome. Symptoms in the newborn include irritability, hyperactivity and disturbed sleep patterns, high-pitched crying, tremors, diarrhoea and failure to gain weight;
• Sleep apnoea (breathing pauses during sleep).

If you experience any of the side effects listed above, contact your doctor, pharmacist or nurse.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oxycodone

Keep this medicine out of the sight and reach of children. Store this medicine in a safe place, not accessible to others. It may cause serious harm and can be fatal to people for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the vial label and on the carton after “Exp.”.
This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from light. Once the vial has been opened, the injection must be administered immediately. Any unused medicine must be discarded immediately.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Oxycodone contains

• The active substance is oxycodone hydrochloride.
• The other components are: citric acid monohydrate, sodium citrate, sodium chloride, diluted hydrochloric acid, sodium hydroxide, water for injections.

Description of the appearance of Oxycodone and contents of the pack
This injection is a clear, colourless solution supplied in transparent glass vials. The 50 mg/ml concentration is available in 1 ml vials 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 (Florence) - Italy
Tel: +3905573611
Fax: +39055720057
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Oxycodone Molteni 50 mg/ml, solution for injection or infusion – France
Oxycodone Molteni 50 mg/ml, solution for injection or infusion – United Kingdom
Oxycodone Molteni – Poland

The following information is intended exclusively for healthcare professionals

Oxycodone Molteni 50 mg/ml, injectable solution or for infusion
Oxycodone hydrochloride
This leaflet provides technical information for healthcare professionals on Oxycodone Molteni 50 mg/ml, injectable solution or for infusion.
Dosage and method of administration
Dosage:
The dose must be adjusted according to the intensity of pain, the patient's general condition, and previous or ongoing therapy.
Adults over 18 years:
The following initial doses are recommended for patients not previously treated with opioids. The initial dose must be adjusted based on previous or ongoing therapy (especially if the patient has previously been treated with other opioids), the patient's general condition, and pain intensity. In case of inadequate analgesia or increased pain intensity, the dose may need to be gradually increased.

• i.v. (bolus): Dilute in 0.9% sodium chloride solution, 5% dextrose solution, or water for injections. In opioid-naïve patients, administer a bolus dose of 1 to 10 mg slowly over 1–2 minutes. Doses should not be administered more frequently than every 4 hours.
• i.v. (infusion): Dilute in 0.9% sodium chloride solution, 5% dextrose solution, or water for injections. For opioid-naïve patients, an initial dose of 2 mg/hour is recommended.
• i.v. (PCA): Dilute in 0.9% sodium chloride solution, 5% dextrose solution, or water for injections. In opioid-naïve patients, a bolus dose of 0.03 mg/kg should be administered with a minimum lockout interval of 5 minutes.
• s.c. (bolus): Dilute in 0.9% sodium chloride solution, 5% dextrose solution, or water for injections. In opioid-naïve patients, a dose of 5 mg every 4 hours as needed is recommended.
• s.c. (infusion): Dilute in 0.9% sodium chloride solution, 5% dextrose solution, or water for injections as needed. In opioid-naïve patients, an initial dose of 7.5 mg/day is recommended, gradually titrated according to symptom control. In cancer patients previously taking oral oxycodone, much higher doses may be required (see below).
  Switching from oral oxycodone to parenteral oxycodone: The dose should be determined considering that 2 mg of oral oxycodone are equivalent to 1 mg of parenteral oxycodone. It should be emphasized that this is only a guideline for the required dose. Inter-patient variability requires that the appropriate dose be carefully titrated for each individual patient.
  Elderly: Elderly patients should be treated with caution. Administration of the lowest dose with careful titration for pain control is recommended.
  Patients with renal or hepatic impairment: For these patients, initial dosing should follow a conservative approach. The recommended initial adult dose should be reduced by 50% (e.g., a total daily oral dose of 10 mg in opioid-naïve patients), and the dose should be adjusted for each patient to achieve adequate pain control based on individual clinical circumstances.
  Paediatric population: There are no data on the use of injectable oxycodone solution in patients under 18 years of age.

Use in non-malignant pain:
Opioids are not first-line therapy for chronic non-malignant pain and are not recommended as sole treatment. Strong opioids have proven useful in relieving the following types of chronic pain: chronic osteoarticular pain and pain due to intervertebral disc disease.
Method of administration
Subcutaneous injection or infusion.
Intravenous injection or infusion.
Objectives and discontinuation of treatment
Before initiating treatment with Oxycodone, a treatment strategy including duration, treatment goals, and a plan for treatment discontinuation should be agreed upon with the patient and in accordance with pain management guidelines. During treatment, frequent contact between physician and patient is necessary to evaluate the need for continuing therapy, consider discontinuation, and adjust dosage as needed. When a patient no longer requires oxycodone therapy, it is advisable to gradually reduce the dose to prevent withdrawal symptoms. In the absence of adequate pain control, the possibility of hyperalgesia, tolerance, and progression of the underlying disease should be considered (see section 4.4 of the Summary of Product Characteristics).
Duration of treatment
Oxycodone should not be used longer than necessary.
Special precautions for disposal and handling
The vial is single-use for a single patient only. The injection must be administered immediately after opening the vial; any unused residue must be discarded. Chemical and physical stability during use has been demonstrated for 24 hours at a temperature of 15–25 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8 °C, unless reconstitution, dilution, etc., have been carried out under controlled and validated aseptic conditions.
Oxycodone 50 mg/ml injectable solution, undiluted or diluted to 3 mg/ml with 0.9% w/v sodium chloride solution, 5% w/v dextrose solution, or water for injections, is physically and chemically stable for more than 24 hours at room temperature when in contact with polypropylene or polycarbonate syringes, polyethylene or PVC tubing, and PVC or EVA infusion bags. Oxycodone 50 mg/ml injectable solution, undiluted or diluted to 3 mg/ml in infusion fluids and in contact with the various materials used in the studies, does not require protection from light.
Inappropriate handling of the undiluted solution after opening the original vial, or of diluted solutions, may compromise the sterility of the product.
Refer to the Summary of Product Characteristics for further information.

Package leaflet: Information for the patient

Oxycodeine Molteni 10 mg/ml, solution for injection or infusion

Oxycodone hydrochloride
Equivalent Medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be dangerous.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Oxycodeine is and what it is used for
2. What you need to know before being given Oxycodeine
3. How Oxycodeine will be given to you
4. Possible side effects
5. How to store Oxycodeine
6. Contents of the pack and other information

1. What Oxycode is and what it is used for

The full name of the medicine is Oxycode Molteni injectable solution. In this leaflet,
the shortened name 'Oxycode' is used. It contains the active substance oxycodone hydrochloride. This
belongs to a group of medicines called painkillers (or 'analgesics').
Oxycode is used for moderate to severe pain.

2. What you should know before being given Oxycodone

Do not take Oxycodone if:

• you are allergic to oxycodone hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• you have breathing problems, such as 'severe chronic bronchial obstruction', 'severe asthma' or 'severe respiratory depression' causing shortness of breath, cough or slower and weaker breathing;
• you have severe abdominal pain or a part of your intestine is not functioning properly ('paralytic ileus');
• you have heart problems caused by long-term lung disease ('cor pulmonale');
• you have moderate to severe liver problems;
• you frequently suffer from constipation;
• you are under 18 years of age.

If any of the above warnings apply to you, do not use Oxycodone. If you are unsure, speak with your
doctor, pharmacist or nurse before being administered Oxycodone.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using this medicine if:

• you are elderly or debilitated;
• you have reduced thyroid function ('hypothyroidism') – you may need a lower dose;
• you suffer from myxoedema (a thyroid disorder characterized by dry, cold and swollen skin, affecting the face and legs);
• you have a head injury, severe headache or malaise – these could indicate increased pressure in the head;
• you have reduced blood volume ('hypovolemia'); this may occur following severe internal or external bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting;
• you have low blood pressure ('hypotension');
• you have mental disorders due to intoxication ('toxic psychosis');
• you have gallbladder or bile duct disorders;
• you suffer from inflammation of the pancreas (which may cause severe abdominal or back pain); you have inflammatory bowel disorders;
• you have prostate problems;
• you feel weak or experience dizziness, nausea or vomiting, or have weight loss – these could be symptoms of adrenal gland dysfunction;
• you have breathing problems, such as 'severe lung disease' causing shortness of breath and cough;
• you have previously experienced withdrawal symptoms such as restlessness or anxiety, tremors or sweating when stopping alcohol or medication;
• you have kidney problems;
• you have liver problems.

If any of the above warnings apply to you (or you are unsure), speak with your doctor before being
administered this medicine.
Tolerance, dependence and abuse
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers may reduce the effectiveness of the medicine (you become accustomed to the medicine, a phenomenon known as tolerance).
Repeated use of Oxycodone may also lead to dependence, abuse and addiction, which can result in potentially fatal overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.
Dependence or abuse may make you feel that you no longer have control over how much medicine you take or how often you take it. You may feel the need to continue taking the medicine, even when it does not help relieve pain.
The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to Oxycodone if:

• you or a family member has ever abused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction");
• you are a smoker;
• you have had mood disorders (depression, anxiety or personality disorders) or have been treated by a psychiatrist for other mental illnesses. If any of the following signs appear while you are taking Oxycodone, this may indicate that you have become dependent or addicted:
• you need to take the medicine for longer than prescribed by your doctor;
• you need to take a higher dose than recommended;
• you are using the medicine for reasons other than prescribed, for example, "to stay calm" or "to help sleep";
• you have repeatedly tried, without success, to stop or control your use of the medicine;
• when you stop taking the medicine you feel unwell, and feel better after restarting it ("withdrawal symptoms"). If any of these signs occur, speak with your doctor to discuss the best treatment approach for you, including when and how to safely stop treatment (see section 3 “If you stop treatment with Oxycodone”). Sleep-related breathing disorders Oxycodone may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxaemia (low levels of oxygen in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to breathlessness, difficulty maintaining sleep or excessive daytime sleepiness. If you or someone else observes these symptoms, speak with your doctor. Your doctor may consider reducing your dose.

Children and adolescents
Do not use this medicine if under 18 years of age.
For athletes: using this medicine without a medical need constitutes doping and may lead to a positive
result in anti-doping tests.
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 may alter the effect of other medicines. Other medicines may also alter the effect of Oxycodone.
The concomitant use of Oxycodone Molteni and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Oxycodone Molteni together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendations carefully. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
The risk of adverse effects increases when taking 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 and rhythmic muscle contractions, including muscles controlling eye movements, restlessness, excessive sweating, tremor, exaggerated reflexes, increased muscle tension and body temperature above 38°C. Contact your doctor if you experience these symptoms.
Do not take this medicine and inform your doctor or pharmacist if you are taking:

• medicines called 'monoamine oxidase inhibitors', such as tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid.

Inform your doctor or pharmacist if you are taking:

• certain types of antidepressants called monoamine oxidase inhibitors or if you have taken these medicines within the last two weeks;
• medicines for sleep, such as tranquillisers, hypnotics or sedatives, including benzodiazepines;
• medicines for depression;
• medicines for mental disorders, such as phenothiazines or neuroleptics;
• other strong painkillers or 'analgesics';
• muscle-relaxing medicines;
• 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 HIV medicine called 'protease inhibitors', such as boceprevir, ritonavir, indinavir, nelfinavir or saquinavir;
• rifampicin (for the treatment of tuberculosis);
• carbamazepine (a medicine for the treatment of seizures and epileptic fits, convulsions and certain types of pain);
• phenytoin (a medicine for the treatment of seizures and epileptic fits, convulsions);
• cimetidine, used for stomach ulcers, indigestion or heartburn;
• quinidine, used for tachycardia (rapid heartbeat);
• anaesthetics, used before surgery or medical procedures;
• a herbal remedy called St. John’s wort (also known as Hypericum perforatum);
• antihistamines;
• medicines for the treatment of Parkinson’s disease.

If any of the above conditions apply to you (or you are unsure), speak with your doctor or pharmacist before
being administered this medicine.
Oxycodone with food, drinks and alcohol

• Do not drink grapefruit juice during treatment with Oxycodone.
• Do not drink alcohol during treatment with Oxycodone. This is because it may cause drowsiness or increase the risk of serious adverse effects such as shortness of breath, respiratory depression and loss of consciousness.

Pregnancy and breastfeeding
Pregnancy
This medicine should not be used during pregnancy unless specifically advised by your doctor, and should not be administered during childbirth, as it may cause slow and shallow breathing (respiratory depression) or withdrawal symptoms in the newborn.
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, consult your doctor before being administered this medicine.
Breastfeeding
Do not breastfeed while taking Oxycodone. This is because the medicine may pass into breast milk.
Driving and using machines
While taking Oxycodone, you may experience adverse effects such as drowsiness, weakness, dizziness or loss of consciousness. These are more common at the beginning of treatment or when increasing to a higher dose. If you experience such symptoms, do not drive or operate tools or machinery.
Oxycodone contains sodium
Oxycodone Molteni 10 mg/ml – 1 ml vial contains less than 1 mmol (23 mg) of sodium per vial, i.e.
essentially 'sodium-free'.
Oxycodone Molteni 10 mg/ml – 2 ml vial contains less than 1 mmol (23 mg) of sodium per vial, i.e.
essentially 'sodium-free'.
Oxycodone Molteni 10 mg/ml – 20 ml vial contains 57.0 mg of sodium (main component of table salt) per vial. This corresponds to 2.85% of the maximum daily intake recommended in an adult's diet.

3. How to take Oxycodeine

Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from using Oxycodeine, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also "Stopping Oxycodeine treatment").

Oxycodeine will be administered to you by a doctor or nurse. The injection must be given immediately after opening the vial.

Administration of the medicine

The injection can be given in 3 ways:

• intravenously over a period of 1 to 2 minutes;
• subcutaneously using a fine needle;
• by infusion ('drip').

Dosage

Your doctor will calculate the correct dose. The dose and frequency of administration may be adjusted depending on the intensity of pain.

Generally, initial doses are:

• single intravenous injection, usually 1 to 10 mg, administered slowly over 1–2 minutes. Doses should be given at intervals of at least 4 hours;
• single subcutaneous injection using a fine needle: the recommended initial dose is 5 mg, usually administered every 4 hours.

By infusion ('drip'):

• intravenous infusion: the usual initial dose is 2 mg per hour;
• subcutaneous infusion using a fine needle: the usual initial dose is 7.5 mg per day;
• patient-controlled analgesia ('PCA'), the dose depends on body weight (0.03 mg per kg body weight). The frequency of drug administration will be determined by the doctor or nurse.

If pain persists while taking Oxycodeine, contact your doctor, pharmacist, or nurse.

Use in children and adolescents

This medicine must not be used in individuals under 18 years of age.

Patients with kidney or liver problems

Speak to your doctor, pharmacist, or nurse if you have kidney or liver problems. This is because you may need to be given a different medicine or a lower dose of oxycodone.

If you are given more oxycodone than you should, or if the medicine is used by someone else

Do not use a dose of oxycodone higher than that prescribed by your doctor. If in doubt, check with your doctor or pharmacist. If you think too much medicine has been given (‘overdose’), inform your doctor immediately and go to hospital at once. Take the medicine pack with you. Do not drive or operate machinery or do anything that requires you to be alert.

In case of overdose, the following symptoms may occur:

• constricted pupils;
• slower or weaker breathing than normal (respiratory depression);
• drowsiness or loss of consciousness;
• loss of muscle tone (hypotonia);
• slowed pulse rate;
• low blood pressure;
• a brain disorder (known as toxic leukoencephalopathy).

In severe cases, overdose may lead to fainting (‘loss of consciousness’) or death.

Stopping Oxycodeine treatment

Do not stop using this medicine abruptly unless your doctor tells you to. If you wish to stop taking this medicine, discuss it first with your doctor. Your doctor will advise you on the correct way to do so. Usually, the dose should be reduced gradually to avoid unwanted effects.

The following symptoms may occur if you stop using this medicine abruptly:

• anxiety or restlessness;
• palpitations;
• tremor;
• sweating.

For further information about the use of this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this injection can cause side effects, although not everyone experiences them.

Serious side effects
Stop taking Oxycodone and contact your doctor immediately if you experience any of the following serious side effects:

• Allergic reactions – symptoms may include sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching – these may affect the whole body;
• Breathing problems (symptoms may include slow or weak breathing).

If any of the above-mentioned serious side effects occur, stop taking oxycodone and contact your doctor immediately.

Other side effects
Contact your doctor, pharmacist or nurse if you experience any of the following side effects:

Very common: may affect more than 1 in 10 people

• Constipation – your doctor may prescribe a medicine to help with this;
• Nausea or vomiting – these usually disappear within a few days. If they do not, your doctor may prescribe medication to help;
• Drowsiness – this is more likely at the beginning of treatment or when the dose is increased, but should improve after a few days;
• Headache;
• Dizziness;
• Itching.

Common: may affect up to 1 in 10 people

• Dry mouth, loss of appetite, indigestion, stomach pain or discomfort, diarrhoea;
• Confusion, depression, weakness, tremors, lack of energy, fatigue, anxiety or nervousness, difficulty falling asleep, strange thoughts or dreams;
• Wheezing or difficulty breathing, shortness of breath, inability to cough normally;
• Rash;
• Sweating.

Uncommon: may affect up to 1 in 100 people

• Allergic reactions;
• Breathing difficulties;
• Fast or irregular heartbeat, flushing;
• Dizziness; seeing or hearing things that are not real (hallucinations), mood swings, unpleasant mood or discomfort, feelings of euphoria, restlessness, agitation or general malaise, memory loss;
• Difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness in hands and feet, seizures, changes in vision, fainting, unusual muscle stiffness or relaxation, involuntary muscle contractions;
• Dry skin, severe peeling or flaking of the skin;
• Dehydration, feeling thirsty, chills, sweating of hands, ankles or feet;
• Flushing of the face, constricted pupils, muscle spasms, high body temperature;
• Difficulty swallowing, belching, hiccups, bloating, a condition in which the bowel does not function properly (ileus), stomach problems, changes in taste;
• Difficulty urinating, erection problems, decreased sex drive, low levels of sex hormones in the blood (hypogonadism, detectable by blood tests);
• Need to take higher doses of the medicine than normal to achieve the same level of pain relief (tolerance): as with all strong painkillers, there is a risk of becoming dependent on or tolerant to this medicine, withdrawal symptoms (see section 2 “Warnings and precautions”);
• Changes in liver function test results, biliary colic.

Rare side effects

• Low blood pressure;
• Feeling faint, especially when standing up;
• Hives.

Frequency not known: frequency cannot be estimated from the available data

• Increased sensitivity to pain;
• Aggression;
• Dental caries;
• Absence of menstrual periods;
• Blockage of bile flow from the liver (cholestasis). This may cause itching of the skin, yellowish skin, very dark urine and very pale stools;
• Long-term use of Ossicodone Molteni during pregnancy may cause potentially fatal neonatal withdrawal syndrome. Symptoms in the newborn include irritability, hyperactivity and disturbed sleep patterns, high-pitched crying, tremor, diarrhoea and failure to gain weight;
• Sleep apnoea (pauses in breathing during sleep).

If you experience any of the side effects listed above, contact your doctor, pharmacist or nurse.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oxycodone

Keep this medicine out of the sight and reach of children. Store this medicine in a safe place, inaccessible to others. It may cause serious harm and can be fatal to people for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the vial label and on the carton after “Exp.”.
This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from light. Once the vial has been opened, the injection must be administered immediately. Any unused medicine must be discarded immediately.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ossicodone contains

• The active substance is oxycodone hydrochloride.
• The other components are: citric acid monohydrate, sodium citrate, sodium chloride, diluted hydrochloric acid, sodium hydroxide, water for injections. Ossicodone Molteni contains a component with known effects (sodium). See section 2.

Description of the appearance of Ossicodone and contents of the pack
This injection is a clear, colourless solution supplied in transparent glass vials.
The 10 mg/ml strength is available in vials containing 1 ml, 2 ml and 20 ml of solution (containing
10 mg, 20 mg and 200 mg of oxycodone hydrochloride, respectively).

Marketing Authorisation Holder and Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio SpA - Strada Statale 67, Fraz. Granatieri - 50018
Scandicci (Florence) – Italy
Tel: +3905573611
Fax: +39055720057
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area Member States under the following names:
Oxycodone Molteni 10 mg/ml, solution injectable or pour perfusion France
Oxycodone Molteni 10 mg/ml, solution for injection or infusion United Kingdom
Oxycodone Molteni Poland

The following information is intended exclusively for healthcare professionals

Oxycodone Molteni 10 mg/ml, injectable solution for injection or infusion
Oxycodone hydrochloride
This package leaflet provides technical information for healthcare professionals on Oxycodone Molteni 10 mg/ml, injectable solution for injection or infusion.
Dosage and method of administration
Dosage:
The dose must be adjusted according to the intensity of pain, the patient's general condition, and previous or concomitant therapy.
Adults over 18 years:
The following initial doses are recommended for patients not previously treated with opioids. The initial dose should be adjusted based on prior or ongoing therapy (especially if the patient has previously received other opioids), the patient's general condition, and the intensity of pain. If analgesia is inadequate or pain intensity increases, the dose may need to be gradually increased.

• i.v. (bolus): Dilute to 1 mg/ml in 0.9% sodium chloride solution, 5% dextrose solution, or water for injections. Administer a bolus dose of 1 to 10 mg slowly over 1–2 minutes. Doses should not be administered more frequently than every 4 hours.
• i.v. (infusion): Dilute to 1 mg/ml in 0.9% sodium chloride solution, 5% dextrose solution, or water for injections. An initial dose of 2 mg/hour is recommended.
• i.v. (PCA): Dilute to 1 mg/ml in 0.9% sodium chloride solution, 5% dextrose solution, or water for injections. A bolus dose of 0.03 mg/kg should be administered with a minimum lockout interval of 5 minutes.
• s.c. (bolus): Use the 10 mg/ml concentration as supplied. An initial dose of 5 mg is recommended, repeated every 4 hours as needed.
• s.c. (infusion): Dilute in 0.9% sodium chloride solution, 5% dextrose solution, or water for injections if necessary. For patients not previously treated with opioids, an initial dose of 7.5 mg/day is recommended, gradually titrated according to symptom control. In oncology patients previously taking oral oxycodone, much higher doses may be required (see below).
  Switching from oral oxycodone to parenteral oxycodone:

The dose should be determined considering that 2 mg of oral oxycodone are equivalent to 1 mg of parenteral oxycodone. It should be emphasized that this is only a guideline for the required dose. Inter-patient variability requires that the appropriate dose be carefully titrated for each individual patient.
Elderly:
It is recommended to administer the lowest dose with careful titration for pain control.
Patients with renal or hepatic impairment:
For these patients, initial dose determination should follow a conservative approach.
The recommended initial dose for adults should be reduced by 50% (e.g., a total daily oral dose of 10 mg in opioid-naïve patients), and the dose for each patient should be adjusted to achieve adequate pain control based on individual clinical circumstances.
Paediatric population:
There are no data on the use of injectable oxycodone solution in patients under 18 years of age.
Use in non-malignant pain:
Opioids are not first-line therapy for chronic non-malignant pain and are not recommended as sole treatment. Strong opioids have proven useful in relieving the following types of chronic pain: chronic osteoarthritic pain and pain due to intervertebral disc disease.
Method of administration
Subcutaneous injection or infusion.
Intravenous injection or infusion.
Objectives and discontinuation of treatment
Before initiating oxycodone treatment, a treatment strategy including duration, treatment goals, and a plan for discontinuation should be agreed upon with the patient and in accordance with pain management guidelines. During treatment, frequent contact between physician and patient is required to assess the need for continuing therapy, consider discontinuation, and adjust dosage if necessary. When a patient no longer requires oxycodone therapy, it is advisable to gradually reduce the dose to prevent withdrawal symptoms. In the absence of adequate pain control, the possibility of hyperalgesia, tolerance, and progression of the underlying disease should be considered (see section 4.4 of the Summary of Product Characteristics).
Duration of treatment
Oxycodone should not be used longer than necessary.
Special precautions for disposal and handling
The vial is single-use for a single patient only. The injection should be administered immediately after opening the vial; any unused residue must be discarded. Chemical and physical stability during use has been demonstrated for 24 hours at 15–25 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8 °C, unless reconstitution, dilution, etc., have been carried out under controlled and validated aseptic conditions.
Injectable oxycodone solution, undiluted or diluted to 1 mg/ml with 0.9% w/v sodium chloride solution, 5% w/v dextrose solution, or water for injections, is physically and chemically stable for more than 24 hours at room temperature when in contact with polypropylene or polycarbonate syringes, polyethylene or PVC tubing, and PVC or EVA infusion bags. Injectable oxycodone solution, undiluted or diluted to 1 mg/ml in infusion fluids and in contact with the various materials used in the studies, does not require protection from light.
Inappropriate handling of the undiluted solution after opening the original vial, or of diluted solutions, may compromise the sterility of the product.
Refer to the Summary of Product Characteristics for further information.