Oxicodone Molteni

Package Leaflet: Information for the User

Oxycodone Molteni, 50 mg/ml, Solution for Injection/Infusion

Oxycodone Hydrochloride

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• 4.

Contents of the Pack and Other Information

• 1. What Oxycodone is and What It is Used For
• 2. 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 the medicine is Oxycodone Molteni. In this leaflet, it will be referred to as Oxycodone. The medicine contains the active substance oxycodone hydrochloride. It belongs to a group of medicines called painkillers (or "analgesics"). Oxycodone is used for the treatment of moderate to severe pain.

2. Before You Use Oxycodone

When You Should Not Use Oxycodone:

• if you are allergic to oxycodone or any of the other ingredients of this medicine (listed in section 6)
• if you have breathing problems, such as severe chronic obstructive pulmonary disease, severe asthma, or severe respiratory depression, and you are not being monitored
• if you have a condition where the small intestine does not work properly (paralytic ileus)
• if you have severe abdominal pain
• if you have heart problems caused by long-term lung disease (cor pulmonale)
• if you have moderate or severe liver problems
• if you have a history of epilepsy or are prone to seizures
• if you are under 18 years old. Do not use Oxycodone if any of the above applies to you. If you are in any doubt, consult your doctor, pharmacist, or nurse before using Oxycodone.

Warnings and Precautions

Before starting treatment with Oxycodone, you should discuss it with your doctor, pharmacist, or nurse if:

• you are elderly or frail
• you have hypothyroidism (an underactive thyroid gland) - your dose may need to be reduced
• you have myxoedema (a condition where the skin and mucous membranes become swollen)
• you have had a head injury, have severe headaches, or feel unwell - this may indicate raised pressure within the skull
• you have low blood volume (hypovolemia) - this can happen if you have severe external or internal bleeding, severe burns, excessive sweating, severe diarrhea, or vomiting
• you have low blood pressure
• you have mental disorders caused by intoxication (toxic psychosis)
• you have problems with your gallbladder or bile duct
• you have pancreatitis (inflammation of the pancreas, which causes severe abdominal and back pain)
• you have inflammatory bowel disease
• you have prostate problems
• you feel weak, dizzy, or have nausea, vomiting, or weight loss - these could be signs of adrenal insufficiency
• you have breathing problems, such as severe lung disease, and you experience shortness of breath with coughing
• you have a history of withdrawal symptoms when stopping drinking alcohol or using drugs
• you have kidney problems
• you have liver problems. If any of the above applies to you, or if you are in any doubt, consult your doctor, pharmacist, or nurse before using Oxycodone.

Tolerance, Dependence, and AddictionThis medicine contains oxycodone, which is an opioid. It can cause dependence and (or) addiction. Repeated use of opioid painkillers may lead to tolerance, so that you need higher doses to achieve the same level of pain relief. Repeated use of Oxycodone can lead to dependence, abuse, and addiction, which can be life-threatening. The risk of these side effects may be greater if you use higher doses or for longer than recommended. Dependence or addiction can mean that you cannot control how much of the medicine you use or how often you use it. You may feel a need to use the medicine even when it is no longer needed for pain relief. If you notice any of the following signs, it could mean that you are becoming dependent on or addicted to Oxycodone:

• needing to use the medicine for longer than your doctor told you
• needing to use more of the medicine than your doctor told you
• using the medicine for reasons other than those for which it was prescribed, such as to feel good or to help you sleep
• trying many times to stop or cut down using the medicine but being unable to
• feeling unwell or getting withdrawal symptoms when you try to stop using the medicine (see section 3 "How to stop using Oxycodone").

Sleep-Related Breathing DifficultiesOxycodone may cause sleep-related breathing difficulties, such as sleep apnea (pauses in breathing during sleep) and hypoxemia during sleep (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up during the night feeling short of breath, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, you should contact your doctor. Your doctor may consider reducing your dose.

Children and Adolescents

Oxycodone should not be used in children and adolescents under 18 years of age.

Interactions with Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, or might take, including those you have bought without a prescription, such as herbal medicines. Oxycodone may interact with other medicines, and other medicines may interact with Oxycodone. Concomitant use of Oxycodone and sedatives, such as benzodiazepines or similar 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 other treatment options are not possible.

Food, Drink, and Alcohol

• Do not drink grapefruit juice while taking Oxycodone.
• Do not drink alcohol while taking Oxycodone, as this may increase the risk of serious side effects, such as drowsiness, and can lead to life-threatening breathing difficulties and loss of consciousness.

Pregnancy and Breastfeeding

Pregnancy

Oxycodone should not be used during pregnancy unless your doctor considers it essential. Do not use Oxycodone during labor, as it may cause slow or shallow breathing (respiratory depression) or withdrawal symptoms in the newborn. If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Oxycodone.

Breastfeeding

Oxycodone should not be used during breastfeeding, as it may pass into breast milk.

Driving and Using Machines

Oxycodone may cause drowsiness, dizziness, or other side effects that can affect your ability to drive or use machines. Do not drive or operate machinery if you are affected.

Oxycodone Contains Sodium

Oxycodone Molteni contains less than 1 mmol of sodium per ampoule, which is essentially "sodium-free".

3. How to Use Oxycodone

Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect when using Oxycodone, when and how to use it, when to contact your doctor, and when to stop using it (see also "How to stop using Oxycodone"). Oxycodone is usually given by a doctor or nurse. The solution should be used immediately after opening.

How to Use Oxycodone

The solution can be given in three ways:

• intravenously over 1 to 2 minutes
• subcutaneously using a needle
• as an infusion (drip).

Recommended Dose

Your doctor will decide the correct dose for you, depending on the severity of your pain. The dose and frequency of administration may be adjusted according to your pain level. The usual starting dose depends on the method of administration - your doctor will decide this. Usual starting doses are as follows:

• single intravenous injection - usually 1 to 10 mg given slowly over 1 to 2 minutes. Further single doses should be given at intervals of not less than 4 hours
• single subcutaneous injection - the recommended starting dose is 5 mg. Further single doses should be given at intervals of not less than 4 hours
• intravenous infusion - the usual starting dose is 2 mg given over 1 hour
• subcutaneous infusion - the usual starting dose is 7.5 mg per day
• patient-controlled analgesia (PCA) - the dose is based on body weight (0.03 mg per kg body weight). Your doctor or nurse will decide the frequency of administration for you.

If you experience inadequate pain relief after using Oxycodone, you should contact your doctor or pharmacist.

Children and Adolescents

Oxycodone should not be used in children and adolescents under 18 years of age.

Patients with Kidney or Liver Problems

If you have kidney or liver problems, you should consult your doctor or pharmacist, as you may need a different dose or a different medicine.

Using More Than the Recommended Dose or Using the Medicine for Longer Than Recommended

Do not use more Oxycodone than your doctor has told you. If you think you have used too much Oxycodone (overdose), you should contact your doctor or go to the hospital immediately. Take the medicine pack with you. Do not drive or operate machinery. Symptoms of overdose may include:

• pupil constriction
• slow or shallow breathing (respiratory depression)
• feeling drowsy or fainting
• low blood pressure
• slow heart rate
• low blood pressure
• brain disorders (toxic leukoencephalopathy). In severe cases, overdose can lead to loss of consciousness or even death.

How to Stop Using Oxycodone

Unless your doctor has told you to, do not suddenly stop using Oxycodone. If you want to stop using Oxycodone, you should discuss this with your doctor first. Your doctor will advise you on how to stop using Oxycodone gradually, to avoid withdrawal symptoms. If you stop using Oxycodone suddenly, you may experience withdrawal symptoms, such as:

• feeling anxious or restless
• palpitations
• shaking
• sweating.

If you have any further questions about using Oxycodone, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Oxycodone can cause side effects, although not everybody gets them.

Severe Side Effects

Stop using Oxycodone and contact your doctor immediately if you experience any of the following severe side effects:

• allergic reactions - symptoms may include sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching - these can affect the whole body
• breathing problems - symptoms may include slow or shallow breathing

Other Side Effects

If you experience any of the following side effects, you should contact your doctor or nurse:

Very Common:may affect more than 1 in 10 people

• constipation - your doctor may prescribe a laxative to help
• nausea, vomiting - these symptoms should usually go away after a few days. If they do not, your doctor may prescribe a medicine to help
• feeling drowsy - this is most common when you start using Oxycodone or when your dose is increased, but it should wear off after a few days
• headache
• dizziness
• itching .

Common:may affect up to 1 in 10 people

• dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhea
• confusion, depression, feeling weak, shaking, lack of energy, tiredness, anxiety, or nervousness, sleep disturbances, abnormal thinking or dreams
• breathing difficulties or wheezing, feeling short of breath, coughing difficulties
• rash
• sweating.

Uncommon:may affect up to 1 in 100 people

• allergic reactions
• breathing difficulties
• fast or irregular heartbeats, flushing
• feeling dizzy or faint
• seeing or hearing things that are not there (hallucinations), mood changes, feeling unpleasant or disturbed, feeling elated, feeling anxious or agitated, restlessness, or general feeling of being unwell, memory loss
• difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness in hands and feet, seizures, vision disturbances, fainting, unusual stiffness or floppiness of muscles, involuntary muscle contractions
• dry skin, severe peeling or shedding of skin
• dehydration, feeling thirsty, shivering, swelling of hands, ankles, or feet
• flushing of the face, constriction of the pupils, muscle spasms, high body temperature
• difficulty swallowing, hiccup, gas, a condition where the bowel does not work properly (ileus), stomach problems, changes in taste
• difficulty urinating, problems getting an erection, reduced sex drive, low levels of sex hormones in the blood (hypogonadism, as shown by blood tests)
• need for higher doses of Oxycodone to achieve the same level of pain relief (tolerance) - as with all strong painkillers, there is a risk of dependence and tolerance, withdrawal symptoms (see section 2 "Warnings and precautions")
• changes in liver function tests, gallstones.

Rare:may affect up to 1 in 1,000 people

• low blood pressure
• feeling faint or dizzy, especially when standing up
• hives (nettle rash).

Unknown Frequency:frequency cannot be estimated from the available data

• increased sensitivity to pain
• aggression
• tooth decay
• absence of menstrual periods
• blockage of the flow of bile from the liver (cholestasis). This can cause itching, yellowing of the skin, dark urine, and pale stools
• a condition affecting the valve in the intestines, which can cause severe abdominal pain (dysfunction of the sphincter of Oddi)
• sleep apnea (pauses in breathing during sleep). If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Reporting 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 national reporting system listed in the "Further information" section. 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 in a locked cupboard or other secure place, where other people cannot get to it. It can be very harmful and may cause death if taken by someone for whom it has not been prescribed. Do not use Oxycodone after the expiry date stated on the carton and ampoule label after EXP. Store in the original packaging to protect from light. After opening the ampoule, use the solution immediately. Dispose of any unused solution immediately. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Oxycodone Contains

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

What Oxycodone Looks Like and Contents of the Pack

Oxycodone is a clear, colorless solution in transparent glass ampoules. Oxycodone 50 mg/ml is available as a solution in 1 ml ampoules (containing 50 mg oxycodone hydrochloride).

Marketing Authorization Holder and Manufacturer

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. Strada Statale 67, Fraz. Granatieri 50018 Scandicci (Firenze), Italy Tel: +3905573611 Fax: +39055720057 e-mail: [email protected]

This Medicine is Authorized in the Member States of the European Economic Area Under the Following Names:

Poland: Oxycodone Molteni United Kingdom: Oxycodone Molteni France: Oxycodone Molteni Italy: Ossicodone Molteni Date of Last Revision of the Leaflet: 02/2025

Information for Healthcare Professionals

Oxycodone Molteni, 50 mg/ml, Solution for Injection/Infusion

Oxycodone HydrochlorideThis leaflet provides specialized information for healthcare professionals about Oxycodone Molteni, 50 mg/ml, Solution for Injection/Infusion.

Dosage and Administration

Dosage:The dosage should be adjusted according to the severity of the pain and the individual patient's response and current or previous opioid use. Adults Over 18 Years:The following starting doses are recommended for patients not previously treated with opioids. The initial dose should be adjusted according to previous or concurrent opioid use, overall patient condition, and severity of pain. If analgesic response is inadequate, or if pain severity increases, the dose may be increased.

• iv.(bolus): The medicine should be diluted with sodium chloride 0.9% solution, dextrose 5% solution, or water for injections. A single dose of 1 to 10 mg should be given slowly over 1 to 2 minutes in patients not previously treated with opioids. Doses should not be given more frequently than every 4 hours.
• iv. (infusion): The medicine should be diluted with sodium chloride 0.9% solution, dextrose 5% solution, or water for injections. The recommended starting dose is 2 mg per hour in patients not previously treated with opioids.
• iv. (PCA): The medicine should be diluted with sodium chloride 0.9% solution, dextrose 5% solution, or water for injections. A dose of 0.03 mg per kg body weight should be given as a bolus, with a minimum lockout interval of 5 minutes in patients not previously treated with opioids.
• sc. (bolus): The medicine should be diluted with sodium chloride 0.9% solution, dextrose 5% solution, or water for injections. The recommended starting dose is 5 mg, given at intervals of not less than 4 hours, as needed, in patients not previously treated with opioids.
• sc. (infusion): If necessary, the medicine should be diluted with sodium chloride 0.9% solution, dextrose 5% solution, or water for injections. The recommended starting dose is 7.5 mg per day, with gradual titration according to symptom control. Patients with cancer who are being switched from oral oxycodone to parenteral oxycodone may require much higher doses (see below).

Switching from Oral Oxycodone to Parenteral Oxycodone:The dose should be based on the following ratio: 2 mg oral oxycodone is equivalent to 1 mg parenteral oxycodone. It should be noted that this is a recommended starting dose. Individual differences require careful dose titration for each patient. Elderly:Oxycodone should be used with caution in elderly patients. The lowest dose should be used with careful titration to achieve pain control. Patients with Renal or Hepatic Impairment:The starting dose should be used with caution in these patients. The recommended starting dose for adults should be reduced by 50% (e.g., total daily dose of 10 mg orally in patients not previously exposed to opioids), and each patient should have their dose carefully titrated to achieve adequate pain control, according to their clinical condition. Pediatric Population:There are no data on the use of oxycodone injection in patients under 18 years of age. Chronic Non-Malignant Pain:Opioids are not the first-line treatment for chronic non-malignant pain. They are not recommended as the only treatment for chronic pain. Chronic pain that can be relieved by strong opioids includes chronic inflammatory pain and degenerative disc disease. Route of Administration:Subcutaneous injection or infusion. Intravenous injection or infusion. Treatment Goals and Discontinuation:Before starting treatment with Oxycodone, a treatment strategy should be agreed upon with the patient, including the treatment goals, duration of treatment, and plan for discontinuation, in accordance with pain treatment guidelines. During treatment, the doctor should have regular contact with the patient to assess the need for continued treatment, consider discontinuation, and adjust the dose as needed. When the patient no longer requires opioid treatment, it is recommended to gradually reduce the dose to prevent withdrawal symptoms. If adequate pain relief is not achieved, consideration should be given to the possibility of hyperalgesia, tolerance, and progression of the underlying disease (see section 4.4 of the Summary of Product Characteristics). Duration of TreatmentOxycodone should not be used for longer than necessary.

Instructions for Use/Handling

Each ampoule is for single use in one patient only. The medicine should be used immediately after opening the ampoule, and any unused solution should be discarded. Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (15-25°C). 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 has been carried out in controlled and validated aseptic conditions. Oxycodone 50 mg/ml, undiluted or diluted to 3 mg/ml with sodium chloride 0.9% solution, dextrose 5% solution, or water for injections, is physically and chemically stable for 24 hours at room temperature when stored in polypropylene or polyethylene syringes, polyethylene or PVC tubing, or PVC or EVA infusion bags. Oxycodone 50 mg/ml, undiluted or diluted to 3 mg/ml in infusion fluids used in the studies, and stored in various administration sets, does not need to be protected from light. Improper handling of the undiluted solution after opening the original ampoule, or of the diluted solutions, may compromise the sterility of the product. Further information can be found in the Summary of Product Characteristics.

Date of Last Revision of the Leaflet: 02/2025