Package leaflet: Information for the user

Oxycodone Molteni, 50 mg/ml, solution for injection / for infusion
Oxycodoni hydrochloridum
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 further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Oxycodone is and what it is used for
What you need to know before using Oxycodone
How to use Oxycodone
Possible side effects
How to store Oxycodone
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, the shorter name "Oxycodone" is used. The medicine contains the active substance oxycodone hydrochloride. It belongs to a group of medicines called painkillers (or "analgesics").
Oxycodone is used to treat moderate to severe pain.

2. Important information before using Oxycodone

When not to use Oxycodone:

if the patient is allergic to oxycodone or any of the other ingredients of this medicine (listed in section 6)
when the patient has breathing problems such as: severe chronic obstructive pulmonary disease, severe bronchial asthma, or severe respiratory depression, especially if the patient experiences shortness of breath, coughing, or slow or shallow breathing
in case of patient conditions such as severe abdominal pain or intestinal dysfunction (ileus)
in patients with heart problems caused by long-term lung disease (cor pulmonale)
in patients with moderate or severe liver impairment
in patients who frequently suffer from constipation
in patients under 18 years of age. Do not use Oxycodone if any of the above conditions apply. If in doubt, consult a doctor, pharmacist, or nurse before using Oxycodone.

Warnings and precautions
Before starting treatment, discuss with your doctor, pharmacist, or nurse if the patient:

is elderly or frail
has hypothyroidism (hypothyreosis) – a dose reduction may be necessary
has myxoedema (a thyroid disorder characterized by dry, cold, and swollen [puffy] skin on the face and limbs)
has sustained a head injury, has severe headaches, or feels unwell – these may be signs of increased intracranial pressure
has low blood volume (hypovolemia); this may occur due to severe external or internal bleeding, severe burns, excessive sweating, severe diarrhoea, or vomiting
has low blood pressure (hypotension)
has mental disturbances due to poisoning (toxic psychosis)
has gallbladder or biliary tract problems
has pancreatitis (which causes severe abdominal and back pain)
has inflammatory bowel diseases
has prostate problems
experiences weakness, dizziness, nausea, vomiting, or weight loss – these may be symptoms of adrenal insufficiency
has breathing problems, such as severe lung disease, with shortness of breath and cough
has previously experienced withdrawal symptoms such as restlessness or anxiety, tremors, or sweating when stopping alcohol or narcotic use
has kidney problems
has liver problems. If any of the above conditions apply (or if the patient is uncertain), consult a doctor, pharmacist, or nurse before using Oxycodone. Contact a doctor if the patient develops severe upper abdominal pain radiating to the back, nausea, vomiting, or fever, as these may be symptoms of pancreatitis or biliary tract disorders.

Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid. It may lead to dependence and/or addiction.
This medicine contains oxycodone, an opioid analgesic. Repeated use of opioid painkillers may lead to reduced effectiveness of the medicine (the patient's body becomes accustomed to it, known as tolerance).
Repeated use of Oxycodone may lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these adverse effects may be higher when higher doses are used over a prolonged period.
Dependence or addiction may cause the patient to lose control over how much medicine to take or how often to take it. The patient may feel a need to take the medicine even if it is not relieving pain.
The risk of dependence or addiction varies among individuals. The risk of addiction or dependence on Oxycodone may be higher if:

the patient or a family member has ever abused or been dependent on alcohol, prescription medicines, or drugs ("addiction");
the patient is a smoker;
the patient has ever had mood disorders (depression, anxiety, or personality disorder) or has been treated by a psychiatrist for other mental disorders. If the patient notices any of the following symptoms while taking Oxycodone, it may indicate developing dependence or addiction:
need to take the medicine longer than prescribed by the doctor;
need to take a higher dose than recommended;
use of the medicine for reasons other than prescribed, e.g., "to calm down" or "to help fall asleep";
repeated unsuccessful attempts to stop or reduce medicine use;
feeling unwell after stopping the medicine and improvement after restarting it ("withdrawal effect"). If the patient observes any of these symptoms, they should contact their doctor to discuss the best treatment plan, including the appropriate timing and safe way to discontinue treatment (see section 3 "Stopping Oxycodone treatment").

Sleep-related breathing disorders
Oxycodone may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and nocturnal hypoxemia (low blood oxygen levels during sleep).
Symptoms may include breathing pauses during sleep, waking up at night due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else notices such symptoms, contact a doctor. The doctor may consider reducing the dose.

Children and adolescents
This medicine should not be used in individuals under 18 years of age.

Oxycodone and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including herbal medicines, as Oxycodone may affect the action of other medicines, and some other medicines may affect how Oxycodone works.
Concomitant use of Oxycodone Molteni and sedative medicines such as benzodiazepines or similar drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered if no other treatment options are available.
If a doctor prescribes Oxycodone Molteni together with sedative medicines, the doctor should also limit the dose and duration of combined treatment.
Inform the doctor about all sedative medicines the patient is taking and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members so they are aware of the possible signs and symptoms listed above. If any of the above symptoms occur, contact a doctor.
The risk of adverse effects increases if the patient is taking antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, causing the following symptoms in the patient: involuntary rhythmic muscle contractions, including muscles controlling eye movements, restlessness, excessive sweating, tremors, increased reflexes, increased muscle tension, and elevated body temperature above 38°C. If any of these symptoms occur, contact a doctor.

Do not take this medicine and inform your doctor or pharmacist if you are taking:

a type of medicine known as a "monoamine oxidase inhibitor" (MAOI), such as tranylcypromine, phenelzine, isocarboxazid, moclobemide, or linezolid.

Inform your doctor or pharmacist if you are taking:

medicines known as monoamine oxidase inhibitors or if you have taken such medicines within the last two weeks
medicines to help you sleep, such as sedatives or hypnotics, including benzodiazepines
antidepressant medicines
medicines used for mental health problems, such as phenothiazines or neuroleptics
other strong painkillers or "analgesics"
muscle relaxants
medicines for high blood pressure
medicines used for infections, such as clarithromycin, erythromycin, or telithromycin
antifungal medicines, such as ketoconazole, voriconazole, itraconazole, or posaconazole
a type of medicine used for HIV called "protease inhibitors", such as boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir
rifampicin (used in the treatment of tuberculosis)
carbamazepine (a medicine used to treat seizures, epilepsy, or certain pain syndromes)
phenytoin (a medicine used to treat epilepsy, seizures, or convulsions)
cimetidine, used to treat peptic ulcer disease, indigestion, or heartburn
quinidine, used for fast heart rate
anaesthetics used before surgery or medical procedures
the herbal substance St. John's wort (also known as Hypericum perforatum)
antihistamines
medicines used to treat Parkinson's disease. If any of the above conditions apply (or if the patient is uncertain), consult a doctor, pharmacist, or nurse before using Oxycodone.

Oxycodone with food, drink, and alcohol

Do not drink grapefruit juice during treatment with Oxycodone.
Do not drink alcohol during treatment with Oxycodone, as it may cause drowsiness or increase the risk of serious adverse effects such as shallow breathing, risk of respiratory arrest, and loss of consciousness.

Pregnancy and breastfeeding
Pregnancy
Do not use this medicine during pregnancy unless your doctor has specifically advised it. This medicine should not be used during childbirth, as it may cause slow and shallow breathing (respiratory depression) or withdrawal symptoms in the newborn.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Breastfeeding
Do not breastfeed while taking Oxycodone, as this medicine may pass into breast milk.

Driving and using machines
The patient may feel drowsy or experience other adverse effects such as weakness, dizziness, or fainting while taking Oxycodone. These effects are more likely at the beginning of treatment or when the dose is increased. In such cases, do not drive or operate tools or machinery.

Oxycodone contains sodium
Oxycodone Molteni contains less than 1 mmol of sodium (23 mg) per vial, meaning the medicine is considered "sodium-free".

3. How to use Oxycodone

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

Oxycodone is usually administered by a doctor or nurse. The solution should be used immediately after opening.

How to use the medicine

The solution may be given in 3 ways:

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

Recommended dose

Your doctor will determine the appropriate dose for you. The dose and frequency may be adjusted depending on your level of pain. The usual starting dose generally depends on the route of administration – your doctor will decide the route. The usual starting doses are as follows:

single intravenous injection – usually 1 to 10 mg administered slowly over 1 to 2 minutes. Subsequent single doses should be given at intervals of at least 4 hours
single subcutaneous injection using a fine needle – the recommended starting dose is 5 mg. Subsequent single doses should be given at 4-hour intervals
as an infusion (drip):
- intravenous infusion – the usual starting dose is 2 mg per hour
- subcutaneous infusion using a fine needle – the usual starting dose is 7.5 mg per day
patient-controlled infusion (patient-controlled analgesia, PCA) – the dose depends on the patient's body weight (0.03 mg per kg body weight). Your doctor or nurse will determine the frequency of dosing.

If pain persists while taking Oxycodone, consult your doctor or pharmacist.

Children and adolescents

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

Patients with kidney or liver problems

If you have any kidney or liver problems, consult your doctor or pharmacist, as you may require a different medicine or a lower dose of Oxycodone.

Taking more than the recommended dose of Oxycodone, or giving the medicine to someone else

Do not take more Oxycodone than prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

If you think you have taken too much (overdose), contact your doctor or go immediately to hospital. Take the medicine pack with you. Do not drive or operate machinery requiring concentration.

Symptoms of overdose may include:

constricted pupils
slower or shallower breathing than usual (respiratory depression)
drowsiness or fainting
reduced muscle tone (hypotonia)
slower heart rate
low blood pressure
brain disorders (known as toxic leukoencephalopathy). In some severe cases, overdose may lead to unconsciousness or death.

Stopping Oxycodone

Unless otherwise advised by your doctor, do not stop taking Oxycodone suddenly.

If you wish to discontinue the medicine, consult your doctor first. Your doctor will determine how to stop treatment. The dose should be reduced gradually to avoid withdrawal symptoms.

If treatment is stopped abruptly, the following symptoms may occur:

feeling agitated or anxious
rapid heartbeat
tremor
sweating.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Discontinue use of Oxycodone and contact your doctor immediately if any of the following adverse reactions occur:

Allergic reactions – symptoms may include sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching – symptoms may affect the whole body
Breathing problems – symptoms may include slower or shallower breathing

Discontinue use of Oxycodone and contact your doctor immediately if any of the above adverse reactions occur.

Other adverse reactions
If any of the following adverse reactions occur, contact your doctor or nurse:
Very common: may affect more than 1 in 10 patients

Constipation – your doctor may prescribe appropriate medicines to help you
Nausea, vomiting – these symptoms usually resolve within a few days. If they persist, your doctor may prescribe appropriate medicines to help you
Drowsiness – most commonly occurs when starting treatment or after a dose increase, but symptoms should resolve within a few days
Headache
Dizziness
Itching of the skin

Common: may affect from 1 to 10 in 100 patients

Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea
Confusion, depression, feeling weak, tremor, lack of energy, fatigue, restlessness or nervousness, sleep disturbances, abnormal thinking or vivid dreams
Difficulty breathing or wheezing, feeling short of breath, difficulty coughing properly
Rash
Sweating

Uncommon: may affect more than 1 in 100 patients

Allergic reactions
Breathing difficulties
Fast or irregular heartbeat, flushing
Feeling of spinning (vertigo)
Seeing or hearing things that are not real (hallucinations), mood changes, unpleasant or disturbed mood, feeling of euphoria, feeling anxious, agitation or general malaise, memory loss
Difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness in hands and feet, seizures, visual disturbances, fainting, unusual muscle stiffness or floppiness, involuntary muscle contractions
Dry skin, severe peeling or shedding of the skin
Dehydration, feeling thirsty, chills, swelling of hands, ankles or feet
Flushing of the face, constricted pupils in the eyes, muscle cramps, high body temperature
Difficulty swallowing, belching, hiccups, gas, a condition in which the bowel does not work properly (intestinal obstruction), stomach problems, changes in taste sensation
Difficulty passing urine, problems achieving erection, reduced sex drive, low levels of sex hormones in the blood (‘hypogonadism’, detected in blood tests)
Needing to use a higher dose of the medicine than normal to achieve the same level of pain relief (tolerance) – as with all other strong painkillers, there is a risk of dependence or development of tolerance to the medicine, withdrawal symptoms (see section 2, “Warnings and precautions”)
Changes in liver function test results, biliary colic

Rare: may affect 1 in 1,000 people

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 menstruation
Blockage in the flow of bile from the liver (cholestasis). This may cause itching of the skin, yellowing of the skin, very dark urine and very pale stools
A disorder affecting the valve in the intestines, which may cause severe pain in the upper abdomen (Oddi sphincter dysfunction)
Prolonged use of Oxycodone Molteni during pregnancy may cause life-threatening withdrawal symptoms in newborn babies. Symptoms to watch for in the baby include: irritability, hyperactivity and sleep disturbances, high-pitched crying, tremors, diarrhoea and failure to gain weight
Sleep apnoea (pauses in breathing during sleep)

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, speak to your doctor or pharmacist.

Reporting of adverse reactions
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Oxycodone

Keep this medicine out of the sight and reach of children. This medicine must be stored in a closed and secure place inaccessible to others. It may be highly harmful and may cause death in a person for whom it has not been prescribed. Do not use this medicine after the expiry date stated on the carton and vial after: EXP.
This medicine does not require any special storage conditions. Store in the original packaging to protect from light. After opening the vial, the solution should be used immediately. Any unused medicine must be immediately discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the Package and Other Information

What Oxycodone contains

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

What Oxycodone Molteni looks like and contents of the pack
Oxycodone is a clear, colourless solution contained in transparent glass ampoules.
The 50 mg/ml strength is available as a solution in 1 ml ampoules (containing 50 mg of oxycodone hydrochloride).

Marketing Authorisation 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 medicinal product is authorised 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

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Oxycodone molteni