Oxycodone molteni: detailed information

Patient Information Leaflet

Oxycodone Molteni, 10 mg/ml, solution for injection/infusion
Oxycodoni hydrochloridum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

Keep this leaflet, as 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 a specific individual. 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, tell your doctor, pharmacist or nurse. See section 4.

Leaflet Contents

What Oxycodone is and what it is used for
What you need to know before you are given Oxycodone
How Oxycodone is given
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 problems such as severe abdominal pain or intestinal dysfunction (intestinal obstruction)
in case of 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 a doctor, pharmacist, or nurse if the patient:

is elderly or debilitated
has hypothyroidism (hypothyreosis) – dose reduction may be necessary
has myxoedema (a thyroid disorder characterized by dry, cold, and swollen [puffy] skin of 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 psychiatric disorders caused by intoxication (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, in which the patient experiences shortness of breath with cough
has previously experienced withdrawal symptoms such as agitation 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 experiences severe upper abdominal pain radiating to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis or biliary tract inflammation.

Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid. It may cause dependence and/or addiction.
This medicine contains oxycodone, which is 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, misuse, and addiction, which may result in life-threatening overdose. The risk of these adverse effects may be higher when higher doses are used for prolonged periods.
Dependence or addiction may cause the patient to lose control over how much medicine they take or how often they take it. The patient may feel a need to take the medicine even if it no longer relieves pain.
The risk of dependence or addiction varies among individuals. The risk of developing addiction or dependence on Oxycodone may be higher if:

the patient or a family member has ever misused 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 psychiatric disorders. If the patient notices any of the following symptoms while taking Oxycodone, it may indicate the development of 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 use of the medicine;
feeling unwell after stopping the medicine and improvement upon resuming use (withdrawal symptoms). 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 method of discontinuation (see section 3 "Discontinuing Oxycodone").

Sleep-related breathing disorders
Oxycodone may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and nocturnal hypoxemia (low oxygen levels in the blood during sleep).
Symptoms may include pauses in breathing 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 these symptoms, contact a doctor. The doctor may consider reducing the dose.
Children and adolescents
This medicine should not be used in patients under 18 years of age.
Oxycodone and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including herbal medicines. 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 when no alternative treatment options are available.
If a doctor prescribes Oxycodone Molteni together with sedative medicines, the doctor should also limit the dose and duration of concomitant 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 possibility of the symptoms mentioned above. If the above symptoms occur, contact a doctor.
The risk of adverse effects increases if the patient takes 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, agitation, excessive sweating, tremors, increased reflexes, increased muscle tone, and elevated body temperature above 38°C. If these symptoms occur, contact a doctor.
Do not take this medicine and inform the doctor or pharmacist if taking:

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

Inform the doctor or pharmacist if taking:

monoamine oxidase inhibitors or if the patient has taken such medicines within the last two weeks
medicines to help the patient sleep, such as sedatives or hypnotics, including benzodiazepines
antidepressants
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 in the treatment of 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 in the treatment of 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 with risk of respiratory arrest and loss of consciousness.

Pregnancy and breastfeeding
Pregnancy
Do not use this medicine during pregnancy unless otherwise advised by a doctor. 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 child, she should consult a doctor or pharmacist before using this medicine.
Breastfeeding
Do not breastfeed while taking Oxycodone, as the medicine may pass into breast milk.
Driving and operating machinery
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, 10 mg/ml – 1 ml ampoule contains less than 1 mmol (23 mg) of sodium per ampoule, meaning the medicine is considered "sodium-free".
Oxycodone Molteni, 10 mg/ml – 2 ml ampoule contains less than 1 mmol (23 mg) of sodium per ampoule, meaning the medicine is considered "sodium-free".
Oxycodone Molteni, 10 mg/ml – 20 ml ampoule contains 57.0 mg of sodium (main component of table salt) per ampoule. This corresponds to 2.85% of the maximum recommended daily dietary sodium intake for adults.

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 can 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 depends on the route of administration – the route is determined by your doctor.
Typical 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 administered 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 administered 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 dosing frequency for you.

If pain persists during treatment with 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 it may be necessary to use a different medicine or a lower dose of Oxycodone.

Taking more than the recommended dose of Oxycodone, or using the medicine by another person
Do not take more Oxycodone than prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
If you suspect that too high a dose has been taken (overdose), contact your doctor or go directly to hospital.
Take the medicine packaging with you. Do not drive or perform activities requiring concentration.
If too high a dose is taken, the following symptoms may occur:

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

Stopping Oxycodone
Unless otherwise directed by your doctor, do not stop taking Oxycodone suddenly.
If you wish to stop taking the medicine, consult your doctor first. Your doctor will determine the appropriate way to discontinue 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
You must stop taking Oxycodone and contact your doctor immediately if any of the following adverse effects 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.

You must stop taking Oxycodone and contact your doctor immediately if any of the above adverse effects occur.
Other adverse effects
If any of the following adverse effects occur, contact your doctor or nurse:
Very common: may affect more than 1 in 10 people

constipation – your doctor may prescribe appropriate medicines to help you
nausea, vomiting – these symptoms should 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 increasing the dose, but symptoms should resolve within a few days
headache
dizziness
itching of the skin.

Common: may affect 1 to 10 people in 100

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 breathless, difficulty coughing effectively
rash
sweating.

Uncommon: may affect more than 1 in 100 people

allergic reactions
breathing difficulties
fast or irregular heartbeat, flushing
sensation of spinning, 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 weakness, involuntary muscle contractions
dry skin, severe peeling or shedding of skin
dehydration, feeling thirsty, chills, swelling of hands, ankles or feet
flushing of the face, pinpoint pupils in the eyes, muscle cramps, high body temperature
difficulty swallowing, belching, hiccups, gas, condition in which the intestine does not function properly (intestinal obstruction), stomach problems, changes in taste sensation
difficulty passing urine, problems achieving erection, decreased sex drive, low levels of sex hormones in the blood (‘hypogonadism’, detected in blood tests)
need to use a higher dose of 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
urticaria (hives).

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
disorder affecting the valve in the intestine, which may cause severe upper abdominal pain (Oddi sphincter dysfunction)
prolonged use of Oxycodone Molteni during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to look out for in the child include:

irritability, hyperactivity and sleep disturbances, high-pitched crying, tremor, diarrhoea and failure to gain weight

sleep apnoea (pauses in breathing during sleep). If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult your doctor or pharmacist.

Reporting of adverse effects
If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring 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 effects can also be reported to the marketing authorisation holder. By reporting adverse effects, additional information on the safety of the medicine can be collected.

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, as 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 special storage conditions. Store in the original packaging to protect from light. After opening the vial, the solution should be used immediately. Any unused portion of the medicine must be discarded immediately.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging 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.

Oxycodone Molteni contains a substance with a known effect (sodium). See section 2.
What Oxycodone Molteni looks like and contents of the pack
The medicine is a clear, colourless solution contained in transparent glass ampoules.
The 10 mg/ml strength is available as a solution in ampoules of 1 ml, 2 ml or 20 ml (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 S.p.A.
Strada Statale 67, Fraz. Granatieri 50018
Scandicci (Firenze), Italy
Tel: +3905573611
Fax: +39055720057
e-mail: [email protected]
This medicine is authorised for sale in the European Economic Area countries
under the following names:
Poland: Oxycodone Molteni
United Kingdom: Oxycodone Molteni
France: Oxycodone Molteni
Italy: Ossicodone Molteni
 --------------------------------------------------------------------------------------------------------------------------------
Information for Medical Personnel
Oxycodone Molteni, 10 mg/ml, solution for injection / for infusion
Oxycodoni hydrochloridum
This leaflet provides information for medical personnel on Oxycodone Molteni, 10 mg/ml, solution for injection / for infusion.
Dosage and method of administration
Dosage:
Dosage should be adjusted according to the intensity of pain and individual patient sensitivity, as well as concomitant or previous medication.
Adults over 18 years of age:
The following initial doses are recommended for patients not previously treated with opioids. The initial dose should be adjusted according to prior or concurrent treatment (particularly if the patient has previously been treated with other opioids), the patient's general condition, and the intensity of pain. If analgesic effect is insufficient or if pain intensity increases, the dose may need to be gradually increased.

iv (bolus): Dilute the solution to 1 mg/ml with 0.9% sodium chloride solution, 5% dextrose solution or water for injections. Administer a single bolus dose of 1 to 10 mg slowly over 1–2 minutes. Doses should not be administered more frequently than every 4 hours.
iv (infusion): Dilute the solution to 1 mg/ml with 0.9% sodium chloride solution, 5% dextrose solution or water for injections. Initially, a dose of 2 mg/h is recommended.
iv (PCA): Dilute the solution to 1 mg/ml with 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 refractory period of 5 minutes.
sc (bolus): Use the 10 mg/ml solution. Initial treatment is recommended to start with a 5 mg dose, repeated as needed every 4 hours.
sc (infusion): If necessary, dilute the solution with 0.9% sodium chloride solution, 5% dextrose solution or water for injections. The initial dose is 7.5 mg/day and is recommended for patients not previously treated with opioids, with gradual titration according to symptom control. Cancer patients in whom oral oxycodone has been switched to parenteral oxycodone may require significantly higher doses (see below).

Conversion from oral oxycodone to parenteral oxycodone:
The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It should be emphasized that this is the recommended required dose. Individual differences between patients require careful dose adjustment for each patient.
Elderly patients:
The lowest dose should be used with cautious dose titration to control pain.
Patients with renal or hepatic impairment:
Initial dosing should be used with caution in these patients. The recommended initial dose in adults should be reduced by 50% (e.g. total daily dose of 10 mg orally in opioid-naïve patients), and each patient should have their dose individually adjusted according to clinical status and adequate pain control.
Paediatric population:
There are no data on the use of oxycodone injection in patients below 18 years of age.
Use in chronic non-malignant pain:
Opioids are not first-line agents for chronic non-malignant pain and are not recommended as the sole treatment. Chronic pain conditions shown to respond to strong opioids include degenerative pain and degenerative disc disease.
Route of administration:
Subcutaneous injection or infusion.
Intravenous injection or infusion.
Therapeutic goals and discontinuation:
Before initiating treatment with Oxycodone, the treatment strategy, including duration and goals of therapy, and a plan for discontinuation, should be agreed upon with the patient, in accordance with pain management guidelines. During treatment, the physician should maintain regular contact with the patient to assess the need for continued therapy, consider discontinuation, and modify dosing as necessary. When the patient no longer requires oxycodone treatment, gradual dose reduction is recommended to prevent withdrawal symptoms. In case of inadequate pain control, consider the possibility of hyperalgesia, tolerance, and progression of the underlying disease (see section 4.4 of the Summary of Product Characteristics).
Duration of treatment
Oxycodone should not be used for longer than necessary.
Instructions for use/handling
Each ampoule is intended for single use in a single patient. The medicine should be administered immediately after opening the ampoule, and any unused solution should be discarded. Chemical and physical stability in use 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, the user is responsible for the storage time and conditions, which should not exceed 24 hours at 2–8°C, unless reconstitution, dilution, etc., has been carried out under controlled and validated aseptic conditions.
Oxycodone injection, either 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 in contact with representative brands of syringes made of polypropylene or polycarbonate, tubing made of polyethylene or PVC, or infusion bags made of PVC or EVA, over a period of 24 hours at room temperature.
The injection, whether undiluted or diluted to 1 mg/ml in infusion fluids used in studies and contained in various sets, does not need to be protected from light.
Improper handling of the undiluted solution after opening the original ampoule or of diluted solutions may compromise the sterility of the product.
Further information can be found in the Summary of Product Characteristics.