Oxinorm

Leaflet accompanying the packaging: patient information

OxyNorm, 10 mg/ml, solution for injection / concentrate for solution for injection / for infusion

for injection / for infusion
Oxycodone hydrochloride

You should read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What OxyNorm is and what it is used for
• 2. Important information before taking OxyNorm
• 3. How to take OxyNorm
• 4. Possible side effects
• 5. How to store OxyNorm
• 6. Contents of the packaging and other information

1. What OxyNorm is and what it is used for

OxyNorm is a strong pain-relieving medicine belonging to the opioid group.
OxyNorm is used to relieve moderate to severe pain in adults, which can only be adequately relieved by opioid pain-relieving medicines.
OxyNorm is used to treat severe pain in adults and adolescents from 12 years of age and above.

2. Important information before taking OxyNorm

When not to take OxyNorm

• If you are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• If you have severe and prolonged lung disease with breathing difficulties (severe chronic obstructive pulmonary disease, also known as COPD);
• If you have heart problems diagnosed as cor pulmonale (changes in the heart due to chronic lung disease);
• If you have severe asthma;
• If you have breathing problems, such as shallow and slow breathing (severe respiratory depression with insufficient oxygen levels and elevated carbon dioxide levels in the blood);
• If you have a condition where the intestine stops working (paralytic ileus).

Warnings and precautions

Before starting treatment with OxyNorm, you should discuss it with your doctor, pharmacist, or nurse, especially:

• in elderly or frail patients;
• in patients with severe lung disease;
• when taking MAO inhibitors or if you have taken an MAO inhibitor in the last 2 weeks; these are used to treat depression (tranylcypromine, phenelzine, isocarboxazid, moclobemide), Parkinson's disease (selegiline), and infections (linezolid);
• in patients with thyroid disease characterized by dry, cold, swollen, and thickened skin of the face, hands, and feet („myxedema”);
• in patients with insufficient thyroid hormone secretion;
• in patients with Addison's disease;
• in patients having difficulty urinating due to an enlarged prostate gland
• in patients who have been diagnosed with a mental disorder caused by alcohol or other substance abuse;
• in patients who are currently or have been addicted to opioids;
• in patients experiencing symptoms of alcohol withdrawal, such as hallucinations or tremors;
• in patients suffering from epilepsy or with a predisposition to seizures;
• in patients with head injuries associated with severe headaches or nausea, which may indicate increased intracranial pressure;
• in patients with low blood pressure;
• in patients with gallbladder problems, gallstones, or bile duct problems;
• in patients with pancreatitis, which causes severe abdominal and back pain (pancreatitis);
• in patients with inflammatory bowel disease or with obstruction;
• in patients in whom the doctor suspects intestinal obstruction;
• in patients with constipation;
• in patients with liver or kidney disease;
• in patients who abuse or are addicted to alcohol.

Respiratory depression associated with sleep
OxyNorm may cause respiratory depression associated with sleep, 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, nighttime awakenings due to shortness 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 the dose.
You should inform your doctor if the above information applies to you.
The main risk associated with opioid overdose is shallow and slow breathing (respiratory depression). This occurs most frequently in elderly and frail patients. It can also cause a decrease in oxygen levels in the blood. This can be life-threatening, e.g., lead to fainting.
During long-term use of OxyNorm, the patient may develop tolerance to the medicine and may require progressively higher doses of OxyNorm to maintain pain control. You should not increase the dose of OxyNorm without consulting your doctor.
Opioids are not the first choice for treating non-cancer pain and are not recommended as the only treatment. In the treatment of chronic pain, other medicines should be used in addition to opioids. Your doctor should closely monitor your condition and adjust the dose accordingly while taking OxyNorm to prevent addiction and abuse.
Prolonged use of OxyNorm may lead to physical dependence. In case of sudden discontinuation of treatment, withdrawal symptoms may occur, including: yawning, pupil dilation, lacrimation, rhinorrhea, tremors, sweating, anxiety, and restlessness, seizures, difficulty sleeping, and muscle pain. If continued treatment with OxyNorm is no longer necessary, it is recommended to gradually reduce the dose to prevent these symptoms.
Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid pain-relieving medicines can lead to decreased efficacy of the medicine (the patient's body gets used to it, which is called tolerance). Repeated use of OxyNorm may lead to dependence, abuse, and addiction, which can lead to life-threatening overdose.
The risk of these side effects may be higher when using higher doses for longer periods.
Dependence or abuse may cause the patient to feel that they have lost control over the dose they take or how often they take it. The patient may feel that they need to continue taking the medicine, even if it no longer relieves pain.
The risk of dependence on OxyNorm may be higher if:

• you or a family member have ever abused or been addicted to alcohol, prescription medicines, or illegal substances (addiction);
• you smoke;
• you have ever had mood disorders (depression, anxiety, or personality disorders) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while taking OxyNorm, it may indicate that you are developing tolerance to the medicine or are becoming dependent:

• You need to take the medicine for longer than your doctor recommended.
• You need to take a higher dose than recommended.
• You use the medicine for reasons other than those recommended by your doctor, such as "to feel calm" or "to help you sleep".
• You have made repeated, unsuccessful attempts to stop or control the use of the medicine.
• You feel unwell after stopping the medicine and feel better after taking it again ("withdrawal symptoms").

If you have noticed any of these symptoms, you should contact your doctor to discuss the best treatment plan for you, including the right time and safe way to stop treatment (see section 3 "Stopping OxyNorm").
The active substance in OxyNorm, oxycodone hydrochloride, can be abused and lead to dependence, like other strong opioids used to treat pain. It should be used with caution in patients who abuse alcohol or medicines.
The patient may experience increased sensitivity to pain (hyperalgesia), despite receiving increasing doses of OxyNorm. Only your doctor can decide whether to change the dose or switch to a stronger pain-relieving medicine.
You should inform your doctor about taking OxyNorm before planned surgery.
While taking these tablets, hormonal changes may occur, such as changes in prolactin, cortisol, and testosterone levels. Your doctor may decide to monitor these changes.
Taking OxyNorm may result in a positive test result in a doping control test.
Taking OxyNorm as a doping agent poses a risk to life.

OxyNorm and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of opioids (including oxycodone) and sedatives, such as benzodiazepines or similar medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
If your doctor has prescribed OxyNorm together with sedatives, they should limit the dose and duration of concomitant treatment.
You should inform your doctor about all sedatives you are taking and strictly follow your doctor's dosage recommendations. It may be helpful to inform friends or relatives to be aware of the possibility of the above symptoms. If any symptoms occur, you should contact your doctor.
Side effects may occur more frequently or be more severe if OxyNorm is used with medicines that affect brain function, such as sleep-inducing and sedative medicines, medicines used to treat mental or psychological disorders, antidepressants, antihistamines, medicines used to treat motion sickness, medicines used to treat nausea and vomiting, and other opioids. Examples of side effects include respiratory failure (shallow and slow breathing), constipation, dry mouth, and difficulty urinating.
The risk of side effects increases if you are taking antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, causing symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, excessive sweating, tremors, increased reflexes, muscle tension, and elevated body temperature above 38°C. If you experience any of these symptoms, you should contact your doctor.
You should tell your doctor or pharmacist if you are taking:

• sleep-inducing or sedative medicines (e.g., sedatives or sleep-inducing medicines, including benzodiazepines);
• antidepressant medicines (e.g., paroxetine, amitriptyline);
• MAO inhibitors (see section "Warnings and precautions");
• antihistamine medicines, motion sickness, or anti-nausea medicines (e.g., antihistamines, anti-nausea medicines);
• medicines used to treat mental or psychological disorders (such as antipsychotics, phenothiazine derivatives, neuroleptics);
• muscle relaxants used to relieve muscle spasms (e.g., tizanidine);
• medicines used to treat Parkinson's disease;
• medicines used to treat epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
• other strong pain-relieving medicines;
• cimetidine (a medicine used to treat stomach ulcers, indigestion, and heartburn);
• medicines used to treat fungal infections (such as ketoconazole, voriconazole, itraconazole, or posaconazole);
• medicines used to treat bacterial infections (such as clarithromycin, erythromycin, or telithromycin);
• rifampicin used to treat tuberculosis;
• specific groups of medicines known as protease inhibitors used to treat HIV infections (these include: boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir);
• carbamazepine (a medicine used to treat epilepsy or seizures and some pain conditions);
• phenytoin (a medicine used to treat epilepsy or seizures);
• a herbal medicine called St. John's Wort (also known as Hypericum perforatum)
• quinidine (a medicine used to treat irregular heartbeat);
• medicines known as coumarins that prevent blood clotting or help with blood clotting (such as phenprocoumon).

OxyNorm with food, drink, and alcohol

Drinking alcohol while taking OxyNorm may cause drowsiness or increase the risk of side effects, such as shallow breathing with the risk of respiratory arrest and loss of consciousness. You should avoid drinking alcohol while taking OxyNorm.
You should avoid drinking grapefruit juice while taking OxyNorm.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, you should ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Pregnancy
You should not take OxyNorm during pregnancy.
There is limited data on the use of oxycodone hydrochloride in pregnant women.
Long-term use of oxycodone hydrochloride during pregnancy may lead to the development of withdrawal symptoms in newborns. The use of oxycodone hydrochloride during delivery may cause shallow and slow breathing (respiratory depression) in the newborn.
Breastfeeding
OxyNorm should not be used during breastfeeding, as oxycodone hydrochloride may pass into breast milk and may cause sedation and shallow and slow breathing (respiratory depression) in the breastfed child.

Driving and using machines

Taking OxyNorm may impair your ability to drive and use machines.
This is especially true at the beginning of treatment, when increasing the dose, or when switching to another similar medicine, and when OxyNorm is taken with alcohol or in combination with medicines that affect brain function.
During stable treatment, there is no restriction on driving. The decision in each individual case is made by the doctor, taking into account the existing circumstances. You should consult your doctor about the possibility and any conditions for driving a car or operating machines.

OxyNorm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml and is considered "sodium-free".

3. How to take OxyNorm

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from taking OxyNorm, when and how long you should take it, when to contact your doctor, and when to stop taking it (see also "Stopping OxyNorm").

Dosage

Your doctor will adjust the dose according to the severity of your pain and your individual sensitivity. The injection is usually prepared and administered by a doctor or nurse.

Elderly patients

In elderly patients without liver or kidney problems, dose adjustment is usually not necessary.
Children under 12 years of age
There are insufficient data on the safety and efficacy of OxyNorm in children under 12 years of age. Therefore, OxyNorm is not recommended for use in children under 12 years of age.

Patients with liver or kidney problems

Patients with liver or kidney problems who have not previously received opioids should initially take half the recommended adult dose at the start of therapy.

Patients at high risk

Patients with low body weight and slow metabolism should initially take half the recommended adult dose at the start of therapy.
Method of administration
For intravenous administration, OxyNorm can be diluted to a concentration of 1 mg/ml using 0.9% (w/v) sodium chloride solution, 5% (w/v) glucose solution, or water for injection.
For subcutaneous administration, if necessary, OxyNorm may be diluted with 0.9% (w/v) sodium chloride solution, 5% (w/v) glucose solution, or water for injection. The dosage is dependent on the method of administration.
The medicine is administered by a doctor or nurse.
OxyNorm is intended for bolus injection or infusion (intravenously = i.v.) or subcutaneously (subcutaneously = s.c.).
Duration of treatment
Your doctor will decide on the duration of treatment.
You should not stop taking OxyNorm without consulting your doctor (see "Stopping OxyNorm").
Oxycodone should not be used for longer than necessary.
During long-term use of OxyNorm, the patient's response to the medicine should be monitored.
Regular medical check-ups are necessary to achieve adequate pain relief and to treat any side effects that may occur, and to decide on further action.
If you feel that the effect of OxyNorm is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of OxyNorm than recommended

If you take a higher dose of OxyNorm than recommended, you should immediately inform your doctor.
The following symptoms may occur:

• pupil constriction
• shallow and slow breathing (respiratory depression)
• progressive drowsiness leading to unconsciousness
• decreased muscle tone
• slow heart rate
• low blood pressure
• brain disorders (toxic leukoencephalopathy).

In severe cases, the following may occur: loss of consciousness (coma), fluid accumulation in the lungs, and circulatory collapse. These can lead to death.
You should absolutely avoid situations that require a high level of concentration, such as driving a car.

Missing a dose of OxyNorm

Taking a lower dose of OxyNorm than recommended or missing a dose may lead to inadequate pain relief.
You should continue taking the doses as scheduled.
You should not take a double dose to make up for a missed dose.

Stopping OxyNorm

You should not stop taking OxyNorm without consulting your doctor.
If it is no longer necessary to take OxyNorm, it is recommended to gradually reduce the daily dose. If treatment is stopped suddenly, withdrawal symptoms may occur (symptoms: yawning, pupil dilation, lacrimation, rhinorrhea, tremors, sweating, anxiety, and restlessness, seizures, difficulty sleeping, or muscle pain).
If you have any further questions about taking OxyNorm, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, OxyNorm can cause side effects, although not everybody gets them.
Similar to other strong pain-relieving medicines, there is a risk of physical dependence (not very common).

Important side effects or symptoms to know about and actions to take if they occur:

If you experience any of the important side effects, you should immediately contact your nearest available doctor.

• Sudden breathing difficulties, swelling of the eyelids, face, or lips, rash, or itching, especially those affecting the whole body (frequency not known) or any other allergic reactions - these are symptoms of severe allergic reactions (frequency: not very common)
• Shallow and slow breathing (respiratory depression; frequency not known) - occurs mainly in elderly and frail patients or if too high a dose of OxyNorm is given; shortness of breath (dyspnea; frequency: not very common)
• Low blood pressure - can cause dizziness and fainting (frequency: rare)
• Abdominal cramps and bloating, nausea, vomiting, and inability to pass gas or stool, which may be caused by mechanical obstruction of the intestine (obstruction; frequency: not very common)

Other possible side effects

Very common(may affect more than 1 in 10 people):

• Constipation - can be prevented by drinking plenty of fluids, eating fiber-rich foods
• Nausea, vomiting - especially at the beginning of treatment, if nausea or vomiting occurs, your doctor may prescribe medicines to prevent them
• Drowsiness greater than normal (up to sedation), dizziness, headache

Common(may affect up to 1 in 10 people):

• Abdominal pain, diarrhea, dry mouth, hiccups, indigestion
• Decreased appetite to complete loss of appetite
• Anxiety, confusion, depression, decreased activity, restlessness, hyperactivity, nervousness, difficulty sleeping
• tremors, sluggishness
• Skin reactions, rash, sweating
• Difficulty urinating, increased urge to urinate
• Feeling of unusual weakness, fatigue

Uncommon(may affect up to 1 in 100 people):

• Injuries due to accidents
• Dehydration
• Agitation, mood swings, feeling of extreme happiness, perception disorders (e.g., hallucinations, feeling of unreality)
• Decreased sex drive
• Seizures (especially in people with a history of seizures or predisposition to seizures)
• Memory loss, distraction, migraines
• Unusual muscle stiffness, involuntary muscle contractions, decreased sensitivity to pain and touch, coordination disorders
• Fainting
• Numbness (numbness in hands and feet), changes in taste
• Visual disturbances, narrow pupils
• Hearing disturbances, feeling of dizziness or "spinning" (vertigo)
• Fast heartbeat, palpitations
• Flushing of the skin
• Difficulty speaking, voice changes (hoarseness), cough
• Mouth ulcers, mouth inflammation, difficulty swallowing
• gas and bloating, belching
• Worsening of liver function tests (visible in blood tests)
• Dry skin
• Inability to fully empty the bladder
• Impotence, decreased sex hormone levels
• Chills
• Withdrawal symptoms, need to take increasingly higher doses of OxyNorm to achieve the same level of pain relief (tolerance), pain (chest pain), general malaise
• Swelling of hands, ankles, or feet
• Thirst

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

• Feeling of fainting, especially when standing up
• Dark, tar-like stools, changes in teeth, gum bleeding,
• Infections such as ulcers or herpes (which can cause blisters around the mouth or genitals)
• Increased appetite
• Itchy rash (hives)
• Weight gain, weight loss

Unknown(frequency cannot be estimated from available data):

• Aggression
• Increased sensitivity to pain
• Sleep apnea (pauses in breathing during sleep)
• Tooth decay
• Abdominal pain due to colic, bile flow problems
• Absence of menstruation
• Withdrawal symptoms in children born to mothers who took OxyNorm during pregnancy

OxyNorm may also cause bronchial muscle spasms (causing shortness of breath) and decreased coughing ability.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to: Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OxyNorm

The medicine should be kept out of sight and reach of children. This medicine should be stored in a closed and secure place, to which other people do not have access. It can be very harmful and may cause death in a person for whom it was not prescribed.
You should not use this medicine after the expiry date stated on the carton, label, or ampoule. The expiry date refers to the last day of the month stated.
There are no specific precautions for storage of the medicinal product.
Use immediately after opening.
OxyNorm diluted with 0.9% (w/v) sodium chloride solution, 5% (w/v) glucose solution, or water for injection shows physical and chemical stability for 24 hours at 25°C.
From a microbiological point of view, the medicine should be used immediately after dilution.
In other cases, the responsibility for the storage period and conditions before administration lies with the user, but generally, this period should not exceed 24 hours if the solution is stored at a temperature between 2°C and 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
You should visually inspect the solution before administration, also after dilution. Only a clear solution free of particles and contaminants should be used.
Any unused product or waste material should be disposed of in accordance with local regulations.

6. Contents of the packaging and other information

What OxyNorm contains

The active substance of OxyNorm is oxycodone hydrochloride. 1 ml of the solution for injection contains 10 mg of oxycodone hydrochloride, which corresponds to 8.97 mg of oxycodone.
One ampoule of 1 ml contains 10 mg of oxycodone hydrochloride.
One ampoule of 2 ml contains 20 mg of oxycodone hydrochloride.
The other ingredients of the medicine are: citric acid monohydrate, sodium citrate, sodium chloride, sodium hydroxide, diluted hydrochloric acid, water for injection.

What OxyNorm looks like and contents of the pack

OxyNorm 10 mg/ml solution for injection / concentrate for solution for injection / for infusion is a clear, colorless liquid.
OxyNorm is available in glass ampoules of 1 ml and 2 ml, packaged in 5 and 10 units.
Not all pack sizes may be marketed.

Marketing authorization holder

Mundipharma A/S
Frydenlundsvej 30
2950 Vedbæk, Denmark

Manufacturer

Mundipharma GmbH
Mundipharma Strasse 2
65549 Limburg, Germany
Mundipharma DC B.V,
Leusderend 16
3832 RC Leusden, Netherlands
To obtain more detailed information on this medicine, you should contact the representative of the marketing authorization holder: Mundipharma Polska Sp. z o.o., ul. J. Kochanowskiego 45A, 01-864 Warsaw, tel. +48 22 866 87 12.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland OxyNorm
Date of last revision of the leaflet: July 2023
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The following information is intended for healthcare professionals only:

Detailed information on this medicine can be found in the Summary of Product Characteristics available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (https://urpl.gov.pl).