Oxynorm

Package leaflet: Information for the patient

OxyNorm, 10 mg/ml, injection solution / concentrate for preparation of solution for injection / for infusion
Oxycodoni hydrochloridum
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What OxyNorm is and what it is used for

OxyNorm is a potent analgesic belonging to the group of opioids.
OxyNorm is used to relieve moderate to severe pain in adults,
which can only be adequately managed with opioid analgesics.
OxyNorm is used in the treatment of severe pain in adults and adolescents aged 12 years and older.

2. Important information before using OxyNorm

When not to use OxyNorm

• If the patient is allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• If the patient suffers from severe and chronic lung disease associated with breathing difficulties (severe chronic obstructive pulmonary disease, also known as COPD);
• If the patient has heart problems diagnosed as a condition called cor pulmonale (heart changes due to chronic lung disease);
• If the patient suffers from severe asthma;
• If the patient has breathing problems, e.g. significantly slowed and shallow breathing (severe respiratory depression with insufficient oxygen levels and elevated carbon dioxide levels in the blood);
• If the patient has a condition in which the intestine stops functioning (paralytic ileus).

Warnings and precautions
Before starting treatment with OxyNorm, discuss this with your doctor, pharmacist or
nurse, particularly:

• In elderly or weakened patients;
• In patients with severe lung diseases;
• When using MAO inhibitors or if the patient has taken an MAO inhibitor within the last 2 weeks; these are used to treat depression (tranylcypromine, phenelzine, isocarboxazid, moklobemide), Parkinson’s disease (selegiline), and infections (linezolid);
• In patients with thyroid disease presenting with dry, cold, swollen and thickened skin of the face (“puffy face”), hands and feet;
• In patients with insufficient thyroid hormone secretion;
• In patients with Addison’s disease;
• In patients experiencing difficulty urinating due to an enlarged prostate gland;
• In patients diagnosed with a mental disorder caused by alcohol or other substance intoxication;
• In patients currently or previously dependent on opioids;
• In patients suffering from alcohol withdrawal symptoms such as delirium or tremors;
• In patients suffering from epilepsy or predisposed 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 biliary tract disorders;
• In patients with pancreatitis, causing severe abdominal and back pain;
• In patients with inflammatory bowel disease or bowel obstruction;
• In patients in whom the doctor suspects intestinal dysfunction;
• In patients with constipation;
• In patients with liver or kidney disease;
• In patients who abuse or are dependent on alcohol.

Sleep-related breathing disorders
OxyNorm may cause sleep-related breathing disorders, such as sleep apnoea
(periodic breathing pauses during sleep) and nocturnal hypoxemia (low blood oxygen levels during sleep).
Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty
maintaining sleep or excessive daytime sleepiness. If the patient or someone else observes such
symptoms, contact a doctor. The doctor may consider reducing the dose.
Inform your doctor if any of the above apply to you.
The main risk associated with opioid overdose is shallow and slowed breathing
(respiratory depression). This occurs most frequently in elderly or weakened patients. It may also
cause reduced blood oxygen levels, which may lead, for example, to fainting.
With prolonged use of OxyNorm, the patient may develop tolerance to the medicine and may require
gradually increasing doses of OxyNorm to maintain adequate pain control. Do not increase the dose of
OxyNorm on your own without consulting your doctor.
Opioids are not the first-line treatment for non-cancer-related pain and are not recommended as the sole therapy.
For chronic pain treatment, other medications should be used in addition to opioids. The doctor should closely monitor the patient’s condition and appropriately adjust the dose during OxyNorm treatment to prevent dependence and abuse.
Prolonged use of OxyNorm may lead to physical dependence. If treatment is abruptly stopped, symptoms such as yawning, dilated pupils, lacrimation, runny nose, tremor, sweating, restlessness, motor agitation, seizures, difficulty sleeping and muscle pain may occur. When continued treatment with OxyNorm is no longer necessary, gradual dose reduction is recommended to prevent these symptoms.
Tolerance, dependence and addiction
This medicine contains oxycodone, which is an opioid medicine. 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 OxyNorm 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 for a longer period.
Dependence or abuse may cause the patient to feel they have lost control over the dose or frequency of medicine intake. The patient may feel compelled to continue taking the medicine, even if it no longer helps relieve pain.
The risk of drug dependence or addiction varies between patients. The risk of dependence on OxyNorm may be higher if:

• The patient or a family member has ever abused or been dependent on alcohol, prescription medicines or illegal substances;
• The patient smokes cigarettes;
• The patient has ever had mood disorders (depression, anxiety or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If, during treatment with OxyNorm, the patient notices any of the following symptoms, this may indicate developing tolerance to the medicine or dependence:

• The patient needs to take the medicine longer than prescribed by the doctor.
• The patient must take a higher dose than recommended.
• The patient uses the medicine for reasons other than those prescribed by the doctor, e.g. “to stay calm” or “to help with sleep”.
• The patient has made repeated, unsuccessful attempts to discontinue or control medicine use.
• The patient feels unwell after stopping the medicine and feels better after resuming it (“withdrawal effects”).

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 discontinuing treatment (see section 3 “Stopping OxyNorm treatment”).
The active substance in this medicine, oxycodone hydrochloride, may be abused and lead to dependence, similar to other strong opioids used for pain treatment. Use with particular caution in patients who abuse alcohol or medicines.
The patient may experience increased pain sensitivity (hyperalgesia), despite receiving increasing doses of OxyNorm. The decision on dose adjustment or changing to another strong painkiller can only be made by the doctor.
Before a planned surgery, it is essential to inform the doctor about taking OxyNorm.
Hormonal changes, e.g. in prolactin, cortisol and testosterone levels, may occur during treatment with these tablets. The doctor may decide to monitor these changes.
OxyNorm may give a positive result in anti-doping control tests.
Using OxyNorm as a doping agent poses a life-threatening risk.

OxyNorm and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
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 may be life-threatening. Therefore, concomitant use of these medicines should only be considered when no other treatment options are possible.
If the doctor prescribes OxyNorm together with sedative medicines, the dose and duration of combined treatment should be limited.
Inform your doctor about all sedative medicines being taken and strictly follow the doctor’s dosing instructions. It may be helpful to inform friends or relatives so they are aware of the possibility of the above-mentioned symptoms. Contact your doctor if any symptoms occur.
Adverse effects may occur more frequently or be more severe if OxyNorm is used with medicines affecting brain function, such as: sleeping pills and sedatives, medicines used to treat mental disorders, antidepressants, antihistamines, medicines used to treat motion sickness, medicines used to treat nausea and vomiting, and other opioids. Examples of adverse effects include: respiratory failure (shallow and slowed breathing), constipation, dry mouth and difficulty urinating.
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, tremor, increased reflexes, increased muscle tension, elevated body temperature above 38°C. If any of the above symptoms occur, contact your doctor.
Tell your doctor, pharmacist or nurse if the patient is taking:

• Medicines that help with sleep or sedatives (e.g. tranquilizers or sleeping pills, including benzodiazepines);
• Antidepressants (e.g. paroxetine, amitriptyline);
• MAO inhibitors (see section Warnings and precautions);
• Antiallergic medicines, medicines for motion sickness or vomiting (e.g. antihistamines, antiemetics);
• Medicines used to treat mental disorders (such as antipsychotics, phenothiazine derivatives, neuroleptics);
• Medicines known as muscle relaxants, used to relieve muscle spasms (e.g. tizanidine);
• Medicines used in Parkinson’s disease treatment;
• Medicines used to treat epilepsy, pain and anxiety disorders, such as gabapentin and pregabalin;
• Other strong painkillers;
• Cimetidine (a medicine used to treat peptic ulcer disease, 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 infection (including: boceprevir, ritonavir, indinavir, nelfinavir or saquinavir);
• Carbamazepine (a medicine used to treat epileptic seizures or convulsions and certain pain conditions);
• Phenytoin (a medicine used to treat epileptic seizures or convulsions);
• 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 in the blood clotting process (such as phenprocoumon).

OxyNorm with food, drink and alcohol
Drinking alcohol while taking OxyNorm may cause drowsiness or increase the risk of adverse effects such as shallow breathing with risk of respiratory arrest and loss of consciousness. Avoid consuming alcohol during treatment with OxyNorm.
Avoid drinking grapefruit juice during treatment with OxyNorm.

Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult your doctor, pharmacist or nurse before using this medicine.
Pregnancy
Do not use OxyNorm during pregnancy.
There are insufficient data on the use of oxycodone hydrochloride in pregnant women.
Prolonged use of oxycodone hydrochloride during pregnancy may lead to withdrawal symptoms in newborns.
Use of oxycodone hydrochloride during childbirth may cause shallow breathing and slowed respiration (respiratory depression) in the newborn.
Breastfeeding
OxyNorm should not be used by breastfeeding mothers, as oxycodone hydrochloride may pass into human milk and may cause sedation and shallow, slowed breathing (respiratory depression) in the breastfed infant.

Driving and operating machinery
Using OxyNorm may impair the ability to drive and operate machinery.
This is particularly relevant during the initial phase of OxyNorm treatment, dose increases, switching to another similar medicine, or when OxyNorm is taken with alcohol or in combination with medicines affecting brain function.
During stable treatment, there is no driving ban. The decision in each individual case is made by the doctor, considering the specific circumstances. Consult your doctor regarding the possibility and any conditions for driving or operating machinery.

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 use OxyNorm

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from using OxyNorm, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also "Stopping OxyNorm").

Dosage
Your doctor will adjust the dose according to the intensity 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 impaired liver or kidney function, dosage adjustment is generally not required.

Children under 12 years of age
There have not been sufficient studies on the safety and efficacy of OxyNorm in children under 12 years of age. Therefore, the use of OxyNorm is not recommended in children under 12 years of age.

Patients with impaired liver or kidney function
Patients with impaired liver or kidney function who have not previously received opioids should initially be given half the adult starting dose.

Patients at increased risk
Patients with low body weight and those who metabolize drugs slowly should initially be given half the adult starting dose.

Method of administration
For intravenous administration, OxyNorm may be diluted to a concentration of 1 mg/ml using 0.9% (m/v) sodium chloride solution, 5% (m/v) glucose solution, or water for injections.
For subcutaneous administration, if necessary, OxyNorm may be diluted with 0.9% (m/v) sodium chloride solution, 5% (m/v) glucose solution, or water for injections. The dosage depends on the route of administration.
The medicine is administered by a doctor or nurse.
OxyNorm is intended for administration as an intravenous bolus or infusion (intravenous = i.v.) or subcutaneously using a fine needle (subcutaneous = s.c.).

Duration of treatment
Your doctor will decide on the duration of treatment.
Do not stop treatment with OxyNorm without consulting your doctor (see section "Stopping OxyNorm").
Oxycodone should not be used for longer than necessary.
If OxyNorm is used long-term, the patient's response to the medicine should be monitored.
Regular medical check-ups are necessary to achieve adequate pain relief and, in case of adverse reactions, to allow prompt treatment, dose adjustment, or decisions regarding further management.
If you feel the effect of OxyNorm is too strong or too weak, consult your doctor or pharmacist.

Use of a higher than recommended dose of OxyNorm
If a higher than recommended dose of OxyNorm is used, inform your doctor immediately.
The following symptoms may occur:

• constricted pupils
• shallow and slowed breathing (respiratory depression)
• increasing drowsiness up to stupor
• reduced skeletal muscle tone
• slowed heart rate
• low blood pressure
• brain disorders (known as toxic leukoencephalopathy).

In more severe cases, the following may occur: loss of consciousness (coma), accumulation of fluid in the lungs, and circulatory collapse. These may lead to death.
The patient must absolutely avoid situations requiring high concentration, such as driving a car.

Missed dose of OxyNorm
Taking a lower than recommended dose of OxyNorm or missing a dose may result in unsatisfactory and/or insufficient pain relief.
Continue taking the doses according to the prescribed schedule.
Do not take a double dose to make up for a missed dose.

Stopping OxyNorm
Do not stop taking OxyNorm without consulting your doctor.
If treatment with OxyNorm is no longer necessary, it is recommended to gradually reduce the daily dose. Abruptly stopping treatment may lead to withdrawal symptoms (symptoms: yawning, dilated pupils, tearing, runny nose, tremor (chills), sweating, restlessness, seizures, difficulty falling asleep, or muscle pain).
If you have any further doubts regarding the use of 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.
As with other strong painkillers, there is a risk of physical dependence (not uncommon).

Important adverse reactions or symptoms to be aware of, and actions to take if they occur:
If any of the following serious adverse reactions occur in a patient, contact the nearest available doctor immediately.

• Sudden difficulty in breathing, swelling of the eyelids, face or lips, rash or itching, especially affecting the whole body (frequency unknown), or any other allergic reactions – these are symptoms of severe allergic reactions (frequency: not uncommon)
• Shallow and slowed breathing (respiratory depression; frequency: unknown) – occurs mainly in elderly or weakened patients, or if too high a dose of the medicine has been administered; shortness of breath (dyspnoea; frequency: not uncommon)
• Drop in blood pressure – may cause dizziness and fainting (frequency: rare)
• Abdominal cramps and bloating, nausea, vomiting and inability to pass wind or stool, which may be due to functional intestinal obstruction (obstruction; frequency: not uncommon)

Other possible adverse reactions
Very common (may affect more than 1 in 10 treated patients):

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

Common (may affect less than 1 in 10 treated patients):

• Abdominal pain, diarrhoea, dry mouth, hiccups, indigestion
• Decreased appetite to complete loss of appetite
• Anxiety, confusion, depression, reduced activity, motor restlessness, excessive mobility, nervousness, difficulty sleeping, abnormal thinking
• Tremor, drowsiness
• Skin reactions, rashes, sweating
• Pain during urination, increased urge to urinate
• Feeling of unusual weakness, fatigue

Uncommon (may affect less than 1 in 100 treated patients):

• Injuries due to accidents
• Dehydration
• Agitation, mood swings, feeling of extreme happiness, perceptual disturbances (e.g. hallucinations, feeling of unreality)
• Reduced libido
• Seizures (especially in patients with epilepsy or predisposition to seizures)
• Memory loss, difficulty concentrating, migraines
• Unusual muscle stiffness, involuntary muscle contractions, reduced sensitivity to pain and touch, coordination disturbances
• Fainting
• Tingling (pins and needles in hands and feet), changes in taste
• Visual disturbances, pinpoint pupils
• Hearing disturbances, sensation of dizziness or "spinning" (vertigo)
• Rapid heartbeat, palpitations
• Skin flushing
• Difficulty speaking, voice changes (hoarseness), cough
• Oral ulceration, inflammation of the mouth, difficulty swallowing
• Abdominal distension with flatulence, belching
• Worsening of liver function parameters (detected in blood tests)
• Dry skin
• Inability to completely empty the bladder
• Impotence, decreased levels of sex hormones
• Chills
• Withdrawal symptoms, need to take increasingly higher doses of the medicinal product OxyNorm to achieve the same level of pain relief (tolerance), pain (referred chest pain), general malaise
• Swelling of the hands, ankles or feet
• Thirst

Rare (may affect less than 1 in 1,000 treated patients):

• Feeling faint, especially when standing up
• Dark, tarry stools, changes in teeth, bleeding gums
• Infections such as ulcers or herpes (which may cause blisters around the mouth or genitals)
• Increased appetite
• Itchy rash (urticaria)
• Weight gain, weight loss

Unknown (frequency cannot be estimated from available data):

• Aggression
• Increased sensitivity to pain
• Sleep apnoea (pauses in breathing during sleep)
• Dental caries
• Abdominal pain due to colic, problems with bile flow
• Absence of menstruation
• Withdrawal symptoms in children born to mothers who were treated with OxyNorm during pregnancy

The medicine OxyNorm may also cause bronchospasm (resulting in shortness of breath) and reduced ability to cough.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to: Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store OxyNorm

Keep this medicine out of the sight and reach of children. This medicine must be stored in a closed and secure place to which others cannot gain access. It may be highly harmful and may cause death in individuals for whom it has not been prescribed. Do not use this medicine after the expiry date stated on the cardboard box, blister pack, or ampoule. The expiry date refers to the last day of the stated month.
There are no specific precautions regarding the storage of this medicinal product.
After opening, use immediately.
OxyNorm diluted with 0.9% (w/v) sodium chloride solution, 5% (w/v) glucose solution, or water for injections maintains physical and chemical stability for 24 hours at a temperature of 25°C.
From a microbiological standpoint, the medicine should be administered immediately after dilution.
Otherwise, the responsibility for the storage conditions and duration prior to administration lies with the user, provided that this period does not exceed 24 hours if the solution is stored at a temperature of 2 to 8°C, unless dilution has been carried out under controlled and validated aseptic conditions.
A visual inspection of the solution should be performed before administration, including after dilution. Only clear solutions free from particles and discoloration should be used.
Any unused product or waste material must be disposed of in accordance with local regulations.

6. Contents of the pack and other information

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

What OxyNorm looks like and contents of the pack
OxyNorm 10 mg/ml solution for injection / concentrate for solution for infusion is a clear, colourless liquid.
OxyNorm is available in 1 ml and 2 ml glass ampoules, packed in packs of 5 and 10.
Not all pack sizes may be marketed.

Marketing Authorisation 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, The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: Mundipharma Polska Sp. z o.o., ul. J. Kochanowskiego 45A, 01-864 Warsaw, Poland, tel. +48 22 866 87 12.

This medicinal product is authorised in the countries of the European Economic Area under the following names:
Poland: OxyNorm

The following information is intended exclusively for healthcare professionals:

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