10 mg / ml solution for injection
What OxyNorm solution for injection is and what it is used for
OxyNorm solution for injection contains oxycodone hydrochloride, which belongs to a group of medicines called opioids and has a strong analgesic effect.
OxyNorm solution for injection is used for severe pain such as cancer pain.
Oxycodone hydrochloride contained in OxyNorm solution for injection may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor or another healthcare professional if you have any further questions and always follow their instructions.
What you need to know about OxyNorm solution for injection
You should not be treated with OxyNorm solution for injection:
- if you are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if you have severely impaired breathing ( respiratory depression ) with too little oxygen in the blood ( hypoxia ) and/or too much carbon dioxide ( hypercapnia ) in the blood
- if you have severe chronic lung disease (COPD = chronic obstructive pulmonary disease ), heart disease due to chronic congestion of the pulmonary circulation (cor pulmonale), or acute , severe tracheal asthma
- if you have a certain type of blockage in the intestine (paralytic ileus ).
Warnings and cautions
Talk to your doctor or nurse before being treated with OxyNorm solution for injection if you:
- is older
- has impaired lung function
- has impaired renal function
- has impaired liver function
- have repeated pauses in breathing while sleeping ( sleep apnea ), as this condition may worsen
- has impaired thyroid function ( hypothyroidism )
- has impaired adrenal function (eg Addison’s disease )
- have prostate enlargement ( prostate hypertrophy )
- is or has previously been addicted to alcohol
- is or has previously been addicted to strong painkillers ( opioids )
- suffers from mental illness due to an overdose of another drug (toxic psychosis )
- have pancreatitis ( pancreatitis )
- has a head injury or increased pressure in the brain
- have low blood pressure ( hypotension )
- have diseases of the bile duct
- have inflammatory bowel disease
- have or usually have constipation
- have hypovolemia (decreased blood volume)
- take drugs that affect brain function, see section 2 “Other drugs and OxyNorm solution for injection”
- take, or have recently (within 2 weeks) taken, MAO inhibitors (for the treatment of depression).
Tell your doctor that you are being treated with OxyNorm solution for injection.
When OxyNorm is used for a long time, tolerance to the effects may mean that an increased dose is required to maintain pain control.
Prolonged use of OxyNorm may lead to physical dependence and withdrawal symptoms may occur with abrupt discontinuation of treatment. When a patient no longer needs oxycodone treatment, it is advisable to reduce the dose gradually to prevent withdrawal symptoms (see section 3 “If treatment is discontinued”).
The risk of developing physical or psychological dependence is small when used as directed by patients suffering from long-term pain and this risk must be weighed against the potential benefit. Discuss this with your doctor.
Opioids are not the first-line treatment for long-term pain that is not caused by cancer and are not recommended as the only treatment. If you are taking this medicine for this type of pain, your doctor will monitor you closely and make the necessary dose adjustments to prevent addiction and abuse.
An increased sensitivity to pain, which does not respond to a dose increase of oxycodone, may occur during treatment with OxyNorm. This is unusual, but if it does, your doctor may reduce your dose or switch to another opioid.
OxyNorm can cause sleep-related respiratory disorders such as sleep apnea (repeated pauses when you sleep) and hypoxemia (low oxygen content in the blood). Symptoms of this can be shortness of breath during sleep, waking up short of breath, difficulty sleeping, or excessive fatigue during the day. If you or anyone else observes these symptoms, consult a doctor. Your doctor may reduce your dose one.
OxyNorm solution for injection should not be used with alcohol. Alcohol can increase the risk of serious side effects such as drowsiness/drowsiness, impaired and slow breathing, unconsciousness, coma and can even be life-threatening.
Children and young people
OxyNorm solution for injection should not be given to children and adolescents under 18 years of age as there is no experience in the treatment of these patient categories.
Other medicines and OxyNorm solution for injection
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
The risk of side effects increases if you are treated with OxyNorm solution for injection and at the same time take medicines that affect brain function. In such cases, the side effects may be exacerbated. For example, fatigue/drowsiness, impaired and slow breathing may worsen and may lead to unconsciousness, coma, and may even be life-threatening.
Examples of drugs that affect brain function are:
- Other strong painkillers ( opioids )
- Medicines for epilepsy, pain, and anxiety (gabapentin and pregabalin)
- Hypnotics and sedatives ( sedatives (including benzodiazepines ), hypnotics, anxiolytics )
- Drugs for mental or mental illness (antipsychotics such as phenothiazines and neuroleptics )
- Medicines used under anesthesia or anesthesia
- Muscle relaxants used to relieve muscle cramps
- Medicines used to treat allergies, motion sickness, or nausea ( antihistamines or antiemetics)
Concomitant use of opioids, including OxyNorm, and sedatives such as benzodiazepines or similar drugs increase the risk of drowsiness, difficulty breathing ( respiratory depression ), and coma and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible. If your doctor prescribes OxyNorm at the same time as sedatives, the dose and treatment time should be limited by your doctor.
Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
The risk of side effects is increased if you take antidepressant drugs (for example, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine ). These drugs can affect or be affected by oxycodone, and you may experience symptoms such as involuntary, rhythmic muscle contractions, including in the muscles that control eye movements, sudden movements, heavy sweating, tremors, excessive reflexive movements, increased muscle tension, body temperature above 38 ° C. Contact your doctor if you experience these symptoms.
If you are given OxyNorm solution for injection at the same time as medicines (coumarin derivatives) that reduce the blood’s ability to coagulate (clot), the coagulation time may increase or decrease. It may be necessary to adjust the OxyNorm dose.
Some medicines may increase the effect of OxyNorm and therefore a dose reduction may be necessary:
- Certain types of antibiotics (macrolide antibiotics)
- Protease inhibitors (used to treat HIV )
- Cimetidine (antacid used to treat stomach ulcers and heartburn)
Some medicines may reduce the effect of OxyNorm and therefore an increase in dose may be necessary:
- Rifampicin (used to treat tuberculosis )
- Carbamazepine (used in epilepsy and certain pain conditions)
- Phenytoin (used in epilepsy )
- St. John’s wort
OxyNorm solution for injection with food, drink, and alcohol
If you drink alcohol while being treated with OxyNorm solution for injection, it may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of respiratory arrest and unconsciousness. You should not drink alcohol while being treated with OxyNorm.
You should avoid drinking grapefruit juice when you are being treated with OxyNorm solution for injection as it may increase the effect of the medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
The use of this product should be avoided if possible in pregnant women. Prolonged use of OxyNorm during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms that should be noticed in the infant are irritability, hyperactivity, screaming, shaking, vomiting, and not gaining weight.
OxyNorm solution for injection should not be used during breastfeeding as oxycodone passes into breast milk and may cause breathing problems in the breast-fed baby.
Driving and using machines
OxyNorm impairs the ability to concentrate and react. This should be taken into account when sharper attention is required, e.g. when driving and when handling machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or nurse.
OxyNorm solution for injection contains sodium
OxyNorm solution for injection contains less than 1 mmol (23 mg) sodium per ml, ie it is essentially ‘sodium-free’.
How to be treated with OxyNorm solution for injection
Your doctor will tell you what dose you are taking and how to get it. If you have any further questions, ask your doctor or healthcare professional.
Dose one is determined individually for each patient and is tailored to your pain. You will normally be given OxyNorm solution for injection by a doctor or nurse.
For information on handling, see information for physicians and healthcare professionals.
If you take more OxyNorm than you should
OxyNorm solution for injection will be given to you by a doctor or other healthcare professional and it is, therefore, unlikely that you will receive too much. If you think you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor at the hospital for an assessment of the risk and advice.
The following symptoms may occur with overdose: decreased pupil size, impaired breathing ( respiratory depression, pulmonary edema ), muscle weakness, slow heart rate, and drop in blood pressure. In severe cases, drowsiness and unconsciousness ( coma ) may occur.
If a dose has been missed
Ask your doctor or healthcare professional if you think you have not received OxyNorm.
If treatment is stopped
Contact your doctor if you wish to discontinue treatment with OxyNorm.
If use is stopped abruptly after a long period of treatment, withdrawal symptoms such as restlessness, anxiety, anxiety, insomnia, involuntary muscle contractions, tremors, and gastrointestinal problems may occur. Your doctor will tell you how to stop the treatment to reduce the risk of withdrawal symptoms, usually done by gradually reducing the dose.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following frequency data are used to evaluate the side effects:
Very common: May affect more than 1 user in 10
Common: May affect up to 1 in 10 people
Uncommon: May affect up to 1 in 100 people
Rare: May affect up to 1 in 1,000 people
Very rare: May affect up to 1 in 10,000 people
Has been reported: Occurs in an unknown number of users
Contact a doctor immediately if any of the following symptoms occur:
Very slow or weak breathing ( respiratory depression ). This is the most serious risk with medicines such as OxyNorm solution for injection ( opioids ) and can even be life-threatening.
Drowsiness, dizziness, headache, constipation, nausea, vomiting, itching.
Decreased appetite, anxiety, confusion, depression, insomnia, nervousness, abnormal thinking, tremors, drowsiness ( lethargy ), impaired breathing, tracheal cramps, abdominal pain, diarrhea, dry mouth, indigestion, rash, sweating, feeling weak.
Allergic reactions, dehydration, restlessness, gloom, elation, mood swings, hallucinations, decreased sexual desire, drug dependence, memory loss, seizures, high blood pressure, loss of sensation, involuntary muscle movements, speech disorders, fainting, and crawling, dizziness, puffiness, puffiness dizziness), palpitations (associated with abstinence ), dilation of blood vessels, very slow or weak breathing, difficulty swallowing, gas in the stomach, belching, intestinal upset, elevated liver enzyme levels, urethral spasm, dry skin, difficulty urinating, impotence, decreased hormone production in testicles/ovaries ( hypogonadism ), increased ADH -release, chills, abstinence, malaise, accumulation of fluid in the tissues ( edema ), swelling in the arms and legs due to fluid accumulation, drug tolerance, thirst.
Low blood pressure, tendency to faint standing up, hives.
Has been reported (occurs in an unknown number of users)
Anaphylactic reactions, anaphylactoid reaction, aggression, increased sensitivity to pain (hyperalgesia), repeated pauses in breathing during sleep ( sleep apnea ) (see section 2 “Warnings and precautions”), dental problems, bile arrest (cholestasis), biliary spasm, missed menstruation, neonatal abstinence.
How to store OxyNorm solution for injection
No special storage instructions for unopened packaging. For further information on use after opening the package, see information for physicians and healthcare professionals.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
The active substance is oxycodone hydrochloride.
Other ingredients are:
• Citric acid monohydrate
• Sodium citrate
• Sodium chloride
Hydrochloric acid ( pH adjuster)
• Sodium hydroxide ( pH adjuster)
Water for injections
What the medicine looks like and the contents of the pack
OxyNorm solution for injection is a clear, colorless solution.
OxyNorm solution for injection is supplied in packs of 5 x 1 ml, 5 x 2 ml or 4 x 20 ml ampoules .
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Mölndalsvägen 30 B
412 63 Gothenburg
Mundipharma DC BV
3832 RC Leusden