10 mg / ml solution for injection / infusion
oxycodone hydrochloride
What Oxycodone Orion is and what it is used for
This solution for injection and infusion contains the active ingredient oxycodone, which belongs to a group of medicines called opioids.
This medicine has been prescribed for you by your doctor to relieve severe pain that can only be controlled with opioid analgesics.
Oxycodone hydrochloride contained in Oxycodone Orion may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Oxycodone Orion
Do not use Oxycodone Orion
- if you are allergic to oxycodone or any of the other ingredients of this medicine (listed in section 6).
- if you have severe breathing problems
- if you have problems clearing mucus from the airways
- if you have seizures
- if you have a coma
- if you have acute abdominal pain
- if you have severe hepatic impairment
- if you have previously had anxiety under the influence of alcohol or sedatives
- if you have intestinal upset
- if you have too high a concentration of carbon dioxide in your blood
- if you have a disease that affects both the heart and lungs and is called cor pulmonale
- if you have severe chronic asthma or severe chronic obstructive pulmonary disease
Warnings and cautions
Talk to your doctor before receiving Oxycodone Orion
- if you have severe lung function
- if you have myxedema (diseases of the thyroid gland with symptoms such as dry, waxy swelling of the skin, low metabolism)
- impaired thyroid function
- if you have impaired adrenal function (your adrenal cortex does not work properly) for example Addison’s disease
- if you have psychosis caused by toxic substances
- if you have an enlarged prostate ( prostate hypertrophy )
- if you are or have been addicted to alcohol or drugs
- if you suffer from delirium tremens due to alcohol withdrawal
- if you have a head injury
- if you have low blood pressure
- if you have reduced blood volume
- if you have kidney or liver problems
- if you have inflammatory bowel disease
- if you have a biliary tract disease
- if you have spasms in the gallbladder or urinary tract
- if you have inflammation of the pancreas
- if you are using monoamine oxidase (MAO) inhibitors (used to treat depression or Parkinson’s disease )
- if you are elderly or debilitated
- if you have recently undergone an operation or if an operation is planned within the next few days
Inform your doctor during treatment:
- when the bowel function does not work properly. This may indicate a blockage in the intestine and then the treatment should be stopped immediately.
- if your pain is not relieved even if oxycodone dose one is increased.
Long-term treatment
Using Oxycodone Orion for long periods may cause physical dependence. Therefore, dose one should be gradually reduced at the end of treatment (see section 3 “If your treatment with Oxycodone Orion is stopped”).
Children and young people
There is not enough information to recommend the use of Oxycodone Orion in children.
Other medicines and Oxycodone Orion
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. If you use Oxycodone Orion with certain other medicines, the effect of Oxycodone Orion, or the other medicines, may change.
Tell your doctor or pharmacist if you are taking:
- medicines to help you sleep or to treat anxiety (anti-anxiety drugs, sleeping pills, or sedatives)
- antidepressants
- medicines for the treatment of mental or mental illness (eg phenothiazines or neuroleptics )
- other strong painkillers (eg other opioids )
- medicines to relieve allergic reactions ( antihistamines )
- medicines to relieve nausea and vomiting (antiemetics)
- drugs for the treatment of Parkinson’s disease
- cimetidine, which is used to treat heartburn or stomach ulcers
- medicines to stop the blood from clotting ( warfarin )
- macrolide antibiotics
- medicines for fungal infections
- medicines for HIV / AIDS
- drugs to treat tuberculosis
- drugs to treat epilepsy
- drugs to treat cardiac arrhythmias
- St. John’s wort
- or if you have been taking a monoamine oxidase inhibitor (MAO) inhibitor in the last two weeks. MAO inhibitors are used to treat depression or Parkinson’s disease.
Concomitant use of Oxycodone Orion with sedatives or sleeping pills such as benzodiazepines or similar medicines increases the risk of drowsiness, difficulty breathing ( breathing depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible. If your doctor prescribes Oxycodone Orion at the same time as sedatives, you should take a dose one and the treatment time is limited by the 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 listed 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.
Oxycodone Orion with food, drink, and alcohol
Oxycodone Orion solution for injection or infusion can be used with food and drink.
However, avoid grapefruit juice as it may affect the plasma levels of Oxycodone.
Alcohol
Do not drink alcohol during treatment. Alcohol may aggravate certain dangerous side effects of oxycodone, e.g. severe respiratory problems, when used during treatment.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The use of Oxycodone Orion should be avoided as far as possible during pregnancy and lactation.
Pregnancy
There are limited data on the use of oxycodone in pregnant women. Oxycodone passes the placenta into the baby’s bloodstream. The use of oxycodone during pregnancy may lead to withdrawal symptoms in the newborn. Infants whose mothers have received oxycodone during the last 3-4 weeks before delivery can cause severe breathing problems in newborns. Oxycodone Orion should only be used during pregnancy if the benefit outweighs the potential risks to the baby.
Breast-feeding
Oxycodone can pass into breast milk and may cause breathing difficulties in the newborn baby. Oxycodone Orion should therefore not be used during breastfeeding.
Driving and using machines
This medicine may impair your ability to react and cause side effects such as dizziness and drowsiness which may affect your ability to drive or use machines. These are usually most noticeable when you first start using Oxycodone Orion or when switching to a higher dose. Do not drive or use tools or machines if you are affected.
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 pharmacist.
Oxycodone Orion contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Oxycodone Orion
Your doctor will prescribe an individual dose for you depending on your age, how severe your pain is, your general condition, any concomitant illnesses, and your previous and concomitant medication.
Healthcare professionals will prepare and give you this medicine either as an injection (under the skin, in a blood vessel, or a muscle) or as a drip (under the skin or in a blood vessel).
You will be given Oxycodone Orion for as short a time as possible
Instructions for use for healthcare professionals can be found at the end of this leaflet.
If you take more Oxycodone Orion than you should
Oxycodone Orion is given to you by healthcare professionals. An overdose is therefore unlikely.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
The symptoms of overdose are small pupils, severe difficulty breathing, drowsiness, muscle weakness, slow heart rate, and low blood pressure. In severe cases, coma and death can also occur. When seeking medical attention, bring this leaflet and any remaining solution and show it to your doctor.
If your treatment with Oxycodone Orion is stopped
You should not suddenly stop using this medicine unless your doctor recommends it. If you want to stop using the medicine, discuss this with your doctor first. Dose one is usually reduced gradually so that you do not experience unpleasant effects. Abrupt discontinuation of treatment can cause withdrawal symptoms within 24 hours such as restlessness, watery eyes, and nose, sweating, and difficulty sleeping.
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.
This medicine can in some rare cases cause serious side effects. Stop taking Oxycodone Orion and contact your doctor immediately if the following occur :
- respiratory depression, which is most likely in elderly or debilitated patients. This medicine can also cause bronchospasm, difficulty breathing, and suppress the cough reflex.
- dizziness, which may be a symptom of a severe drop in blood pressure
- small pupils, which may be a symptom of overdose
- gallstone attack
- life-threatening allergic reaction (anaphylactoid and anaphylactic reaction) Oxycodone can also cause the following side effects:
Very common (may affect more than 1 user in 10):
- dizziness, drowsiness, headache
- constipation, nausea, vomiting. Your doctor may prescribe appropriate medications to treat these symptoms.
- itching.
Common (may affect up to 1 in 10 people):
- anxiety, confusion, nervousness, depression, abnormal thoughts, insomnia
- tremors
- drop in blood pressure when you stand up which can cause dizziness, dizziness or fainting
- difficulty breathing
- abdominal pain, loss of appetite, diarrhea, digestive problems, dry mouth
- skin rash, excessive sweating
- fluid retention, dullness
- sweating, chills, lack or loss of strength and energy.
Uncommon (may affect up to 1 in 100 people):
- agitation, hallucinations, memory loss, emotional instability, euphoria
- cramps, involuntary muscle contractions, excessive muscle tension, decreased sensation of touch, feeling of numbness or tingling in the skin, difficulty speaking, fainting, dizziness
- dilation of blood vessels
- altered taste buds, gastrointestinal problems, flatulence, difficulty swallowing, intestinal blockage, belching
- elevated liver enzyme values
- hives, dry skin
- difficulty urinating, spasms of the urethra
- absence of menstruation, decreased sex drive, impotence
- swelling of the arms and legs, thirst, withdrawal syndrome, malaise, drug tolerance
- hypersensitivity
- dehydration
- drug addiction
- visual disturbances
- palpitations (in connection with the release of oxycodone).
Rare (may affect up to 1 in 1,000 people):
- allergic reaction, severe hypersensitivity reaction
No known frequency (occurs in an unknown number of users):
- aggression
- abnormally increased pain sensation
- caries
- stop or decrease the flow of bile.
- Prolonged use of Oxycodone Orion during pregnancy may cause life-threatening withdrawal symptoms in newborns. Symptoms that should be noticed in the infant are irritability, hyperactivity, abnormal sleep patterns, screaming, shaking, vomiting, diarrhea, and not gaining weight.
How to store Oxycodone Orion
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 ampoule label and carton after EXP. The expiration date is the last day of the specified month.
This medicine does not require any specific temperature instructions. Store in the original package. Sensitive to light.
Once the ampoule has been opened, the solution for injection/infusion should be used immediately. Unused solutions should be discarded.
Medicines 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
Content declaration
- The active substance is oxycodone hydrochloride. Each ml contains 10 mg of oxycodone hydrochloride.
- The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
What the medicine looks like and the contents of the pack
Oxycodone Orion solution for injection/infusion is a clear, colorless solution.
It is delivered in glass ampoules packaged in cardboard boxes containing 5 x 1 ml, 5 x 2 ml, or 5 x 10 ml.
1 ml liquid in 2 ml glass ampoule with two yellow rings, 2 ml glass ampoule with two colored rings where the upper ring is brown and the lower is yellow and 10 ml glass ampoule with two colored rings where the upper is dark blue and the lower is yellow.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orion Corporation
Orionvägen 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionvägen 1
FI-02200 Espoo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Oxycodone Orion 10 mg/ml solution for injection and infusion
Finland: Oxycodone Orion 10 mg / ml injection / infusion test, limos
Sweden: Oxycodone Orion 10 mg / ml solution for injection / infusion