Package leaflet: Information for the patient
Oxycodone Orion 10 mg/ml solution for injection / infusion
Oxycodone hydrochloride
Read all of this leaflet carefully before you are given this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1.
What Oxycodone Orion is and what it is used for
2.
What you need to know before you are given Oxycodone Orion
3.
How to use Oxycodone Orion
4.
Possible side effects
5.
How to store Oxycodone Orion
6.
Contents of the pack and other information
1.
What Oxycodone Orion is and what it is used for
This solution for injection / infusion contains the active ingredient oxycodone, which belongs to a group of
medicines called opioids.
This medicinal product is prescribed for you by your doctor to relieve severe pain which can be adequately
managed only with opioid analgesics.
2.
What you need to know before you are given Oxycodone Orion
Do not use Oxycodone Orion
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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 with clearing the mucus from your airways
if you have convulsions
if you have coma
if you have acute abdominal pain
if you have severe liver impairment
if you have previously suffered anxiety during influence of alcohol or sedatives
if you have a type of bowel obstruction called paralytic ileus
if you have too high blood carbon dioxide concentration
if you have a disease affecting both heart and lungs called cor pulmonale
if you have severe chronic asthma or severe chronic obstructive lung disease.
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Warnings and precautions
Talk to your doctor, before you are given Oxycodone Orion
if you have severely impaired lung function
if you have myxedema (illnesses of the thyroid gland with symtoms like dry, waxy swelling of the
skin, low metabolism)
impaired function of the thyroid gland
if you have adrenal insufficiency for example Addison’s disease
if you have psychosis caused by toxic substances
if you have enlarged prostate (prostatic hypertrophy)
if you are or have ever been addicted to alcohol or drugs
if you have delirium tremens due to alcohol withdrawal
if you have head injury
if you have low blood pressure
if you have decreased blood volume
if you have problems in kidney or liver
if you have inflammatory bowel disorders
if you have a disease of the biliary tract
if you have spasms in gallbladder or urinary tract
if you have inflammation of the pancreas
if you use monoamine oxidase (MAO) inhibitors (used to treat depression or Parkinson’s disease)
if you are older and debilitated
if you have recently undergone any surgery or if a surgery is planned in the next few days
Tell your doctor during treatment
when your bowels does not work properly. This may indicate intestinal obstruction and then the
treatment should be stopped immediately.
if your pain is not relieved even if the oxycodone dose is increased.
Long-term use
Use of Oxycodone Orion over long periods can cause physical dependence. Therefore, the dose should be
reduced gradually when treatment is stopped (see section 3, “If your treatment with Oxycodone Orion is
stopped”).
Children
There is not enough information to recommend the use of Oxycodone Orion to children.
Other medicines and Oxycodone Orion
Tell your doctor if you are using, have recently used or might use any other medicines, including medicines
obtained without a prescription. If you use Oxycodone Orion with some other medicines, the effect of this
injection or the other medicines may be changed.
Tell your doctor or pharmacist if you are taking
medicines to help you sleep or to treat anxiety (tranquillisers, hypnotics or sedatives)
medicines to treat depression
medicines to treat psychiatric or mental disorders (such as phenothiazines or neuroleptics)
other strong analgesics (for instance other opioids)
medicines to relieve allergic reactions (antihistamines)
medicines to relieve nausea or vomiting (antiemetics)
medicines to treat Parkinson’s disease
cimetidine, which is used to treat heartburn or peptic ulcer
medicines to stop blood from clotting (warfarin)
macrolide antibiotics
medicines to treat fungal infections
medicines to treat HIV/AIDS
medicines to treat tuberculosis
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medicines to treat epilepsy
medicines to treat heart arrhythmia
St. John’s Wort
or if you have taken a monoamine oxidase (MAO) inhibitor during the last two weeks. MAO
inhibitors are used to treat depression or Parkinson’s disease.
Oxycodone Orion with food, drink and alcohol
Oxycodone Orion solution for injection / infusion can be used with food and drink. However, avoid
grapefruit juice as it can affect oxycodone plasma levels.
Alcohol
Do not drink alcohol during treatment. Alcohol can enhance some dangerous side effects of oxycodone, such
as severe breathing problems, when used during treatment.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 to the extent possible during pregnancy and breast-feeding.
Pregnancy
There are limited data from the use of oxycodone in pregnant women. Oxycodone crosses the placenta into
the blood circulation of the baby. Use of oxycodone during pregnancy may cause withdrawal symptoms in
the newborn. Infants born to mothers who have recieved oxycodone during the last 3-4 weeks before labour
can cause severe breathing difficulties in the newborn. Oxycodone Orion should only be used during
pregnancy if the benefit outweighs the possible risks to the baby.
Breast-feeding
Oxycodone may pass into breast milk and may cause breathing difficulties in the newborn. Oxycodone Orion
should therefore not be used during breast-feeding.
Driving and using machines
This medicinal product may impair your reaction and cause side effects such as dizziness and sleepiness
which could effect your ability to drive or use machines. These are usually most noticeable when you first
start using the injection, or when changing to a higher dose. Do not drive or use any tools or machines if you
are affected.
Oxycodone Orion contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
3.
How to use Oxycodone Orion
Your doctor prescribes the dose individually to you according to your age, the severity of your pain, the
general condition, possible concomitant diseases, and your previous and concomitant medication. A
healthcare professional will prepare and give this medicinal product to you either as an injection (under the
skin, into a vein or into a muscle) or as a drip (under the skin or into a vein).
You will be given Oxycodone Orion for as short a period of time as possible.
Instructions for use for medical or healthcare professionals are provided at the end of this leaflet.
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If you are given more Oxycodone Orion than you should
Oxycodone Orion is given to you by healthcare professionals. An overdose is therefore unlikely. If you have
received more medicine than you should have, contact your doctor or hospital immediately.
The symptoms for overdose are small pupils, severe breathing problems, sleepiness, skeletal muscle
flaccidity, slow heart rate and too low blood pressure. In severe cases even coma and death may occur. When
seeking medical attention take this leaflet and any remaining solution for injection or infusion with you and
show to the doctor.
If your treatment with Oxycodone Orion is stopped
You should not suddenly stop using this medicine unless your doctor tells you to. If you want to stop using
your injection, discuss this with your doctor first. The dose is usually reduced gradually, so that you do not
experience unpleasant effects. Abrupt withdrawal of treatment can cause withdrawal symptoms such as
restlessness, runny eyes and nose, sweats and broken sleep within 24 hours.
If you have any further questions on the use of this product, ask your doctor or nurse.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
This medicine can in some uncommon cases cause severe side effects. Stop taking Oxycodone Orion and
contact your doctor immediately if following symptoms occur:
Depressed breathing, which is most likely to occur in elderly or debilitated patients. This medicine can
also cause bronchial spasms, difficulty in breathing and suppress the cough reflex.
dizziness which can be a symptom of severe drop in blood pressure
constricted pupils which can be a symptom of overdosing
gallstone attack
life-threatening allergic reaction (anafylactoid and anaphylactic reactions)
Oxycodone can also cause following side effects:
Very common (may affect more than 1 in 10 people):
dizziness, sleepiness, headache
constipation, nausea, vomiting. Your doctor can prescribe appropriate medicines to treat these
symptoms.
itching.
Common (may affect up to 1 in 10people):
anxiety, confusional state, nervousness, depression, abnormal thinking, insomnia
tremor
a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting
difficulties in breathing
abdominal pain, loss of appetite, diarrhoea, problems with digestion, dry mouth
rash, excessive sweating
fluid retention, faintness, sweating, chills, lack or loss of strength and energy.
Uncommon (may affect up to 1in 100 people):
agitation, hallucinations, amnesia, emotional lability, euphoria
convulsions, involuntary muscle contractions, excessive muscle tension, reduced sence of touch,
sensation of numbness or tingling of the skin, speech disorder, fainting, vertigo
widening of blood vesselschange in sense of taste, gastrointestinal disorder, flatulence, difficulty in
swallowing, intestinal obstruction, belching
increased liver enzyme values
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urticaria, dryness of the skin
difficulty in passing urine urethral spasmabsence of menstruation, decreased libido, impotence
swelling of extremities, thirst, drug withdrawal syndrome, malaise, drug tolerance
hypersensitivity
dehydration
drug dependence
visual impairment
palpitations (in connection with oxycodone withdrawal).
Rare (may affect up to 1in 1,000people):
allergic reaction, severe hypersensitivity reactions
Not known (frequency cannot be estimated from the available data):
aggression
abnormally increased pain sense
dental caries
stoppage or suppression of the flow of bile.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can
help provide more information on the safety of this medicine.
[To be completed nationally]
5.
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 label and carton after EXP. The expiry
date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. Store in the original package in
order to protect from light. Once the ampoule is opened the solution for injection / infusion should be used
immediately. Any unused portion should be discarded.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.
6.
Contents of the pack and other information
What Oxycodone Orion contains
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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 Oxycodone Orion looks like and contents of the pack
Oxycodone Orion solution for injection or infusion is a clear, colourless solution.
It is supplied in glass ampoules packed in cardboard boxes including 5 x 1 ml, 5 x 2 ml or 5 x 10 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
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Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark: Oxycodone Orion 10 mg/ml injektions- og infusionsvæske, opløsning
Finland: Oxycodone Orion 10 mg/ml injektio-/infuusioneste, liuos
Greece: Oxycodone Orion 10 mg/ml διάλυμα για ένεση ή έγχυση
Lithuania: Oxycodone Orion 10 mg/ml injekcinis / infuzinis tirpalas
Sweden: Oxycodone Orion 10 mg/ml injektions- eller infusionsvätska, lösning
This leaflet was last revised in 2015-05-07
<[To be completed nationally]>
Detailed information on this medicine is available on the website of {MS/Agency}
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----------------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only. See SmPC for more information.
These instructions provide technical information about Oxycodone Orion 10 mg/ml solution for injection
or infusion.
Instructions for use/handling
Use solution for injection or infusion immediately after opening. Any unused portion should be discarded.
If needed, dilute with 9 mg/ml (0.9%) saline or 50 mg/ml (5%) glucose or water for injections.
If Oxycodone Orion injection is used concurrently with cyclizine, mixed solution is diluted with water for
injections. 9 mg/ml (0.9%) sodium chloride solution must not be used. If the concentration of cyclizine in the
mixed combination is under 3 mg/ml, mixture is physically and chemically stable for 24 hours at room
temperature. If the concentration of cyclizine in the mixture is over 3 mg/ml, solution is unstable and may be
precipitated.
Prochlorperazine is chemically incompatible with Oxycodone Orion injection.
Oxycodone Orion injection, undiluted or diluted to 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%)
glucose solution or water for injections is physically and chemically stable when in contact with
polypropylene or polycarbonate syringes, polyethylene or PVC tubing and PVC, EVA, polyolefin /
polyamide, low density polyethylene and polypropylene infusion bags, over 24 hours at room temperature.
The injection, whether undiluted or diluted, does not need to be protected from light, if it is used with the
solution for infusion and equipment combinations used in these studies.
Inappropriate handling of the undiluted solution after opening of the original ampoule, or of the diluted
solutions may compromise the sterility of the product.
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.
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