Document: Oxycodone Orion 10 mg per ml solution for injection or infusion ENG PL change

• Oxycodone Orion solution for injection or infusion PL
• Oxycodone Orion 10 mg per ml solution for injection or infusion ENG PL

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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

6. Contents of the pack and other information

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.

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 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.

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.

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/infusion 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

• 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 Oxycodone Orion, 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’.

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.

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):

• constipation, nausea, vomiting. Your doctor can prescribe appropriate medicines to treat these symptoms.

• itching.

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

• 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 1 in 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 vessels

• change in sense of taste, gastrointestinal disorder, flatulence, difficulty in swallowing, intestinal obstruction, belching

• increased liver enzyme values

• urticaria, dryness of the skin

• difficulty in passing urine, urethral spasm

• absence 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 1 in 1,000 people):

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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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

• 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/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

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

Sweden: Oxycodone Orion 10 mg/ml injektions-/infusionsvätska, lösning

This leaflet was last revised in 15 July 2016

<[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/infusion.

Instructions for use/handling

Use solution for injection/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/infusion 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/infusion.

Oxycodone Orion injection/infusion, 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/infusion, 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.