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Oxynorm 50 Mg/Ml Solution For Injection Or Infusion

Document: leaflet MAH BRAND_PL 16950-0155 change

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OxyNorm® 50 mg/ml, solution for injection or infusion

Oxycodone hydrochloride


1. What OxyNorm injection is and what it is used for


Package leaflet: Information for the user


Read all of this leaflet carefully before you start using 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 pharmacist.

•    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

What OxyNorm injection is and what it is used for

What you need to know before you use OxyNorm injection

How to use OxyNorm injection

Possible side effects

How to store OxyNorm injection

Contents of the pack and other information

This injection has been prescribed for you by your doctor to relieve moderate to severe pain. It contains the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or ‘painkillers’. The other ingredients are listed in section 6 of this leaflet.

2. What you need to know before you use OxyNorm injection_

Do not use OxyNorm injection if you:

•    are allergic to oxycodone, or any of the other ingredients of OxyNorm injection (listed in section 6);

•    have breathing problems, such as severe chronic obstructive lung disease, severe bronchial asthma or severe respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;

•    have a condition where the small bowel does not work properly (paralytic ileus) or you have severe pain in your abdomen;

•    have a heart problem after long-term lung disease (cor pulmonale);

•    have moderate to severe liver problems. If you have other long term liver problems you should only use OxyNorm injection if recommended by your doctor;

•    have ongoing problems with constipation;

•    are under 18 years of age.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before treatment with

OxyNorm injection if you:

•    are elderly or weakened;

•    have an under-active thyroid gland (hypothyroidism), as you may need a lower dose of OxyNorm injection;

•    have myxoedema (a thyroid disorder with dryness, coldness and swelling [‘puffiness’] of the skin affecting the face and limbs;

•    have a head injury, severe headache or feel sick as this may indicate that the pressure in your skull is increased;

•    have low blood pressure (hypotension);

•    have low blood volume (hypovolaemia); this can happen with severe external or internal bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting;

•    have a mental disorder as a result of an infection (toxic psychosis);

•    have inflammation of the pancreas (which causes severe pain in the abdomen and back);

•    have problems with your gall bladder or bile duct;

•    have inflammatory bowel disease;

•    have an enlarged prostate gland, which causes difficulty in passing urine (in men);

•    have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick), e.g. Addison’s disease;

•    have breathing problems such as severe pulmonary disease. Your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing;

•    have kidney or liver problems;

•    have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping taking alcohol or drugs;

•    are or have ever been addicted to alcohol or drugs or have a known opioid dependence;

•    have an increased sensitivity to pain;

•    need to take increasingly higher doses of OxyNorm to gain the same level of pain relief (tolerance).

If you are going to have an operation, please tell the doctor at the hospital that you are taking this medicine.

Other medicines and OxyNorm injection

Please tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines, including medicines obtained without a prescription. If you use OxyNorm injection with some other medicines, the effect of OxyNorm injection or the other medicines may be changed.

Tell your doctor or pharmacist if you are taking:

•    a type of medicine known as a monoamine oxidase inhibitor or you have taken this type of medicine in the last two weeks;

•    medicines to help you sleep or stay calm (for example tranquillisers, hypnotics or sedatives);

•    medicines to treat depression (such as paroxetine);

•    medicines to treat psychiatric or mental disorders;

•    other strong analgesics (‘painkillers’);

•    muscle relaxants;

•    medicines to treat high blood pressure;

•    quinidine (a medicine to treat a fast heart beat);

•    cimetidine (a medicine for stomach ulcers, indigestion or heartburn);

•    antifungal medicines (such as ketoconazole, voriconazole, itraconazole and posaconazole);

•    antibiotics (such as clarithromycin, erythromycin or telithromycin);

•    medicines known as ‘protease inhibitors’ to treat HIV (e.g. boceprevir, ritonavir, indinavir, nelfinavir or saquinavir);

•    rifampicin (to treat tuberculosis);

•    carbamazepine (a medicine to treat seizures, fits or convulsions and certain pain conditions);

•    phenytoin (a medicine to treat seizures, fits or convulsions);

•    a herbal remedy called St. John’s Wort (also known as Hypericum perforatum);

•    antihistamines;

•    medicines to treat Parkinson’s disease

Using OxyNorm injection with food, drink and alcohol

Drinking alcohol during your treatment with OxyNorm injection may make you sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while you’re taking OxyNorm injection.

You should avoid drinking grapefruit juice during your treatment with this medicine.

Pregnancy and breastfeeding

Do not use OxyNorm injection if you are pregnant or breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel sleepy when you first start using OxyNorm injection, or when increasing to a higher dose. If you are affected you should not drive or use machinery.

This medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive while you have this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’).

•    This defence applies when:

•    The medicine has been prescribed to treat a medical or dental problem; and

•    You have taken it according to the instructions given by the prescriber and in the information provided with the medicine.

•    Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).

Details regarding a new driving offence concerning driving after drugs

have been taken in the UK may be found here:

https://www.gov.uk/drug-driving-law

Talk to your doctor or pharmacist if you are not sure whether it is safe for

you to drive while taking this medicine.

OxyNorm injection contains less than 1 mmol sodium (23 mg) per 1 ml, i.e. it is essentially “sodium-free”.

3. How to use OxyNorm injection

A doctor or nurse will usually prepare and administer the injection for you. The injection should be used immediately after opening. The dose and how often the injection is given may be adjusted according to the severity of your pain.

Adults (over 18 years of age)

The usual starting dose is dependent upon how the injection is administered. The usual starting doses are as follows:

•    As a single injection into a vein, the usual dose is 1 to 10 mg given slowly over 1 to 2 minutes. This can be repeated every 4 hours.

•    As an infusion into a vein, the usual starting dose is 2 mg/hour.

Information for Health Professionals

OxyNorm® 50 mg/ml, solution for injection or infusion

OXycodone hydrochloride


This leaflet provides technical information for the healthcare professional about OxyNorm 50 mg/ml, solution for injection or infusion.

Posology and method of administration

Posology:

The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication.

Adults over 18 years:

The following starting doses are recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases.

i.v. (Bolus): Dilute in 0.9% saline, 5% dextrose or water for injections.

Administer a bolus dose of 1 to 10 mg slowly over 1-2 minutes in opioid naive patients. Doses should not be administered more frequently than every 4 hours. i.v. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for injections. A starting dose of 2 mg/hour is recommended for opioid naive patients.

i.v. (PCA): Dilute in 0.9% saline, 5% dextrose or water for injections. Bolus doses of 0.03 mg/kg should be


administered with a minimum lock-out time of 5 minutes for opioid naive patients.

s.c. (Bolus): Use the 10 mg/ml or the 50 mg/ml strength and dilute in 0.9% saline, 5% dextrose or water for injections if required. A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as required for opioid naive patients. s.c. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for injections if required. A starting dose of 7.5 mg/day is recommended in opioid naive patients, titrating gradually according to symptom control. Cancer patients transferring from oral oxycodone may require much higher doses (see below).

Transferring patients between oral and parenteral oxycodone:

The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasised that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

Elderly patients:

Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control.


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Patients with renal and hepatic impairment: o The dose initiation should follow a conservative approach in gj these patients. The recommended adult starting dose should ° be reduced by 50% (for example a total daily dose of 10 mg g orally in opioid naive patients), and each patient should be ? titrated to adequate pain control according to their clinical situation.

Paediatric population:

There are no data on the use of OxyNorm injection in patients imder 18 years of age.

Use in non-malignant pain:

Opioids are not first-line therapy for chronic non-malignant pain, nor are they recommended as the only treatment.

Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoartbritic pain and intervertebral disc disease. The need for continued treatment in non-malignant pain should be assessed at regular intervals.

Route of administration:

Subcutaneous injection or infusion.

Intravenous injection or infusion.

Duration of treatment:

Oxycodone should not be used for longer than necessary. Discontinuation of 'treatment:

When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.


Instructions for use/handling

The injection should be given immediately after opening the ampoule. Once opened any unused portion should be discarded. Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution / dilution (etc) has taken place in controlled and validated aseptic conditions.

OxyNorm injection, undiluted or diluted to 1 mg/ml with 0.9% w/v saline, 5% w/v dextrose or water for injections, is physically and chemically stable when in contact with representative brands of polypropylene or polycarbonate syringes, polyethylene or PVC tubing and PVC or EVA infusion bags, over a 24 hour period at room temperature. The injection, whether undiluted or diluted to 1 mg/ml in the infusion fluids used in these studies and contained in the various assemblies, does not need to be protected from light. Inappropriate handling of the undiluted solution after opening of the original ampoule, or of the diluted solutions may compromise the sterility of the product.

This leaflet was last revised in November 2015.

® OxyNorm, NAPP and the NAPP logo are registered trade marks.

0 2009-2015 Napp Pharmaceuticals Limited.



•    As a single injection through a fine needle into the tissue under the skin, the usual starting dose is 5 mg repeated at 4-hourly intervals if needed.

•    As an infusion through a fine needle into the tissue under the skin, the usual starting dose is 7.5 mg/day.

•    If given by patient controlled analgesia (PCA), the dose is worked out according to your weight (0.03 mg per kg of body weight). Your doctor or nurse will set a suitable frequency.

Children

Children and adolescents imder 18 years of age should not be given the injection.

Patients with kidney or liver problems

Please tell your doctor if you suffer from kidney or liver problems as they may prescribe a lower dose depending on your condition.

The dose recommended by the doctor should not be exceeded. Check with the doctor or pharmacist if you are unsure.

If you find that you are still in pain whilst being given OxyNorm injection discuss this with your doctor.

If you use more OxyNorm injection than you should, or if someone else uses your injection Call your doctor or hospital straight away. People who have been given an overdose may feel very sleepy and sick. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining injection with you to show to the doctor.

If you stop using OxyNorm injection You should not suddenly stop using this injection unless your doctor tells you to. If you want to stop using your injection, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects.

If you have any further questions on the use of OxyNorm injection, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, OxyNorm injection can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties inbreathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.

The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression). Tell your doctor immediately if this happens to you.

As with all strong painkillers, there is a risk that you may become addicted or reliant on OxyNorm injection.

Very common side effects

(May affect more than l in 10 people)

•    Constipation (your doctor can prescribe a laxative to overcome this problem).

•    Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem).

•    Drowsiness (this is most likely when you start taking your medicine or when your dose is increased, but it should wear off after a few days).

OXYNORM INJ 50MG-ML PIL UK 196022 022003-I V2.indd 3

•    Sodium hydroxide

•    Water for injections

What OxyNorm injection looks like and the contents of the pack

OxyNorm injection is a clear, colourless solution supplied in clear glass ampoules. Tlie 50 mg/ml strength is available as 1 ml of solution (containing 50 mg of oxycodone hydrochloride).

Marketing Authorisation Holder and Manufacturer

OxyNorm injection is made by Bard Pharmaceuticals Limited for tlie Marketing Authorisation holder, Napp Pharmaceuticals Limited, both at Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.

This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on :

0800 198 5000

You will need to give details of the product name and reference number.

These are as follows:

Product name: OxyNorm solution for injection or infusion Reference number: 16950/0155

This leaflet was last revised in November 2015.

® OxyNorm, NAPP and tlie NAPP logo are registered trade marks.

0 2009-2015 Napp Pharmaceuticals Limited.

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•    Dizziness.

•    Headache.

•    Itchy skin.

Common side effects

(May affect up to 1 in lOpeople)

•    Dry mouth, loss of appetite, indigestion abdominal pain or discomfort, diarrhoea.

•    Confusion depression a feeling of unusual weakness, shaking, lack of energy, tiredness, anxiety, nervousness, difficulty in sleeping, abnormal thoughts or dreams.

•    Difficulty in breathing or wheezing, shortness of breath, decreased cough reflex.

•    Rash.

•    Sweating.

Uncommon side effects

(May affect up to 1 in 100 people)

•    Difficulty in swallowing, belching, hiccups, wind, a condition where the bowel does not work properly (ileus), inflammation of tlie stomach changes in taste.

•    A feeling of dizziness or ‘spinning’, hallucinations, mood changes, unpleasant or uncomfortable mood, a feeling of extreme happiness, restlessness, agitation, generally feeling unwell, loss of memory, difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness in the hands or feet, seizures, fits or convulsions, blurred vision, fainting, unusual muscle stiffness or slackness, involuntary muscle contractions.

•    Difficulty passing urine, impotence, decreased sexual drive, low levels of sex hormones in the blood (‘hypogonadism’, seen in a blood test).

•    Fast, irregular heart beat, flushing of the skin.

•    Dehydration, thirst, chills, swelling of the hands, ankles or feet.

•    Dry skin, severe flaking or peeling of the skin.

•    Redness of the face, reduction in size of the pupils in the eye, muscle spasm, high temperature.

•    A need to take increasingly higher doses of this medicine to obtain tlie same level of pain relief (tolerance).

•    Colicky abdominal pain or discomfort.

•    A worsening of liver function tests (seen in a blood test).

Rare side effects

(May affect up to 1 in 1,000 people)

•    Low blood pressure.

•    A feeling of ‘faintness’ especially on standing up.

•    Hives (nettle rash).

Frequency not known

(Frequency cannot be estimated from tlie available data)

•    An increased sensitivity to pain.

•    Aggression.

•    Tooth decay.

•    Absence of menstrual periods.

•    A blockage in tlie flow of bile from tlie liver (cholestasis). This can cause itchy skin, yellow skin, very dark urine and very pale stools.

•    Long term use of OxyNorm injection during pregnancy may cause life-threatening withdrawal symptoms in tlie newborn. Symptoms to look for in tlie baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via tlie Yellow Card Scheme at: www.mlira.gov.nk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    Him to store OxyNorm injection

Keep this medicine out of tlie sightand reach of children. Accidental overdose by a child is dangerous and may be fatal.

Do not use OxyNorm injection after tlie expiry date which is stated on tlie ampoule label and carton. EXP 08 2020 means that you should not use tlie injection after tlie last day of that month i.e. August 2020.

There are no special precautions for storage prior to use however once tlie ampoule is opened tlie injection should be used immediately. Any unused portion should be discarded immediately.

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 tlie environment.

6.    Contents of the pack and other information

What OxyNorm injection contains

Tlie active ingredient is oxycodone hydrochloride.

The other ingredients are:

•    Citric acid monohydrate

•    Sodium citrate

•    Sodium chloride

•    Hydrochloric acid, dilute


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