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1. Oxynorm 10mg/Ml Solution For Injection Or Infusion
2. Oxynorm 10mg/Ml Solution For Injection Or Infusion

Document: leaflet MAH BRAND_PL 16950-0128 change

• leaflet MAH BRAND_PL 16950-0128
• leaflet MAH BRAND_PLPI 18799-2760
• leaflet MAH BRAND_PLPI 20636-1701

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

Do not use OxyNorm injection if you:

•    are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the 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 this 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;

•    have myxoedema (a thyroid disorder with dryness, coldness and swelling [‘pufliness’] 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 bums, 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 this injection 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:

•    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 (such as phenothiazines or neuroleptics);

•    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 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.

Also tell your doctor if you have recently

been given an anaesthetic.

OXYNORM INJ 10MG-ML PIL UK 196016 016003-i V2.indd 2

Using OxyNorm injection with food, drink and alcohol

Drinking alcohol during your treatment with this 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 this injection if you are pregnant or breastfeeding.

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

Driving and using machines This injection may cause a number of side effects such as drowsiness which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually most noticeable when you first start using the injection, or when changing 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.

•    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.

_ be reduced by 50% (for example a total g daily dose of 10 mg orally in opioid naive g patients), and each patient should be titrated 5 to adequate pain control according to their (o clinical situation.

§ Paediatric population:

? There are no data on the use of OxyNorm injection in patients under 18 years of age. Use in non-malignantpain:

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 osteoarthritic 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 treatnwnt:

Oxycodone should not be used for longer than necessary.

Discontinuation of treatnwnt:

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 Each ampoule is for single use in a single patient. The injection should be given immediately after opening the ampoule and 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 file 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 device logo are registered trade marks.

© 2009-2015 Napp Pharmaceuticals Limited.

OXYNORM INJ 10MG-ML PIL UK 196016 016003-1 V2.indd 3

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).

•    Dizziness.

•    Headache.

•    Itchy skin.

Common side effects

(May affect up to 1 in 10 people)

•    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 the 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, drills, swelling of the hands, ankles or feet.

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

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

•    A need to take increasingly higher doses of this medicine to obtain the 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 the

available data)

•    An increased sensitivity to pain.

•    Aggression.

•    Tooth decay.

•    Absence of menstrual periods.

•    A blockage in tire flow of bile from tire 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 tire newborn. Symptoms to look for in the 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 the Yellow Card Scheme at: www.nrlrra.gov.uk/yellowcard. By reporting side effects you can help provide more information on tire safety of this medicine.

5. How to store OxyNorm injection

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

Do not use this injection after tire expiry date which is stated on the ampoule label and carton. EXP 08 2020 means that you should not use tire injection after tire last day of that month i.e. August 2020. There are no special precautions for storage prior to use however once tire ampoule is opened tire injection should be used immediately. Any unused portion should be discarded immediately.

Do not throw away airy 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.

What OxyNorm injection contains

The active ingredient is oxycodone hydrochloride.

The other ingredients are:

•    Citric acid nronohydrate

•    Sodium citrate

•    Sodium chloride

•    Hydrochloric acid, dilute

•    Sodium hydroxide

•    Water for injections