Oxynorm 10mg/Ml Solution For Injection Or Infusion
Out of date information, search anotherOxyNorm® 10 mg/ml 07,0.™81]
Solution for Injection or Infusion
(oxycodone hydrochloride)
PATIENT INFORMATION LEAFLET
The name of your medicine is OxyNorm 10mg/ml Solution for Injection or Infusion but will be referred to as OxyNorm injection throughout the leaflet.
Read all of this leaflet carefully before you start using this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What OxyNorm injection is and what it is used for
2. Before you use OxyNorm injection
3. How to use OxyNorm injection
4. Possible side effects
5. How to store OxyNorm injection
6. Further information
1. WHAT OXYNORM INJECTION IS AND WHAT IT IS USED FOR
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'.
2. 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 (see section 6 ‘Further Information');
- have breathing problems, such as chronic obstructive airways disease, chronic bronchial asthma or respiratory depression. You 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 head injury that causes a severe headache or makes you feel sick. This is because the injection may make these symptoms worse or hide the extent of the head injury;
- 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 severe kidney problems or moderate to severe liver problems. If you have other long term kidney or liver problems you should only use this injection if recommended by your doctor;
- have ongoing problems with constipation;
- are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks;
- are under 18 years of age.
Take special care with OxyNorm injection
Before treatment with this injection tell your doctor or pharmacist if you:
- have an under-active thyroid gland (hypothyroidism), as you may need a lower dose;
- have a severe headache or feel sick as this may indicate that the pressure in your skull is increased;
- have low blood pressure (hypotension);
- 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) or problems with your gall bladder;
- have inflammatory bowel disease;
- have prostate problems;
- 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);
- 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;
- are or have ever been addicted to alcohol or drugs;
- have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping taking alcohol or drugs.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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.
This injection must not be used together with a monoamine oxidase inhibitor, or you have taken this type of medicine in the last two weeks (see section 2 “Do not use...”).
Tell your doctor or pharmacist if you are taking:
- medicines to help you sleep (for example tranquillisers, hypnotics or sedatives);
- medicines to treat depression;
- medicines to treat psychiatric or mental disorders (such as phenothiazines or neuroleptics);
- other strong analgesics or ‘painkillers';
- muscle relaxants;
- medicines to treat high blood pressure.
Also tell your doctor if you have recently been given an anaesthetic.
Using OxyNorm injection with alcohol
Drinking alcohol during your treatment with this injection may make you sleepy. If you are affected you should avoid drinking alcohol.
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-drivinglaw.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Important information about some of the ingredients of OxyNorm injection
This 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.
- 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 under 18 years of age should not be given the injection.
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 this injection discuss this with your doctor.
Information for Health Professionals
OxyNorm® 10 mg/ml Solution for Injection or Infusion
(oxycodone hydrochloride)
This leaflet provides technical information for the healthcare professional about OxyNorm 10 mg/ml, solution for injection or infusion.
Posology and method of administration
Route of administration:
Subcutaneous injection or infusion.
Intravenous injection or infusion.
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): 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:
Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control.
Patients with renal and hepatic impairment:
Patients with mild to moderate renal impairment and/or mild hepatic impairment should be treated with caution. The lowest dose should be given with careful titration to pain control.
Children under 18 years:
There are no data on the use of OxyNorm injection in patients under 18 years of age.
PL No: 20636/1701
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, sick or dizzy. 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. Withdrawal symptoms such as agitation, anxiety, palpitations, shaking or sweating may occur if you suddenly stop using this injection.
If you have any further questions on the use of this injection, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this 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 in breathing, 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).
As with all strong painkillers, there is a risk that you may become addicted or reliant on this injection.
Common side effects
(Probably affecting more than 1 in 100 people using this injection)
- 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 using your injection or when your dose is increased, but it should wear off after a few days).
- Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea.
- Headache, confusion, a feeling of unusual weakness, dizziness, anxiety, nervousness, twitching, difficulty in sleeping, abnormal thoughts or dreams.
- Difficulty in breathing or wheezing, shortness of breath, decreased cough reflex.
- Rash, itchy skin.
- Sweating, chills.
Uncommon side effects
(Probably affecting fewer than 1 in 100 people using this injection)
- Difficulty in swallowing, belching, hiccups, wind, gastrointestinal disorders (e.g. upset stomach), changes in taste.
- A feeling of dizziness or ‘spinning', a feeling of ‘faintness' especially on standing up, hallucinations, mood changes, depression, a feeling of extreme happiness, restlessness, agitation, generally feeling unwell, loss of memory, shaking, difficulties with speech, reduced sensitivity to pain or touch, tingling in the hands or feet, seizures, fits or convulsions, blurred vision.
- Difficulty passing urine, impotence, decreased sexual drive, absence of menstrual periods.
- Fast, irregular heartbeat, low blood pressure, flushing of the skin.
- Dehydration, thirst, 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 to obtain the same level of pain relief (tolerance).
Uncommonly, this injection may affect the results of blood tests to check that your liver is working properly.
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.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE OXYNORM INJECTION
Keep out of the reach and sight of children. Accidental overdose by a child is dangerous and may be fatal.
Do not use this injection after the expiry date which is stated on the ampoule label and carton.
EXP 08 2010 means that you should not use the injection after the last day of that month i.e. August 2010. There are no special precautions for storage prior to use however once the ampoule is opened the injection should be used immediately.
Any unused portion should be discarded immediately.
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.
6. FURTHER INFORMATION What OxyNorm injection contains
The injection contains the active ingredient oxycodone as 10 mg/ml of oxycodone hydrochloride.
Each 1ml ampoule contains 10 mg of oxycodone hydrochloride equivalent to 9mg oxycodone. Each 2ml ampoule contains 20 mg of oxycodone hydrochloride equivalent to 18 mg oxycodone.
The solution also contains the following inactive ingredients, but they are not medicines: citric acid monohydrate, sodium citrate, sodium chloride, sodium hydroxide, water for injections, hydrochloric acid, dilute.
What OxyNorm injection looks like and the contents of the pack
In each box there are 5 clear glass ampoules, containing 1 ml or 2 ml of colourless solution for injection or infusion.
Marketing Authorisation Holder and Manufacturer
OxyNorm injections are made by Boots Contract Manufacturing, 1 Thane Road, Nottingham, Nottinghamshire, NG2 3AA, United Kingdom. Procured from within the EU by Product Licence holder Star Pharmaceuticals Ltd,
5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
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Leaflet revision and issue date (Ref :) 07.10.14[8]
OxyNorm is a registered trademark of Napp Pharmaceuticals Limited.
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 osteoarthritic pain and intervertebral disc disease.
The need for continued treatment in non-malignant pain should be assessed at regular intervals.
Cessation of Therapy:
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 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.
Leaflet revision and issue date (Ref :) 07.10.14[8]