OxyNorm
10 mg/ml, solution for injection or infusion
Oxycodone hydrochloride
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
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’.
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. 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 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.
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”.
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.
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.
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 heart beat, 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.
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.
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.
Further information
What OxyNorm injection contains
The active ingredient is oxycodone hydrochloride.
The other ingredients are:
- Citric acid monohydrate
- Sodium citrate
- Sodium chloride
- Hydrochloric acid, dilute
- Sodium hydroxide
- Water for injections
What OxyNorm injection looks like and the contents of the pack
This injection is a clear, colourless solution supplied in clear glass ampoules. The 10 mg/ml strength is available as either 1 ml or 2 ml of solution (containing 10 mg or 20 mg of oxycodone hydrochloride respectively).
Marketing Authorisation Holder and Manufacturer
This injection is made by
The marketing authorisation holder is
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: 16950/0128
This leaflet was last revised in July 2009.
OxyNorm and the NAPP device (logo) are Registered Trade Marks.
© 2009 Napp Pharmaceuticals Limited
P0056-A R2V2 UK AW 16-02-09
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