Oxynorm 10mg
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OXYNORM® 5mg CAPSULES OXYNORM® 10mg CAPSULES OXYNORM® 20mg CAPSULES (oxycodone hydrochloride)
Patient Information Leaflet
27mm
This product is available as all of the above strengths and will be referred to as Oxynorm capsules throughout this leaflet
Read all of this leaflet carefully before you start taking 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 capsules are and what they are used for
2. Before you take Oxynorm capsules
3. How to take Oxynorm capsules
4. Possible side effects
5. How to store Oxynorm capsules
6. Further information
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1. What Oxynorm capsules are and what they are used for
These capsules have been prescribed for you by your doctor to relieve moderate to severe pain. They contain the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or ‘painkillers'.
2. Before you take Oxynorm capsules
Do not take Oxynorm capsules if you:
• are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the capsules (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 capsules 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), your stomach empties more slowly than it should (delayed gastric emptying) 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 take these capsules 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 capsules
Before treatment with these capsules 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 ever have 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.
If you are going to have an operation, please tell the doctor at the hospital that you are taking these capsules.
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 take these capsules with some other medicines, the effect of these capsules or the other medicine may be changed.
These capsules must not be used together with a monoamine oxidase inhibitor, or if you have taken this type of medicine in the last two weeks (see section 2 "Do not take...”).
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 neuroleptic drugs);
• other strong analgesics or ‘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);
• antibiotics (such as erythromycin).
Also tell your doctor if you have recently been given an anaesthetic.
Taking Oxynorm capsules with alcohol
Drinking alcohol during your treatment with these capsules may make you sleepy. If you are affected you should avoid drinking alcohol.
Pregnancy and breastfeeding
Do not take these capsules if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
These capsules may cause a number of side effects such as drowsiness which may 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 taking the capsules, 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.
Important information about some of the ingredients of Oxynorm capsules
The 5 mg capsules contain sunset yellow (E110) which may cause allergic reactions.
WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY WARNING! THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
MUST BETAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
3. How to take Oxynorm capsules
Always take these capsules exactly as your doctor has told you. The label on your medicine will tell you how many capsules to take and how often.
27mm
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Adults (over 18 years of age)
The usual starting dose is one 5 mg capsule every 4 to 6 hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these capsules discuss this with your doctor.
Children
Children and adolescents under 18 years of age should not take the capsules.
Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure. Swallow your capsules whole with water. Do not chew or crush them.
You must only take the capsules by mouth. The capsules contents should never be injected as this may lead to serious side effects, which may be fatal.
If you take more Oxynorm capsules than you should or if someone accidentally swallows your capsules
Call your doctor or hospital straight away.
People who have taken 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 capsules with you to show to the doctor.
If you forget to take Oxynorm capsules
If you miss a dose you should take the next dose as soon as you remember then carry on as before. Do not take two doses within 4 hours. Do not take a double dose to make up for forgotten capsules.
If you stop taking Oxynorm capsules
You should not suddenly stop taking these capsules unless your doctor tells you to.
If you want to stop taking your capsules, 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 taking these capsules.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, these capsules 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 these capsules.
Common side effects
(Probably affecting more than 1 in 100 people taking these capsules.)
• 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 capsules 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 taking these capsules)
• 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 or numbness, seizures, fits or convulsions, blurred vision.
• Difficulty in 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, these capsules 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 capsules
• Keep out of the sight and reach of children.
• Accidental overdose by a child is dangerous and may be fatal.
• Do not use any capsules after the expiry date which is stated on the carton, carton label or blister label. Exp 08 2010 means that you should not take the capsules after the last day of that month i.e. August 2010.
• Do not store above 30°C. Keep in a safe place where children cannot see or reach them.
• If your doctor tells you to stop using the capsules, then you must take the unused capsules back to your pharmacist for safe disposal.
• If the capsules become discoloured or show any other signs of deterioration, you should ask your doctor or pharmacist for advice.
• 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
Your medicine is called Oxynorm capsules.
Each Oxynorm 5mg capsule contains 5mg of the active ingredient oxycodone hydrochloride in a hard gelatin capsule which has a brown cap marked ‘ONR' and an orange body marked ‘5' in black.
Each Oxynorm 10mg capsule contains 10mg of the active ingredient oxycodone hydrochloride in a hard gelatin capsule which has a brown cap marked ‘ONR' and a white body marked ‘10' in black.
Each Oxynorm 20mg capsule contains 20mg of the active ingredient oxycodone hydrochloride in a hard gelatin capsule which has a brown cap marked ‘ONR' and a pink body marked ‘20' in black.
Oxynorm capsules also contain the following inactive ingredients, microcrystalline cellulose, sodium lauryl sulphate, magnesium stearate, indigo carmine (E132), red iron oxide (E172), yellow iron oxide (E172), gelatin and titanium dioxide (E171).
Printing ink contains: shellac, black iron oxide and propylene glycol.
Oxynorm 5mg capsule also contains sunset yellow (E110).
Oxynorm capsules, all strengths, are available in packs of 56 capsules.
WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY WARNING! THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
MUST BETAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
PL No: 18799/2555 Oxynorm 5mg capsules PL No: 18799/2553 Oxynorm 10mg capsules PL No: 18799/2554 Oxynorm 20mg capsules
These products are manufactured by Bard Pharmaceuticals Ltd., Cambridge Science Park, Milton Road, Cambridge, England and procured from within the EU and repackaged by the Product Licence holder who is:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, UK.
POM
Leaflet revision and issue date (Ref.) 27.04.2015 Oxynorm is a registered trademark of Mundipharma AG.
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