OXYCODONE HYDROCHLORIDE 5MG CAPSULES

Active substance: OXYCODONE HYDROCHLORIDE

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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.

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’.

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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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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.

01/04/14
TVT CHECKED

UK PIL DATED JULY 2009
REPORTING OF SIDE EFFECTS
DRUG DRIVING TEXT

DATE OF PROOF:

06464/2969F

DT

CODE:

04-1957

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.

Oxynorm 5mg caps

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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…”).

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CUSTOMER: Waymade

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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.

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.
The 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 if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
• 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 or in the information provided with the medicine
and
• It was not affecting your ability to drive safely
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.
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.
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.

WARNING!

This product is known as the above name but will be referred to as Oxynorm capsules throughout this leaflet. Other strengths
(10mg and 20mg) are also available.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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WARNING!

OXYNORM® 5mg CAPSULES/
OXYCODONE HYDROCHLORIDE 5mg CAPSULES
(oxycodone hydrochloride)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
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
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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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.

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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.

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.

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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 not take the capsules after the last day of that month i.e. August 2010
Do not store above 30˚C.
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 5mg capsules/Oxycodone hydrochloride 5mg capsules.

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

Each Oxynorm 5mg capsule/Oxycodone hydrochloride 5mg capsules contains 4.5mg of the active ingredient oxycodone
(equivalent to 5mg oxycodone hydrochloride) in a hard gelatin capsule which has a brown cap marked ‘ONR’ and an orange body
marked ‘5’ in black.

06464/2969F
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UK PIL DATED JULY 2009
REPORTING OF SIDE EFFECTS
DRUG DRIVING TEXT

Oxynorm 5mg caps

Oxynorm 5mg capsules/Oxycodone hydrochloride 5mg capsules are available in packs of 28 and 56 capsules.

PRODUCT:

CUSTOMER: Waymade

Oxynorm capsules also contain the following inactive ingredients, microcrystalline cellulose, sodium Lauryl sulfate, magnesium
stearate, indigo carmine (E132), iron oxide (E172), gelatin, titanium dioxide (E171) and sunset yellow (E110).

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PL No: 06464/2969

This product is manufactured by Bard Pharmaceuticals Ltd., Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United
Kingdom and procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR.
Leaflet revision and issue date (Ref.) 01.04.2014
Oxynorm is a registered trademark of Mundipharma AG.

WARNING!

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.

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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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

WARNING!

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
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
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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