OXYNORM 5 MG CAPSULES

Active substance: OXYCODONE HYDROCHLORIDE

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Package leaflet: Information for the user

OxyNorm® 5 mg capsules
(oxycodone hydrochloride)
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.
OxyNorm is available in other strengths and forms
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
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.
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.
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
blister and carton. 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 your capsules above 30°C.
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 capsules contain
The active substance is oxycodone hydrochloride.
Each capsule contains 5 mg of oxycodone hydrochloride.
The other ingredients are:
Microcrystalline cellulose
Magnesium stearate
Titanium dioxide (E171)
Red and yellow iron oxide (E172)
Indigo carmine (E132)
Sodium laurilsulphate
Gelatin
Shellac
Propylene glycol
Sunset yellow (E110).
Black iron oxide (E172)
What OxyNorm capsules look like and the contents of the pack
The capsules orange/beige and are marked ONR on cap and 5 on
body.
In each box there are 28, 56 or 98 capsules.
Manufacturer
Bard Pharmaceuticals Limited,
Cambridge Science Park,
Milton Road,
Cambridge,
CB4 0GW.
Procured within the EU
Product Licence holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride G75 0TD.
PL 19065/0395

CD

POM

This leaflet was last revised 24.09.2014
® OxyNorm is a registered trade mark Mundipharma AG
E0395/4

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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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