Description

OxyNorm 5mg Capsules/OxyNorm 10mg Capsules/OxyNorm 20mg Capsules
(oxycodone hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
*
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called OxyNorm 5mg,10mg and 20mg capsules but will be
referred to as OxyNorm capsules throughout this leaflet.
What is in this leaflet
What oxycodone are and what they are used for
What you need to know before you take OxyNorm capsules
How to take OxyNorm 5mg capsules
Possible side effects
How to store OxyNorm capsules
Contents of the pack and other information
What oxycodone 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’.
What you need to know before you take OxyNorm 5mg
capsules
Do not take oxycodone if you:
*
are allergic to oxycodone, or any of the other ingredients of the capsules
(listed in section 6);
*
have breathing problems, such as severe chronic obstructive lung disease,
severe bronchial asthma or severe 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 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 moderate to severe liver problems. If you have other long-term liver
problems you should only take these capsules if recommended by your
doctor;
*
have ongoing problems with constipation;
*
are under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking these capsules if you:
*
are elderly or weakened;
*
have an under-active thyroid gland (hypothyroidism), as you may need a
lower dose;
*
have myxoedema (a thyroid disorder with dryness, coldness and swelling
[‘puffiness’] of the skin affecting the face and limbs;
*
have a head injury, severe headache or feel sick as this may indicate that
the pressure in your skull is increased;
*
have low blood pressure (hypotension);
*
have low blood volume (hypovolaemia); this can happen with severe
external or internal bleeding, severe burns, excessive sweating, severe
diarrhoea or vomiting;
*
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);
*
have problems with your gall bladder or bile duct;
*
have inflammatory bowel disease;
*
have an enlarged prostate gland, which causes difficulty in passing urine
(in men);
*
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), e.g. Addison’s disease;
*
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;
*
have kidney or liver problems;
*
have previously suffered from withdrawal symptoms such as agitation,
anxiety, shaking or sweating, upon stopping taking alcohol or drugs;
*
are or have ever been addicted to alcohol or drugs or have a known
opioid dependence;
*
have an increased sensitivity to pain;
*
need to take increasingly higher doses of OxyNorm 5mg to gain the same level
of pain relief (tolerance).
If you are going to have an operation, please tell the doctor at the hospital
that you are taking these tablets.
Other medicines and OxyNorm 5mg capsules
Please tell your doctor or pharmacist if you are taking, have recently taken
or might take 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.
Tell your doctors or-pharmacist if you are taking:
*
a type of medicine known as a monoamine oxidase inhibitor or you have
taken this type of medicine in the last two weeks;
* medicines to help you sleep or stay calm (for example tranquillisers,
hypnotics or sedatives);
* medicines to treat depression (such as paroxetine);
* medicines to treat psychiatric or mental disorders (such as phenothiazines
or neuroleptic drugs);
*
other strong analgesics (‘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, voriconazole, itraconazole
and posaconazole);
*
antibiotics (such as clarithromycin, erythromycin or telithromycin);
* medicines known as ‘protease inhibitors’ to treat HIV (e.g. boceprevir,
ritonavir, indinavir, nelfinavir or saquinavir);
*
rifampicin (to treat tuberculosis);
*
carbamazepine (a medicine to treat sezures, fits or convulsions and certain
pain conditions);
*
phenytoin (a medicine to treat seizures, fits or convulsions);
*
a herbal remedy called St. John’s Wort (also known as Hypericum
perforatum);
*
antihistamines;
* medicines to treat Parkinson’s disease.
Also tell your doctor if you have recently been given an anaesthetic.
Taking OxyNorm capsules with food, drink and alcohol
Drinking alcohol during your treatment with these capsules may make you
sleepy or increase the risk of serious side effects such as shallow breathing
with a risk of stopping breathing, and loss of consciousness. It is
recommended not to drink alcohol while you’re taking OxyNorm 5mg capsules.
You should avoid drinking grapefruit juice during your treatment with this
medicine.
Pregnancy and breastfeeding
Do not take these capsules if you are pregnant or breastfeeding.
Ask your doctors 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-drivinglaw
Talk to your doctors or-pharmacist if you are not sure whether it is safe for
you to drive while taking this medicine.
OxyNorm 5 mg capsules contain sunset yellow (E110)
The 5 mg capsules contain sunset yellow (E110) which may cause allergic
reactions.
How to take OxyNorm 5mg 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.
Patients with kidney or liver problems
Please tell your doctor if you suffer from kidney or liver problems as they
may prescribe a lower dose depending on your condition.