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Package leaflet: Information for the user

OxyContin® 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg,
60 mg, 80 mg and 120 mg prolonged release tablets
Oxycodone hydrochloride

Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it
• 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 OxyContin tablets are and what they are
used for
2. Before you take OxyContin tablets
3. How to take OxyContin tablets
4. Possible side effects
5. How to store OxyContin tablets
6. Further information

OXYCONTIN TABS 5-120MG PIL UK 4439-5 V5.indd 2

1. What OxyContin tablets are and what
they are used for
These tablets have been prescribed for you by
your doctor to relieve moderate to severe pain
over a period of 12 hours. They contain the
active ingredient oxycodone which belongs to a
group of medicines called strong analgesics or

2. Before you take OxyContin tablets
Do not take OxyContin tablets if you:
• are allergic (hypersensitive) to oxycodone, or
any of the other ingredients of the tablets (see
section 6 ‘Further Information’);
• have breathing problems, such as chronic
obstructive lung disease, severe 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 tablets 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 longterm kidney or liver problems you should only
take these tablets if recommended by your
have ongoing problems with constipation;
are taking a type of medicine known as a
monoamine oxidase inhibitor (examples include
tranylcypromine, 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 OxyContin tablets
Before treatment with these tablets tell your
doctor or pharmacist if you:
• are elderly or weakened;
• have an under-active thyroid gland
(hypothyroidism), as you may need a lower
• have myxoedema (a thyroid disorder with
dryness, coldness and swelling [‘puffiness’] of
the skin affecting the face and limbs;

• have a severe headache or feel sick as this
may indicate that the pressure in your skull is
• 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
• 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
• 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
OxyContin 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.
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 tablets with
some other medicines, the effect of these tablets
or the other medicine may be changed.
These tablets 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 or stay calm
(for example tranquillisers, hypnotics or
• medicines to treat depression (such as
• 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
• 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
• phenytoin (a medicine to treat seizures, fits or
• a herbal remedy called St. John’s Wort (also
known as Hypericum perforatum).
Also tell your doctor if you have recently been
given an anaesthetic.
Taking OxyContin tablets with food, drink
and alcohol
Drinking alcohol whilst taking OxyContin
tablets may make you feel more 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 OxyContin tablets.
You should avoid drinking grapefruit juice
during your treatment with this medicine.
Pregnancy and breastfeeding
Do not take these tablets if you are pregnant or
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
These tablets 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 taking the
tablets, or when changing to a higher dose. If
you are affected you should not drive or use
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:
•  he medicine has been prescribed to treat a
medical or dental problem; and
•  ou 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:
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 OxyContin tablets
These tablets contain lactose which is a form of
sugar. If you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking these tablets.

3. How to take OxyContin tablets
Always take these tablets exactly as your doctor
has told you. The label on your medicine will tell
you how many tablets to take and how often.
Adults (over 18 years of age)
The usual starting dose is one 10 mg tablet every
12 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
tablets, discuss this with your doctor.
Do not exceed the dose recommended by your
doctor. You should check with your doctor or
pharmacist if you are not sure.
Swallow your tablets whole with water. Do not
crush, dissolve or chew them.
OxyContin tablets are designed to work
properly over 12 hours when swallowed
whole. If a tablet is broken, crushed, dissolved
or chewed, the entire 12-hour dose may be
absorbed rapidly into your body. This can be
dangerous, causing serious problems such as
an overdose, which may be fatal.
You should take your tablets every 12 hours. For
instance, if you take a tablet at 8 o’clock in the
morning, you should take your next tablet at
8 o’clock in the evening.
You must only take the tablets by mouth. The
tablets should never be crushed or injected as
this may lead to serious side effects, which may
be fatal.
Children and adolescents under 18 years of age
should not take the tablets.

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550x148mm (LSN-NAPP-02) (L) V1

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.
If you take more OxyContin tablets than you
should or if someone accidentally swallows your
Call your doctor or hospital straight away. People
who have taken an overdose may feel very
sleepy, sick or dizzy, or have hallucinations. 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 tablets with you to show to the
If you forget to take your OxyContin tablets
If you remember within 4 hours of the time your
tablet was due, take your tablet straight away. Take
your next tablet at your normal time. If you are
more than 4 hours late, please call your doctor or
pharmacist for advice. Do not take a double dose to
make up for a forgotten tablet.
If you stop taking OxyContin tablets
You should not suddenly stop taking these tablets
unless your doctor tells you to. If you want to stop
taking your tablets, 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 tablets.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

OXYCONTIN TABS 5-120MG PIL UK 4439-5 V5.indd 3

4. Possible side effects
Like all medicines, these tablets 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). Tell your
doctor immediately if this happens to you.
As with all strong painkillers, there is a risk that
you may become addicted or reliant on these
Very common side effects
(May affect more than 1 in 10 people)
• 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 tablets or when your dose is
increased, but it should wear off after a few
• Dizziness.
• Headache.
• Itchy skin.

Common side effects
(May affect up to 1 in 10 people)
• Dry mouth, loss of appetite, indigestion,
abdominal pain or discomfort, diarrhoea.
• Confusion, depression, a feeling of unusual
weakness, shaking, anxiety, nervousness,
difficulty in sleeping, abnormal thoughts or
• Difficulty in breathing or wheezing, shortness
of breath, decreased cough reflex.
• Rash.
• Sweating, chills.
Uncommon side effects
(May affect up to 1 in 100 people)
• Difficulty in swallowing, belching, hiccups,
wind, a condition where the bowel does not
work properly (ileus), inflammation of the
stomach, changes in taste, tooth decay.
• A blockage in the flow of bile from the liver
(cholestasis). This can cause itchy skin, yellow
skin, very dark urine and very pale stools.
• A feeling of dizziness or ‘spinning’,
hallucinations, mood changes, unpleasant or
uncomfortable mood, a feeling of extreme
happiness, restlessness, agitation, generally
feeling unwell, loss of memory, difficulty
in speaking, reduced sensitivity to pain or
touch, tingling or numbness, seizures, fits or
convulsions, blurred vision, fainting, unusual
muscle stiffness or slackness, involuntary
muscle contractions.
• Difficulty in passing urine, impotence,
decreased sexual drive, absence of menstrual

• Fast, irregular heart beat, low blood pressure,
a feeling of ‘faintness’ especially on standing
up, flushing of the skin.
• Dehydration, thirst, swelling of the hands,
ankles or feet.
• Dry skin, severe flaking or peeling of the skin,
hives (nettle rash).
• Redness of the face, reduction in size of
the pupils in the eye, muscle spasm, high
• A need to take increasingly higher doses of the
tablets to obtain the same level of pain relief
• Colicky abdominal pain or discomfort.
• A worsening of liver function tests (seen in a
blood test).
Frequency unknown
(Frequency cannot be estimated from the
available data)
• An increased sensitivity to pain.
• Aggression.
You may see the remains of the tablets in your
faeces. This should not affect how the tablets
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:
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store OxyContin tablets
Keep out of the reach and sight of children.
Accidental overdose by a child is dangerous and
may be fatal.
Do not use any tablets after the expiry date
which is stated on the blister and carton.
EXP 08 2020 means that you should not take
the tablets after the last day of that month
i.e. August 2020.
Do not store your tablets above 25ºC.
Do not take your tablets if they are broken or
crushed as this can be dangerous and can cause
serious problems such as overdose.
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 OxyContin tablets contain
The active ingredient is oxycodone
hydrochloride. Each tablet contains
5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg,
60 mg, 80 mg or 120 mg of oxycodone
The other ingredients are:
• Lactose monohydrate
• Povidone
• Ammoniomethacrylate polymer
• Sorbic acid
• Triacetin
• Stearyl alcohol

• Talc
• Magnesium stearate
• Hypromellose (E464)
• Titanium dioxide (E171)
• Macrogol
In addition, the tablet coatings contain the
5 mg – brilliant blue (E133)
10 mg – hydroxypropylcellulose
15 mg – iron oxide (E172)
20 mg, 30 mg, 40 mg, 60 mg and 120 mg –
polysorbate 80 (E433), and iron oxide (E172)
80 mg – hydroxypropylcellulose, iron oxide
(E172), and indigo carmine (E132)
What OxyContin tablets look like and the
contents of the pack
The tablets are marked OC on one side and the
strength on the other (5, 10, etc). All strengths
are round,
bi-convex, film coated tablets.
The tablets are all film coated in the following
colours: 5 mg – light blue, 10 mg – white,
15 mg – grey, 20 mg – pink, 30 mg – brown,
40 mg – yellow, 60 mg – red, 80 mg – green,
120 mg – purple.
In each box there are 28 or 56 tablets.

Marketing Authorisation Holder and
The tablets are made by
Bard Pharmaceuticals Limited for
the marketing authorisation holder
Napp Pharmaceuticals Limited, both at
Cambridge Science Park, Milton Road,
Cambridge CB4 0GW, UK.

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: OxyContin
Reference number: 16950/0123
This leaflet was last revised in April 2015.
OxyContin® tablets are protected by European Patent (UK) Nos. 0576643, 1325746,
1438959 and 1502592.

® OxyContin, NAPP and the NAPP device (logo) are Registered Trade Marks.
© 2009-2014 Napp Pharmaceuticals Limited.

30/04/2015 11:52

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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.