OXYCONTIN 10 MG PROLONGED RELEASE TABLETS

Active substance: OXYCODONE HYDROCHLORIDE

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Package leaflet: Information for the user
OxyContin® 5 mg, 10 mg, 20 mg,
40 mg and 80 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 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 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

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
‘painkillers’.

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 airways
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 long-term kidney or
liver problems you should only take
these tablets 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.
If you are going to have an operation,
please tell the doctor at the hospital that
you are taking these tablets.
Take special care with OxyContin
tablets
Before treatment with these tablets 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;
• have previously suffered from
withdrawal symptoms such as
agitation, anxiety, shaking or
sweating, upon stopping taking
alcohol or drugs.
These tablets should be avoided in
patients with a history of, or present
alcohol or drug abuse.
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 (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 or voriconazole);
• antibiotics (such as erythromycin).
Also tell your doctor if you have recently
been given an anaesthetic.
Taking OxyContin tablets with 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.

Pregnancy and breastfeeding
Do not take these tablets if you are
pregnant or breastfeeding.
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 machinery.
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.

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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
Children and adolescents under 18 years
of age should not take the tablets.
If you take more OxyContin tablets
than you should or if someone
accidentally swallows your tablets
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 doctor.
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.
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).
As with all strong painkillers, there is a
risk that you may become addicted or
reliant on these tablets.
Common side effects
(Probably affecting more than 1 in 100
people taking these tablets)
• 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 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 tablets)
• Difficulty in swallowing, belching,
hiccups, wind, gastrointestinal
disorders (e.g. upset 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’,
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 tablets may affect
the results of blood tests to check that
your liver is working properly.
You may see the remains of the tablets
in your faeces. This should not affect
how the tablets work.
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.
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, 20 mg, 40 mg or 80 mg of oxycodone
hydrochloride.
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
following:
5 mg - brilliant blue (E133)
10 mg – hydroxypropylcellulose
20 mg and 40 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,
20 mg - pink, 40 mg - yellow,
80 mg - green.
In each box there are 28 or 56 tablets.

Marketing Authorisation Holder
and Manufacturer
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 May 2011.
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.
© 2009-2011 Napp Pharmaceuticals Limited

19/05/2011 12:23

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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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