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OXYCONTIN 80MG FILM-COATED PROLONGED RELEASE TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

OXYCONTIN 80MG FILM-COATED
PROLONGED RELEASE TABLETS
(oxycodone hydrochloride)

OxyContin is available in the following strengths: 5mg, 10mg,
20mg, 30mg, 40mg, 60mg, 80mg and 120mg. This leaflet only
applies to OxyContin 80mg film-coated Prolonged Release Tablets
which will be referred to as OxyContin Tablets throughout this
leaflet.

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.
2.
3.
4.
5.
6.

What OxyContin Tablets are and what they are used for
Before you take OxyContin Tablets
How to take OxyContin Tablets
Possible side effects
How to store OxyContin Tablets
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);

Assessed against UK PIL dated May 2011
By Aneela Mahmood at 10:19 am, Nov 22, 2011

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);

Page 1 of 2

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 breast-feeding

Do not take these tablets if you are pregnant or breast-feeding.
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 10mg 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

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 antisickness 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 store above 25 C.
Do not use after the expiry date which is printed on the carton
and the blisters.
Do not take your tablets if they are broken or crushed as this can
be dangerous and cause serious problems such as overdose.
If you have any unused tablets, take them to a pharmacy for safe
disposal.
If your tablets appear discoloured or show any other signs of
deterioration, take them to your pharmacist who will advise you.
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.
Page 2 of 2

6. Further information
What OxyContin Tablets contain

The active ingredient is oxycodone. Each film-coated, prolonged
release tablet contains 72mg of oxycodone as 80mg of oxycodone
hydrochloride.
The other ingredients are:
Lactose monohydrate
Povidone
Sorbic acid
Triacetin
Stearyl alcohol
Talc
Magnesium stearate
Hypromellose (E464)
Hydroxypropylcellulose
Ammoniomethacrylate copolymer
Titanium dioxide (E171)
Macrogol
Iron oxide (E172)
Indigo carmine (E132)

What OxyContin Tablets looks like and the contents
of the pack
OxyContin Tablets are round, bi-convex, green, film-coated
tablets with the markings 80 on one side and OC on the
reverse. The tablets have a white core.
OxyContin Tablets come in packs of 28 or 56 tablets.

Manufacturer

Manufactured by: Bard Pharmaceuticals Ltd., Cambridge Science
Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW,
UK.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
CD

POM

PL No: 08929/0562

Other formats:
To request a copy of this leaflet in Braille, large print or audio
please call 01302 365000 and ask for the Regulatory Department.
Please be ready to give the following information:
Product name
OxyContin 80mg film-coated Prolonged Release Tablets
Reference number
08929/0562
Leaflet issue and revision date (Ref): 14.11.11
OxyContin is a registered trademark of Napp Pharmaceutical
Holdings Limited.

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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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