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OXYCONTIN 40MG PROLONGED RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER




OXYCONTIN® 40MG
PROLONGED RELEASE TABLETS



OxyContin is available in the following strengths: 5mg, 10mg,
20mg, 30mg, 40mg, 60mg, 80mg and 120mg.



(oxycodone hydrochloride)

This leaflet only applies to OxyContin 40mg 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 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.

In this leaflet:

1.
2.
3.
4.
5.
6.

What OxyContin Tablets are and what they are used for
What you need to know before you take OxyContin
Tablets
How to take OxyContin Tablets
Possible side effects
How to store OxyContin Tablets
Contents of the pack and other 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. What you need to know 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 (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 tablets 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 tablets
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 OxyContin to
gain the same level of pain relief (tolerance).

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.

If you are going to have an operation, please tell the doctor
at the hospital that you are taking these tablets.

Talk to your doctor or pharmacist if you are not sure whether
it is safe for you to drive while taking this medicine.

Other medicines and OxyContin

OxyContin tablets contain lactose

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
tablets with some other medicines, the effect of these tablets
or the other medicine may be changed.

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.

Tell your doctor 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 seizures, 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.

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.

Also tell your doctor if you have recently been given an
anaesthetic.

Children

Taking OxyContin Tablets with food, drink and
alcohol

3. How to take OxyContin Tablets

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 and adolescents under 18 years of age should not
take the tablets.

Patients with kidney or liver problems

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.

Please tell your doctor if you suffer from kidney or liver
problems as they may prescribe a lower dose depending on
your condition.

You should avoid drinking grapefruit juice during your
treatment with this medicine.

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.

Pregnancy and breast-feeding

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.

Page 1 of 2

If you take more OxyContin Tablets than you should
or if someone accidentally swallows your tablets

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). Tell your doctor immediately if this happens
to you.

Frequency not known

(Frequency cannot be estimated from the available data)

An increased sensitivity to pain.

Aggression.

Tooth decay.

Absence of menstrual periods.

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.

Long term use of OxyContin during pregnancy may
cause life-threatening withdrawal symptoms in the
newborn. Symptoms to look for in the baby include
irritability, hyperactivity and abnormal sleep pattern,
high pitched cry, shaking, being sick, diarrhoea and not
putting on weight.
You may see the remains of the tablets in your faeces. This
should not affect how the tablets work.

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.

As with all strong painkillers, there is a risk that you may
become addicted or reliant on these tablets.

5. How to store OxyContin Tablets

Very common side effects

Keep out of the sight and reach of children. Accidental
overdose by a child is dangerous and may be fatal.

(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 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).

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, lack of energy, tiredness, anxiety, nervousness,
difficulty in sleeping, abnormal thoughts or dreams.

Difficulty in breathing or wheezing, shortness of breath,
decreased cough reflex.

Rash.

Sweating.

Uncommon side effects

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.

6. Contents of the pack and other
information
What OxyContin Tablets contain

(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.

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, low levels of sex hormones in the blood
(‘hypogonadism’, seen in a blood test).

Fast, irregular heart beat, flushing of the skin.

Dehydration, thirst, chills, 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 of the tablets
to obtain the same level of pain relief (tolerance).

Colicky abdominal pain or discomfort.

A worsening of liver function tests (seen in a blood test).

OxyContin Tablets are round, bi-convex, yellow, film-coated
tablets with the markings ‘40’ on one side and ‘OC’ on the
reverse. The tablets have a white core.

Rare side effects

OxyContin Tablets come in packs of 28 or 56 tablets.

(May affect up to 1 in 1,000 people)

Low blood pressure.

A feeling of ‘faintness’ especially on standing up.

Hives (nettle rash).

The active ingredient is oxycodone.

Each prolonged release tablet contains 36mg of oxycodone as
40mg of oxycodone hydrochloride.
The














other ingredients are:
Lactose monohydrate
Povidone
Sorbic acid
Triacetin
Stearyl alcohol
Talc
Magnesium stearate
Hypromellose (E464)
Ammoniomethacrylate copolymer
Titanium dioxide (E171)
Macrogol
Polysorbate 80
Iron oxide (E172)

What OxyContin Tablets look like and the contents
of the pack

Page 2 of 2

Manufacturer

Manufactured by:
Bard Pharmaceuticals Ltd., Cambridge Science Park,
Milton Road, Cambridge, Cambridgeshire, CB4 0GW, UK
or
Mundipharma GmbH, Mundipharma str.2, 65549 Limburg,
Germany.
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.
PL No: 08929/0561

POM

CD

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 40mg prolonged release tablets
Reference number
08929/0561
Leaflet issue and revision date (Ref): 23.03.16
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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