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OXYCONTIN 40MG PROLONGED RELEASE TABLET

Active substance(s): OXYCODONE HYDROCHLORIDE

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Package leaflet: Information for the user
®

OXYCONTIN 10mg PROLONGED-RELEASE TABLETS
®
OXYCONTIN 20mg PROLONGED-RELEASE TABLETS
®
OXYCONTIN 40mg PROLONGED-RELEASE TABLETS
®
OXYCONTIN 80mg PROLONGED-RELEASE TABLETS
(oxycodone hydrochloride)

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.
The name of your product is OXYCONTIN® 10mg
or 20mg or 40mg or 80mg PROLONGEDRELEASE TABLETS, but it will be referred as
Oxycontin tablets throughout this leaflet. Please
note that this leaflet also contains information
about other strengths such as, OXYCONTIN®
5mg, 15mg, 30mg, 60mg, and 120mg
PROLONGED-RELEASE TABLETS.
In this leaflet:
1. What Oxycontin tablets are and what they
are used for
2. What you need to know before you take
Oxycontin tablets
3. How to take Oxycontin tablets
4. Possible side effects
5. How to store Oxycontin tablets
6. 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).
If you are going to have an operation, please tell
the doctor at the hospital that you are taking
these tablets.

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

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).

Taking Oxycontin tablets with food, drink
and alcohol
Drinking alcohol whilst taking Oxycontin tablets

3. How to take Oxycontin tablets

Other medicines and Oxycontin

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

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.
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);

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

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

Oxycontin tablets contain lactose
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.

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.
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 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).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
tablets.

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
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
(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).
Rare side effects
(May affect up to 1 in 1,000 people)
Low blood pressure.
A feeling of ‘faintness’ especially on
standing up.
Hives (nettle rash).
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.

5. How to store Oxycontin tablets
Do not store above 25°C. Keep them in a
safe place where children cannot see or
reach them.
Do not use after the expiry date printed on
the carton or blister label. If they are out of
date take them to your pharmacy for safe
disposal.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Accidental overdose by a child is dangerous
and may be fatal.
If your doctor tells you to stop using the
tablets, then you must take the unused
tablets back to the pharmacist for safe
disposal.
If the tablets become discoloured or show
any other signs of deterioration, you should
ask your doctor or pharmacist for advice.
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 contains
Each Oxycontin 10mg prolonged-release
tablet contains 10mg of the active ingredient
oxycodone hydrochloride (equivalent to 9mg
of oxycodone).
Each Oxycontin 20mg prolonged-release
tablet contains 20mg of the active ingredient
oxycodone hydrochloride (equivalent to 18mg
of oxycodone).
Each Oxycontin 40mg prolonged-release
tablet contains 40mg of the active ingredient
oxycodone hydrochloride (equivalent to 36mg
of oxycodone).
Each Oxycontin 80mg prolonged-release
tablet contains 80mg of the active ingredient
oxycodone hydrochloride (equivalent to 72mg
of oxycodone).

Oxycontin prolonged-release tablets also
contain the following inactive ingredients,
lactose monohydrate, povidone,
ammoniomethacrylate co-polymer, sorbic
acid, glyceryl triacetate, stearyl alcohol, talc,
magnesium stearate, hypromellose,
macrogol, and titanium dioxide (E171).
Oxycontin 10mg prolonged-release tablets
also contains hydroxypropylcellulose.
Oxycontin 20mg prolonged-release tablets
and Oxycontin 40mg prolonged-release
tablets also contains polysorbate 80 and iron
oxide (E172)
Oxycontin prolonged-release tablets also
contains hydroxypropylcellulose, iron oxide
(E172) and indigo carmine (E132).

What Oxycontin tablets look like and the
contents of the pack
Oxycontin 10mg prolonged-release tablets
are white round film-coated tablets marked
‘OC’ on one side and ‘10’ on the reverse.
Oxycontin 20mg prolonged-release tablets
are pink round film-coated tablets marked
‘OC’ on one side and ‘20’ on the reverse.
Oxycontin 40mg prolonged-release tablets
are yellow round film-coated tablets marked
‘OC’ on one side and ‘40’ on the reverse.
Oxycontin 80mg prolonged-release tablets
are green round film-coated tablets marked
‘OC’ on one side and ‘80’ on the reverse.
Oxycontin prolonged-release tablets, all
strengths, are available in packs of 28 and 56
tablets.

Manufactured by:
Bard Pharmaceuticals Ltd., Cambridge Science
Park, Milton Road, Cambridge, UK.

Procured from within the EU and
repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, UK.
OXYCONTIN® 10mg PROLONGED-RELEASE
TABLETS
PL 18799/2606
OXYCONTIN® 20mg PROLONGED-RELEASE
TABLETS
PL 18799/2609
OXYCONTIN® 40mg PROLONGED-RELEASE
TABLETS
PL 18799/2520
OXYCONTIN® 80mg PROLONGED-RELEASE
TABLETS
PL 18799/2522
Leaflet date: 23.02.2016

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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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