OXYCONTIN 20MG TABLETS

Active substance: OXYCODONE HYDROCHLORIDE

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OxyContin ® 20mg Film-coated, Prolonged Release Tablets

Ref: 1130/060514/1/F

(oxycodone hydrochloride)
Patient Information Leaflet
Your medicine is called OxyContin 20mg Film-coated, Prolonged Release
Tablets but will be referred to as OxyContin tablets throughout the 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 get 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,
moclobamide 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 heartbeat);
* 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.
The 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 if this medicine affects your ability to drive.
* However, you would not be committing an offence if:
- 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 or in the information provided with the medicine and
- It was not affecting your ability to drive safely
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 chew, crush or dissolve them.

OxyContin® 20mg Film-coated, Prolonged Release Tablets

Ref: 1130/060514/1/B

(oxycodone hydrochloride)
Patient Information Leaflet (continued)
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.

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

*
*
*

Do not store above 25°C.
Accidental overdose by a child is dangerous and may be fatal.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use this medicine after the expiry date shown on the carton or blister
strip. If your doctor tells you to stop taking this medicine, return any unused
medicine to your pharmacist for safe disposal. Only keep this medicine, if your
doctor tells you to. If your medicine becomes discoloured or shows any other
signs of deterioration, consult your pharmacist who will tell you what to do.

6
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.

How to store OxyContin tablets

Further information

What OxyContin tablets contain
Each prolonged release tablet contains 18mg of oxycodone, equivalent to
20mg of oxycodone hydrochloride as the active ingredient.
OxyContin tablets also hve the following inactive ingredients: lactose
monohydrate, povidone K30, ammoniomethacrylate co-polymer, triacetin,
stearyl alcohol, talc, magnesium stearate, hypromellose (E464), titanium
dioxide (E171), macrogol polysorbate 80 and red iron oxide (E172).
What OxyContin tablets look like and contents of the pack
OxyContin tablets are pink round tablets, marked OC on one side and 20
on the other side.
OxyContin tablets come in packs of 28 and 56 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Bard Pharmaceuticals Limited, Cambridge
Science Park, Cambridge, CB4 0GW, United Kingdom and is procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL 15184/1130
OxyContin 20mg Film-coated, Prolonged Release Tablets

® OxyContin is a registered trademark of Napp Pharmaceuticals Holdings
Limited.
Revision date: 06/05/14

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Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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