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OxyContin ® 5mg Film-coated, Prolonged Release Tablets

Ref: 1014/080716/1/F

(oxycodone hydrochloride)
Patient Information Leaflet
Your medicine is called OxyContin 5mg 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
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
* 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 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


What OxyContin tablets are and what they are used

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’.

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
* antihistamines;
* medicines to treat Parkinson’s disease.
Also tell your doctor if you have recently been given an anaesthetic.
Taking OxyContin tablets with food, drink and 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.
You should avoid drinking grapefruit juice during your treatment with this


What you need to know before you take OxyContin

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
* 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.
Other medicines and OxyContin
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.

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.
This medicine can affect your ability to drive as it may make you sleepy or
* 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;
* 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:
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.


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
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.

OxyContin® 5mg Film-coated, Prolonged Release Tablets

Ref: 1014/080716/1/B

(oxycodone hydrochloride)
Patient Information Leaflet (continued)
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
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.


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
* 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,
* 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
* 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:
By reporting side effects you can help provide more information on the
safety of this medicine.

How to store OxyContin tablets



Do not store above 25°C.
Accidental overdose by a child is dangerous and may be fatal.

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.


Contents of the pack and other information

What OxyContin tablets contain
Each prolonged release tablet contains 4.5mg of the active ingredient
oxycodone, which is equivalent to 5mg of oxycodone hydrochloride.
OxyContin tablets also have the following inactive ingredients: lactose
monohydrate, povidone K30, ammoniomethacrylate co-polymer, triacetin,
stearyl alcohol, talc, magnesium stearate, hypromellose (E464), macrogol
400, titanium dioxide (E171) and brilliant blue (E133).
What OxyContin tablets look like and contents of the pack
OxyContin tablets are round, brilliant blue tablets, marked OC on one side
and 5 on the other side.
OxyContin tablets come in packs of 28 or 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.


PL 15184/1014
OxyContin 5mg Film-coated, Prolonged Release Tablets

® OxyContin is a registered trademark of Napp Pharmaceuticals Holdings
Revision date: 08/07/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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Further information

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