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OXYCONTIN 120 MG PROLONGED RELEASE TABLETS

Active substance: OXYCODONE HYDROCHLORIDE

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OxyContin® 120 mg
Prolonged Release Tablets

2474
25.03.13[2]

(oxycodone hydrochloride)
PATIENT INFORMATION LEAFLET
Your medicine will be referred to as OxyContin throughout the leaflet.
OxyContin is also available in other strengths.
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. 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 tranylcypromine, 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);
- 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.
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 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 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.
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 sight and reach of children. Accidental overdose by a child
is dangerous and may be fatal.
Do not use any tablets after the expiry date which is stated on the blister
and carton.
Do not store your tablets above 25ºC.
Do not take your tablets if they are broken or crushed as this can be
dangerous and can cause serious problems such as overdose.
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. FURTHER INFORMATION
What OxyContin tablets contain
The active ingredient is oxycodone hydrochloride.
Each prolonged release tablet contains 108 mg of oxycodone as 120 mg
oxycodone hydrochloride.
The other ingredients are:
lactose monohydrate, povidone K30, ammoniomethacrylate co-polymer
(type B)(dispersion 30%), triacetin, stearyl alcohol, talc, magnesium
stearate, hypromellose, titanium dioxide (E171), macrogol 400, black iron
oxide (E172), red iron oxide (E172) and polysorbate 80.
What OxyContin tablets look like and the contents of the pack
OxyContin are round, purple coloured tablets marked ‘O C’ on one side and
‘120’ on the other side.
OxyContin is available in a calendar blister strip packs of 28 and 56 tablets
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Bard Pharmaceuticals Limited, Cambridge Science Park,
Milton Road, Cambridge CB4 0GW, UK.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.

POM CD
OxyContin 120 mg Prolonged Release Tablets

PL 20636/2474

Leaflet revision and issue date (Ref) 25.03.13[2]
OxyContin is a 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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