OXYCONTIN 10MG TABLETS

Active substance: OXYCODONE HYDROCHLORIDE

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S1086-88 LEAFLET OxyContin 20140527



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.

PACKAGE LEAFLET: INFORMATION FOR USER

OXYCONTIN 10mg TABLETS
OXYCONTIN 40mg TABLETS
(oxycodone hydrochloride)
Your medicine is known by either of the above name but will be
referred to as OxyContin tablets throughout the following leaflet.

These tablets should be avoided in patients with a history of, or
present alcohol or drug abuse.

Information for other strength of OxyContin tablets also may be
present in this leaflet.

Taking other medicines

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.

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);

In this leaflet:



other strong analgesics or painkillers;

1. What OxyContin tablets are and what they are used for



muscle relaxants;

2. Before you take OxyContin tablets



medicines to treat high blood pressure;

3. How to take OxyContin tablets



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);



If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

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’.

 antibiotics (such as erythromycin).
Also tell your doctor if you have recently been given an anaesthetic.
Taking OxyContin tablets with alcohol

2. BEFORE YOU TAKE OXYCONTIN TABLETS

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 OxyContin tablets if you:

Do not take these tablets if you are pregnant or breastfeeding.



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;

Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines





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;



are taking a type of medicine known as a monoamine oxidase
inhibitor (examples include tranylcypromide, phenelzine,
isocarboxazid, moclobemide and linezolid), or you have taken
this type of medicine in the last two weeks;

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:
o

The medicine has been prescribed to treat a medical or
dental problem and

o

You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine
and

o

It was not affecting your ability to drive safely

have ongoing problems with constipation;



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.



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);

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 crush, dissolve or
chew them.



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.



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.

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).

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

Uncommonly, these tablets may affect the results of blood tests to
check that your liver is working properly.

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.

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.

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


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Accidental overdose by a child is dangerous and may be fatal.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

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

6. FURTHER INFORMATION
What OxyContin tablets contain


OxyContin 10mg Tablets, each film-coated, prolonged release
tablet contains 9mg of the active ingredient, oxydone as 10mg
of oxycodone hydrochloride



OxyContin 40mg Tablets, each film-coated, prolonged release
tablet contains 36mg of the active ingredient, oxydone as 40mg
of oxycodone hydrochloride



OxyContin Tablets also contain the following inactive
ingredients: lactose monohydrate, magnesium stearate,
ammoniomethacrylate copolymer dispersion, povidone K30,
stearyl alcohol, talc, triacetin, hypromellose E464, macrogol,
hydroxypropylcellulose and titanium dioxide (E171).
OxyContin 40mg Tablets also contains polysorbate 80 and iron
oxide E172.

(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).



OxyContin 10mg Tablets, round white tablet marked ‘10’ on
one side and ‘OC’ on the other.



Dry mouth, loss of appetite, indigestion, abdominal pain or
discomfort, diarrhoea.



OxyContin 40mg Tablets, are round yellow tablet marked ‘40’
on one side and ‘OC’ on the other.



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.

What OxyContin tablets looks like and contents of the pack



OxyContin Tablets are available as blister packs of 28 or 56
tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Wembley,
HA0 1DX.
Manufacturer
This product is manufactured by Bard Pharmaceuticals Ltd,
Cambridge Science Park, Milton Rd, Cambridge CB4 0GW U.K.
POM
PL No. 19488/1086 OxyContin 10mg Tablets
PL No. 19488/1088 OxyContin 40mg Tablets
Leaflet revision date: 27 May 2014
OxyContin is a registered trade mark of Napp Pharmaceutical
Holdings Limited, UK.
S1086-88 LEAFLET OxyContin 20140527

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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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