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OXYCONTIN 5MG TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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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;

Please note that information regarding other strength of OxyContin
tablets is also present in the below leaflet.



are or have ever been addicted to alcohol or drugs or have a known
opioid dependence;

Read all of this leaflet carefully before you start taking this
medicine.



have an increased sensitivity to pain;



need to take increasingly higher doses of OxyContin to gain the
same level of pain relief (tolerance).

S1085 LEAFLET Oxycontin 20150910

PACKAGE LEAFLET: INFORMATION FOR USER
®

OxyContin 5mg tablets
(oxycodone hydrochloride)
Your medicine is known as OxyContin 5mg tablets but will be referred
to as OxyContin tablets throughout the following leaflet.



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.

If you are going to have an operation, please tell the doctor at the
hospital that you are taking these tablets.
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.

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

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…”).

2. Before you take OxyContin tablets

Tell your doctor or pharmacist if you are taking:

3. How to take OxyContin tablets



4. Possible side effects
5. How to store OxyContin tablets

medicines to help you sleep or stay calm (for example tranquillisers,
hypnotics or sedatives);



medicines to treat depression (such as paroxetine);

6. Further information



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);

2. BEFORE YOU TAKE OXYCONTIN TABLETS



antibiotics (such as clarithromycin, erythromycin or telithromycin);

Do not take OxyContin tablets if you:



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).

In this leaflet:

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’.



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 lung 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;

Also tell your doctor if you have recently been given an anaesthetic.
Taking OxyContin tablets with food, drink and alcohol



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);

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.



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;

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



have ongoing problems with constipation;

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



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;

Ask your doctor or pharmacist for advice before taking any medicine.

 are under 18 years of age.
Take special care with OxyContin tablets
Before treatment with these tablets tell your doctor or pharmacist 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 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;

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 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).

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.
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

Uncommon side effects

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.

(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, 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’, 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,
absence of menstrual periods.



Fast, irregular heart beat, low blood pressure, a feeling of ‘faintness’
especially on standing up, flushing of the skin.



Dehydration, thirst, swelling of the hands, ankles or feet.



Dry skin, severe flaking or peeling of the skin, hives (nettle rash).



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).

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.
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.

Frequency unknown

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.

(Frequency cannot be estimated from the available data)
An increased sensitivity to pain.

 Aggression.
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.

If you stop taking OxyContin tablets

5. HOW TO STORE 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.



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.

4. POSSIBLE SIDE EFFECTS



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.

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.

6. FURTHER INFORMAT ION

As with all strong painkillers, there is a risk that you may become
addicted or reliant on these tablets.



Each film-coated, prolonged release tablet contains 4.5mg of the
active ingredient, oxydone as 5mg of oxycodone hydrochloride

Very common side effects



OxyContin tablets also contain the following inactive ingredients:
lactose monohydrate, magnesium stearate, ammoniomethacrylate
copolymer dispersion, povidone K30, stearyl alcohol, talc, triacetin,
hypromellose E464, macrogol 400, titanium dioxide (E171) and
brilliant blue (E133).

What OxyContin tablets contain

(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).

What OxyContin tablets look like and contents of the pack



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.



OxyContin 5mg tablets are round, blue film-coated tablet marked
‘5’ on one side and ‘OC’ on the other

OxyContin tablets are available as blister packs of 28, 30, 56 or
60 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence
holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA0 1DX.

Common side effects

Manufacturer

(May affect up to 1 in 10 people)

This product is manufactured by Bard Pharmaceuticals Ltd,
Cambridge Science Park, Milton Rd, Cambridge CB4 0GW U.K.



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



Confusion, depression, a feeling of unusual weakness, shaking,
anxiety, nervousness, difficulty in sleeping, abnormal thoughts or
dreams.



Difficulty in breathing or wheezing, shortness of breath, decreased
cough reflex.



Rash.



Sweating, chills.

POM

PL 19488/1085

Leaflet revision date: 10 September 2015
® OxyContin is a registered trade mark of Napp Pharmaceutical
Holdings Limited.
S1085 LEAFLET Oxycontin 20150910

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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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