Medication Guide App

OXYCONTIN 15 MG PROLONGED RELEASE TABLETS

Active substance: OXYCODONE HYDROCHLORIDE

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CUSTOMER: Waymade
OxyContin 15mg 30mg 60mg PR Tabs

CODE:

06464/2945 2946 2947E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

PRODUCT:

07/08/14

Q.A.
APPROVED:
DATE:

PROOF HISTORY:
v.2 - waymade - 07/08/14

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MAY 2011 REPORTING OF SIDE EFFECTS
DRUG DRIVING TEXT

Pg 1

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What OxyContin tablets look like and the contents of the pack
OxyContin 15 mg Prolonged release Tablets are grey round, bi-convex, round, convex film-coated tablets
marked ‘OC’ on one side and ‘15’ on the other side.
OxyContin 30 mg Prolonged release Tablets are brown, round, convex film-coated tablets marked with ‘OC’
on one side and ‘30’ on the other side.
OxyContin 60 mg Prolonged release Tablets are red, round, convex film-coated tablets marked with ‘OC’ on
one side and ‘60’ on the other side.
OxyContin tablets are available as blister packs of 28 or 56 tablets.
CD
POM

PL No: 06464/2945 OxyContin 15 mg Prolonged release tablets
PL No: 06464/2946 OxyContin 30 mg Prolonged release tablets
PL No: 06464/2947 OxyContin 60 mg Prolonged release tablets

These products are manufactured by Bard Pharmaceuticals Ltd., Cambridge Science Park, Milton Road,
Cambridge, CB4 0GW England and procured from within EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon Essex. SS14 3FR.
Leaflet revision date (Ref.) 07.08.2014
OxyContin is a registered trademark of Napp Pharmaceutical Holdings Limited

OXYCONTIN® 15mg PROLONGED RELEASE TABLETS
OXYCONTIN® 30mg PROLONGED RELEASE TABLETS
OXYCONTIN® 60mg PROLONGED RELEASE TABLETS
(oxycodone hydrochloride)
Patient Information Leaflet
This product is available as all of the above strengths and will be referred to as OxyContin tablets throughout
this leaflet. Other strengths (5 mg, 10 mg, 20 mg, 40 mg, 80 mg and 120 mg) are also available.
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
tranylcypromide, 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…”).

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WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade
OxyContin 15mg 30mg 60mg PR Tabs

CODE:

06464/2945 2946 2947E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

PRODUCT:

07/08/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.2 - waymade - 07/08/14

DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MAY 2011 REPORTING OF SIDE EFFECTS
DRUG DRIVING TEXT

Pg 2

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.
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.

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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).

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.

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

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.

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.

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.

You may see the remains of the tablets in your faeces. This should not affect how the tablets work.

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 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.
If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your
pharmacist who will advise you what to do.
These measures will help to protect the environment.

6. Further information
What OxyContin tablets contain
Each OxyContin 15 mg Prolonged Release Tablet contains 13.5 mg of oxycodone as 15 mg oxycodone
hydrochloride.
Each OxyContin 30 mg Prolonged Release Tablet contains 27 mg of oxycodone as 30 mg oxycodone
hydrochloride
Each OxyContin 60 mg Prolonged Release Tablet contains 54 mg of oxycodone as 60 mg oxycodone
hydrochloride
The other ingredients are: lactose monohydrate, magnesium stearate, ammonio methacrylate copolymer
type b, povidone, stearyl alcohol, talc, triacetin, hypromellose, macrogol, iron oxide (E172) and titanium
dioxide (E171).
In addition, the tablet coatings contain the following:
30 mg and 60 mg – polysorbate 80 (E433)

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WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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