OXYCONTIN 160 MG FILM-COATED PROLONGED RELEASE TABLETS.

Active substance: OXYCODONE HYDROCHLORIDE

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4597-2

OxyContin Tabs 160mg PIL UK 4597-2 V3.indd 1

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Times

Date of Approval

All boxes to be checked including those marked “N/A”

N/A
N/A
17, 18

PRD-PMS-005
LSN-008
Spec. 15
460x148mm
148x36/34

All boxes to be checked including those marked “N/A”

Date of Approval

Packaging Artworker Signature (Existing/Contractor)

Leaflet
PMS Spec. No.:
Leaflet Spec. No.:
Dimensions Spec. No.:
Dimensions Flat:
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Counter-Signature for Launch / New Design

Colours: PMS 280

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PPT Signature (Napp New and Production Change)

OxyContin Tablets 160mg
UK
4597-2
Datamatrix - 4597-2
3
27-01-06
Adobe InDesign CS
Rebecca Philpott

Packaging Artworker Signature

Item Description:
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Date Created:
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Artwork Created By:

Napp Pharmaceuticals Ltd.
Packaging Artwork Team
Cambridge Science Park, Milton Road, Cambridge CB4 0GW
Tel: +44 (0)1223 424 444
Fax: +44 (0)1223 426 174
ISDN: +44 (0)1223 425 769

02-2006

What you should know about OxyContin® 160 mg
film-coated prolonged release tablets
Oxycodone hydrochloride

Please
6x6mm read this leaflet carefully before you start taking your tablets.
4x4mm

6x6mm

Keep this leaflet in a safe place - you may want to read it again.

OxyContin tablets are designed to work properly over 12 hours only when swallowed whole. If a
tablet is broken, crushed, dissolved or chewed, the entire 12-hour dose will be absorbed rapidly
into your body. This can be dangerous, causing serious problems such as an overdose, which may
be fatal.
Only take the tablets if they have been prescribed for you. Never give them to other people, even if their
symptoms are the same as yours.
If you have any questions or you are not sure about anything, please ask your doctor or pharmacist.
What is in the tablets?
The prolonged release tablets contain the active ingredient oxycodone as 160 mg of oxycodone
hydrochloride. Oxycodone belongs to a group of medicines called analgesics or ʻpainkillersʼ.
The following ingredients are also included in OxyContin 160 mg tablets, but they are not medicines:
• Lactose monohydrate
• Triacetin
• Talc
• Ammoniomethacrylate polymer
• Hypromellose (E464)
• Titanium dioxide (E171)
• Polysorbate 80
In each box there are 56 tablets.








Povidone
Stearyl alcohol
Magnesium stearate
Sorbic acid
Macrogol
Indigo carmine (E132)

The tablets are made by Bard Pharmaceuticals Limited for the marketing authorisation holder Napp
Pharmaceuticals Limited, both at Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.

PAT scan-check approval signature

What are the tablets for?
Your tablets have been prescribed to relieve moderate or severe pain, e.g. after an operation.
Who can take the tablets?
Adults over 18 years old can take the tablets. They are not recommended for children under 18 years
old.
Do not take OxyContin tablets if:
• you are pregnant or breast-feeding;
• you are sensitive or allergic to oxycodone, or to any other ingredients in the tablets;
• you are taking monoamine oxidase inhibitors (MAOIs) or you have taken this type of medicine in the
last two weeks (you should know if you are taking an MAOI as your doctor or pharmacist will have
told you and you may have a treatment card);
• you have a bowel problem called paralytic ileus, or sharp and severe pain in your abdomen;
• you have had constipation over a long period;
• you have a head injury that causes a severe headache or makes you feel sick, because the tablets may
make these symptoms worse or cover up the extent of the injury;
• you have cor pulmonale (a heart problem after long-term lung disease).
Also tell your doctor or pharmacist if you have any condition in the list below:









Problems with breathing properly.
An under-active thyroid (hypothyroidism), as you may need a lower dose of OxyContin tablets.
Poor adrenal gland function.
Kidney or liver problems, as you may need a lower dose of OxyContin tablets.
Difficulty passing urine.
Pancreatitis (inflammation of the pancreas) or problems with your gall bladder.
Inflammatory bowel disease.
Low blood pressure, hypercarbia (high concentration of carbon dioxide in the blood), or hypovolaemia
(low blood volume).
• Toxic psychosis (a major mental disorder as a result of an infection).
• An addiction to alcohol or drugs, or a severe reaction to stopping alcohol (delirium tremens) or drugs.
• An intolerance to some sugars (e.g. lactose).
If you take OxyContin tablets with some other medicines, the effect of OxyContin tablets or the other
medicine may be increased. Tell your doctor or pharmacist if:

• you are taking medicines to help you sleep (for example tranquillisers, hypnotics or sedatives);
• you are taking medicines to treat depression;
• you are taking other strong analgesics or ʻpainkillersʼ;
• you are taking medicines to treat psychiatric or mental disorders;
• you have recently been given an anaesthetic;
• you are taking medicines to treat high blood pressure;
• you have recently been given a muscle relaxant;
• you are taking cimetidine (a medicine for ulcers, indigestion, or heartburn);
• you are taking quinidine (a medicine to treat a fast heart beat);
• you are taking antifungal medicines (such as ketoconazole);
• you are taking antibiotics (such as erythromycin).
If you are going to have an operation, please tell the doctor at the hospital that you are taking these
tablets.
Drinking alcohol during your treatment with OxyContin tablets may make you drowsy. If you are
affected you should avoid drinking alcohol.
OxyContin tablets may make you feel sleepy. If affected, you should not drive or use machinery.
How do I take my tablets?
The label on your medicine will tell you how many tablets to take and how often. If you are not sure,
ask your doctor or pharmacist. Do not take more tablets than the label tells you to.
Swallow your tablets whole with water. Do not chew, crush or dissolve them.
The usual dose for adults over 18 years old is one tablet every 12 hours. However, your doctor will
prescribe the dose required to treat your pain.
Children under 18 years old should not take the tablets.
You should take your tablets every 12 hours. For instance, if you take a tablet at 8 oʼclock in the
morning, you should take your next tablet at 8 oʼclock in the evening.
You must only take OxyContin tablets by mouth. The tablets should never be crushed or injected as this
may lead to serious side effects, which may be fatal.
What should I do if I forget to take my tablets?
If you forget to take your tablets, take your next dose as soon as you remember, unless it is almost time
for your next dose, then go on as before.
What should I do if someone accidentally swallows my tablets or I take too many?
Call your doctor or hospital straight away. In cases of overdose, the stomach may need to be washed
out (gastric lavage) at hospital. People who have taken an overdose may feel very drowsy and sick, and
may have breathing difficulties leading to unconsciousness or even death. An antidote can be given by
injection to reverse severe side effects.
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Will I have any problems?
As well as benefits, all medicines occasionally have unwanted effects in some patients. These are called
side effects.
Most people will have constipation when they take these tablets. Your doctor can prescribe a laxative to
overcome this problem.
You may feel sick or vomit (be sick) when you take your tablets. Your doctor can prescribe an
anti-vomiting medicine if it causes problems.
You may find that you cannot concentrate or that you feel more sleepy than normal when you start
taking your tablets or when your dose is increased. This should wear off after a few days.
Tell your doctor if you have:
• a severe skin reaction;
• an allergic reaction;
• difficulty breathing;
• a fit.
Sometimes you may have:
• a dry mouth or a loss of appetite;
• diarrhoea;
• heartburn;
• pain in your stomach;
• a headache;
• confusion, nervousness, or anxiety;
• a feeling of weakness;
• a feeling of faintness, especially on standing up;
• dizziness.
You may also have:
• insomnia (inability to sleep) or abnormal thoughts or dreams;
• twitching;
• difficulty breathing or shortness of breath;
• decreased cough reflex;
• a rash or itchy skin;
• sweating or chills.
There are also a number of side effects that rarely happen. Do not be alarmed by this list of possible
events. If you notice these or any other problems while taking these tablets, please tell your doctor.
Some of these rare side effects can affect your gut causing:
• difficulty in swallowing;
• belching or flatulence (wind);
• gastrointestinal disorders (e.g. upset stomach);
• ileus (slowing of the bowel);
• taste changes;
• hiccups.
Others may affect your central nervous system (your brain and major nerves) causing:
• vertigo (problems of balance);
• hallucinations or disorientation;
• hypertonia (abnormal increase in muscle tone);
• mood changes or depression;
• a feeling of restlessness, excitement, or agitation;
• tremors, seizures or a loss of muscle tone;
• tolerance or dependence (reliance on the medicine);
• loss of memory;
• malaise (generally feeling unwell);
• tingling or numbness in fingers or toes or impairment in the feeling of touch;
• speech disorder;
• blurred vision, or miosis (constriction of pupils).
Other rare side effects include:
• difficulty in passing urine, impotence or decreased sexual drive, or amenorrhoea (absence of
periods);
• palpitations or irregular heart beat, low blood pressure, syncope (fainting), or vasodilation
(widening of blood vessels);
• dehydration or a feeling of thirst, or swelling, for example in the legs and ankles;
• dry skin, facial flushing (redness of the face), muscle spasm, or fever;
• severe allergic reaction.
Further information on taking or stopping your medicine
Do not exceed the dose recommended by your doctor. There is a risk of addiction with strong opioid
painkillers. It is not known how often patients with pain become addicted to strong painkillers, but the
risk has been reported to be small. If during the treatment you find that oxycodone is not providing
sufficient pain relief discuss this with your doctor. You should not suddenly stop taking this medicine
unless your doctor tells you to. If your doctor wants you to stop taking your tablets he/she will tell you
how to do this, usually reducing the dose gradually so you do not experience unpleasant effects. If you
want to stop taking your tablets, talk to your doctor.
How should I keep my tablets and for how long?
There is a ʻuse-byʼ date on the label. For example, EXP 8.2010 means that you should not take the
tablets after the end of August 2010. After the ʻuse-byʼ date, or if you have any unused tablets, take them
to a pharmacy for safe disposal.
Do not keep your tablets above 25˚C. Keep them in a safe place where children cannot see or reach
them. Accidental overdose by a child is dangerous and may be fatal.
Date this leaflet was written:
December 2005

OxyContin tablets are the subject of European Patents (UK)
Numbers 0 253 104, 0 576 643 and European Patent Application 96102992.3.
® The NAPP device (logo) and OxyContin are Registered Trade Marks.
© Napp Pharmaceuticals Limited, 2005.
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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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