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500473/PL1h

®

OxyContin 5 mg Film-Coated, Prolonged-Release Tablets

(oxycodone hydrochloride)

Patient Information Leaflet

The name of your medicine is: OxyContin® 5 mg Film-Coated, Prolonged-Release Tablets. Throughout this leaflet it will be referred to as OxyContin® tablets.

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^^I

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... ”).

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.

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.    Continued overleaf

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.

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.

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.

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. EXP 08 2020 means that you should not take the tablets after the last day of that month i.e. August 2020.

Do not store your tablets above 25°C.

Do not take your tablets if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.

If you notice any sign of discolouration or deterioration of the tablets, tell your pharmacist immediately.

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

Each film-coated, prolonged-release tablet contains 5 mg of oxycodone hydrochloride.

The other ingredients are:

•    lactose monohydrate

•    povidone K30

•    ammoniomethacrylate copolymer

•    triacetin

•    stearyl alcohol

•    talc

•    magnesium stearate

•    hypromellose (E464)

•    titanium dioxide (E171)

•    macrogol 400

•    brilliant blue (E133)

What OxyContin^® tablets look like and the contents of the pack

•    OxyContin® 5 mg Film-Coated, Prolonged-Release Tablets are light blue, round and convex, marked OC on one side and 5 on the other.

In each box there are 28 tablets.

Product Licence Holder and Manufacturer

Procured from within the EU. Product Licence Holder Ginova Limited and repackager Ginova UK Limited both of St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.

Manufactured by Bard Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.

OxyContin® 5 mg Film-Coated, Prolonged-Released Tablets

PL No: 18067/0233

|CD POM|

OxyContin^® is a registered trademark of Napp Pharmaceutical Holdings Limited.

This leaflet was last approved on 28^th March 2014.

To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.

500473/PL1h