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Document: leaflet MAH BRAND_PLPI 18067-0235 change

• leaflet MAH BRAND_PLPI 15184-1243
• leaflet MAH BRAND_PLPI 18067-0235
• leaflet MAH BRAND_PLPI 19488-1059

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5004/5/PL1e    ®

OxyContin 10 mg Film-Coated, Prolonged-Release Tablets OxyContin® 20 mg Film-Coated, Prolonged-Release Tablets OxyContin® 40 mg Film-Coated, Prolonged-Release Tablets OxyContin® 80 mg Film-Coated, Prolonged-Release Tablets

(oxycodone hydrochloride)

Patient Information Leaflet

The name of your medicine is:

®

OxyContin 10 mg Film-Coated, Prolonged-Release Tablets, OxyContin® 20 mg Film-Coated, Prolonged-Release Tablets, OxyContin® 40 mg Film-Coated, Prolonged-Release Tablets, OxyContin® 80 mg Film-Coated, Prolonged-Release Tablets Throughout this leaflet it will be referred to as OxyContin® tablets. Other strengths are available.

In this leaflet:

1)    What OxyContin® tablets are and what they are used for

2)    What you need to know before you take OxyContin® tablets

3)    How to take OxyContin® tablets

4)    Possible side effects

5)    How to store OxyContin tablets

6)    Contents of the pack and other 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'.

•    are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the tablets (listed in section 6);

•    have breathing problems, such as severe chronic obstructive lung disease, severe bronchial asthma or severe 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 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 moderate to severe liver problems. If you have other long-term liver problems you should only take these tablets if recommended by your doctor;

•    have ongoing problems with constipation;

•    are under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking these tablets 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 head injury, 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;

•    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;

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

•    have an increased sensitivity to pain;

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

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

Other medicines and OxyContin

Please tell your doctor or pharmacist if you are taking, have recently taken or might take 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.

Tell your doctor or pharmacist if you are taking:

•    a type of medicine known as a monoamine oxidase inhibitor or you have taken this type of medicine in the last two weeks;

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

•    medicines to treat depression (such as paroxetine);

•    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);

•    antibiotics (such as clarithromycin, erythromycin or telithromycin);

•    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);

•    antihistamines;

•    medicines to treat Parkinson's disease.

Also tell your doctor if you have recently been given an anaesthetic.

Taking OxyContin® tablets with food, drink and 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.

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

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.

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.

OxyContin® tablets contain lactose

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.

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.

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). Tell your doctor immediately if this happens to you.

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

Very common side effects

(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).

•    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.

Common side effects

(May affect up to 1 in 10 people)

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

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

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

•    Rash.

•    Sweating.

Uncommon side effects

(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.

•    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, low levels of sex hormones in the blood ('hypogonadism', seen in a blood test).

•    Fast, irregular heart beat, flushing of the skin.

•    Dehydration, thirst, chills, 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 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).

Rare side effects

(May affect up to 1 in 1,000 people)

•    Low blood pressure.

•    A feeling of 'faintness' especially on standing up.

•    Hives (nettle rash).

Frequency not known

(Frequency cannot be estimated from the available data)

•    An increased sensitivity to pain.

•    Aggression.

•    Tooth decay.

•    Absence of menstrual periods.

•    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.

•    Long term use of OxyContin during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight.

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) CONTENTS OF THE PACK AND OTHER INFORMATION

What OxyContin® tablets contain

Each film-coated, prolonged-release tablet 10 mg, 20 mg, 40 mg or 80 mg of oxycodone

The other ingredients are:

•    lactose monohydrate

•    povidone K30

•    ammoniomethacrylate copolymer

•    sorbic acid

•    triacetin

•    stearyl alcohol

•    talc

•    magnesium stearate

•    hypromellose (E464)

•    titanium dioxide (E171)

•    macrogol 400

In addition, the tablet coatings contain the following:

10 mg - hydroxypropylcellulose

20 mg and 40 mg - polysorbate 80 (E433), and iron oxide (E172)

80 mg - hydroxypropylcellulose, iron oxide (E172), and indigo carmine (E132)

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

•    OxyContin® 10 mg Film-Coated, Prolonged-Release Tablets are white, round and convex, marked OC on one side and 10 on the other.

•    OxyContin^® 20 mg Film-Coated, Prolonged-Release Tablets are pink, round and convex, marked OC on one side and 20 on the other.

•    OxyContin® 40 mg Film-Coated, Prolonged-Release Tablets are yellow, round and convex, marked OC on one side and 40 on the other.

•    OxyContin® 80 mg Film-Coated, Prolonged-Release Tablets are green, round and convex, marked OC on one side and 80 on the other.

In each box there are 28 or 56 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® 10 mg Film-Coated, Prolonged-Released Tablets

PL No: 18067/0234

OxyContin® 20 mg Film-Coated, Prolonged-Released Tablets

PL No: 18067/0235

OxyContin® 40 mg Film-Coated, Prolonged-Released Tablets

PL No: 18067/0236

OxyContin® 80 mg Film-Coated, Prolonged-Released Tablets

PL No: 18067/0238

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

This leaflet was last approved on 29^th February 2016.

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

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