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Document: leaflet MAH BRAND_PL 16950-0150 change

• leaflet MAH BRAND_PL 16950-0150
• leaflet MAH BRAND_PLPI 10383-1967

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Read all of this leaflet carefully before you

start taking this medicine because it contains

important information for you.

•    Keep this leaflet. You may need to read it

•    Ifyouhaveanyfartherquestions,askyour doctor or pharmacist.

•    This medicine has been prescribed for you only. Donotpassitontoothers. Itmayharm them, even iftheir signs of illness arethe same

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

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

2.    What you need to know before you take OxyConlin 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

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 ofmedicines called strong analgesics or 'painkillers’.

Do not take OxyContin tablets if you:

•    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;

•    haveaheartproblemafterlong-termlung disease (cor pulmonale);

•    have moderate to severe liver problems. If you have other long-term liver problems you should onlytake these tablets ifrecommended by your doctor;

•    have ongoing problems with constipation;

•    areunder18yearsofage.

Warnings and precautions

Talk to your doctor or pharmacist before taking

these tablets ifyou:

•    are elderly or weakened;

•    haveanunder-activethyroidgland (hypothyroidism), as youmay need alower dose;

•    havemyxoedema(athyroiddisorderwith 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;

•    haveamentaldisorderasaresultofan infection (toxic psychosis);

•    haveinflammationofthepancreas(which causes severe pain in the abdomen and back);

•    have problems with your gall bladder or bile

•    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 orbeing 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;

•    havekidneyorliverproblems;

•    have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or

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

•    have an increased sensitivity to pain;

•    needtotakeincreasinglyhigherdosesof 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 ifyou are taking:

•    atypeofmedicineknownasamonoamine 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;

•    medicinestotreathighbloodpressure;

•    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 ortelithromycin);

•    medicines known as 'protease inhibitors’ to treat HIV (e.g. boceprevir, ritonavir, indinavir, nelfinavir or saquinavir);

•    rifampicin(totreattuberculosis);

•    carbamazepine (a medicine to treat sezures, fits or convulsions and certain pain conditions);

•    phenytoin (a medicine to treat seizures, fits or convulsions);

•    aherbalremedy called St. John’s Wort (also known as Hypericum perforatum);

•    antihistamines;

•    medicinestotreatParkinson’sdisease.

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 grapefruitjuice 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.

•    Itisan 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 dentalproblem; 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 unfitbecause ofthe 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 ifyou 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.

| 3. Howtotake 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. 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. Ifyou find that you are still in pain whilst taking these tablets, discuss this with your doctor.

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 totake your    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 ifyou suddenly stop taking these tablets. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

| 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 ofthe 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 arisk that you may become addicted or reliant on these tablets.

Very common side effects (Mayaffectmorethan 1 in lOpeople)

•    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

•    Dizziness.

•    Headache.

•    Itchy skin.

Common side effects (Mayaffectupto 1 in lOpeople)

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

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

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

•    Rash.

•    Sweating.

Uncommon side effects

(May affect uptolin lOOpeople)

•    Difficulty in swallowing, belching, hiccups, wind, a condition where the bowel does not work properly (ileus), inflammation ofthe 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 inablood test).

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

•    Dehydration, thirst, chills, swelling ofthe hands, ankles or feet.

•    Dry skin, severe flaking or peeling ofthe skin.

•    Rednessoftheface,reductioninsizeof the pupils in the eye, muscle spasm, high temperature.

•    Aneed to take increasingly higher doses of the tablets to obtain the same level ofpain relief (tolerance).

•    Colicky abdominal pain or discomfort.

•    Aworsening ofliver function tests (seen in a blood test).

Rare side effects

(May affect uptolin 1,OOO people)

•    Lowbloodpressure.

•    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

•    Absenceofmenstrualperiods.

•    Ablockage intheflow ofbile 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.

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

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 ofthis medicine.

| 5. How to store OxyContin tablets    |

Keep this medicine 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 O8 2O2Omeans that you should not take thetablets afterthelast day ofthat month i.e. August 2O2O.

Do not store your tablets above 25^oC.

Donot take your tablets ifthey are broken or crushed as this can be dangerous and can cause serious problems such as overdose.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What OxyContin tablets contain

The active ingredient is oxycodone hydrochloride. Each tablet contains 5 mg, lOmg, l5 mg, 20 mg, 3Omg, 4O mg, 6O mg, 8Omg or l20 mg of oxycodone hydrochloride. The other ingredients are:

•    Lactose monohydrate

•    Povidone

•    Ammoniomethacrylate polymer

•    Sorbic acid

•    Triacetin

•    Stearyl alcohol

•    Talc

•    Magnesium stearate

•    Hypromellose (E464)

•    Titaniumdioxide(El7l)

•    Macrogol

In addition, the tablet coatings contain the following:

5 mg - brilliant blue (El33) lO mg-hydroxypropylcellulose l5 mg - ironoxide (El72)

2O mg, 3O mg, 4O mg, 6O mg and l2O mg -polysorbate 8O (E433), and iron oxide (El72)

8O mg - hydroxypropylcellulose, iron oxide (El72), and indigo carmine (El32)

What OxyContin tablets look like and the contents of the pack

The tablets are marked OC on one side and the strength on the other (5, lO, etc). All strengths are round, bi-convex, film coated tablets.

The tablets are all film coated in the following colours: 5 mg - light blue, lO mg - white, l5 mg

-    grey, 2O mg - pink, 3Omg-brown, 4Omg

-    yellow, 6O mg - red, 8O mg - green, l2O mg -purple.

In each box there are 28 or 56 tablets.

Marketing Authorisation Holder and Manufacturer

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 OGW, UK.

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