Package leaflet: Information for the user

Oxeltra 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg,

60 mg and 80 mg Prolonged-Release Tablets

Oxycodone hydrochloride

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 again.

•    Ifyou haveanyfurtherquestions, askyourdoctoror pharmacist.

•    This medicine has been prescribed foryou only. Do not pass it on to others. It may harmthem, even iftheir signs of illness arethesameasyours.

•    Ifyou get any side effects,talktoyour doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Oxeltra tabletsare and whatthey are used for

2.    Whatyou need to know beforeyou take Oxeltra tablets

3.    HowtotakeOxeltratablets

4.    Possiblesideeffects

5.    HowtostoreOxeltratablets

6.    Contents ofthe packand other information

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

Thesetablets have been prescribed foryou byyourdoctorto relieve moderateto severe pain overa period of12 hours.

- They contain the active ingredient oxycodonewhich belongs ■ toa group of medicines called strong analgesics or 'painkillers'

2. What you need to know before you take Oxeltra tablets

Do not take Oxeltra tablets if you:

" • are allergic (hypersensitive)to oxycodone, orany ofthe other ingredients ofthetablets (see section 6'Further Information’);

•    have breathing problems, such as chronic obstructive airwaysdisease, severe bronchial asthma or severe respiratorydepression with low levels ofoxygen in your blood (hypoxia), or too much carbon dioxide in your blood. Your doctorwill havetold you ifyou have anyofthese conditions. Symptoms may include breathlessness, coughing or breathing moreslowlyorweaklythan expected;

•    have a head injurythat causes a severe headache or makes you feel sick. This is becausethetablets may makethese symptomsworse or hidethe extent ofthe head injury;

•    have a condition wherethe small bowel does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) oryou have severe pain inyourabdomen;

•    have a heart problem after long-term lung disease (cor pulmonale);

•    have severe kidney problems or moderate to severe liver problems. Ifyou have other long-term kidneyor liver problems you should onlytakethesetablets if recommended byyourdoctor;

•    have ongoing problems with constipation;

•    are taking a type of medicine known as a monoamine oxidase inhibitor (examples includetranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid), or you havetaken this type of medicine in the lasttwoweeks;

•    areunder18yearsofage.

Ifyou are going to have an operation, please tell the doctor at the hospitalthatyou are taking thesetablets.

Warnings and precautions

Talkto yourdoctor or pharmacist before taking Oxeltra tablets ifyou:

•    areolderanddebilitated(weak);

•    have an under-activethyroid gland (hypothyroidism), as you may need a lower dose;

•    have a thyroid disorderwith dryness, coldnessand swelling ('puffiness') ofthe skin, affecting theface and limbs (myxoedema);

•    have a severe headache orfeel sick as this may indicate that the pressure in your skull is increased;

•    have low blood pressure (hypotension) or reduced blood volume;

•    have a mental disorderas a result ofan infection (toxic psychosis);

•    have inflammation ofthe pancreas (which causes severe pain in the abdomen and back) or problemswith your gall bladder;

•    haveinflammatoryboweldisorders;

•    have recently had abdominal surgery;

•    haveprostateproblems;

•    have poor adrenal gland function (your adrenal gland is not working properlywhich maycause symptoms including weakness, weight loss, dizziness, feeling or being sick);

•    haveseverelungproblems;

•    haveliverorkidneyproblems;

•    have previouslysuffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs;

•    sufferfrom alcoholism or are undergoing alcohol withdrawal;

•    have a historyofalcohol or drug abuse.

Other medicines and Oxeltra tablets

Please tell your doctor or pharmacist ifyou aretaking or have recentlytaken anyother medicines, including medicines obtained without a prescription. Ifyou take thesetabletswith some other medicines, the effect ofthesetablets orthe other medicine may be changed.

Thesetablets must not be used togetherwith a monoamine oxidase inhibitor, or ifyou havetaken this type of medicine in the lasttwo weeks (see section 2"Do not take...").

Tell your doctor or pharmacist ifyou aretaking:

•    medicinesto help you sleep (for exampletranquillisers, hypnotics or sedatives);

•    medicinesto treat depression (such as paroxetineand fluoxetine);

•    medicinesto treat psychiatric or mental disorders (such as phenothiazines or neuroleptic drugs);

•    otherstrong analgesics or painkillers;

•    medicinestotreat allergies, travel sickness or nausea (antihistamines or antiemetics)

•    muscle relaxants;

•    medicinestotreat high blood pressure;

•    medicines used totreat Parkinson's disease;

•    quinidine (a medicineto treat a fast heart beat);

•    cimetidine (a medicineforstomach ulcers, indigestion or heartburn);

•    rifampicin (usedtotreattuberculosis);

•    carbamazepine (used totreat seizures, fits or convulsions and certain pain conditions);

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

•    StJohn'sWort(aherbalmedicine)

•    antifungal medicines (such as ketoconazole,voriconazole, itraconizoleand posaconazole);

•    antibiotics (such as erythromycin, clarithromycin and telithromycin).

Also tell your doctor ifyou have recently been given an

anaesthetic.

Taking Oxeltra tablets with food, drink and alcohol

Drinking alcohol whilst taking Oxeltra tablets may makeyou feel more sleepy or increasethe riskofserious side effects such as shallow breathing with a riskofstopping breathing, and loss ofconsciousness. It is recommended notto drink alcohol whileyou'retaking Oxeltra tablets.

You should avoid drinking grapefruitjuicewhileyou are takingthesetablets.

Pregnancy and breastfeeding

Do not takethese tablets ifyou are pregnant or breastfeeding. Askyour doctoror pharmacistfor advice before taking any medicine.

Driving and using machines

The medicine can affect your ability to drive as it may make you sleepyordizzy.

•    Do notdrivewhiletaking this medicine until you know how it affectsyou.

•    It is an offenceto drive if this medicine affectsyourabilityto drive.

•    However, you would not be committing an offence if:

o The medicine has been prescribed totreat a medical or dental problem and

o You havetaken it according to the instructions given by the prescriberor in the information provided with the medicine and

o Itwas not affecting your ability to drive safely Talkto your doctor or pharmacist ifyou are not surewhether it is safe for you to drivewhiletaking this medicine.

These tablets may affect your ability to operate machines. Discusswith you doctorwhetheryou mayoperate machines.

Important information about some of the ingredients of Oxeltra tablets

Thesetablets contain lactosewhich is a form ofsugar. Ifyou : have been told byyour doctorthat you have an intolerances ! some sugars, contact yourdoctor beforetaking thesetablets. ■

3. How to take Oxeltra tablets

Always takethese tablets exactlyasyourdoctor has told you. The label on your medicinewill tell you how manytabletsto takeand how often.

Adults (over 18 years of age)

The usual starting dose is one 10 mg tablet every 12 hours. However,your doctorwill prescribethe dose required totreat your pain. Ifyou findthat you are still inpain whilst taking these tablets,discuss this with your doctor.

Do not exceed the dose recommended byyourdoctor. You should checkwith your doctor or pharmacist ifyou are not sure.

Swallow yourtablets whole with water. Do not crush, dissolve or chew them.

Oxeltra 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 takeyourtablets 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 onlytake 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 adolescentsunder 18years ofage should not takethetablets.

If you take more Oxeltra tablets than you should or if someone accidentally swallows your tablets

Call yourdoctor or hospital straight away. People who have takenan overdose mayfeel very sleepy, sickor dizzy, or have hallucinations.They mayalso have breathing difficulties leading tounconsciousness or even death and may need emergencytreatment in hospital. When seeking medical attention make surethatyou takethis leaflet and any remainingtablets withyou to show to the doctor.

If you forget to take your Oxeltra tablets

Ifyou remember within4 hours ofthe time yourtablet was due,take yourtablet straight away. Take your next tablet at yournormal time. Ifyou are morethan 4 hours late, please call yourdoctor or pharmacist for advice. Do nottake a double doseto makeupfor a forgotten tablet.

If you stop taking Oxeltra tablets

You should not suddenly stop taking thesetabletsunlessyour doctortellsyou to. Ifyou wantto stoptaking yourtablets, discuss this withyourdoctorfirst.They will tell you howto do _ this, usually by reducing the dose gradually so you do not g experience unpleasant effects. Withdrawal symptoms such as

■    agitation, anxiety, palpitations, shaking orsweating may occur - ifyou suddenly stoptaking thesetablets.

■    Ifyou have any furtherquestions on the use of this medicine,

“ askyourdoctor or pharmacist.

This should not affect howthe tablets work.

Reporting of side effects

Ifyou getany side effects/talkto yourdoctor or pharmacist. This includesany possible side effects not listed inthis leaflet. You canalso report sideeffectsdirectlyvia theYellowCard Scheme at http://www.mhra.aov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Oxeltra tablets

Keep out ofthe sight and reach of children. Accidental overdose by a child is dangerous and may be fatal.

Do not useanytablets afterthe expirydate which is stated on the blister and carton or bottle label. The expiry date refers to the last day ofthat month.

Do not store above 25°C.

Do nottakeyourtablets iftheyare broken orcrushed as this can be dangerous and can cause serious problems such asoverdose.

Medicines should not be disposed ofvia wastewateror household waste. Askyour pharmacist howtodispose of medicines no longer required.These measures will helpto protectthe environment.

6. Contents of the pack and other information

4. Possible side effects

Like all medicines,these tablets can cause side effects, although not everybody gets them.

All medicines can causeallergic reactions,although serious allergic reactionsare rare.Tell yourdoctor immediately ifyou get any sudden wheeziness, difficulties in breathing, swelling ofthe eyelids, face orlips, rash or itching especiallythose covering yourwhole body.

The most seriousside effect is a condition where you breathe more slowly or weaklythan expected (respiratory depression).

As with all strong painkillers, there is a riskthatyou may become addicted or reliant on thesetablets.

Other possible side effects

Very common (may affect more than 1 in 10 people):

•    headache

•    feelingsick(nausea)

•    beingsick(vomiting)

•    constipation

•    drowsiness

•    dizziness

•    itchy skin

Common (may affect up to 1 in 10 people):

•    dry mouth, loss ofappetite, indigestion, abdominal pain, diarrhoea

•    confusion, a feeling ofunusual weakness, anxiety,depression, nervousness, difficulty in sleeping,abnormal thoughts

•    difficulty in breathing or wheezing, shortness of breath

•    rash

•    sweating

•    shaking.

Uncommon (may affect up to 1 in 100 people):

•    difficulty in swallowing, belching, wind, changes in taste

•    a feeling ofdizziness or'spinning', a feeling of'faintness' especially on standing up, hallucinations, mood changes, a feeling ofextreme happiness, agitation, generally feeling unwell, loss of memory,twitching, difficulties with speech, reduced sensitivityto pain ortouch/tingling or numbness, seizures, fits or convulsions, blurred vision

•    difficulty in passing urine, impotence, decreased sexual drive

•    flushing ofthe skin

•    dehydration/thirst, chills, swelling ofthe hands,ankles or feet

•    dry skin

•    reduction in size ofthe pupils inthe eye, muscle spasm

•    a need totake increasingly higher dosesto obtain the same level of pain relief (tolerance).

Uncommonly/thesetablets mayaffectthe results of blood teststo checkthatyour liver is working properly.

Rare (may affect up to 1 in 1,000 people):

•    lowbloodpressure.

Not known (frequency cannot be estimated from the available data):

•    tooth decay

•    a blockage in the flow of bile from the liver (cholestasis). This can cause itchy skin yellow skin, very darkurineand very pale stools

•    absenceofmenstrualperiods

•    aggression

•    increasedsensitivitytopain.

You may see the remains ofthe tablets inyourfaeces.

What Oxeltra tablets contain

The active ingredient is oxycodone hydrochloride. Eachtablet contains 5 mg, 10 mg, 15 mg, 20 mg, 30 mg,40 mg, 60 mg or 80 mg ofoxycodone hydrochloride.

The other ingredients are: lactose monohydrate, hypromellose (E464), povidone, stearic acid, magnesiumstearateand anhydrous silica colloidal.

lnaddition,the tablet coatings contain the following:

5mg- polyvinyl alcohol (E1203),titaniumdioxide (E171), macrogol (E1521), talc (E553b), indigo carminealuminium lake (E132) and iron oxide yellow (E172).

10mg- hypromellose (E464),titaniumdioxide (E171), macrogol (E1521), polysorbate (E433).

15mg- polyvinylalcohol (E1203), titaniumdioxide (E171), macrogol (E1521), talc (E553b), iron oxide black(E172) and iron oxide yellow (E172).

20 mg - polyvinyl alcohol(E1203),titaniumdioxide (E171), macrogol (E1521), talc (E553b) and iron oxide red (E172).

30 mg - polyvinyl alcohol (E1203), macrogol (E1521), talc (E553b), iron oxide red (E172), ironoxide black(E172) and indigo carminealuminium lake (E132).

40 mg - polyvinyl alcohol(E1203),titaniumdioxide (E171), macrogol (E1521), talc (E553b) and iron oxide yellow (E172).

60 mg-polyvinyl alcohol (E1203), macrogol (E1521),talc(E553b), iron oxide red (E172), carmine and iron oxide black(E172).

80 mg - polyvinylalcohol (E1203), titaniumdioxide (E171), macrogol (E1521), talc(E553b), indigo carminealuminium lake (E132) and iron oxide yellow (E172).

What Oxeltra tablets look like and the contents of the pack

The tablets are marked OX along withthe strength (5,10,etc) on one side. All strengths are round, bi-convex,filmcoated tablets.

The tablets are all film coated in the following colours:

5 mg - blue, 10mg- white, 15 mg - grey, 20 mg - pink,

30 mg- brown,40 mg-yellow,60 mg- red,80 mg-green. Oxeltra 5mg Tablets are available in cartons containing    j

28or100tablets.    ■

Oxeltra 10mg, 15mg, 20mg, 30mg,40mg, 60mg and 80mg I Tabletsare available in cartons containing 56or 100tablets. ■ Notall packsizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK Manufacturer

CPPharmaceuticals Ltd,Ash Road North, Wrexham, LL13 9UF, UK Other formats:

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Please be ready to give the following information:

This is a service provided bythe Royal National Institute of Blind People.

Leaflet Prepared: 08/2014.

PwOCKHARDT

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