878l21170710-1

ARCOXIA 30 mg, 60 mg, 90 mg & 120 mgFilm-coated Tablets

PACKAGELEAFLET: INFORMATION FORTHE USERArcoxia 30 mg Film coated TabletsArcoxia 60 mg Film coated TabletsArcoxia 90 mg Film coated TabletsArcoxia 120 mg Film coated Tabletsetoricoxib

Read all of this leaflet carefully before you start taking thismedicine.

Keep this leaftet You may need to read it again.If you have any further questio s ask your doctor orpharmacistThis medicine has been prescribed for you. Do not pass it onto 0 ers.lt may harm them, even 'f their symptoms are thesame asyours.If any of the side effects gets serious, or if you notice anyside effects not listed in this leaflet, please tell your octor orpharmacist.

In this leaflet:1.What Arcoxia is and what it is used for2. Before you take Arcoxia3. How to take Arcoxia4. Possible side effects5. How to store Arcoxia6. Further information

1. WHAT ARCOIIA IS Nl>WHAT IT IS USED FOIl

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if you have serious liver diseaseif you have serious kidney diseaseif you are or could be pregnant or are breast·feeding (see'Pregnancy and breast feeding')if you are under 16 years of ageif you have inflammatory bowel disease, such asCrohrrsDisease, Ulcerative Colitis, or Colitisif your doctor has diagnosed heart problems induding heartfailure (moderate or severe types), angina (chest pain) orif you have had a heart attack. bypass surgery, peripheralarterial disease (poor circulation in legs or feet due to narrowor blocked arteries 0 any kind of stroke (including mini·stroke, transient ischae ic attack or T1A).Etoricoxib mayslightly increase your risk of heart attack and stroke and thisis why it should not be used in those who have already hadheart problems or strokeif you have high blood pressure that has not been controlledby treatment (check with your doctor or nurse if you are notsure whether your blood pressure is adequately controlled)

If you think any of these are relevant to you, do not take thetablets until you have consulted your doctor.Take special care with ARCOXIAAfCOy;" m.,'f not ho C! ,jt,b'n for "0" or "0" m2" coad to ho

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3. HOW TOTAKE ARCOXIAAlways take Arcoxia exactly asyour doctor has told you. Youshould check with your doctor or pharmacist if you are not sure.Arcoxia Tablets should not be taken by children or adolescentsunder 16 years of age.Take Arcoxia Tablets by mouth once a day. Arcoxia can be takenwith or without food.Do not take more than the recommended dose for yourcondition. Your doctor will want to discuss your treatment fromtime to ime.lt is important that you use the lowest dose thatcontrols your pain and you should not take Arcoxia for longerthan necessary,This is because the risk of heart attacks andstrokes might increase after prolonged treatment, especially withhigh doses.Osteoarthritise recom ended dose is 30 mg once a day, increase to a

maximum of 60 mg once a day if needed.Rheumatoid arthritisThe recommended dose is 90 mg once a day.GoutThe recommended dose is 120 mg once a day which should onlybe used for the acute painful period, limited to a maximum of8 days treatment.People with liver problems• If you have mild liver disease, you should not take more than

60 mg a day.If you ave moderate liver disease, you should not take more- 60 P19 e ery other day or 30 mg a day.

If you take more Arcoxia than you shouldYou shoY never take more tablets than the doctorrecommends. If you do take too many Arcoxia Tablets, you shouldseek medica attention immediately.If you forget to take ArcoxiaIt is important to take Arcoxia as your doctor has prescribed.If you miss a dose, just resume your usual schedule the followingday. Do not take a double dose to make up for the forgottentablet.If you have aA)I f~rther4:juestion5-OA-the us~ptOdua..as,,,- __ -.,your doctor or pharmacist

4. POSSIBLESIDE EFFEm

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Jke all medidnes, co ca cause side effe<ts. although noeverybody gets eIf you develop any of ese signs you should stop Arcoxia andtalk to your doctor immediately:

shortness of breath, chest pains, or an e swelling appear orif they get worseyellowing of the skin and eyes (jaundice) - these are signs ofliver problemssevere or continual stomach pain or your stools becomeblackan a ergic reaction- which can include skin problems suchas ke-s or ering, or swelling of the face, lips, tongue, orthroa" y cause d' culty in breathing

The fo s e effe<ts can occur during treatment withArcoaCom greater than 1 out of 1DO and essthan10 0' eWea ess fa gue, dizziness, headache, ftu-like illness,diarrhoea, wind, nausea, indigestion (dyspepsia), stomach painor discomfort, heartburn, changes in blood tests related toyour liver, swelling of the legs and/or feet due to fluid retention(oedema), increased blood pressure, palpitations, bruising.Uncommon (occurring in greater than lout of 1000 and less thanlout of 100 people)Stomach bloating, chest pain, heart failure, heart attack. stroke,mini-stroke (transient ischaemic attack), abnormal heartrhythm (atrial fibrillation), upper respiratory infection, highlevels of potassium in your blood, changes in blood or urinetests relating to your kidney, changes in your bowel habitsincluding constipation, dry mouth, mouth ulcers, taste alteration,gastroenteritis, gastritis, stomach ulcer, being sick (vomiting),irritable bowel syndrome, inflammation of the esophagus,blurred vision, eye irritation and redness, nose bleed, ringing inthe ears, vertigo, appetite increases or decreases, weight gain,muscle cramp/spasm, muscle pain/stiffness, inability to sleep,sleepiness, numbness or tingling, anxiety, depression, decreasesin mental sharpness, breathlessness, cough, swelling of the face,flushing, skin rash or itchy skin, urinary tract infection.Rare (occurring in greater than lout of 10,000 and less than loutof 1000 people)low blood Ipvels of sodillm I• I• I••• ,,I•• I,•

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monitored regularly while taking it if any of the following applyto you:

You have a history of stomach bleeding or ulcers.You are dehydrated, for example by a prolonged bout ofvomiting or diarrhoea.You have swelling due to fluid retention.You have a history of heart failure, heart attack or any otherform of heart disease.You have a history of stroke or mini stroke.You have a history of high blood pressure. Arcoxia canincrease blood pressure in some people, espeoa Iy inhigh doses, and your doctor will want to check your bloodpressure from time to time.You have any history of liver or kidney disease.You are being treated for an infecti Arcoxia can mas orhide a fever, which is a sign of infection.You are a woman trying to bec e oreqnant,You are elderly (Le, over 65 years rage.ou ave diabe es. high choles e are a smoker. eseca .ncrease your ris of heart d' sease,a-e 0 a a ta

.or 0:<Ja 0 see ~ s medicine isfor you.Arcoxia works equally well in older and younger ad - - . nts.If you are elderly (l.e, over 65 years of age), your d IIwantto appropriately keep a check on you. No dosage ec ent isnecessary for elderly patients.Taking other medicinesPleasetell your doctor or pharmacist if you are ta or haverecently taken any other medicines. ncluding medobtained without a presaip 'en

,..are wor1tin9 property, once you start ta ng Arcoxia:

medicines that thin your blood (anticoagulants), such aswarfarinrifampicin (an antibiotic)methotrexate (a drug used for suppressing the immunesystem, and often used in rheumatoid arthritis)medicines used to help control high blood pressure anaheart failure called ACEinhibitors and angio ensin rece orblockers, examples include enalapril and ra ril, andlosartan and valsartan

ospori or tacrolm s s used for s pp theimmune system}digoxin (a medicine for heart failure and irregu a' -.eartrhythm)minoxidil (a drug used to treat high blood presssalbutamol tablets or oral solution (a medicine for asthma)birth control pillshormone replacement therapyaspirin, the risk of stomach ulcers is greater if you takeArcoxia with aspirin.Arcoxia can be taken with low-dose aspirin. If you arecu ta ow-dose lSP" 0 pre en heart attacks or

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of• be ta d _ 'lancy.lf you arec be preg .00 are planning

o become pregna <10 no ta e tile ta ets," ou becomepregnant. stop taking the tablets and consul you doctor.Consult your doctor if you are unsure or need more advice.It is not known if Arcoxia is excreted in human milk. If you arebreast-feeding, or planning to breastfeed, consult your doctorbefore taking Arcoxia.lf you are using Arcoxia, you must notbreast-feed.Driving and using machinesDizziness and sleepiness have been reported in some patientstaking Arcoxia.Do not drive if you experience dizziness or sleepiness.Do not use any tools or machines if you experience dizziness orsleepiness.Important information about some of the ingredients of ArcoxiaArcoxia contains lactose. If you have been told by your doctorthat you are unable to tolerate some sugars, contact your doctorbefore taking this medicinal product.

1.1.1 ••• 111•• /1.Very Rare (occurring in lessthan lout of 10,000 people)Allergic reactions (which may be serious enough to requireimmediate medical attention) including hives, swelling of theface, lips, tongue, and/or throat which may cause difficulty inbreathing or swallowing, bronchospasm (wheezing or shortnessof breath), severe skin reactions, inflammation of the stomachlining or stomach ulcers that can become serious and may leadto bleeding, liver problems, serious kidney problems, severeincrease in blood pressure, confusion, seeing, feeling or hearing

-things that are not there (hallucinationS).If any of the side effects gets serious, or if you notice anyside effects not listed in this leaflet, please tell your doctor orpharmacist

5. HOW TO STOREARCOXIAof the reach and sight of children.se Arcoxia after the expiry date which is stated on the

pa e expiry date refers to the last day of the month.Bo~: Keep the container tightly closed in order to protect from

reosters; 5 e i ect

moisture.Medicines should not be disposed of via wastewater orhousehold waste. Ask your pharmacist how to dispose ofmedicines no longer required. These measures will help toprotect the environment. -6. FURTHER INFORMATION --What Arcoxia contains•The active substance is etoricoxib. Each film coated tabletcontains 30, 60, 90 or 120 mg of etoricoxib.•The other ingredients are:

-e: •.• droge ohospha a drousl. aoscarmellose- _- ..,ag es m stearate, microcrystalline ce lulose.

a et coa ng: carnauba wax, lactose monohydrate,h e lose, titanium dioxide (E171), triacetin. The 3D-, 6()..and12 _ tablets also contain yellow ferric oxide {El72, colouringage' indigo carmine lake (E132, colouring agent).What Artoxia looks like and contents of the packArcoxa - ets are available in four strengths:30 mg e-qreen, apple-shaped, biconvex film coated tabletsmarkeo ex 30'on one side and'tnron the other.60 dark green, apple-shaped, biconvex film coated tabletsma edARCOXIA 60' on one side and '200' on the other.90 "~e, a e-shaped. 'co ex <, coa:ed tab e ma ed'ARCO 90' on one side and 202 on the 0 er.12 "'19 pale-green, apple-shaped, bicon ex film coated tablets

ed 'ARCOXIA120' on one side and '204' on the other.Pad sizes:3 mg:Pack sizesof 28 tablets in blisters.60,90, 120 mg:Pack sizesof 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets inblisters; or 30 and 90 tablets in bottles.Not all pack sizes may be marketed.Marketing Authorisation HolderMerck Sharp & Dohme Ltd,Hertford RoadHoddesdonHertfordshireENl19BUUKThis lea e was last approved in {09/2007} .PILAcx.Oti.UK.2387This is a medicamentedicament is a product which affect your health, and its

consumption contray to instructions is dangerous for you. Followstrictly the doctor's prescription, the method of use and theinstructions of the pharmacist who sold the medicament. Thedoctor and the pharmacist are experts in medicine, its benefitsand risks.Do not by yourself interrupt the period of treatmentprescribed. Do not repeat the same prescription withoutconsultinyour doctor.KEEPMEDICAMENT OUT OF REACHOF CHILDRENCouncil of Arab Health MinistersUnion of Arab Pharmacists

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