ARCOXIA 60 MG FILM COATED TABLETS

Active substance: ETORICOXIB

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Package leaflet: Information for the user

EN

30 mg film-coated tablets 60 mg film-coated tablets 90 mg film-coated tablets 120 mg film-coated tablets

Etoricoxib

Technical Info

Etoricoxib

Etoricoxib

Etoricoxib

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
What is in this leaflet
1. What ARCOXIA is and what it is used for
2. What you need to know before you take ARCOXIA
3. How to take ARCOXIA
4. Possible side effects
5. How to store ARCOXIA
6. Contents of the pack and other information

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1. What ARCOXIA is and what it is used for
• ARCOXIA is one of a group of medicines called selective COX-2 inhibitors. These belong to a family
of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• ARCOXIA helps to reduce the pain and swelling (inflammation) in the joints and muscles of people
with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.
• ARCOXIA is also used for the short term treatment of moderate pain after dental surgery.
What is osteoarthritis?
Osteoarthritis is a disease of the joints. It results from the gradual breakdown of cartilage that cushions
the ends of the bones. This causes swelling (inflammation), pain, tenderness, stiffness and disability.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long term inflammatory disease of the joints. It causes pain, stiffness, swelling,
and increasing loss of movement in the joints it affects. It may also cause inflammation in other areas
of the body.
What is gout?
Gout is a disease of sudden, recurring attacks of very painful inflammation and redness in the joints.
It is caused by deposits of mineral crystals in the joint.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large joints.

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3. How to take ARCOXIA

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Always take this medicine exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
ARCOXIA Tablets should not be taken by children or adolescents under 16 years of age.
Take ARCOXIA Tablets by mouth once a day. ARCOXIA can be taken with or without food.
Do not take more than the recommended dose for your condition. Your doctor will want to discuss
your treatment from time to time. It is important that you use the lowest dose that controls your pain
and you should not take ARCOXIA for longer than necessary. This is because the risk of heart attacks
and strokes might increase after prolonged treatment, especially with high doses.
Osteoarthritis
The recommended dose is 30 mg once a day, increase to a maximum of 60 mg once a day if needed.
Rheumatoid arthritis
The recommended dose is 90 mg once a day.
Ankylosing spondylitis
The recommended dose is 90 mg once a day.
Acute pain conditions
Etoricoxib should be used only for the acute painful period.
Gout
The recommended dose is 120 mg once a day which should only be used for the acute painful period,
limited to a maximum of 8 days treatment.
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a maximum of 3 days treatment.
People with liver problems
• If you have mild liver disease, you should not take more than 60 mg a day.
• If you have moderate liver disease, you should not take more than 30 mg a day.
If you take more ARCOXIA than you should
You should never take more tablets than the doctor recommends. If you do take too many
ARCOXIA tablets, you should seek medical attention immediately.

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2. What you need to know before you take ARCOXIA
Do not take ARCOXIA:
• if you are allergic (hypersensitive) to etoricoxib or any of the other ingredients of ARCOXIA
(see Further information, section 6)
• if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and
COX-2 inhibitors (see Possible Side Effects, section 4)
• if you have a current stomach ulcer or bleeding in your stomach or intestines
• if you have serious liver disease
• if you have serious kidney disease
• if you are or could be pregnant or are breast-feeding (see ‘Pregnancy and breast feeding’)
• if you are under 16 years of age
• if you have inflammatory bowel disease, such as Crohn’s Disease, Ulcerative Colitis, or Colitis
• if your doctor has diagnosed heart problems including heart failure (moderate or severe types),
angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease
(poor circulation in legs or feet due to narrow or blocked arteries), or any kind of stroke (including
mini-stroke, transient ischaemic attack or TIA). Etoricoxib may slightly increase your risk of heart
attack and stroke and this is why it should not be used in those who have already had heart
problems or stroke
• if you have high blood pressure that has not been controlled by treatment (check with your doctor
or nurse if you are not sure whether your blood pressure is adequately controlled)
If you think any of these are relevant to you, do not take the tablets until you have consulted your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking ARCOXIA if:
• You have a history of stomach bleeding or ulcers.
• You are dehydrated, for example by a prolonged bout of vomiting or diarrhoea.
• You have swelling due to fluid retention.
• You have a history of heart failure, or any other form of heart disease.
• You have a history of high blood pressure. ARCOXIA can increase blood pressure in some people,
especially in high doses, and your doctor will want to check your blood pressure from time to time.
• You have any history of liver or kidney disease.
• You are being treated for an infection. ARCOXIA can mask or hide a fever, which is a sign of infection.
• You are a woman trying to become pregnant.
• You are elderly (i.e., over 65 years of age).
• You have diabetes, high cholesterol, or are a smoker. These can increase your risk of heart disease.
If you are not sure if any of the above apply to you, talk to your doctor
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before taking ARCOXIA to see if this medicine is suitable for you.
ARCOXIA works equally well in older and younger adult patients. If you are elderly (i.e., over 65 years
of age), your doctor will want to appropriately keep a check on you. No dosage adjustment is
necessary for elderly patients.
Children and Adolescents
Do not give this medicine to children and adolescents under 16 years of age.
Other medicines and ARCOXIA
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.
In particular if you are taking any of the following medicines, your doctor may want to monitor you to
check that your medicines are working properly, once you start taking ARCOXIA:
• medicines that thin your blood (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a drug used for suppressing the immune system, and often used in rheumatoid
arthritis)
• medicines used to help control high blood pressure and heart failure called ACE inhibitors and
angiotensin receptor blockers, examples include enalapril and ramipril, and losartan and valsartan
• lithium (a medicine used to treat some types of depression)
• diuretics (water tablets)
• ciclosporin or tacrolimus (drugs used for suppressing the immune system)
• digoxin (a medicine for heart failure and irregular heart rhythm)
• minoxidil (a drug used to treat high blood pressure)
• salbutamol tablets or oral solution (a medicine for asthma)
• birth control pills
• hormone replacement therapy
• aspirin, the risk of stomach ulcers is greater if you take ARCOXIA with aspirin.
- ARCOXIA can be taken with low-dose aspirin. If you are currently taking low-dose aspirin to
prevent heart attacks or stroke, you should not stop taking aspirin until you talk to your doctor
- do not take high dose aspirin or other anti-inflammatory medicines while taking ARCOXIA
Pregnancy and breast-feeding
ARCOXIA tablets must not be taken during pregnancy. If you are pregnant or think you could be pregnant,
or if you are planning to become pregnant, do not take the tablets. If you become pregnant, stop taking
the tablets and consult your 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 are breast-feeding, or planning to breast-feed,
consult your doctor before taking ARCOXIA. If you are using ARCOXIA, you must not breast-feed.
ARCOXIA with food and drink
The onset of the effect of ARCOXIA may be faster when taken without food.
Driving and using machines
Dizziness and sleepiness have been reported in some patients taking ARCOXIA.
Do not drive if you experience dizziness or sleepiness.
Do not use any tools or machines if you experience dizziness or sleepiness.
ARCOXIA contains lactose
If you have been told by your doctor that you are unable to tolerate some sugars, contact your doctor
before taking this medicinal product.

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If you forget to take ARCOXIA
It is important to take ARCOXIA as your doctor has prescribed. If you miss a dose, just resume your
usual schedule the following day. Do not take a double dose to make up for the forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

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4. Possible side effects

Technical Info

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Like all medicines, ARCOXIA can cause side effects, although not everybody gets them.
If you develop any of these signs you should stop ARCOXIA and talk to your doctor
immediately:
• shortness of breath, chest pains, or ankle swelling appear or if they get worse
• yellowing of the skin and eyes (jaundice) – these are signs of liver problems
• severe or continual stomach pain or your stools become black
• an allergic reaction- which can include skin problems such as ulcers or blistering, or swelling of the
face, lips, tongue, or throat which may cause difficulty in breathing
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000).
The following side effects can occur during treatment with ARCOXIA:
Very Common:
• stomach pain
Common:
• dry socket (inflammation and pain after a tooth extraction)
• swelling of the legs and/or feet due to fluid retention (oedema)
• dizziness, headache
• palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia),
• increased blood pressure
• wheezing or shortness of breath (bronchospasms)
• constipation, wind (excessive gas), gastritis (inflammation of the lining of the stomach),
heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, being sick (vomiting),
inflammation of the oesophagus, mouth ulcers
• changes in blood tests related to your liver
• bruising
• weakness and fatigue, flu-like illness
Uncommon:
• gastroenteritis (inflammation of the gastrointestinal tract that involves both the stomach and small
intestine/stomach flu), upper respiratory infection, urinary tract infection
• decreased number of red blood cells, decreased number of white blood cells, platelets decreased
• hypersensitivity (an allergic reaction including hives which may be serious enough to require
immediate medical attention
• appetite increases or decreases, weight gain
• anxiety, depression, decreases in mental sharpness; seeing, feeling or hearing things that are not
there (hallucinations)
• taste alteration, inability to sleep, numbness or tingling, sleepiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (sensation of spinning while remaining still)
• abnormal heart rhythm (atrial fibrillation), fast heart rate, heart failure, feeling of tightness,
pressure or heaviness in the chest (angina pectoris), heart attack
• flushing, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure,
inflammation of the blood vessels
• cough, breathlessness, nose bleed
• stomach or bowel bloating, changes in your bowel habits, dry mouth, stomach ulcer, inflammation
of the stomach lining that can become serious and may lead to bleeding, irritable bowel
syndrome, inflammation of the pancreas
• swelling of the face, skin rash or itchy skin, redness of the skin
• muscle cramp/spasm, muscle pain/stiffness
• high levels of potassium in your blood, changes in blood or urine tests relating to your kidney,
serious kidney problems
• chest pain
Rare:
• angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat which may
cause difficulty in breathing or swallowing, which may be serious enough to require immediate
medical attention)/anaphylactic/anaphylactoid reactions including shock (a serious allergic
reaction that requires immediate medical attention)
• confusion, restlessness
• liver problems (hepatitis)
• low blood levels of sodium
• liver failure, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.

5. How to store ARCOXIA
Keep this medicine out of the sight and reach of children.
Do not use ARCOXIA after the expiry date which is stated on the pack. The expiry date refers to the
last day of the month.
Bottles: Keep the container tightly closed in order to protect from moisture.
Blisters: Store in the original package in order to protect from moisture.
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.

6. Contents of the pack and other information
What ARCOXIA contains
• The active substance is etoricoxib. Each film coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
• The other ingredients are:
Core: calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate,
microcrystalline cellulose.
Tablet coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171),
triacetin. The 30-, 60- and 120-mg tablets also contain yellow ferric oxide (E172, colouring agent)
and indigo carmine lake (E132, colouring agent).
What ARCOXIA looks like and contents of the pack
ARCOXIA Tablets are available in four strengths:
30 mg blue-green, apple-shaped, biconvex film coated tablets marked ‘ACX 30’ on one side and ‘101’
on the other.
60 mg dark green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 60’ on one side and
‘200’ on the other.
90 mg white, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 90’ on one side and ‘202’
on the other.
120 mg pale-green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 120’ on one side
and ‘204’ on the other.
30 mg:
Pack sizes of 2, 7, 14, 20, 28, 49 tablets or multi-packs containing 98 (2 packs of 49) tablets in blisters.
60, 90, 120 mg:
Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100 tablets or multi-packs containing 98 (2 packs of 49)
tablets in blisters; or 30 and 90 tablets in bottles with desiccant containers. The desiccant (one or two
containers) in the bottle, used to keep the tablets dry, should not be swallowed.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder in the UK and Malta is Merck Sharp & Dohme Ltd, Hertford Road,
Hoddesdon, Herts, EN11 9BU, UK.
The Marketing Authorisation Holder in Ireland is Merck Sharp & Dohme Ireland (Human Health) Ltd,
Red Oak North, South County Business Park, Leopardstown, Dublin 18, Ireland.
Manufacturer: Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands.
This medicinal product is authorized in the Member States of the EEA under the following names:
Belgium, Luxemburg
Denmark, Estonia, Iceland, Norway
Malta, Ireland, United Kingdom
Austria
Czech Rep.
Cyprus
Finland
France
Germany
Greece
Hungary
Italy
Latvia
Lithuania
Netherlands
Poland
Portugal
Slovakia
Slovenia
Spain
Sweden

Profile:
Profile Revision:
Profile Revision Date:
Dimensions (mm):

BG148x520_260
7
050708
148 x 520mm

Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés
Arcoxia
ARCOXIA 30, 60, 90 or 120 mg film-coated tablets
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg-Filmtabletten
ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg, potahované tablety
ARCOXIA 30, 60, 90, 120 mg
Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen
ARCOXIA 30, 60 , 90 mg, comprimé pelliculé
ARCOXIA 30/60/90/120 mg Filmtabletten
ARCOXIA 30 mg, 60 mg, 90 mg,120 mg film-coated tablets
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg filmtabletta
ARCOXIA 30, 60, 90, 120 mg compresse rivestite con film
Arcoxia 30 mg, 60 mg, 90 mg un 120 mg apvalkotās tablets
Arcoxia 30, 60, 90, 120 mg plėvele dengtos tabletės
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, filmomhulde tabletten
ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg tabletki powlekane
ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película
ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg
Arcoxia 30/60/90/120 mg filmsko obložene tablete
ARCOXIA 30, 60, 90 y 120 mg comprimidos recubiertos con película
Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter

This leaflet was last revised in March 2013 
© Merck Sharp & Dohme Limited 2013. All rights reserved.
ARCOXIA PIL.ACX.13.UK/IRL.3849-II-057

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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