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What is ARCOXIA?

•    ARCOXIA contains the active substance etoricoxib. 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).

What is ARCOXIA used for?

•    ARCOXIA helps to reduce the pain and swelling (inflammation) in the joints and muscles of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.

•    ARCOXIA is also used for the short term treatment of moderate pain after dental surgery in people 16 years of age and older. 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.

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 this medicine (listed in 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, breast feeding and fertility') if you are under 16 years of age

if you have inflammatory bowel disease, such as Crohn's Disease, Ulcerative Colitis, or Colitis

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 your doctor has diagnosed heart problems including heart failure (moderate or severe types), angina (chest pain) if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries)

•    if you have had 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 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 have diabetes, high cholesterol, or are a smoker. These can increase your risk of heart disease.

You are a woman trying to become pregnant.

You are over 65 years of age.

If you are not sure if any of the above apply to you, talk to your doctor 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 over 65 years of age, your doctor will want to appropriately keep a check on you. No dosage adjustment is necessary for patients over 65 years of age.

Children and adolescents

Do not give this medicine to children and adolescents under 16 years of age.

Other medicines and ARCOXIA

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)

•    ciclosporin or tacrolimus (drugs used for suppressing the immune system)

•    lithium (a medicine used to treat some types of depression)

•    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

•    diuretics (water tablets)

•    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 (the combination may increase your risk of side effects)

•    hormone replacement therapy (the combination may increase your risk of side effects)

•    aspirin, the risk of stomach ulcers is greater if you take ARCOXIA with aspirin.

-    aspirin for prevention of heart attacks or stroke:

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

-    aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs):

do not take high dose aspirin or other anti-inflammatory medicines while taking ARCOXIA.

ARCOXIA with food and drink

The onset of the effect of ARCOXIA may be faster when taken without food.

Pregnancy, breast-feeding and fertility

Pregnancy

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.

Breast-feeding

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.

Fertility

ARCOXIA is not recommended in women attempting to become pregnant.

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.

|3. How to take ARCOXIA

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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.

There are different strengths available for this medicinal product and depending on your disease your doctor will prescribe the tablet strength that is appropriate for you.

The recommended dose is:

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.

you can help provide more information on the safety of this medicine. Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL- Dublin 2,Tel: +353 1 6764971, Fax:+353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie

United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

5. How to store ARCOXIA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that 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 protect the environment.

6. Contents of the packand 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 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 Ltd., Shotton Lane, Cramlington, Northumberland NE23 3JU, United Kingdom.

Distributor: Grunenthal Ltd, Units 1 and 2 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK 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

This leaflet was last revised in March 2015.

PIL.ACX.15.UK.4512

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Arcoxia

60 mg film-coated tablets

Arcoxia

90 mg film-coated tablets 120 mg film-coated tablets 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 guestions, 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. See section 4.

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

1. What ARCOXIA is and what it is used for

What is ARCOXIA?

•    ARCOXIA contains the active substance etoricoxib. 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).

What is ARCOXIA used for?

•    ARCOXIA helps to reduce the pain and swelling (inflammation) in the joints and muscles of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.

•    ARCOXIA is also used for the short term treatment of moderate pain after dental surgery in people 16 years of age and older.

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.

Ankylosing spondylitis is an inflammatory disease of the spine and large joints.

2. Whatyou 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 this medicine (listed in 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, breastfeeding and fertility')

•    ifyou are under 16 years of age

•    ifyou have inflammatory bowel disease, such as Crohn's Disease, Ulcerative Colitis, or Colitis

•    ifyou 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 adeguately controlled)

•    if your doctor has diagnosed heart problems including heart failure (moderate or severe types), angina (chest pain)

•    ifyou have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries)

•    ifyou have had any kind of stroke (including mini-stroke, transient ischaemic attack orTIA). 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 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 have diabetes, high cholesterol, or are a smoker. These can increase your risk of heart disease.

•    You are a woman trying to become pregnant.

•    You are over 65 years of age.

If you are not sure if any of the above apply to you, talk to your doctor 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 over 65 years of age, your doctor will want to appropriately keep a check on you. No dosage adjustment is necessary for patients over 65 years of age.

Children and adolescents

Do not give this medicine to children and adolescents under 16 years of age. Other medicines and ARCOXIA

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)

•    ciclosporin or tacrolimus (drugs used for suppressing the immune system)

•    lithium (a medicine used to treat some types of depression)

•    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

•    diuretics (water tablets)

•    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 (the combination may increase your risk of side effects)

•    hormone replacement therapy (the combination may increase your risk of side effects)

•    aspirin, the risk of stomach ulcers is greater if you take ARCOXIA with aspirin.

-    aspirin for prevention of heart attacks or stroke:

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

-    aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs): do not take high dose aspirin or other anti-inflammatory medicines while taking ARCOXIA.

ARCOXIA with food and drink

The onset of the effect of ARCOXIA may be faster when taken without food. Pregnancy, breast-feeding and fertility

Pregnancy

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.

Breast-feeding

It is not known if ARCOXIA is excreted in human milk. If you are breastfeeding, or planning to breast-feed, consult your doctor before taking ARCOXIA. If you are using ARCOXIA, you must not breast-feed.

Fertility

ARCOXIA is not recommended in women attempting to become pregnant. 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.

3. How to take ARCOXIA

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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.

There are different strengths available for this medicinal product and depending on your disease your doctor will prescribe the tablet strength that is appropriate for you.

The recommended dose is:

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.

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Use in children and adolescents

ARCOXIA tablets should not be taken by children or adolescents under 16 years of age.

Elderly

No dose adjustment is necessary for elderly patients. As with other medicines, caution should be exercised in elderly patients.

Method of administration

ARCOXIA is for oral use. Take the tablets once a day. ARCOXIA can be taken with or without food.

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.

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 guestions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 (see What you need to know before you take ARCOXIA section 2):

•    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 freguency 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 (dyspepsiaj/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

•    changes in laboratory values (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 reguire 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 reguire immediate medical attentionj/anaphylactic/anaphylactoid reactions including shock (a serious allergic reaction that reguires 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 Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects,

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