Arcoxia

PACKAGE LEAFLET

Package leaflet: information for the user

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

etoricoxib
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ARCOXIA is and what it is used for
2. What you need to know before taking 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 ARCOXIA is

• ARCOXIA contains the active substance etoricoxib. ARCOXIA belongs to a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

What ARCOXIA is used for

• ARCOXIA helps reduce pain and swelling (inflammation) in the joints and muscles of people aged 16 years and older who have osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, or gout.
• ARCOXIA is also used for the short-term treatment of moderate pain following dental surgery in people aged 16 years and older.

What is osteoarthritis (OA)?
Osteoarthritis is a joint disease. It is caused by the progressive deterioration of the cartilage that covers the ends of bones. This leads to 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 progressive loss of movement in affected joints. It may also cause inflammation in other parts of the body.

What is gout?
Gout is a disease characterized by sudden and recurrent attacks of very painful inflammation and redness of the joints. It is caused by the deposition of mineral crystals in the joints.

What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease affecting the spine and large joints.

2. What you should know before taking ARCOXIA

Do not take ARCOXIA

• if you are allergic (hypersensitive) to etoricoxib or to 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 section 4, Possible side effects)
• if you have an active stomach ulcer or active bleeding in the stomach or intestines
• if you have severe liver disease
• if you have severe kidney disease
• if you are pregnant or there is a possibility that you may be pregnant, or if you are breastfeeding (see "Pregnancy, breastfeeding 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 is not controlled by treatment (consult your doctor or pharmacist if you are unsure whether your blood pressure is adequately controlled)
• if your doctor has diagnosed you with heart problems, including heart failure (moderate or severe), angina (chest pain)
• if you have had a heart attack, coronary artery bypass surgery, or peripheral arterial disease (reduced circulation in the legs and feet due to narrowed or blocked arteries)
• if you have ever had any type of stroke (including mini-stroke, transient ischemic attack or TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and therefore should not be used in people who have already had heart problems or stroke.

If you think any of these conditions apply to you, do not take these tablets before
consulting your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking ARCOXIA if:

• You have a history of stomach bleeding or stomach ulcers.
• You are dehydrated, for example due to prolonged 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. In some people, ARCOXIA, especially at high doses, may increase blood pressure, and your doctor will periodically check your blood pressure.
• You have a history of liver or kidney disease.
• You are being treated for an infection. ARCOXIA may mask or hide fever, which is a sign of infection.
• You have diabetes, high cholesterol, or are a smoker. These are conditions that may increase your risk of heart disease.
• You are a woman trying to become pregnant.
• You are over 65 years of age.

If you have any doubts about any of the conditions listed above, discuss them with your doctor before
taking ARCOXIA to determine whether the medicine is suitable for you.
ARCOXIA has the same efficacy in younger and older patients. If you are over 65 years of age, your doctor will monitor you appropriately. No dose adjustment is necessary for patients over 65 years of age.
Children and adolescents
Do not give this medicine to children or adolescents under 16 years of age.
Other medicines and ARCOXIA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
In particular, if you are taking any of the following medicines, your doctor may require monitoring to ensure these medicines remain effective after you start taking ARCOXIA:

• medicines that thin the blood (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used for suppression of the immune system and often used in the treatment of rheumatoid arthritis)
• cyclosporine or tacrolimus (medicines used for suppression of the immune system)
• lithium (a medicine used to treat certain types of depression)
• medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, and losartan and valsartan
• diuretics
• digoxin (a medicine for the treatment of heart failure and irregular heartbeat)
• minoxidil (a medicine used to treat high blood pressure)
• salbutamol tablets or oral solution (a medicine for the treatment of asthma)
• oral contraceptives (combination therapy may increase the risk of side effects)
• hormone replacement therapy (combination therapy may increase the risk of side effects)
• aspirin: the risk of stomach ulcers is higher if you take ARCOXIA with aspirin.
  • aspirin for prevention of heart attacks or strokes: ARCOXIA may be taken with a low dose of aspirin. If you are taking low-dose aspirin for prevention of heart attacks or strokes, do not stop taking aspirin without consulting your doctor.
  • aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs): You should not take a high dose of aspirin or other anti-inflammatory medicines while taking ARCOXIA.

ARCOXIA with food and drink
The onset of ARCOXIA's effect may be faster when taken without food.
Pregnancy, breastfeeding and fertility
Pregnancy
ARCOXIA tablets must not be taken during pregnancy. If you are pregnant or suspect you may be pregnant, or if you think you could become pregnant, do not take the tablets. If you become pregnant, stop taking the tablets and consult your doctor. If you are unsure or need further information, consult your doctor.
Breastfeeding
It is not known whether ARCOXIA is excreted in human milk. If you are breastfeeding or planning to breastfeed, contact your doctor before taking ARCOXIA. If you are using ARCOXIA, you must not breastfeed.
Fertility
ARCOXIA is not recommended for women intending to become pregnant.
Driving and using machines
Some patients taking ARCOXIA have reported dizziness and drowsiness.
Do not drive if you experience dizziness or drowsiness.
Do not operate tools or machinery if you experience dizziness or drowsiness.
ARCOXIA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
ARCOXIA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take ARCOXIA

Take this medicine exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Do not take more than the recommended dose for the treatment of your condition. Your doctor will periodically review your treatment. It is important that you use the lowest effective dose capable of controlling your pain and that you do not take ARCOXIA for longer than necessary. This is because the risk of heart attacks and strokes may increase with prolonged treatment, especially at higher doses.

Different dosage strengths are available for this medicine, and depending on your condition, your doctor will prescribe the tablet strength appropriate for you.
The recommended dose is:

Osteoarthritis
The recommended dose is 30 mg once daily, which may be increased, if necessary, up to a maximum dose of 60 mg once daily.

Rheumatoid arthritis
The recommended dose is 60 mg once daily, which may be increased, if necessary, up to a maximum dose of 90 mg once daily.

Ankylosing spondylitis
The recommended dose is 60 mg once daily, which may be increased, if necessary, up to a maximum dose of 90 mg once daily.

Acute pain conditions
Etoricoxib should be used only for the duration of acute pain.

Gout
The recommended dose is 120 mg once daily, to be used only during the period of acute pain and limited to a maximum of 8 days of treatment.

Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a maximum of 3 days of treatment.

Patients with liver problems

• If you have mild liver disease, you must not take more than 60 mg per day.
• If you have moderate liver disease, you must not take more than 30 mg per day.

Use in children and adolescents
ARCOXIA tablets must not be taken by children or adolescents under 16 years of age.

Elderly
Dose adjustment is not required in 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 daily. ARCOXIA may be taken with or without food.

If you take more ARCOXIA than you should
Never take more tablets than recommended by your doctor. If you take too many ARCOXIA tablets, contact a doctor immediately.

If you forget to take ARCOXIA
It is important to follow the ARCOXIA dose prescribed by your doctor. If you forget a dose, simply resume your usual dosing schedule the next day. Do not take a double dose to make up for the missed tablet.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, you must stop treatment with ARCOXIA and
contact your doctor immediately (see “What you need to know before taking ARCOXIA”,
section 2):

• shortness of breath, chest pain, or swelling of the ankles that develop or begin to worsen
• yellowing of the skin or eyes (jaundice) – these are signs of liver problems
• severe or persistent stomach pain or black stools
• an allergic reaction which may include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may cause breathing difficulties.

The frequency of the possible side effects listed below is defined using the following convention:
Very common (affects more than 1 in 10 people)
Common (affects 1 to 10 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Rare (affects 1 to 10 in 10,000 people)
Very rare (affects less than 1 in 10,000 people)

The following side effects may occur during treatment with ARCOXIA:
Very Common:

• stomach pain

Common:

• alveolitis (inflammation and pain following 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 (bronchospasm)
• constipation, flatulence (excess gas), gastritis (inflammation of the inner stomach lining), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the oesophagus, mouth ulcers
• changes in certain blood tests related to liver function
• bruising
• weakness and fatigue, flu-like illness

Uncommon:

• gastroenteritis (inflammation of the gastrointestinal tract involving both the stomach and small intestine), upper respiratory tract infection, urinary tract infection
• changes in laboratory test values (decreased number of red blood cells, decreased number of white blood cells, decreased platelets)
• hypersensitivity (an allergic reaction including hives, which may be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, reduced mental sharpness, visual, sensory or auditory perceptions not caused by real stimuli (hallucinations)
• altered taste, difficulty sleeping, tingling or numbness, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (persistent sensation of dizziness)
• abnormal heart rhythm (atrial fibrillation), increased heart rate, heart failure, feeling of tightness, pressure or heaviness in the chest (angina pectoris), heart attack
• hot flushes, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, difficulty breathing, nosebleeds
• stomach or intestinal bloating, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the inner stomach lining which may become severe and may lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
• facial swelling, skin rash or itchy skin, redness of the skin
• muscle cramps/spasms, muscle pain/stiffness
• elevated potassium levels in the blood, changes in certain blood or urine tests related to kidney function, severe kidney problems
• chest pain

Rare:

• angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and swallowing, which may be severe enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (a severe allergic reaction requiring immediate medical attention)
• confusion, restlessness
• liver problems (hepatitis)
• low sodium levels in the blood
• liver failure, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 stated on the pack. The expiry date refers to the last day of that month.
Bottle: keep the container tightly closed to protect the medicine from moisture.
Blister: store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 components are:
  Tablet core: dibasic anhydrous calcium phosphate, sodium croscarmellose, magnesium stearate, microcrystalline cellulose.
  Tablet coating: carnauba wax, monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin. Tablets of 30, 60, and 120 mg also contain yellow iron oxide (colouring agent E172) and indigo carmine lake (colouring agent E132).

What ARCOXIA looks like and contents of the pack
ARCOXIA tablets are available in four formulations:
30 mg tablets: biconvex, apple-shaped, blue-green in colour, engraved with “ACX 30” on one side and “101” on the other;
60 mg tablets: biconvex, apple-shaped, dark green in colour, engraved with “ARCOXIA 60” on one side and “200” on the other;
90 mg tablets: biconvex, apple-shaped, white in colour, engraved with “ARCOXIA 90” on one side and “202” on the other;
120 mg tablets: biconvex, apple-shaped, light green in colour, engraved with “ARCOXIA 120” on one side and “204” on the other.

Pack sizes:
30 mg:
Blister packs containing 2, 7, 14, 20, 28, 49, 98 tablets or multi-packs containing 98 (2 packs of 49) tablets in blisters.

60 mg:
Blister packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets in blisters; or bottles containing 30 or 90 tablets, with desiccant containers. The desiccant (one or two containers) in the bottle, used to keep the tablets dry, must not be swallowed.

90 mg:
Blister packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets in blisters; or bottles containing 30 or 90 tablets, with desiccant containers. The desiccant (one or two containers) in the bottle, used to keep the tablets dry, must not be swallowed.

120 mg:
Blister packs containing 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 bottles containing 30 or 90 tablets, with desiccant containers. The desiccant (one or two containers) in the bottle, used to keep the tablets dry, must not be swallowed.

60, 90 and 120 mg:
Aluminium/aluminium blisters (single dose) in packs of 5, 50 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome, Italy

Manufacturer
30, 60, 90 and 120 mg
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium, Luxembourg: Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés
Denmark, Estonia, Iceland, Norway: Arcoxia
Ireland, United Kingdom: ARCOXIA 30, 60, 90 or 120 mg film-coated tablets
Austria: Arcoxia 30 mg, 60 mg, 90 mg, 120 mg-Filmtabletten
Czech Republic: ARCOXIA 30 mg, 60 mg, 90 mg potahované tablety
Cyprus, Malta: ARCOXIA 60, 90, 120 mg film-coated tablets
Finland: Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen
France: ARCOXIA 30, 60 mg, comprimé pelliculé
Germany: ARCOXIA 30/60/90/120 mg Filmtabletten
Greece: ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets
Hungary: Arcoxia 30 mg, 60 mg, 90 mg, 120 mg filmtabletta
Italy: ARCOXIA 30, 60, 90, 120 mg compresse rivestite con film
Latvia: Arcoxia 30 mg, 60 mg, 90 mg un 120 mg apvalkotās tablets
Lithuania: Arcoxia 30, 60, 90, 120 mg plėvele dengtos tabletės
The Netherlands: Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, filmomhulde tabletten
Poland: ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg tabletki powlekane
Portugal: ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película
Slovakia: ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg
Slovenia: Arcoxia 30/60/90/120 mg filmsko obložene tablete
Spain: ARCOXIA 30, 60, 90 y 120 mg comprimidos recubiertos con película
Sweden: Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter