Arcoxia

Leaflet accompanying the packaging: information for the user

ARCOXIA, 30 mg, coated tablets
ARCOXIA, 60 mg, coated tablets
ARCOXIA, 90 mg, coated tablets
ARCOXIA, 120 mg, coated tablets
etoricoxib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Arcoxia and what is it used for
• 2. Important information 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 is Arcoxia and what is it used for

What is Arcoxia?

• Arcoxia contains the active substance etoricoxib. Arcoxia is a medicine belonging to a group of selective cyclooxygenase-2 (COX-2) inhibitors. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

What is Arcoxia used for?

• Arcoxia helps reduce pain and swelling (inflammation) of the joints and muscles in people 16 years of age and older with osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and gout.
• Arcoxia is also a medicine used for short-term treatment of moderate pain associated with surgical dental procedures in people 16 years of age and older.

What is osteoarthritis?

Osteoarthritis is a disease that affects the joints. It occurs as a result of the gradual breakdown of cartilage lining the ends of bones. This causes swelling (inflammation), pain, tenderness, stiffness, and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-standing inflammatory disease of the joints. It causes pain, stiffness, swelling, and increased loss of motion in the joints it affects. It also causes inflammation in other parts of the body.

What is gout?

Gout is a disease characterized by sudden, recurring attacks of very painful inflammation and redness of the joints. This disease is caused by the deposition of crystalline deposits in the joint.

What is ankylosing spondylitis?

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

2. Important information before taking Arcoxia

When not to take Arcoxia

• if you are allergic to etoricoxib or any of the other ingredients of this medicine (listed in section 6).
• if you have had an allergic reaction to non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin, or to COX-2 inhibitors (see Possible side effects, section 4);
• if you have active stomach or intestinal ulcers, or bleeding from the stomach or intestines;
• if you have severe liver problems;
• if you have severe kidney problems;
• in women who are pregnant, think they may be pregnant, or are breast-feeding (see Pregnancy, breast-feeding and fertility);
• in children under 16 years of age;
• if you have inflammatory bowel disease (such as Crohn's disease or ulcerative colitis);
• if you have high blood pressure that is not well-controlled and have been told to take blood pressure medication every day;
• if you have or have had any heart problems, including heart failure, angina, or if you have had a heart attack;
• if you have had a stroke or mini-stroke (TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and so should not be used in people who have had these conditions.

In case of any of the above, consult your doctor before taking the tablets.

Warnings and precautions

Before taking Arcoxia, tell your doctor or pharmacist if:

• you have had stomach or intestinal ulcers, or bleeding from the stomach or intestines in the past;
• you are dehydrated, for example, due to prolonged vomiting or diarrhea;
• you have swelling due to fluid retention;
• you have had heart failure or any other heart problems;
• you have high blood pressure and are taking medication to control it. Arcoxia may increase blood pressure in some people, especially when taken at high doses, so your doctor will want to monitor your blood pressure from time to time;
• you have had liver or kidney problems;
• you are currently being treated for an infection. Arcoxia may mask a fever, which is a sign of infection;
• you have diabetes, high cholesterol, or are a smoker. These conditions increase the risk of heart disease;
• you are planning to become pregnant;
• you are over 65 years of age.

If you are unsure if any of the above apply to you, consult your doctor before taking Arcoxiato discuss whether you should take this medicine.
Arcoxia is just as effective in older patients as in younger adult patients. In patients over 65 years of age, your doctor may want to monitor you more closely.

Children and adolescents

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

Arcoxia and other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
In case you are taking any of the following medicines, your doctor may want to monitor you to make sure your treatment is working and to prevent unwanted side effects:

• blood-thinning medicines (anticoagulants) such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (a medicine used to treat rheumatoid arthritis or some cancers);
• cyclosporin or tacrolimus (medicines used to suppress the immune system);
• lithium (a medicine used to treat some types of depression);
• medicines used to treat high blood pressure and heart failure, called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, and losartan and valsartan;
• diuretics (water tablets);
• digoxin (a medicine used to treat heart failure and irregular heartbeat);
• minoxidil (a medicine used to treat high blood pressure);
• salbutamol tablets or oral solution (a medicine used to treat asthma);
• oral contraceptives (the combination may increase the risk of side effects);
• hormone replacement therapy (the combination may increase the risk of side effects);
• aspirin (the risk of stomach ulcers is greater if you take Arcoxia with aspirin);
• aspirin for prevention of heart attack or stroke: Arcoxia can be taken with low-dose aspirin. If you are currently taking low-dose aspirin to prevent heart attack or stroke, do not stop taking it until your doctor tells you to;
• aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs): do not take high-dose aspirin or other NSAIDs while taking Arcoxia.

Taking Arcoxia with food and drink

The effect of the medicine may start sooner if Arcoxia is taken on an empty stomach.

Pregnancy, breast-feeding, and fertility

Pregnancy
Arcoxia must not be used during pregnancy. Women who are pregnant, think they may be pregnant, or are planning to become pregnant should not take this medicine. If you become pregnant, stop taking the medicine and consult your doctor.
Breast-feeding
It is not known if Arcoxia passes into breast milk. If you are breast-feeding or planning to breast-feed, consult your doctor before taking Arcoxia. If you are taking Arcoxia, do not breast-feed.
Fertility
It is not recommended to take Arcoxia if you are planning to become pregnant.

Driving and using machines

Some patients taking Arcoxia have experienced dizziness and somnolence (sleepiness).
Do not drive or operate machinery if you experience dizziness or somnolence.
Do not use any tools or machines if you experience dizziness or somnolence.

Arcoxia contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Arcoxia contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Arcoxia

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Do not take more than the recommended dose for each condition. Check with your doctor from time to time to review your treatment and to see if the dose can be reduced or if Arcoxia can be stopped. It is important to use the lowest dose that controls your pain and inflammation, and for the shortest time needed to treat your condition. Long-term use of Arcoxia at high doses may increase the risk of heart attack and stroke.
There are different strengths of this medicine available. Depending on your condition, your doctor will prescribe the strength that is right for you.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once daily, increased to a maximum of 60 mg once daily if needed.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily if needed.
Ankylosing spondylitis
The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily if needed.
Acute pain conditions
Etoricoxib should only be used for the acute painful period.
Gout
The recommended dose is 120 mg once daily, and it is not recommended to take this dose for more than 8 days.

Patients with liver problems

• In patients with mild liver problems, the dose should not exceed 60 mg per day.
• In patients with moderate liver problems, the dose should not exceed 30 mg per day.

Use in children and adolescents

Arcoxia should not be used in children and adolescents under 16 years of age.

Use in older people

No dose adjustment is necessary for older people. As with other medicines, caution should be exercised in older people.
Method of administration
Arcoxia is for oral use. Take one tablet once daily. Arcoxia can be taken with or without food.

Overdose

Never take more tablets than your doctor recommends. If you take too many tablets, contact your doctor or hospital immediately.

Missed dose

Take Arcoxia according to your doctor's instructions. If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for a missed dose.
If you have any further questions 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 experience any of the following, stop taking Arcoxia and tell your doctor immediately (see section 2 Important information before taking Arcoxia):
• shortness of breath, chest pain, or swelling of your legs or feet;
• yellowing of the skin and eyes (jaundice) - these are signs of liver problems;
• severe stomach pain or bleeding from your stomach or intestines;
• allergic reactions including hives, itching, or rash, blisters, or peeling skin, which may be accompanied by fever, chills, headache, or aching muscles or joints;

Frequency of possible side effects:
Very common:
occurring in more than 1 in 10 patients
Common:
occurring in 1 in 100 to 1 in 10 patients
Uncommon:
occurring in 1 in 1000 to 1 in 100 patients
Rare:
occurring in 1 in 10,000 to 1 in 1000 patients
Very rare:
occurring in less than 1 in 10,000 patients
The following side effects may occur with Arcoxia:
Very common:

• stomach pain.

Common:

• dry socket (inflammation and pain after tooth extraction);
• swelling of the legs or feet due to fluid retention (edema);
• dizziness, headache;
• palpitations (rapid or irregular heartbeat), irregular heart rhythm (arrhythmia);
• high blood pressure;
• wheezing or shortness of breath (bronchospasm);
• constipation, gas (bloating), stomach upset (dyspepsia), and/or discomfort in the stomach, nausea, vomiting, esophagitis, mouth ulcers;
• changes in liver function tests;
• bruising;
• weakness and fatigue, flu-like symptoms.

Uncommon:

• gastrointestinal disorders (gastroenteritis, which affects both the stomach and intestines), upper respiratory tract infections, urinary tract infections;
• changes in blood or urine tests related to kidney function;
• allergic reactions (hypersensitivity, including anaphylaxis);
• increased or decreased appetite, weight gain;
• anxiety, depression, decreased mental sharpness; hallucinations;
• taste disturbances, insomnia, numbness or tingling, drowsiness;
• blurred vision, eye irritation and redness;
• ringing in the ears, dizziness (feeling of spinning while standing still);
• heart rhythm disorders (atrial fibrillation), rapid heartbeat, heart failure, feeling of tightness, heaviness, or pressure in the chest (angina pectoris), heart attack;
• hot flushes, stroke, transient ischemic attack (TIA), severe increase in blood pressure, vasculitis;
• cough, shortness of breath;
• bloating, change in bowel movements, dry mouth, stomach ulcers, stomach upset, which can be severe and lead to bleeding, irritable bowel syndrome, pancreatitis;
• facial swelling, rash, or itching;
• muscle spasms, muscle pain or stiffness;
• high potassium levels in the blood, changes in blood or urine tests related to kidney function, severe kidney problems;
• chest pain.

Rare:

• angioedema (allergic reaction characterized by swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing, which can be severe and requires immediate medical attention); anaphylactic or anaphylactoid reactions, including shock (a severe allergic reaction that requires immediate medical attention);
• disorientation, anxiety;
• liver problems (hepatitis);
• low sodium levels in the blood;
• liver failure, yellowing of the skin and eyes (jaundice);
• severe skin reactions.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). Side effects can also be reported to the manufacturer.

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 packaging. The expiry date refers to the last day of that month.
Store in the original package 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 pack and other information

What Arcoxia contains

• The active substance is etoricoxib. Each tablet contains 30 mg, 60 mg, 90 mg, or 120 mg of etoricoxib.
• The other ingredients are: Tablet core: calcium phosphate anhydrous, croscarmellose sodium, magnesium stearate, microcrystalline cellulose. Tablet coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin. The 30 mg, 60 mg, and 120 mg tablets also contain yellow iron oxide (E 172, colorant) and indigo carmine (E 132, colorant).

What Arcoxia looks like and contents of the pack

Arcoxia is available in four strengths:
30 mg blue-green coated tablets, apple-shaped, biconvex, with ‘ACX 30’ on one side and ‘101’ on the other side.
60 mg dark green coated tablets, apple-shaped, biconvex, with ‘ARCOXIA 60’ on one side and ‘200’ on the other side.
90 mg white coated tablets, apple-shaped, biconvex, with ‘ARCOXIA 90’ on one side and ‘202’ on the other side.
120 mg pale green coated tablets, apple-shaped, biconvex, with ‘ARCOXIA 120’ on one side and ‘204’ on the other side.
30 mg:
Pack sizes: 7, 14, 28, 49, 98 tablets, or multipacks containing 98 (2 packs of 49) tablets in blisters.
60 mg:
Pack sizes: 5 (single unit pack), 7, 14, 28, or 98 tablets in blisters.
90 mg and 120 mg:
Pack sizes: 5 (single unit pack), 7, 14, or 28 tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

30 mg:
Organon Polska Sp. z o.o.

Manufacturer/Importer

ul. Marszałkowska 126/134
Merck Sharp & Dohme B.V.
00-008 Warszawa
Waarderweg 39
Tel. + 48 22 105 50 01
2031 BN Haarlem
[email protected]

Manufacturer

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Vianex S.A (only for Greece)
15th Km Marathonos Ave.
15351 Pallini Attikis
Athens
Greece
60 mg, 90 mg, and 120 mg:

Manufacturer

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Vianex S.A (only for Greece)
15th Km Marathonos Ave.
15351 Pallini Attikis
Athens
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium, Luxembourg
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés
Denmark, Estonia,
Arcoxia
Iceland, Norway
Ireland,
ARCOXIA 30, 60, 90 or 120 mg film-coated tablets
United Kingdom
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 tabletes
Lithuania
Arcoxia 30, 60, 90, 120 mg plėvele dengtos tabletės
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

Date of last revision of the leaflet: 11/2022.