Arcoxia

Leaflet accompanying the packaging: information for the user

ARCOXIA, 30 mg, film-coated tablets
ARCOXIA, 60 mg, film-coated tablets
ARCOXIA, 90 mg, film-coated tablets
ARCOXIA, 120 mg, film-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 tell 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 to reduce pain and swelling (inflammation) of the joints and muscles in people aged 16 and over with osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and gout.
• Arcoxia is also a medicine used for short-term treatment of moderate pain caused by surgical dental procedures in people aged 16 and over.

What is osteoarthritis?

Osteoarthritis is a disease that affects the joints. It occurs as a result of the gradual breakdown of cartilage that lines 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 can also cause 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

• in women who are pregnant, may be pregnant, or are breast-feeding (see Pregnancy, breast-feeding, and fertility);
• in children under 16 years of age;

In these situations, 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 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 problem;
• 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 need to check your blood pressure from time to time;
• you have or have had any liver or kidney problems;
• you are currently being treated for an infection. Arcoxia may mask the signs of an infection, such as fever;
• you have diabetes, high cholesterol, or are a smoker. These conditions increase the risk of heart disease;
• you are a woman trying to become pregnant;
• you are over 65 years of age.

If you are unsure if any of these conditions apply to you, consult your doctor before taking Arcoxiato discuss whether Arcoxia is suitable for you.
Arcoxia is just as effective in older patients as in younger 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 the case of taking one of the following medicines, your doctor may want to monitor you to make sure that your treatment is working properly from the start of taking Arcoxia :

• blood thinners (anticoagulants), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (a medicine used to treat rheumatoid arthritis and some cancers);
• cyclosporin or tacrolimus (medicines used to suppress the immune system);
• lithium (a medicine used to treat certain 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 the prevention of heart attacks or strokes: Arcoxia can be taken with low-dose aspirin. If you are currently taking low-dose aspirin to prevent heart attacks or strokes, 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 should 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. If you are unsure or need further information, consult your doctor.
Breast-feeding
It is not known whether 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
Arcoxia should not be used in women who are trying 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 film-coated 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. It is important to use the lowest effective dose for the shortest duration necessary to minimize the risk of heart attacks and strokes.
There are different strengths of this medicine available and 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
Etoricoxib should only be used for the acute painful period.
Gout
The recommended dose is 120 mg once daily, and it should only be used during an acute attack for a maximum of 8 days.
Pain following dental surgery
The recommended dose is 90 mg once daily, and the treatment should not exceed 3 days.

Patients with liver problems

• In patients with mild liver disease, the dose should not exceed 60 mg once daily.
• In patients with moderate liver disease, the dose should not exceed 30 mg once daily.

Use in children and adolescents

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

Elderly patients

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. The tablets should be taken once daily.
Arcoxia can be taken with or without food.

Overdose

Never take more tablets than your doctor recommends. If you take more Arcoxia than your doctor recommends, seek medical help immediately.

Missed dose

Arcoxia should be taken as prescribed by your doctor. If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten 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 symptoms, stop taking Arcoxia and contact your doctor immediately (see section 2, Important information before taking Arcoxia):
• shortness of breath, chest pain, or swelling of the feet or ankles;
• yellowing of the skin and eyes (jaundice), which are signs of liver problems;
• severe stomach pain or bleeding, or black stools;
• allergic reactions, including skin problems such as rash, blistering, or peeling (see Possible side effects, section 4);

The frequency of possible side effects is defined as follows:
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 can 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;
• dizziness, headache;
• palpitations (rapid or irregular heartbeat), irregular heartbeat (arrhythmia);
• high blood pressure;
• wheezing or shortness of breath (bronchospasm);
• constipation, gas (bloating), stomach upset (dyspepsia), and nausea, vomiting, inflammation of the esophagus;
• changes in liver function tests;
• bruising;
• weakness and fatigue, flu-like symptoms.

Uncommon:

• gastrointestinal disorders (gastroenteritis, which affects the stomach and intestines), upper respiratory tract infections, urinary tract infections;
• changes in blood tests (decreased red blood cell count, decreased white blood cell count, decreased platelet count);
• allergic reactions (including rash, which can be severe and require immediate medical attention);
• increased or decreased appetite, weight gain;
• anxiety, depression, decreased mental performance; 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, feeling of pressure or heaviness in the chest (angina pectoris), heart attack;
• hot flushes, stroke, mini-stroke (transient ischemic attack), severe increase in blood pressure, blood vessel inflammation;
• cough, shortness of breath;
• bloating, change in bowel habits, dry mouth, stomach ulcers, stomach inflammation, which can be severe and cause bleeding, irritable bowel syndrome, pancreatitis;
• face swelling, rash, or itching;
• muscle spasms, muscle pain or stiffness;
• high levels of potassium in the blood, changes in blood or urine tests related to kidney function, severe kidney problems;
• chest pain.

Rare:

• angioedema (an allergic reaction characterized by swelling of the face, lips, tongue, and throat, which can cause difficulty breathing or swallowing, and requires immediate medical attention); anaphylactic or anaphylactoid reactions, including shock (a severe allergic reaction that requires immediate medical attention);
• confusion, 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 tell your doctor or pharmacist. Side effects can be reported to the national reporting system listed in the website.
Side effects can also be reported to the marketing authorization holder.
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 which is stated on the carton. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help 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 mg, 60 mg, 90 mg, or 120 mg of etoricoxib.
• The other ingredients are: Tablet core: calcium phosphate, 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 film-coated tablets, apple-shaped, biconvex, with ‘ACX 30’ on one side and ‘101’ on the other side.
60 mg dark green film-coated tablets, apple-shaped, biconvex, with ‘ARCOXIA 60’ on one side and ‘200’ on the other side.
90 mg white film-coated tablets, apple-shaped, biconvex, with ‘ARCOXIA 90’ on one side and ‘202’ on the other side.
120 mg pale green film-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, film-coated tablets
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 film-coated tablets
Czech Republic
ARCOXIA 30 mg, 60 mg, 90 mg film-coated tablets
Cyprus, Malta
ARCOXIA 60, 90, 120 mg film-coated tablets
Finland
Arcoxia 30, 60, 90 ja 120 mg film-coated tablets
France
ARCOXIA 30, 60 mg film-coated tablets
Germany
ARCOXIA 30/60/90/120 mg film-coated tablets
Greece
ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets
Hungary
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets
Italy
ARCOXIA 30, 60, 90, 120 mg film-coated tablets
Latvia
Arcoxia 30 mg, 60 mg, 90 mg un 120 mg film-coated tablets
Lithuania
Arcoxia 30, 60, 90, 120 mg film-coated tablets
Netherlands
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets
Poland
ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets
Portugal
ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets
Slovakia
ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets
Slovenia
Arcoxia 30/60/90/120 mg film-coated tablets
Spain
ARCOXIA 30, 60, 90 y 120 mg film-coated tablets
Sweden
Arcoxia 30 mg, 60 mg, 90 mg och 120 mg film-coated tablets

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