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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 the group of selective cyclooxygenase 2 (COX-2) inhibitors. It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

What is Arcoxia used for?

• Arcoxia helps reduce pain and swelling (inflammatory conditions) 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 bone ends. 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 range 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 the patient is allergic to etoricoxib or any of the other ingredients of this medicine (listed in section 6).
• if the patient has hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and selective cyclooxygenase 2 (COX-2) inhibitors (see Possible side effects, section 4);
• if the patient has active peptic ulcer or bleeding from the stomach or intestines;
• if the patient has severe liver dysfunction;
• if the patient has severe kidney dysfunction;
• in pregnant or breastfeeding women, or women who may become pregnant (see Pregnancy, breastfeeding, and fertility);
• in people under 16 years of age;
• if the patient has inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or intestinal colitis;
• if the patient has uncontrolled high blood pressure. Arcoxia may increase blood pressure in some people, especially after taking high doses of the medicine, so the doctor will check blood pressure from time to time;
• if the patient has ever been diagnosed by a doctor with heart problems, including moderate or severe heart failure or angina (chest pain);
• if the patient has had a heart attack, undergone a bypass grafting procedure, or has peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries);
• if the patient has had any type of stroke (including mini-stroke or transient ischemic attack, TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and therefore should not be used in people who have had heart or stroke problems.

In the event of any of the above situations, the doctor should be consulted before taking the tablets.

Warnings and precautions

Before starting to take Arcoxia, the doctor or pharmacist should be consulted:

• if the patient has a history of stomach bleeding or stomach ulcers;
• if the patient is dehydrated, e.g., due to prolonged, recurring vomiting or diarrhea;
• if the patient has swelling due to fluid retention;
• if the patient has a history of heart failure or other heart disease;
• if the patient has a history of high blood pressure. Arcoxia may increase blood pressure in some people, especially after taking high doses of the medicine, so the doctor will check blood pressure from time to time;
• if the patient has a history of liver or kidney dysfunction;
• if the patient is currently being treated for an infection. Arcoxia may mask fever, which is a sign of infection;
• in the case of people with diabetes, high cholesterol, or smokers. These people are at increased risk of heart disease;
• in the case of women planning to become pregnant;
• in the case of people over 65 years of age.

In case of doubt as to whether any of the above situations exist, the doctor should be consulted before taking Arcoxia to clarify whether the medicine can be taken.

Children and adolescents

This medicine should not be given to children and adolescents under 16 years of age.

Arcoxia and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

• blood thinners (anticoagulants), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (a medicine that suppresses the immune system, often used to treat rheumatoid arthritis);
• cyclosporine or tacrolimus (medicines that suppress the immune system);
• lithium (a medicine used to treat certain types of depression);
• medicines used to 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 used to treat heart failure and heart rhythm disorders);
• minoxidil (a medicine used to treat high blood pressure);
• salbutamol in tablet or oral solution form (a medicine used to treat asthma);
• oral contraceptives (combination may increase the risk of side effects);
• hormone replacement therapy (combination may increase the risk of side effects);
• acetylsalicylic acid, the risk of stomach ulcers is higher when taking Arcoxia with acetylsalicylic acid;
• acetylsalicylic acid used for the prevention of heart attacks or strokes: Arcoxia can be taken with a low dose of acetylsalicylic acid. If the patient is currently taking low-dose acetylsalicylic acid to prevent a heart attack or stroke, they should not stop taking acetylsalicylic acid without consulting their doctor;
• acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs): the patient should not take high doses of acetylsalicylic acid or other anti-inflammatory medicines while taking Arcoxia.

Taking Arcoxia with food and drink

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

Pregnancy, breastfeeding, and fertility

Pregnancy
Arcoxia should not be taken by pregnant women. A pregnant woman or a woman who may be pregnant or is planning to become pregnant should not take this medicine. If the patient becomes pregnant, they should stop taking the medicine and consult their doctor. In case of doubt or need for additional information, the patient should consult their doctor.
Breastfeeding
It is not known whether Arcoxia is excreted in breast milk. If the patient is breastfeeding or planning to breastfeed, they should consult their doctor before taking Arcoxia. If the patient is taking Arcoxia, they should not breastfeed.
Fertility
It is not recommended to take Arcoxia in women planning to become pregnant.

Driving and using machines

Some patients taking Arcoxia have reported dizziness and drowsiness.
Do not drive vehicles if you experience dizziness and drowsiness.
Do not operate any machinery or use tools if you experience dizziness and drowsiness.

Arcoxia contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Arcoxia contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means the medicine is essentially 'sodium-free'.

3. How to take Arcoxia

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the doctor or pharmacist should be consulted.
Do not take more than the recommended dose for each condition. The doctor should be consulted from time to time to monitor the treatment. It is important to use the lowest effective dose that provides relief from pain and to not take Arcoxia for longer than necessary. There is an increased risk of heart attacks and strokes with prolonged use of the medicine, especially with high doses.
There are different strengths of this medicinal product, and depending on the condition being treated, the doctor will prescribe the strength that is right for the patient.
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 during periods of acute pain.
Gout
The recommended dose is 120 mg once daily; it should only be used during periods of acute pain, for a maximum of 8 days.
Pain following surgical dental procedures
The recommended dose is 90 mg once daily, and treatment with this dose should not exceed 3 days.

Patients with liver dysfunction

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

Use in children and adolescents

Arcoxia should not be taken by 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 prescribed by the doctor. If too many tablets of Arcoxia are taken, medical help should be sought immediately.

Missed dose

Arcoxia should be taken as prescribed by the doctor. If a dose is missed, the next day the patient should return to their usual dosing schedule. A double dose should not be taken to make up for a missed dose.
In case of further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• If any of the following symptoms occur, the patient should stop taking Arcoxia and seek medical help immediately (see section 2 Important information before taking Arcoxia):
• shortness of breath, chest pain, or swelling of the ankles or feet, or worsening of existing swelling;
• yellowing of the skin and eyes (jaundice), which are signs of liver dysfunction;
• severe or persistent stomach pain, or black stools;
• allergic reactions, which can cause skin problems such as ulcers, blisters, or swelling of the face, lips, tongue, or throat, which can cause difficulty breathing.

The frequency of possible side effects is classified 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 may occur during treatment with Arcoxia:
Very common:

• stomach pain.

Common:

• dry socket (inflammation and pain after tooth extraction);
• swelling of the legs and (or) feet due to fluid retention (edema);
• dizziness, headache;
• palpitations (rapid or irregular heartbeat), irregular heartbeat (arrhythmia);
• increased blood pressure;
• wheezing or shortness of breath (bronchospasm);
• constipation, gas (excess gas in the intestines), stomach upset (gastritis), heartburn, diarrhea, indigestion (dyspepsia), and (or) discomfort in the stomach, nausea, vomiting, esophagitis, mouth ulcers;
• changes in liver blood test results;
• bruises;
• weakness and fatigue, flu-like symptoms.

Uncommon:

• gastroenteritis (inflammation of the digestive tract, which includes both the stomach and the small and (or) large intestine), upper respiratory tract infection, urinary tract infection;
• changes in laboratory test results (decreased red blood cell count, decreased white blood cell count, decreased platelet count);
• hypersensitivity (allergic reaction, including hives, which can be severe enough to require immediate medical attention);
• increased or decreased appetite, weight gain;
• anxiety, depression, decreased mental performance; hallucinations;
• taste disorders, insomnia, numbness or tingling;
• blurred vision, eye irritation and redness;
• ringing in the ears, dizziness (feeling of spinning while at rest);
• heart rhythm disorders (atrial fibrillation), rapid heartbeat, heart failure, feeling of tension, feeling of pressure or heaviness in the chest (angina pectoris), heart attack;
• hot flashes, stroke, mini-stroke (transient ischemic attack, TIA), severe increase in blood pressure, vasculitis;
• cough, shortness of breath;
• bloating, change in bowel movements, dry mouth, stomach ulcers, gastritis, which can be severe and lead to bleeding, irritable bowel syndrome, pancreatitis;
• facial swelling, rash, or itching, redness of the skin;
• muscle cramps, muscle pain, or stiffness;
• high potassium levels in the blood, changes in liver or kidney blood or urine test results, severe kidney dysfunction;
• chest pain.

Rare:

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

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Arcoxia

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Arcoxia contains

• The active substance of Arcoxia 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 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 iron oxide yellow (E 172, colorant) and indigo carmine, lake (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.
60 mg dark green film-coated tablets, apple-shaped, biconvex, with ‘ARCOXIA 60’ on one side and ‘200’ on the other.
90 mg white film-coated tablets, apple-shaped, biconvex, with ‘ARCOXIA 90’ on one side and ‘202’ on the other.
120 mg light green film-coated tablets, apple-shaped, biconvex, with ‘ARCOXIA 120’ on one side and ‘204’ on the other.
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 Warsaw
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, and 120 mg tablets, film-coated
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, and 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
Slovenia
Arcoxia 30/60/90/120 mg film-coated tablets
Spain
ARCOXIA 30, 60, 90, and 120 mg film-coated tablets
Sweden
Arcoxia 30 mg, 60 mg, 90 mg, and 120 mg film-coated tablets

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