Arcoxia: detailed information

Package leaflet: 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

Please read all of 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 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 other people, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Arcoxia is and what it is used for
What you need to know before taking Arcoxia
How to take Arcoxia
Possible side effects
How to store Arcoxia
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 belongs to a group of medicines called selective cyclooxygenase-2 (COX-2) inhibitors. It is a member of a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

What is Arcoxia used for?

Arcoxia helps to reduce pain and swelling (inflammation) in the joints and muscles in people aged 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gouty arthritis.
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?
Osteoarthritis is a joint disease. It occurs as a result of the gradual breakdown of the cartilage that lines the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and loss of function.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long-lasting inflammatory disease of the joints. It causes pain, stiffness, swelling, and reduced range of motion in the affected joints. It may 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 in the joints. It is caused by the deposition of crystal 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 non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, or selective cyclooxygenase-2 (COX-2) inhibitors (see Possible side effects, section 4);
if the patient has active peptic ulceration or gastrointestinal bleeding;
if the patient has severe liver function impairment;
if the patient has severe kidney function impairment;
in pregnant women, women who may be pregnant, or women who are breastfeeding (see Pregnancy, breastfeeding and fertility);
in individuals under 16 years of age;
if the patient has inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or colitis;
if the patient has untreated high blood pressure (if in doubt, consult a doctor or nurse to have blood pressure checked);
if the patient has ever been diagnosed by a doctor with heart problems, including heart failure (moderate or severe type) or angina pectoris (chest pain);
if the patient has had a heart attack, coronary artery bypass surgery, or peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries);
if the patient has had any type of stroke (including mini-stroke, transient ischaemic attack [TIA]). Etoricoxib may slightly increase the risk of heart attack and stroke, and therefore should not be used in patients who have had heart problems or stroke.

If any of the above conditions apply, the patient should consult a doctor before taking Arcoxia tablets.

Warnings and precautions

Before starting treatment with Arcoxia, discuss with a doctor or pharmacist if:

the patient has previously had stomach bleeding or peptic ulcer disease;
the patient is dehydrated, for example due to prolonged or recurring vomiting or diarrhoea;
the patient experiences swelling due to fluid retention;
the patient has previously had heart failure or other heart disease;
the patient has previously had high blood pressure. Arcoxia may increase blood pressure in some people, especially when high doses are used; therefore, the doctor will monitor blood pressure from time to time;
the patient has previously had liver or kidney function disorders;
the patient is currently being treated for an infection. Arcoxia may mask fever, which is a symptom of infection;
the patient has diabetes, high cholesterol levels, or is a smoker. These patients have an increased risk of heart disease;
the patient is a woman planning pregnancy;
the patient is over 65 years of age.

If in doubt whether any of the above situations apply, the patient should consult a doctor before taking Arcoxia to determine whether the medicine can be used.

Arcoxia is equally effective in elderly patients and in younger adult patients. For patients over 65 years of age, the doctor may recommend more frequent check-ups. Dose adjustment is not necessary in patients over 65 years of age.

Children and adolescents

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

Arcoxia and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.

If the patient is taking any of the following medicines, the doctor may decide that monitoring is necessary to ensure proper treatment after starting Arcoxia:

anticoagulants (blood-thinning medicines), such as warfarin;
rifampicin (an antibiotic);
methotrexate (an immunosuppressive medicine, often used in the treatment of rheumatoid arthritis);
cyclosporine or tacrolimus (immunosuppressive medicines);
lithium (a medicine used to treat certain types of depression);
medicines used to control high blood pressure and heart failure, known as ACE inhibitors and angiotensin receptor blockers, for example enalapril and ramipril, or losartan and valsartan;
diuretics;
digoxin (a medicine used in heart failure and heart rhythm disorders);
minoxidil (a medicine used to treat high blood pressure);
oral salbutamol tablets or oral solution (a medicine used in 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 developing stomach ulcers is higher when Arcoxia is taken together with acetylsalicylic acid;
- acetylsalicylic acid used for prevention of heart attack or stroke: Arcoxia may be taken together with low-dose acetylsalicylic acid. If the patient is currently taking low-dose acetylsalicylic acid to prevent heart attack or stroke, do not stop taking acetylsalicylic acid without consulting a doctor;
- acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): high doses of acetylsalicylic acid or other anti-inflammatory medicines should not be taken during treatment with 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 must not be used during pregnancy. A woman who is pregnant, may be pregnant, or is planning pregnancy must not take this medicine. If pregnancy occurs, stop taking the medicine and contact a doctor. In case of doubt or need for further information, consult a doctor.

Breastfeeding
It is not known whether Arcoxia is excreted in human breast milk. If breastfeeding or planning to breastfeed, consult a doctor before taking Arcoxia. Breastfeeding must not be performed during treatment with Arcoxia.

Fertility
Use of Arcoxia is not recommended in women planning pregnancy.

Driving and using machines

Dizziness and drowsiness have been reported in some patients taking Arcoxia.

Do not drive a vehicle if dizziness or drowsiness occurs.

Do not operate any machinery or use tools if dizziness or drowsiness occurs.

Arcoxia contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Arcoxia contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Arcoxia

This medicine should always be taken as prescribed by your doctor. If you have any doubts, consult
your doctor or pharmacist.
Do not take higher doses than those recommended for individual conditions. You should consult your
doctor periodically to review your treatment. It is important to use the lowest effective dose that
provides pain relief, and Arcoxia should not be used for longer than necessary. Prolonged use of
this medicine increases the risk of heart attacks and strokes, especially at higher doses.
This medicinal product is available in various strengths, and depending on the condition being
treated, your doctor will prescribe the appropriate strength for you.
Recommended dose:
Osteoarthritis
The recommended dose is 30 mg once daily, increased if necessary to a maximum of 60 mg once daily.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, increased if necessary to a maximum of 90 mg once daily.
Ankylosing spondylitis
The recommended dose is 60 mg once daily, increased if necessary to a maximum of 90 mg once daily.
Acute pain
Etoricoxib should be used only during episodes of acute pain.
Gouty arthritis
The recommended dose is 120 mg once daily; this should be taken only during episodes of acute
pain, for a maximum of 8 days.
Pain following dental surgery
The recommended dose is 90 mg once daily; treatment with this dose may last for a maximum of 3 days.
Patients with hepatic impairment

In patients with mild hepatic impairment, doses higher than 60 mg once daily should not be used.
In patients with moderate hepatic impairment, doses higher than 30 mg daily should not be used.

Use in children and adolescents
Arcoxia must not be used in children and adolescents under 16 years of age.
Elderly patients
Dose adjustment is not usually necessary in elderly patients. However, as with other medicines,
caution should be exercised when treating elderly patients.
Method of administration
Arcoxia is intended for oral use. Tablets should be taken once daily.
Arcoxia can be taken with or without food.
Taking more Arcoxia than recommended
Never take more tablets than prescribed by your doctor. If you have taken too many Arcoxia tablets,
seek medical help immediately.
Missing a dose of Arcoxia
Take Arcoxia exactly as prescribed by your doctor. If you miss a dose, take your next dose at the
usual time. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.

If any of the following symptoms occur, stop taking Arcoxia and contact your doctor immediately (see section 2 Important information before taking Arcoxia):
shortness of breath, chest pain, or swelling around the ankles, or worsening of existing swelling;
yellowing of the skin and eyes (jaundice) – these are signs of liver dysfunction;
severe or persistent stomach pain, or appearance of black stools;
allergic reactions, which may present as skin problems such as ulcers,

blisters, or swelling of the face, lips, tongue, or throat which may cause
difficulty
breathing.
The frequency of possible adverse reactions 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 adverse reactions may occur during treatment with Arcoxia:
Very common:

stomach pain.

Common:

dry socket (inflammation and pain following tooth extraction);
swelling of the lower limbs 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 intestinal gas), gastritis (inflammation of the stomach lining), heartburn, diarrhoea, indigestion (dyspepsia) and (or) discomfort in the stomach, nausea, vomiting, oesophagitis, oral ulcers;
changes in blood test results related to the liver;
bruising;
weakness and fatigue, flu-like symptoms.

Uncommon:

gastroenteritis (inflammation of the gastrointestinal tract involving both the stomach and small intestine and (or) stomach flu), upper respiratory tract infection, urinary tract infection;
changes in laboratory test results (reduced number of red blood cells, reduced number of white blood cells, reduced number of platelets);
hypersensitivity (allergic reaction, including urticaria, which may be severe enough to require immediate medical intervention);
increased or decreased appetite, weight gain;
anxiety, depression, reduced mental performance; seeing or hearing things that are not real (hallucinations);
taste disturbances, insomnia, numbness or tingling, drowsiness;
blurred vision, eye irritation and redness;
tinnitus, vertigo (spinning sensation while at rest);
heart rhythm disorders (atrial fibrillation), rapid heartbeat, heart failure, feeling of tightness, pressure or heaviness in the chest (angina), heart attack;
hot flushes, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, vasculitis (inflammation of blood vessels);
cough, breathlessness, nosebleeds;
bloating, change in bowel habits, dryness of the oral mucosa, gastric ulcer, inflammation of the stomach lining which may be severe and lead to bleeding, irritable bowel syndrome, pancreatitis;
facial swelling, rash or itching, skin redness;
muscle cramps, muscle pain or stiffness;
high potassium levels in blood, changes in blood or urine tests related to kidneys, severe kidney function disorders;
chest pain.

Rare:

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the 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 carton. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Medicines must 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 coated tablet contains 30 mg, 60 mg, 90 mg, or 120 mg of etoricoxib.
Other ingredients are:
Tablet core: anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate, microcrystalline cellulose.
Tablet coating: Carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin.
Tablets of 30 mg, 60 mg, and 120 mg also contain iron oxide yellow (E 172, colouring agent) and indigo carmine lake (E 132, colouring agent).

What Arcoxia looks like and contents of the pack
Arcoxia is available as coated tablets in four strengths:
30 mg: blue-green, film-coated tablets, shaped like an apple cross-section,
biconvex, marked with ‘ACX 30’ on one side and ‘101’ on the other.
60 mg: dark green, film-coated tablets, shaped like an apple cross-section,
biconvex, marked with ‘ARCOXIA 60’ on one side and ‘200’ on the other.
90 mg: white, film-coated tablets, shaped like an apple cross-section,
biconvex, marked with ‘ARCOXIA 90’ on one side and ‘202’ on the other.
120 mg: light green, film-coated tablets, shaped like an apple cross-section,
biconvex, marked with ‘ARCOXIA 120’ on one side and ‘204’ on the other.

30 mg:
Pack sizes of 7, 14, 28, 49, 98 tablets or multi-packs containing 98 tablets (2 packs of 49) in blister packs.
60 mg:
Pack sizes of 5 (unit pack), 7, 14, 28 or 98 tablets in blister packs.
90 mg and 120 mg:
Pack sizes of 5 (unit pack), 7, 14 or 28 tablets in blister packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder for 30 mg:
Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warsaw
Tel. +48 22 105 50 01
[email protected]

Manufacturer/Importer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Manufacturers
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

For 60 mg, 90 mg and 120 mg:
Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The 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 authorised in the European Economic Area 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 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