ARCOXIA 90 mg FILM-COATED TABLETS

2. What you need to know before you take ARCOXIA

Do not take Arcoxia

• if you are allergic (hypersensitive) to etoricoxib or 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 Possible side effects, section 4)
• if you currently have an ulcer or bleeding in your stomach or duodenum
• if you have severe liver disease
• if you have severe kidney disease
• if you are or may be pregnant, or are breast-feeding (see "Pregnancy, breast-feeding 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 well-controlled with treatment (check with your doctor or nurse if you are not sure if your blood pressure is well-controlled)
• if your doctor has diagnosed heart problems, including heart failure (moderate or severe), angina (chest pain)
• if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in your legs or feet due to narrow or blocked arteries)
• if you have had any kind of stroke (including mini-stroke or transient ischaemic attack).

Etoricoxib may slightly increase your risk of heart attack and stroke, and this risk is higher in patients who already have heart disease or have had a stroke. Therefore, it should not be used in patients who have had heart problems or a stroke.

If you think any of these are relevant to you, do not take the tablets until you have spoken to your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking Arcoxia if:

• You have had stomach ulcers or bleeding.
• 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. Arcoxia may increase blood pressure in some people, especially at high doses, and your doctor will want to check your blood pressure from time to time.
• 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, as these may increase your risk of heart disease.
• You are a woman trying to become pregnant.
• You are over 65 years of age.

If you are not sure if any of the above apply to you, talk to your doctor before taking Arcoxiato check if this medicine is suitable for you.

Arcoxia works just as well in older and younger adult patients. If you are over 65 years of age, your doctor will want to keep a closer check on you. No dose adjustment is necessary for patients over 65 years of age.

Children and adolescents

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

Other medicines and Arcoxia

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 particular, if you are taking any of the following medicines, your doctor may want to check that your medicines are working properly once you start taking Arcoxia:

• medicines that thin your blood (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used to suppress the immune system and often used in rheumatoid arthritis)
• ciclosporin or tacrolimus (medicines used to suppress the immune system)
• lithium (a medicine used to treat some types of depression)
• medicines used to help control high blood pressure and heart failure, called ACE inhibitors and angiotensin receptor blockers, for example enalapril and ramipril, and losartan and valsartan
• diuretics (water tablets)
• digoxin (a medicine for heart failure and irregular heartbeat)
• minoxidil (a medicine used to treat high blood pressure)
• tablets or oral solution of salbutamol (a medicine for asthma)
• oral contraceptives (the combination may increase your risk of side effects)
• hormone replacement therapy (the combination may increase your 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 stroke:

Arcoxia can be taken with low dosesof aspirin. If you are currently taking low doses of aspirin to prevent heart attacks or stroke, do not stop taking aspirin until you talk to your doctor

• Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs):

do not take high dosesof aspirin or other anti-inflammatory medicines while taking Arcoxia.

Taking Arcoxia with food and drink

The onset of effect of Arcoxia may be faster if taken without food.

Pregnancy, breast-feeding and fertility

Pregnancy

Arcoxia tablets should not be taken during pregnancy. Do not take the tablets if you are pregnant, think you may be pregnant or are planning to get pregnant. If you become pregnant, stop taking the tablets and consult your doctor. Consult your doctor if you have any doubts or need more information.

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, you should not breast-feed.

Fertility

Arcoxia should not be used in women who are trying to become pregnant.

Driving and using machines

In some patients taking Arcoxia, dizziness and somnolence have been reported.

Do not drive if you experience dizziness or somnolence.

Do not use tools or machines if you experience dizziness or somnolence.

Arcoxia contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Arcoxia contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially "sodium-free".

3. How to take ARCOXIA

Follow exactly the instructions given to you by your doctor. In case of doubt, consult your doctor or pharmacist again.

Do not take more than the recommended dose for your condition. Your doctor will want to discuss your treatment from time to time. It is important that you use the lowest dose that controls your pain and you should not take Arcoxia for longer than necessary. This is because the risk of heart attacks and strokes might increase after long-term treatment, especially with high doses.

There are different doses available for this medicine, and depending on your disease, your doctor will prescribe the tablet with the dose 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 situations

Etoricoxib should only be used for the period of acute pain.

Gout

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

Post-operative dental 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 should not take more than 60 mg per day.
• If you have moderateliver disease, you should not take more than 30mg per day.

Use in children and adolescents

Children or adolescents under 16 years of age should not take Arcoxia tablets.

Patients over 65 years of age

No dose adjustment is necessary for patients over 65 years of age. As with other medicines, caution should be exercised in elderly patients.

Method of administration

Arcoxia is administered orally. Take the tablets once daily. Arcoxia can be taken with or without food.

If you take more Arcoxia than you should

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

In case of overdose or accidental ingestion, you can also contact the Toxicology Information Service, Tel. 91 562 04 20, stating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Arcoxia

It is important that you take Arcoxia as your doctor has instructed. If you forget a dose, just resume your normal schedule the next day. Do not take a double dose to make up for forgotten doses.

If you have any other questions about 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 develop any of these signs, stop taking Arcoxia and speak to your doctor immediately (see section 2. What you need to know before you take Arcoxia):

• difficulty breathing, chest pain or ankle swelling, or if these get worse
• yellowing of the skin and eyes (jaundice) - these are signs of liver problems
• severe stomach pain or persistent vomiting, or if your stools become black
• an allergic reaction - which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue or throat which may cause difficulty in breathing

The frequency of possible side effects listed below is defined using the following convention:

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

Rare (may affect up to 1 in 1,000 people)

Very rare (may affect up to 1 in 10,000 people)

The following side effects may occur during treatment with Arcoxia:

Very common:

• stomach pain

Common:

• alveolar osteitis (inflammation and pain after tooth extraction)
• swelling of the legs and/or feet due to fluid retention (edema)
• dizziness, headache
• palpitations (fast or irregular heartbeat), irregular heartbeat (arrhythmia)
• high blood pressure
• wheezing or shortness of breath (bronchospasm)
• constipation, gas (excess gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach upset, nausea, vomiting, esophagitis, mouth ulcers
• changes in blood tests related to your liver
• bruising
• weakness and fatigue, flu-like illness

Uncommon:

• gastroenteritis (inflammation of the gastrointestinal tract that affects both the stomach and the small intestine/common cold), cold, urinary tract infection
• changes in laboratory results (decreased red blood cells, decreased white blood cells, decreased platelets)
• hypersensitivity (allergic reaction including hives that may be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, decreased mental sharpness; seeing, hearing or feeling things that are not there (hallucinations)
• altered taste, insomnia, numbness or tingling, somnolence
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (feeling of spinning while standing still)
• abnormal heartbeat (atrial fibrillation), fast heartbeat, heart failure, feeling of tension, pressure or heaviness in the chest (angina pectoris), heart attack
• flushing, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nosebleed
• stomach swelling, changes in bowel movements, dry mouth, stomach ulcer, inflammation of the stomach lining that can be severe and can cause bleeding, irritable bowel syndrome, pancreatitis
• swelling of the face, skin rash or itching
• muscle cramp/spasm, muscle pain/stiffness
• high levels of potassium in your blood, changes in blood or urine tests related to your kidneys, severe kidney problems
• chest pain

Rare:

• angioedema (allergic reaction with swelling of the face, lips, tongue and/or throat that can cause difficulty breathing or swallowing, which can be severe enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (severe allergic reaction that requires immediate medical attention)

• confusion, nervousness
• liver problems (hepatitis)
• low levels of sodium in the blood
• liver disorder, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions

Reporting of side effects:If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month indicated.

Bottles: keep the container tightly closed to protect from moisture.

Blister packs: store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition ofArcoxia

• The active substance is etoricoxib. Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.

• The other ingredients are:

Core of the tablet: hydrogenated calcium phosphate (anhydrous), sodium croscarmellose, magnesium stearate, microcrystalline cellulose.

Coating of the tablet: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E-171), triacetin. The 30, 60 and 120 mg tablets also contain yellow iron oxide (E-172, coloring agent) and carmine indigo lake (E-132, coloring agent).

Appearance and package contents of the product

Arcoxia tablets are available in four doses:

Film-coated tablets of 30 mg, blue-green, apple-shaped, biconvex, engraved with 'ACX 30' on one side and '101' on the other.

Film-coated tablets of 60 mg, dark green, apple-shaped, biconvex, engraved with 'ARCOXIA 60' on one side and '200' on the other.

Film-coated tablets of 90 mg, white, apple-shaped, biconvex, engraved with 'ARCOXIA 90' on one side and '202' on the other.

Film-coated tablets of 120 mg, pale green, apple-shaped, biconvex, engraved with 'ARCOXIA 120' on one side and '204' on the other.

30 mg:

Package sizes of 2, 7, 14, 20, 28, 49, 98 tablets or multi-packs containing 98 (2 packs of 49) tablets in blisters.

60 mg:

Package sizes of 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 30 and 90 tablets in bottles with desiccant. The desiccant (one or two packets) in the bottle, used to keep the tablets dry, should not be swallowed.

90 mg:

Package sizes of 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 30 and 90 tablets in bottles with desiccant. The desiccant (one or two packets) in the bottle, used to keep the tablets dry, should not be swallowed.

120 mg:

Package sizes of 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 30 and 90 tablets in bottles with desiccant. The desiccant (one or two packets) in the bottle, used to keep the tablets dry, should not be swallowed.

60, 90 and 120 mg:

Aluminum/aluminum blister packs (unit dose) in packs of 5, 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

or

Vianex, S.A. (only for Greece)

15th Km Av. Marathonos Ave.

15351 Pallini Attikis,

Athens

Greece

or

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

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

Date of last revision of this leaflet:05/2021.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)