Product Information for the User

ARCOXIA 30Film-Coated Tablets

ARCOXIA 60Film-Coated Tablets

ARCOXIA 90Film-Coated Tablets

ARCOXIA 120Film-Coated Tablets

etoricoxib

Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1.What ARCOXIA is and what it is used for

2.What you need to know before you start taking ARCOXIA

3.How to take ARCOXIA

4.Possible side effects

5.Storage of ARCOXIA

6.Contents of the pack and additional information

What is Arcoxia?

• Arcoxia contains the active ingredient etoricoxib. Arcoxia belongs to a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

What is Arcoxia used for?

• Arcoxia helps to reduce pain and swelling (inflammation) in the joints and muscles of people aged 16 years and over with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Arcoxia is also used for the short-term treatment of moderate pain after dental surgery in people aged 16 years and over.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It causes the gradual breakdown of the cartilage that cushions the ends of the bones. This causes swelling (inflammation), pain, sensitivity, stiffness, and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term inflammatory disease of the joints. It causes pain, stiffness, swelling, and progressive loss of mobility in the affected joints. It also causes inflammation in other areas of the body.

What is gout?

Gout is a disease of sudden and recurrent attacks of very painful and inflamed joints. It is caused by deposits of mineral crystals in the joint.

What is ankylosing spondylitis?

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

Do not take Arcoxia

• if you are allergic (hypersensitive) to etoricoxib or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see Possible side effects, section 4)
• if you currently have a stomach or duodenal ulcer or bleeding
• if you have a severe liver disease
• if you have a severe kidney disease
• if you are or may be pregnant, or are breastfeeding your child (see "Pregnancy, lactation 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 uncontrolled high blood pressure (consult your doctor or nurse if you are unsure if your blood pressure is adequately controlled)
• if your doctor has diagnosed you with heart problems, including heart failure (moderate or severe), angina (chest pain)
• if you have had a heart attack, revascularization surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries)
• if you have had any type of stroke (including transient ischaemic attack or transient ischaemic attack)

Etoricoxib may slightly increase your risk of heart attack and stroke, and therefore should not be used in patients who have had heart problems or a stroke.

If you think you fall into any of these cases, do not take the tablets until you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Arcoxia if:

• You have a history of stomach ulcers or bleeding.
• You are dehydrated, for example, as a result of a prolonged illness with 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 unsure whether any of the above situations affect you, speak with your doctor before taking Arcoxia to check if this medicine is suitable for you.

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

Children and adolescents

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

Other medicines and Arcoxia

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine, including those bought without a prescription.

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

• blood-thinning medicines (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used to suppress the immune system and is 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 antagonists, for example enalapril and ramipril, and losartan and valsartan
• diuretics (tablets to help you pass water)
• digoxin (a medicine for heart failure and irregular heartbeat)
• minoxidil (a medicine used to treat high blood pressure)
• oral tablets or 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 higher if you take Arcoxia with aspirin.

• Aspirin for the prevention of heart attacks or strokes:

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

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

do not takehigh dosesof aspirin or other NSAIDs while taking Arcoxia.

Taking Arcoxia with food and drinks

The onset of the effect of Arcoxiamay be faster if taken without food.

Pregnancy, lactation 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 become 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.

Lactation

It is unknownwhether Arcoxia is excreted in breast milk.maternaIf you arebreastfeedingor plan to do so, consult your doctor before taking Arcoxia. If you are using Arcoxia,you should stop breastfeeding.

Fertility

It is not recommended to use Arcoxia in women who are trying to become pregnant.

Driving and operating machinery

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 machinery 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 certain sugars, consult with him before taking this medicine.

Arcoxia contains sodium

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

Follow exactly the administration instructions of this medication as indicated 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 essential to use the lowest dose that controls your pain and do not take Arcoxia for longer than necessary. This is because the risk of myocardial infarction and cerebral infarction could increase after prolonged treatment, especially with high doses.

There are different doses available for this medication, and depending on your condition, your doctor will prescribe the tablet with the dose that is suitable for you.

The recommended dose is:

Arthritis

The recommended dose is 30mg once a day, increasing up to a maximum of 60mg once a day if necessary.

Rheumatoid Arthritis

The recommended dose is 60mg once a day, increasing up to a maximum of 90mg once a day if necessary.

Ankylosing Spondylitis

The recommended dose is 60mg once a day, increasing up to a maximum of 90mg once a day if necessary.

Acute Pain Situations

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

Gout

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

Postoperative Pain after Dental Surgery

The recommended dose is 90mg once a day, limited to a maximum of 3days of treatment.

Patients with Liver Problems

• If you have a mild liver disease, do not take more than 60mg per day.
• If you have amoderateliver disease, do not take more than30mg per day.

Use in Children and Adolescents

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

Patients over 65years

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

Administration Form

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

If you take more Arcoxia than you should

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 call the Toxicological Information Service, Tfno. 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Arcoxia

It is essential to take Arcoxia as your doctor has indicated. If you forget a dose, limit yourself to resuming the usual regimen the next day.Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you develop any of these signs, stop takingArcoxiaand talk to your doctor immediately (see section2.What you need to know before starting to take Arcoxia):

• difficulty breathing, chest pain, or swelling of the ankle, or if these worsen
• yellowing of the skin and eyes (jaundice) - these are signs of liver problems
• intense or persistent stomach pain or black stools
• an allergic reaction – which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat that can cause difficulty breathing

The frequency of possible side effects included below is defined according to 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 (rapid or irregular heartbeat), irregular heart rhythm (arrhythmia)
• high blood pressure
• shortness of breath or difficulty breathing (bronchospasm)
• constipation, gas (excessive gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, esophageal inflammation, mouth ulcers
• changes in blood test results related to the liver
• bruising
• weakness and fatigue, flu-like illness

Uncommon::

• gastroenteritis (inflammation of the gastrointestinal tract affecting both the stomach and small intestine/gastric catarrh), common cold, urinary tract infection
• changes in laboratory results (decreased red blood cell count, decreased white blood cell count, decreased platelet count)
• hypersensitivity (allergic reaction including urticaria that may be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, decreased mental acuity; seeing, hearing, or feeling things that are not there (hallucinations)
• altered taste, inability to sleep, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (sensation of spinning while standing)
• abnormal heart rhythm (fibrillation), rapid heart rate, heart failure, sensation of tension, pressure, or heaviness in the chest (angina pectoris), myocardial infarction
• redness, cerebral infarction, mini-stroke (transient ischemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nasal bleeding
• stomach swelling, changes in bowel habits, dry mouth, stomach ulcers, severe inflammation of the stomach lining that may cause bleeding, irritable bowel syndrome, pancreatitis
• swelling of the face, skin rash, or itching, skin redness
• muscle cramps/spasms, muscle pain/stiffness
• elevated potassium levels in the blood, changes in blood or urine test results related to the kidneys, severe kidney problems
• chest pain

Rare::

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

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

Reporting of side effects:
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the box. The expiration date is the last day of the month indicated.

Bottles: keep the container perfectly closed to protect it from moisture.

Blisteres: store in the original packaging to protect it from moisture.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition ofArcoxia

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

• The other components are:

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

Film coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E-171), triacetin. The 30, 60 and 120mg tablets also contain yellow iron oxide (E-172, colouring agent) and indigo carmine (E-132, colouring agent).

Appearance of the product and contents of the pack

Arcoxia tablets are available in four doses:

30mg film-coated tablets, blue-green, apple-shaped, biconvex, engraved with ‘ACX 30’ on one side and ‘101’ on the other.

60mg film-coated tablets, dark green, apple-shaped, biconvex, engraved with ‘ARCOXIA 60’ on one side and ‘200’ on the other.

90mg film-coated tablets, white, apple-shaped, biconvex, engraved with ‘ARCOXIA 90’ on one side and ‘202’ on the other.

120mg film-coated tablets, pale green, apple-shaped, biconvex, engraved with ‘ARCOXIA 120’ on one side and ‘204’ on the other.

30mg:

Pack sizes of2, 7, 14, 20, 28, 49, 98tablets ormulti‑packs containing 98(2packs of 49)tablets in blisters.

60mg:

Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100tablets ormulti‑packs containing 98 (2packs of 49)tablets in blisters; or 30 and 90tablets in bottles with desiccant. The desiccant (one or two packs) in the bottle, used to keep the tablets dry, must not be swallowed.

90mg:

Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100tablets ormulti‑packs containing 98 (2packs of 49)tablets in blisters; or 30 and 90tablets in bottles with desiccant. The desiccant (one or two packs) in the bottle, used to keep the tablets dry, must not be swallowed.

120mg:

Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100tablets ormulti‑packs containing 98 (2packs of 49)tablets in blisters; or 30 and 90tablets in bottles with desiccant. The desiccant (one or two packs) in the bottle, used to keep the tablets dry, must not be swallowed.

60, 90 and 120mg:

Aluminium/aluminium (unit dose) blisters in packs of 5, 50 or 100tablets.

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible person for manufacture

Marketing authorisation holder

Responsible person for manufacture

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

Industriepark30

2220Heist‑op‑den‑Berg

Belgium

This medicinal product is authorised in the member states of the European Economic Area with the following names:

Last review date of this leaflet:05/2021.

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)