Arcoxia 90 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ARCOXIA 30mg film-coated tablets

ARCOXIA 60mg film-coated tablets

ARCOXIA 90mg film-coated tablets

ARCOXIA 120mg film-coated tablets

etoricoxib

Read the 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What ARCOXIA is and what it is used for
2. What you need to know 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 ARCOXIA is and what it is used for

What is ARCOXIA?

• ARCOXIA contains the active substance etoricoxib. ARCOXIA belongs to a group of medicines known as selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

What is ARCOXIA used for?

• ARCOXIA helps reduce pain and swelling (inflammation) in the joints and muscles of individuals 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• ARCOXIA is also used for the short-term treatment of moderate pain following dental surgery in individuals 16 years of age and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It causes the gradual breakdown of the cartilage that cushions 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-term inflammatory disease of the joints. It causes pain, stiffness, swelling, and progressive loss of mobility in affected joints. It can also cause inflammation in other parts of the body.

What is gout?

Gout is a condition characterized by sudden and recurrent attacks of very painful inflammation and redness in the joints. It is caused by deposits of mineral crystals in the joint.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease affecting the spine and large joints.

2. What you need to know before starting to take ARCOXIA

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 non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see section 4, Possible side effects)
• if you currently have a stomach or duodenal ulcer or gastrointestinal bleeding
• if you have severe liver disease
• if you have severe kidney disease
• if you are or may be pregnant, or are breastfeeding (see Pregnancy, breastfeeding 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 (ask your doctor or nurse if you are unsure whether 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 myocardial infarction, surgical revascularization, or peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries)
• if you have had any type of stroke (including transient ischaemic attack or ischaemic stroke).

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

If you think any of these apply to you, do not take the tablets until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Arcoxia if:

• You have a history of stomach ulcers or gastrointestinal bleeding.
• You are dehydrated, for example due to 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 may want to monitor your blood pressure periodically.
• 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 apply to you, talk to your doctor before taking Arcoxia to determine whether this medicine is suitable for you.

Arcoxia works equally well in young and older adult patients. If you are over 65 years of age, your doctor will want to monitor you appropriately. 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.

Other medicines and Arcoxia

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 monitor you to ensure 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)

• cyclosporine or tacrolimus (medicines used to suppress the immune system)

• lithium (a medicine used to treat certain types of depression)

• medicines used to help control high blood pressure and heart failure known as ACE inhibitors and angiotensin receptor blockers, for example enalapril and ramipril, 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 adverse effects)

• hormone replacement therapy (the combination may increase your risk of adverse effects)

• aspirin — the risk of stomach ulcers is higher if you take Arcoxia with aspirin.

• Aspirin for prevention of heart attacks or strokes:

Arcoxia may be taken with low-dose aspirin. If you are currently taking low-dose aspirin to prevent heart attacks or stroke, do not stop taking aspirin without first talking to your doctor.

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

do not take high-dose aspirin or other anti-inflammatory medicines while you are taking Arcoxia.

Taking Arcoxia with food and drink

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

Pregnancy, breastfeeding and fertility

Pregnancy

Arcoxia tablets must not be taken during pregnancy. Do not take the tablets if you are pregnant, think you may be pregnant, or plan to become pregnant. If you become pregnant, stop taking the tablets and consult your doctor. Speak to your doctor if you have any doubts or need further information.

Breastfeeding

It is unknown whether Arcoxia is excreted in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Arcoxia. If you are taking Arcoxia, you must stop breastfeeding.

Fertility

Arcoxia is not recommended for use in women attempting to conceive.

Driving and using machines

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

Do not drive if you experience dizziness or drowsiness.

Do not operate tools or machinery if you experience dizziness or drowsiness.

Arcoxia contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him or her 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 for administering this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Do not take more than the recommended dose for your condition. Your doctor will want to review your treatment from time to time. It is important to 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 may increase after long-term treatment, especially with high doses.

Different doses of this medicine are available, and depending on your condition, your doctor will prescribe the tablet with the dose appropriate for you.

The recommended dose is:

Osteoarthritis

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

Rheumatoid arthritis

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

Ankylosing spondylitis

The recommended dose is 60 mg once daily, which may be increased up to a maximum of 90 mg once daily if necessary.

Acute pain situations

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

Gout

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

Postoperative dental surgery 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 moderate liver disease, you should not take more than 30 mg per day.

Use in children and adolescents

Children and adolescents under 16 years of age must 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 medications, 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

You must never take more tablets than your doctor has recommended. If you take too many Arcoxia tablets, seek immediate medical attention.

In case of overdose or accidental ingestion, you may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medication packaging and leaflet to the healthcare professional.

If you forget to take Arcoxia

It is important that you take Arcoxia as prescribed by your doctor. If you miss a dose, simply resume your regular dosing schedule the next day. 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, ask your doctor or pharmacist.

4. Possible side effects

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

If you develop any of the following signs, stop taking Arcoxia and speak to your doctor immediately (see section 2. What you need to know before taking Arcoxia):

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

The frequency of the possible side effects listed 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 following tooth extraction)
• swelling of the legs and/or feet due to fluid retention (oedema)
• dizziness, headache
• palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia)
• high blood pressure
• wheezing or difficulty breathing (bronchospasm)
• constipation, flatulence (excess gas), gastritis (inflammation of the inner lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, oesophagitis, mouth ulcers
• changes in blood tests related to your liver
• bruising
• weakness and fatigue, flu-like illness

Uncommon:

• gastroenteritis (inflammation of the gastrointestinal tract affecting both the stomach and small intestine/gastric flu), cold, urinary tract infection
• changes in laboratory test results (reduced number of red blood cells, reduced number of white blood cells, decreased platelets)
• hypersensitivity (allergic reaction including hives, which may be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, reduced mental alertness; seeing, feeling or hearing things that do not exist (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 still)
• abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, sensation of tightness, pressure or heaviness in the chest (angina), myocardial infarction
• redness, 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 habits, dry mouth, stomach ulcer, inflammation of the inner lining of the stomach which may become severe and lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
• swelling of the face, skin rash or itching, redness of the skin
• muscle cramp/spasm, muscle pain/stiffness
• elevated potassium levels in your blood, changes in blood or urine tests related to your kidneys, serious kidney problems
• chest pain

Rare:

• angioedema (allergic reaction with swelling of the face, lips, tongue, and/or throat which 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, restlessness
• liver problems (hepatitis)
• low sodium levels in blood
• liver impairment, yellowing of the skin and/or eyes (jaundice)
• serious skin reactions

Reporting of side effects: If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Arcoxia

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

• The other components are:

Tablet core: calcium hydrogen phosphate (anhydrous), sodium croscarmellose, magnesium stearate, microcrystalline cellulose.

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

Nature of the product and contents of the pack

Arcoxia tablets are available in four strengths:

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

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

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

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

30 mg:

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

60 mg:

Pack 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 sachets) in the bottle, used to keep the tablets dry, must not be swallowed.

90 mg:

Pack 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 sachets) in the bottle, used to keep the tablets dry, must not be swallowed.

120 mg:

Pack 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 sachets) in the bottle, used to keep the tablets dry, must not be swallowed.

60, 90 and 120 mg:

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Organon Health, S.L. Paseo de la Castellana, 77 28046 Madrid Spain Tel.: 915911279

Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

or

Vianex, S.A. (only for Greece)

15th Km Marathonos Avenue

15351 Pallini Attikis,

Athens

Greece

or

Organon Heist bv

Industriepark 30

2220 Heist‑op‑den‑Berg

Belgium

This medicinal product is authorized in the European Economic Area member states under the following names:

Belgium, Luxembourg	Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, film-coated tablets
Denmark, Estonia, Iceland, Norway	Arcoxia
Ireland, United Kingdom Austria Czech Republic Cyprus, Malta Finland France Germany Greece Hungary Italy Latvia Lithuania	ARCOXIA 30, 60, 90 or 120 mg film-coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg-Filmtabletten ARCOXIA 30 mg, 60 mg, 90 mg potahované tablety ARCOXIA 60, 90, 120 mg film-coated tablets Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen ARCOXIA 30, 60 mg, film-coated tablet ARCOXIA 30/60/90/120 mg Filmtabletten ARCOXIA 30 mg, 60 mg, 90 mg,120 mg film-coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg filmtabletta ARCOXIA 30, 60, 90, 120 mg compresse rivestite con film Arcoxia 30 mg, 60 mg, 90 mg un 120 mg apvalkotas tabletes Arcoxia 30, 60, 90, 120 mg plevele dengtos tabletes
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 the last review 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 Medical Devices (AEMPS) (http://www.aemps.gob.es/)