Package Leaflet: Information for the User

ACOXXEL 30mg Film-Coated Tablets

ACOXXEL 60mg Film-Coated Tablets

ACOXXEL 90mg Film-Coated Tablets

ACOXXEL 120mg Film-Coated Tablets

etoricoxib

Read this 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Contents of thePackage Leaflet

1.What ACOXXEL is and what it is used for

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

3.How to take ACOXXEL

4.Possible side effects

5.Storage of ACOXXEL

6.Contents of the pack and additional information

What is Acoxxel?

• Acoxxelcontains the active ingredient etoricoxib. Acoxxelbelongs to a group of medications called selective COX-2 inhibitors. These belong to a family of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).

What is Acoxxelused for?

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

What is osteoarthritis?

Osteoarthritis is a joint disease. 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 Acoxxel

• 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 moderate or severe heart failure, 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 a 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 categories, do not take the tablets until you have consulted your doctor.

Warnings and precautions

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

• You have a history of ulcers or stomach 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. Acoxxel 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. Acoxxel 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, speak with your doctor before taking Acoxxel to check if this medicine is suitable for you.

Acoxxel works equally 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 for 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 Acoxxel

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

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

• blood-thinning medicines (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 certain types of depression)
• medicines used to help control high blood pressure and heart failure, known as ACE inhibitors and angiotensin receptor antagonists, for example enalapril and ramipril, and losartan and valsartan
• diuretics (tablets to help you urinate)
• 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 Acoxxel with aspirin.

• Aspirin for the prevention of heart attacks or strokes:

Acoxxel 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 Acoxxel.

Taking Acoxxel with food and drink

The onset of Acoxxel's effect may be faster if taken without food.

Pregnancy, lactation and fertility

Pregnancy

Acoxxel 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 Acoxxel is excreted in breast milk.MaternalIf you arebreastfeedingor plan to do so, consult your doctor before taking Acoxxel. If you are using Acoxxel,you must stop breastfeeding.

Fertility

Acoxxel is not recommended for women who are trying to become pregnant.

Driving and operating machinery

In some patients taking Acoxxel, 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.

Acoxxel contains lactose

This medicine contains lactose.If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medicine.

Acoxxel contains sodium

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

Follow exactly the administration instructions for 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 Acoxxelfor longer than necessary. This is because the risk of myocardial infarction and cerebral infarction may 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:

Artrosis

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

Artritis reumatoide

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

Espondilitis anquilosante

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

Situaciones de dolor agudo

Etoricoxib should only be used during the acute pain period.

Gota

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

Dolor postoperatorio tras cirugía dental

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

Pacientes con problemas de hígado

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

Uso en niños y adolescentes

Children or adolescents under 16years of age should not take the Acoxxeltablets.

Pacientes mayores de 65años

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

Forma de administración

Acoxxelis administered orally. Take the tablets once a day. Acoxxelcan be taken with or without food.

Si toma más Acoxxeldel que debe

You should never take more tablets than your doctor recommends. If you take too many Acoxxeltablets, 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.

Si olvidó tomar Acoxxel

It is essential to take Acoxxelas 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 takingAcoxxeland talk to your doctor immediately (see section2.What you need to know before starting to take Acoxxel):

• 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
• severe 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 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 Acoxxel:

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
• choking or difficulty breathing (bronchospasm)
• constipation, gas (excessive gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort,nausea, vomiting, esophagitis (inflammation of the esophagus), mouth ulcers
• changes in blood tests 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), 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
• swelling of the stomach, 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, redness of the skin
• muscle cramps/spasms, muscle pain/stiffness

• elevated potassium levels in the blood, changes in blood or urine tests 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.

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

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofAcoxxel

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

• The other components are:

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

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

Appearance of the product and contents of the package

Acoxxel 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 ‘200’ on one side and smooth on the other.

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

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

Package sizes:

30mg:

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

60mg:

Package 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, should not be swallowed.

90 and 120mg:

Package 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, should not be swallowed.

60, 90 and 120mg:

Aluminum/aluminum (single-dose) blisters in packages of 50 or 100tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Responsible manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

or

Organon Heist bv

Industriepark30

2220Heist‑op‑den‑Berg

Belgium

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

GermanyACOXXEL 30, 60, 90, 120mg Filmtabletten

SpainACOXXEL30,60, 90, 120mg comprimidos recubiertos con película

PortugalACOXXEL30,60, 90, 120mg comprimidos revestidos por película

Last revision date of this leaflet:05/2021.

Detailed and updated 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/)