ACOXXEL 90 mg FILM-COATED TABLETS

Introduction

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 all of this leaflet carefully before you start 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 them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of thepackage leaflet

1. What is ACOXXEL and what is it used for
2. What you need to know before you take ACOXXEL
3. How to take ACOXXEL
4. Possible side effects
5. Storage of ACOXXEL
6. Contents of the pack and other information

1. What is ACOXXEL and what is it used for

What is Acoxxel?

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

What is Acoxxel used for?

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

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It leads to the gradual breakdown of the cartilage that cushions the ends of the bones. This causes swelling (inflammation), pain, tenderness, 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 movement in the affected joints. It also causes inflammation in other areas of the body.

What is gout?

Gout is a disease of sudden and recurring attacks of very painful and red swelling of the 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.

2. What you need to know before you take ACOXXEL

Do not take Acoxxel

• 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 uncontrolled high blood pressure (consult your doctor or nurse if you are not sure if your blood pressure is controlled)
• if your doctor has diagnosed you with heart problems, including heart failure (of moderate or severe type), angina (chest pain)
• if you have had a heart attack, surgical revascularization, peripheral arterial disease (poor circulation in your legs or feet due to narrow or blocked arteries)
• if you have had any type of stroke (including transient ischaemic attack or transient cerebral ischaemia).

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

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

Warnings and precautions

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

• You have a history of stomach ulcers or bleeding.
• You are dehydrated, for example, as a result of prolonged illness with vomiting or diarrhea.
• 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 not sure if any of the above applies to you, talk to your doctor before taking Acoxxelto check if this medicine is suitable for you.

Acoxxel works just as well in adult and elderly patients. If you are over 65 years of age, your doctor will want to keep a close 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 Acoxxel

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 monitor you to check that your medicines are working adequately once you start taking Acoxxel:

• medicines that make your blood less likely to clot (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 antagonists, for example enalapril and ramipril, and losartan and valsartan
• diuretics (water tablets)
• digoxin (a medicine for heart failure and irregular heart rhythm)
• 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 Acoxxel with aspirin.

• Aspirin for the prevention of heart attacks or stroke:

Acoxxel 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 have talked 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 Acoxxel.

Taking Acoxxel with food and drink

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

Pregnancy, breast-feedingand 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 plan 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.

Breast-feeding

It is not known if Acoxxel is excreted in breast milk. If you are breast-feeding or plan to breast-feed, consult your doctor before taking Acoxxel. If you are using Acoxxel, you should stop breast-feeding.

Fertility

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

Driving and using machines

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 machines if you experience dizziness or somnolence.

Acoxxelcontains lactose

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

Acoxxelcontains 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 ACOXXEL

Follow exactly the instructions of administration of this medicine 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 Acoxxel for longer than necessary. This is because the risk of heart attacks and strokes might increase after prolonged 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 suitable 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 conditions

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 period of acute pain, 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.

Patient with liver problems

• If you have mild liver disease, do not take more than 60 mg per day.
• If you have moderateliver disease, do not take more than 30mg per day.

Use in children and adolescents

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

Patient over 65years

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

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

If you take more Acoxxel than you should

Never take more tablets than your doctor recommends. If you take too many Acoxxel 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, indicating the medicine and the amount taken. It is recommended to bring the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Acoxxel

It is important that you take Acoxxel as your doctor has told you. If you forget a dose, just continue with your normal routine 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 takingAcoxxeland talk to your doctor immediately (see section2.What you need to know before you take Acoxxel):

• difficulty breathing, chest pain, or swelling of the ankle, or if these get worse
• yellowing of the skin and eyes (jaundice) - these are signs of liver problems
• severe stomach pain or persistent stomach pain or 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 included in the list 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 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 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, inability to sleep, 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), rapid heartbeat, heart failure, feeling of tension, pressure, or heaviness in the chest (angina pectoris), heart attack
• flushing, stroke, transient ischemic attack (mini-stroke), 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, rash or itching of the skin
• 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 changes, 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 to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ACOXXEL

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.

Blisters: store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofAcoxxel

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

• The other ingredients are:

Tablet core: hydrogenated calcium 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, coloring agent) and indigo carmine lake (E-132, coloring agent).

Appearance of the product and package contents

Acoxxel tablets are available in four doses:

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 '200' on one side and smooth on the other.

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

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

Package sizes:

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 and 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 (unit dose) blisters in packs of 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

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:

Germany ACOXXEL 30, 60, 90, 120 mg film-coated tablets

Spain ACOXXEL 30, 60, 90, 120 mg film-coated tablets

Portugal ACOXXEL 30, 60, 90, 120 mg film-coated tablets

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

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)