ETORICOXIB VIATRIS 120 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Etoricoxib Viatris 30 mg film-coated tablets EFG

Etoricoxib Viatris 60 mg film-coated tablets EFG

Etoricoxib Viatris 90 mg film-coated tablets EFG

Etoricoxib Viatris 120 mg film-coated tablets EFG

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 the pack

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

1. What is Etoricoxib Viatris and what is it used for

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

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

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It is caused by the gradual breakdown of the cartilage that cushions the ends of the bones. This leads to 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 can also cause inflammation in other areas of the body.

What is gout?

Gout is a disease of sudden and recurring attacks of very painful and red swollen 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 large joints.

2. What you need to know before you take Etoricoxib Viatris

Do not take Etoricoxib Viatris:

• If you are allergic 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), such as acetylsalicylic acid (aspirin) or COX-2 inhibitors (see section 4).
• If you have had wheezing, chest tightness or shortness of breath, nasal polyps, or a runny nose after taking acetylsalicylic acid or other NSAIDs.
• If you currently have an ulcer or bleeding in your stomach or intestines.
• If you have severe liver or kidney disease.
• If you are pregnant or think you may be pregnant, or are breast-feeding (see "Pregnancy, breast-feeding, and fertility").
• If you are under 16 years of age.
• If you have an inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or colitis.
• If you have high blood pressure that is not well controlled (above 140/90 mmHg) (check with your doctor or nurse if you are not sure if your blood pressure is under control).
• If your doctor has diagnosed you with heart problems, such as heart failure (moderate or severe), angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in your legs or feet due to narrow or blocked arteries), or any type of stroke (such as a mini-stroke or transient ischaemic attack (TIA)). Etoricoxib may slightly increase the 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 you may be affected by any of these conditions, do not take the tablets until you have spoken to your doctor.

Warnings and precautions

Tell your doctor or pharmacist before you start taking Etoricoxib Viatris if:

• You have had stomach or intestinal ulcers or bleeding.
• You are taking acetylsalicylic acid (even at low doses for heart protection) or other NSAIDs.
• You are dehydrated, for example, due to a prolonged illness with vomiting or diarrhea.
• You have swelling due to fluid retention.
• You have a history of high blood pressure. Etoricoxib 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 any other heart, liver, or kidney problems.
• You are being treated for an infection. Etoricoxib may mask or hide fever, which is a sign of infection.
• You are taking medicines to prevent blood clotting (e.g., warfarin).
• You are a woman trying to become pregnant.
• You are an elderly person (over 65 years of age).
• You have diabetes, high cholesterol, or are a smoker, as these may increase your risk of heart disease.

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

During treatment

In the first month of treatment, the risk of a severe skin reaction is greater. Stop taking Etoricoxib Viatris if you develop a skin rash, mouth sores (damage to the skin or gums), or other signs of an allergic reaction (see section 4 - Possible side effects).

If you develop signs of liver problems, such as a yellowish color in the skin or the white of the eyes, dark-colored urine, pale stools, and a general feeling of being unwell, stop taking Etoricoxib Viatris and talk to your doctor.

Children and adolescents

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

Other medicines and Etoricoxib Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, if you are taking any of the following medicines, your doctor may want to check that your medicines are working adequately once you start taking Etoricoxib Viatris:

• Medicines that make your blood less prone to clotting (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, such as 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 the risk of side effects).
• Hormone replacement therapy (the combination may increase the risk of side effects).
• Acetylsalicylic acid (aspirin) or other NSAIDs; the risk of stomach ulcers is greater if you take etoricoxib with these medicines.

• Etoricoxib can be taken with low doses of aspirin used for the prevention of heart attacks or strokes. If you are currently taking low doses of aspirin for the prevention of heart attacks or strokes, do not stop taking aspirin until you have talked to your doctor.
• Do not take high doses of aspirin or other anti-inflammatory medicines while taking etoricoxib.

Taking Etoricoxib Viatris with food

The onset of the effect of Etoricoxib Viatris may be faster if taken without food. This should be taken into account when rapid relief from pain or inflammation is needed.

Pregnancy, breast-feeding, and fertility

Do not take Etoricoxib Viatris during pregnancy. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, do not take the tablets of this medicine. If you become pregnant, stop taking the tablets and talk to your doctor. Talk to your doctor if you have any doubts or need more information before taking this medicine.

It is not known if etoricoxib passes into breast milk. If you are breast-feeding or about to start breast-feeding, talk to your doctor before taking this medicine. If you are taking Etoricoxib Viatris, do not breast-feed.

Etoricoxib is not recommended in women who are trying to become pregnant.

Driving and using machines

Some patients who have taken etoricoxib have reported dizziness, vertigo (a feeling of spinning without moving), and somnolence.

Do not drive or operate tools or machines if you experience these side effects.

Etoricoxib Viatris contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially sodium-free.

3. How to take Etoricoxib Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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 Etoricoxib Viatris for longer than necessary. This is because the risk of heart attacks and strokes may increase after prolonged treatment, especially with high doses.

Take Etoricoxib Viatris orally once a day. This medicine can be taken with or without food.

Etoricoxib may act faster when taken without food. Take this medicine without food if you need rapid relief from pain or inflammation.

The recommended dose is:

Osteoarthritis

The recommended dose is 30 mg (equivalent to one 30 mg tablet) once daily, increased to a maximum of 60 mg (equivalent to two 30 mg tablets or one 60 mg tablet) once daily if needed.

Rheumatoid arthritis

The recommended dose is 60 mg (equivalent to two 30 mg tablets) once daily, increased to a maximum of 90 mg once daily if needed.

Ankylosing spondylitis

The recommended dose is 60 mg (equivalent to two 30 mg tablets) once daily, increased to a maximum of 90 mg once daily if needed.

Acute pain conditions

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

Gout

The recommended dose is 120 mg (equivalent to four 30 mg tablets, two 60 mg tablets, or one 120 mg tablet) once daily (maximum daily dose) and should only be used during the period of acute pain, limited to a maximum of 8 days of treatment.

Postoperative dental pain

The recommended dose is 90 mg (equivalent to three 30 mg tablets or one 90 mg tablet) once daily (maximum daily dose), limited to a maximum of 3 days of treatment. Talk to your doctor if you still have pain after taking Etoricoxib Viatris.

Patients with liver problems

• If you have mild liver disease, do not take more than 60 mg (equivalent to two 30 mg tablets or one 60 mg tablet) daily.
• If you have moderateliver disease, do not take more than 30 mg daily.

Use in children and adolescents

Children and adolescents under 16 years of age should not take Etoricoxib Viatris.

If you take more Etoricoxib Viatris than you should

Never take more tablets than your doctor recommends. You may have stomach, heart, or kidney problems. If you take too many Etoricoxib Viatris tablets, talk to your doctor immediately or go to the nearest hospital emergency department, taking the pack with you.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Etoricoxib Viatris

It is important that you take Etoricoxib Viatris as your doctor has told you. If you forget a dose, just resume your normal schedule the next day. Do nottake a double dose to make up for forgotten doses.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of these symptoms, stop taking Etoricoxib Viatris and talk to your doctor immediately or go to the nearest hospital emergency department (see section2.What you need to know before taking Etoricoxib Viatris):

• An allergic reaction such as a skin rash, hives, itching, or swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing.
• Difficulty breathing, severe chest pain, severe headaches with confusion or blurred vision and swelling of the ankles. They can be signs of a dangerous increase in blood pressure.
• Yellowing of the skin and eyes, dark urine, fatigue, fever, nausea (vomiting), weakness, drowsiness, and stomach pain. They can be signs of severe liver problems.
• Severe or persistent stomach pain, black stools with a tar-like appearance, vomiting that may contain blood, abdominal swelling due to gas, loss of appetite, or nausea (vomiting). They can be signs of serious stomach, intestine, or pancreas problems.
• A serious skin disease with extensive blistering and bleeding of the lips, eyes, mouth, and nose (Stevens-Johnson syndrome) or severe skin reactions that start with painful areas with redness, large blisters, and finally peeling of the skin layers. It can be accompanied by fever and chills, muscle pain, and general discomfort (toxic epidermal necrolysis).
• An increase in the number of infections that can be detected by the presence of fever, severe chills, sore throat, or ulcers in the mouth. They can indicate that you have a low white blood cell count.
• An abnormal or dangerously fast heartbeat.
• Sudden fainting, numbness or weakness in the arms or legs, headache, dizziness, and confusion, vision disturbances, difficulty swallowing, confused, mixed, or loss of speech. They can be signs of a stroke caused by a clot or hemorrhage that affects blood supply to the brain.
• A feeling of heaviness or pressure in the chest with chest pain and difficulty breathing when exercising (can be signs of angina pectoris).
• Sudden chest pain that spreads to the neck or arm, with difficulty breathing and a feeling of cold. They can be signs of a heart attack or other heart problems.
• Reduced heart function, which can cause fatigue, weakness, and/or fluid retention, such as swelling of the legs and ankles, difficulty breathing with coughing up thick or watery phlegm.
• Little or no urine production, cloudy urine, blood in the urine, pain when urinating, or pain in the lower back. They can be signs of kidney problems.

Other possible adverse effects are the following:

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

• Stomach pain.

Common (may affect up to 1 in 10 people)

• Dry socket (inflammation and pain after tooth extraction).
• Swelling of the legs and/or feet due to fluid retention (edema).
• Dizziness, headache.
• Fast or irregular heartbeat (palpitations), irregular heart rhythm (arrhythmia).
• High blood pressure (hypertension).
• Constipation, gas (excess gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, esophagus inflammation.
• Changes in blood tests related to your liver.
• Bruises.
• Weakness and fatigue, flu-like illness.

Uncommon (may affect up to 1 in 100 people)

• Chest or throat infection.
  • Pain or burning sensation when urinating. It can be a sign of urinary tract infection.

• Fatigue, difficulty breathing, cold hands and feet, paleness. They can be signs of a low red blood cell count.
  • Unexplained bruising or bleeding, more frequent or longer-lasting than usual. They can be signs of a low platelet count.

• Increased or decreased appetite, weight gain.
• Anxiety, depression, decreased mental sharpness; seeing, feeling, or hearing things that really do not exist (hallucinations).
• Changes in taste, inability to sleep, numbness or tingling in hands or feet, reduced skin sensitivity, drowsiness.
• Blurred vision, eye irritation and redness.
• Ringing in the ears, vertigo (feeling of spinning without moving).
• Changes in heart electrical activity.
• Flushing, inflammation of blood vessels.
• Cough, nosebleed.
• Changes in bowel habits, dry mouth, irritable bowel syndrome.
• Muscle cramps or spasms, muscle pain or stiffness.
• High potassium levels in the blood, changes in blood or urine tests related to the kidney.

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

• Confusion, restlessness.

• Low sodium levels in the blood.

Reporting Adverse Effects

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

5. Storage of Etoricoxib Viatris

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

Do not use this medicine after the expiration date that appears on the box after "CAD" or "EXP". The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Etoricoxib Viatris Composition

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

Tablet core:

Anhydrous calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Tablet coating:

30 mg: Hypromellose, lactose monohydrate, titanium dioxide (E-171), triacetin, carnauba wax, brilliant blue FCF (E-133), black iron oxide (E-172), yellow iron oxide (E-172).

60 mg: Hypromellose, lactose monohydrate, titanium dioxide (E-171), triacetin, yellow iron oxide (E-172), indigo carmine (E-132), carnauba wax.

90 mg: Hypromellose, lactose monohydrate, titanium dioxide (E-171), triacetin, carnauba wax.

120 mg: Hypromellose, lactose monohydrate, titanium dioxide (E-171), triacetin, indigo carmine (E-132), yellow iron oxide (E-172), carnauba wax.

Product Appearance and Package Contents

30 mg tablets: Film-coated tablet, greenish-blue in color, round, and marked with "E" on one side and "30" on the other.

60 mg tablets: Film-coated tablet, green in color, round, and marked with "E" on one side and "60" on the other.

90 mg tablets: Film-coated tablet, white in color, round, and marked with "E" on one side and "90" on the other.

120 mg tablets: Film-coated tablet, light green in color, round, and marked with "E" on one side and "120" on the other.

Package sizes:

30 mg:

Blisters containing 2, 5, 7, 14, 20, 28, 49, 98 tablets; unit doses containing 28 or calendar blister containing 28 tablets.

60 mg:

Blisters containing 2, 5, 7, 10, 14, 20, 28, 30, 49, 50, 84, 98, 100 tablets; unit doses containing 5, 28, 50, 100 or calendar blister containing 28 tablets.

90 mg:

Blisters containing 2, 5, 7, 10, 14, 20, 28, 30, 49, 50, 84, 98, 100 tablets; unit doses containing 5, 7, 28, 50, 100 or calendar blister containing 28 tablets.

120 mg:

Blisters containing 2, 5, 7, 10, 14, 20, 28, 30, 49, 50, 84, 98, 100 tablets; unit doses containing 5, 7, 28, 50, 100 or calendar blister containing 28 tablets.

For all doses:

Plastic bottles with screw caps containing 28, 100, or 500 tablets. The 500-tablet bottles are only available for hospital use.

Not all package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Hungary Kft,

Mylan utca 1,

Kómarom, H-2900

Hungary

Generics [UK] Ltd, Station close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Viatris UK Healthcare Limited, Building 20, Station Close, Potters Bar, EN6 1TL, United Kingdom

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Höhe, Benzstrasse 1

61352 Bad Homburg v. d. Höhe

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Germany Etoricoxib Mylan 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets

Spain Etoricoxib Viatris 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets EFG

Finland Etoricoxib Mylan 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets

France Etoricoxib Mylan 30 mg, 60 mg film-coated tablets

Ireland Etorcicoxib 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets

Netherlands Etoricoxib Mylan 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets

Portugal Etoricoxib Mylan 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets

United Kingdom Etoricoxib Mylan 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets

(Northern Ireland)

Date of the last revision of this leaflet: October 2020

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