Prospect: information for the patient

Etoricoxib Viatris 30 mg film-coated tablets

Etoricoxib Viatris 60 mg film-coated tablets

Etoricoxib Viatris 90 mg film-coated tablets

Etoricoxib Viatris 120 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Etoricoxib Viatris

4.Possible adverse effects

5.Storage of Etoricoxib Viatris

6.Contents of the pack and additional information

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

• Etoricoxib helps to reduce pain and swelling (inflammation) in the joints and muscles of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Etoricoxib 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 joint disease. It is caused by 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 joint disease. It causes pain, stiffness, swelling, and progressive loss of mobility 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 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 large joints.

Do not take Etoricoxib Viatris:

• If you are allergic to etoricoxib or any of the other ingredients of this medication (listed in section 6).
• If you are allergic to nonsteroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid (aspirin) or COX-2 inhibitors (see section 4).
• If you have had asthma, chest tightness, or difficulty breathing after taking acetylsalicylic acid or other NSAIDs, nasal secretion or obstruction with facial pain, nasal polyps, or a skin reaction with itching called urticaria or inflammation of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing.
• If you currently have a stomach or intestinal ulcer or bleeding.
• If you have a severe liver or kidney disease.
• If you are pregnant or think you may be pregnant, or are breastfeeding your child (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 high blood pressure, above 140/90 mmHg, that has not been controlled with treatment (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, such as heart failure (moderate or severe), angina (chest pain), or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (such as a mild stroke or a transient ischemic 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 fall into any of these cases, do not take the tablets until you have consulted with your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Etoricoxib Viatris if:

• You have a history of stomach or intestinal ulcers or bleeding.
• You are taking acetylsalicylic acid (although at low doses for heart protection) or other NSAIDs.
• You are dehydrated, for example, as a result of 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 conceal fever, which is a sign of infection.
• You are using medications to prevent blood clotting (e.g., warfarin).
• You are a woman trying to become pregnant.
• You are an older person (over 65 years old).
• You have diabetes, high cholesterol, or are a smoker, as these may increase your risk of heart disease.

If you are unsure whether any of the above situations affect you, talk to your doctor before taking Etoricoxib Viatris to check if this medication is suitable for you.

During treatment

In the first month of treatment, the risk of severe skin reactions is higher. Stop taking Etoricoxib Viatris if you experience 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 experience signs of liver problems, such as yellowing of the skin or the white part of the eyes, dark-colored urine, pale stools, and a general feeling of illness, stop taking Etoricoxib Viatris and talk to your doctor.

Children and adolescents

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

Other medications and Etoricoxib Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Medications that make your blood less thick (anticoagulants), such as warfarin.
• Rifampicin (an antibiotic).
• Metotrexate (a medication used to suppress the immune system and is often used for rheumatoid arthritis).
• Ciclosporin or tacrolimus (medications used to suppress the immune system).
• Lithium (a medication used to treat certain types of depression).
• Medications 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 urinate).
• Digoxin (a medication for heart failure and irregular heartbeat).
• Minoxidil (a medication used to treat high blood pressure).
• Oral tablets or solution of salbutamol (a medication 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 higher if you take etoricoxib with these medications.

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

Taking Etoricoxib Viatris with food

The effect of Etoricoxib Viatris may appear more quickly if taken without food. This should be taken into account when a rapid relief of pain or inflammation is needed.

Pregnancy, breastfeeding, and fertility

Do not take Etoricoxib Viatris during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, do not take the tablets of this medication. If you become pregnant, stop taking the tablets and consult your doctor. Consult your doctor if you have doubts or need more information before taking this medication.

The passage of etoricoxib into breast milk is unknown. If you are breastfeeding or are about to start breastfeeding, you must consult your doctor before taking this medication. If you are taking Etoricoxib Viatris, do not breastfeed.

Etoricoxib is not recommended for women who wish to become pregnant.

Driving and operating machinery

Some patients who have taken etoricoxib have reported dizziness, vertigo (sensation of spinning without moving), and drowsiness.

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

Etoricoxib Viatris contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a intolerance to certain sugars, consult with him before taking this medication.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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 Etoricoxib Viatris for longer than necessary. This is because the risk of myocardial infarction and cerebral infarction may increase after prolonged treatment, especially with high doses.

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

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

The recommended dose is:

Arthritis

The recommended dose is 30 mg (equivalent to one 30 mg tablet) once a day, increasing to a maximum of 60 mg (equivalent to two 30 mg tablets or one 60 mg tablet) once a day, if necessary.

Rheumatoid Arthritis

The recommended dose is 60 mg (equivalent to two 30 mg tablets) once a day, increasing to a maximum of 90 mg once a day if necessary.

Ankylosing Spondylitis

The recommended dose is 60 mg (equivalent to two 30 mg tablets) once a day, increasing to a maximum of 90 mg once a day if necessary.

Acute Pain Situations

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 a day (maximum daily dose) that should only be used during the period of acute pain, limited to a maximum of 8 days of treatment.

Postoperative Pain after Dental Surgery

The recommended dose is 90 mg (equivalent to three 30 mg tablets or one 90 mg tablet) once a day (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 a mild liver disease, do not take more than 60 mg (equivalent to two 30 mg tablets or one 60 mg tablet) per day.
• If you have a moderate liver disease, do not take more than30 mg per day.

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Etoricoxib Viatris

It is essential to take Etoricoxib Viatris as your doctor has indicated. If you forget a dose, simply resume the usual regimen the next day.Do nottake a double dose to compensate for the missed doses.

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

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

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

• A skin rash, hives, itching, or swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.
• Difficulty breathing, intense chest pain, severe headaches with confusion or blurred vision, and swelling of the ankles. They may be signs of a dangerous increase in blood pressure.
• Yellowing of the skin and eyes, dark urine, fatigue, fever, nausea (urge to vomit), weakness, drowsiness, and stomach pain. They may be signs of severe liver problems.
• Intense or persistent stomach pain, black stools with tar-like appearance, vomiting that may contain blood, abdominal swelling due to gas presence, loss of appetite or nausea (urge to vomit). They may be signs of severe stomach, intestine, or pancreas problems.
• A severe skin disease with extensive blister formation and bleeding from 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 may 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, intense chills, sore throat, or mouth ulcers. They may indicate that you have a low white blood cell count.
• An abnormal or life-threatening heart rhythm.
• Sudden fainting, numbness or weakness in the arms or legs, severe headache, dizziness, confusion, vision disturbances, difficulty swallowing, slurred speech, or loss of speech. They may be signs of a stroke caused by a blood clot or hemorrhage affecting blood supply to the brain.
• A feeling of heaviness or oppression in the chest with chest pain and difficulty breathing during exercise (they may be signs of angina pectoris).
• Sudden chest pain that radiates to the neck or arm, with difficulty breathing and a feeling of coldness. They may be signs of a heart attack or other heart problems.
• Reduced heart function, which may cause fatigue, weakness, and/or fluid retention, such as swelling of the legs and ankles, difficulty breathing with cough and thick or watery sputum.
• Little or no urine production, cloudy or bloody urine, painful urination, or lower back pain. They may be signs of kidney problems.

Other possible side effects are as follows:

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 (excessive gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, esophagitis (inflammation of the esophagus).

•Changes in blood tests related to the liver.

•Bruises.

•Weakness and fatigue, pseudogripal disease.

Uncommon (may affect up to 1 in 100 people)

•Thoracic or pharyngeal infection.

• Pain or burning sensation while urinating. It may be a sign of urinary tract infection.

•Fatigue, difficulty breathing, cold hands and feet, pallor. They may be signs oflow red blood cell count.

• Bruises or unexplained bleeding, more frequent or prolonged than normal. They may be signs of low platelet count.

•Increased or decreased appetite, weight gain.

•Anxiety, depression, decreased mental acuity; seeing, feeling, or hearing things that do not exist (hallucinations).

•Changes in taste, inability to sleep, numbness or tingling in the hands or feet, reduced skin sensitivity, drowsiness.

•Blurred vision, eye irritation, and redness.

•Tinnitus, vertigo (sensation of spinning without moving).

•Changes in heart electrical activity.

•Suffocation, inflammation of blood vessels.

•Cough, nasal bleeding.

•Changes in bowel habits, dry mouth, irritable bowel syndrome.

•Muscle cramps or spasms, muscle pain or stiffness.

•Elevated potassium levels in the blood, changes in blood or urine tests related to the kidney.

Rare (may affect between 1 in 1,000 people)

• Confusion, restlessness.

•Low sodium levels in the blood.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance 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 medication 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.

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

Composition of Etoricoxib Viatris

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

Tablet core:

Calcium hydrogen phosphate anhydrous, 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), iron oxide black (E-172), iron oxide yellow (E-172).

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

Appearance of the product and contents of the package

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

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

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

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

Pack sizes:

30 mg:

Blister packs containing 2, 5, 7, 14, 20, 28, 49, 98 tablets; single-dose packs containing 28 tablets; calendar blister packs containing 28 tablets.

60 mg:

Blister packs containing 2, 5, 7, 10, 14, 20, 28, 30, 49, 50, 84, 98, 100 tablets; single-dose packs containing 5, 28, 50, 100 tablets; calendar blister packs containing 28 tablets.

90 mg:

Blister packs containing 2, 5, 7, 10, 14, 20, 28, 30, 49, 50, 84, 98, 100 tablets; single-dose packs containing 5, 7, 28, 50, 100 tablets; calendar blister packs containing 28 tablets.

120 mg:

Blister packs containing 2, 5, 7, 10, 14, 20, 28, 30, 49, 50, 84, 98, 100 tablets; single-dose packs containing 5, 7, 28, 50, 100 tablets; calendar blister packs containing 28 tablets.

For all doses:

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Mylan Hungary Kft,

Mylan utca 1,

Kómarom, H-2900

Hungary

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

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, UK

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Höhe, Benzstrasse 1

61352 Bad Homburg v. d. Höhe

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

GermanyEtoricoxib Mylan 30 mg, 60 mg, 90 mg, 120 mg Filmtabletten

SpainEtoricoxib Viatris 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets

FinlandEtoricoxib Mylan 30 mg, 60 mg, 90 mg, 120 mg tabletti, kalvopäällysteinen

FranceEtoricoxib Mylan 30 mg, 60 mg comprimé pelliculé

IrelandEtorcicoxib 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets

NetherlandsEtoricoxib Mylan 30 mg, 60 mg, 90 mg, 120 mg filmomhulde tabletten

PortugalEtoricoxib Mylan 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película

UKEtoricoxib Mylan 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets

(Northern Ireland)

Last revision date of this leaflet: October 2020

Further 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/