ETORICOXIB VIR 90 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Etoricoxib Vir 30 mg film-coated tablets EFG

Etoricoxib Vir 60 mg film-coated tablets EFG

Etoricoxib Vir 90 mg film-coated tablets EFG

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

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

What is Etoricoxib Vir?

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

What is Etoricoxib Vir used for?

• Etoricoxib Vir helps to reduce pain and swelling (inflammation) of the joints and muscles in people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.

• Etoricoxib Vir 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 that causes the gradual breakdown of the cartilage that cushions the ends of the bones, leading to swelling (inflammation), pain, tenderness, stiffness, and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term inflammatory disease of the joints that 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 with sudden and recurring attacks of very painful and inflamed joints, which is caused by the deposition 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 Vir

Do not take Etoricoxib Vir

• 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), including aspirin and COX-2 inhibitors (see section 4, Possible side effects).
• 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 the section "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 uncontrolled high blood pressure (see your doctor or nurse if you are not sure if your blood pressure is under control)
• if your doctor has diagnosed you with any heart condition, such as heart failure (moderate or severe), angina (chest pain)
• if you have had a heart attack, have had heart bypass surgery, have had peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries)
• if you have had any type of stroke (such as a transient ischemic attack or TIA). Etoricoxib may slightly increase the risk of you having a heart attack or stroke, and it is for this reason that it should not be used in patients who have already had heart or stroke problems.

If you think you may be in any of these situations, do not take the tablets until you have consulted your doctor.

Warnings and precautions

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

• You have a history of stomach or duodenal bleeding or ulcers.
• You are dehydrated, for example, as a result of prolonged episodes of vomiting or diarrhea.
• You have fluid retention.
• You have a history of heart failure or any other type of heart disease.
• You have a history of high blood pressure. Etoricoxib Vir may increase blood pressure in some people, especially when taking 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. Etoricoxib may mask or hide fever, which is a sign of infection.
• You have diabetes, high cholesterol, or are a smoker, as these conditions may increase the risk of heart disease.
• You are a woman trying to become pregnant.
• You are an elderly person (i.e., over 65 years of age).

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

Etoricoxib Vir works just as well in elderly patients as it does in younger adults. If you are over 65 years of age, your doctor will want to monitor you closely. No dose adjustment is necessary in patients over 65 years of age.

Children and adolescents

This medicine is contraindicated in children and adolescents under 16 years of age.

Taking Etoricoxib Vir with other medicines

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

• 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 blockers, among others, such as enalapril, 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 the risk of side effects).
• Hormone replacement therapy (the combination may increase the risk of side effects).
• Aspirin. The risk of stomach ulcers is greater if you take etoricoxib with aspirin.

• Aspirin for the prevention of heart attacks or strokes:

Etoricoxib can be taken with low dosesof aspirin. If you are currently taking low doses of aspirin to prevent heart attacks or strokes, do not stop taking aspirin without first talking to your doctor.

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

Do not take high dosesof aspirin or other anti-inflammatory drugs while taking etoricoxib.

Taking Etoricoxib Vir with food

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

Pregnancy, breast-feeding, and fertility

Pregnancy

Etoricoxib should not be used during pregnancy. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant, stop taking this medicine and consult your doctor. Ask your doctor if you have any doubts or need more information.

Breast-feeding

It is not known if etoricoxib is excreted in breast milk. If you are breast-feeding or planning to breast-feed, consult your doctor before taking etoricoxib. Breast-feeding should be interrupted during treatment with etoricoxib.

Fertility

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

Driving and using machines

In some patients taking etoricoxib, dizziness and drowsiness have been reported. Do not drive if you experience dizziness or drowsiness. Do not use tools or machines if you experience dizziness or drowsiness.

Etoricoxib Vir contains 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.

Etoricoxib Vir contains sodium

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

3. How to take Etoricoxib Vir

Follow exactly the administration instructions of this medicine given by your doctor. If you are not sure, 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 etoricoxib for longer than necessary. This is because the risk of heart attacks and strokes could increase after prolonged treatment, especially with high doses.

This medicine is available in different doses, and depending on your condition, your doctor will prescribe the tablet with the dose that is most 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 necessary.

Rheumatoid arthritis

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

Ankylosing spondylitis

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

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.

Postoperative dental pain

The recommended dose is 90 mg once daily, limited to a treatment period of no more than 3 days.

Patient with liver problems

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

Use in children and adolescents

Etoricoxib tablets should not be given to children and adolescents under 16 years of age.

Patient over 65 years

No dose adjustment is necessary in patients over 65 years of age. As with other medicines, caution should be exercised in elderly patients.

Method of administration

Etoricoxib Vir is taken orally. Take the tablets once daily. Etoricoxib can be taken with or without food.

If you take more Etoricoxib Vir than you should

Never take more tablets than your doctor recommends. If you take too many etoricoxib tablets, seek medical attention immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount taken.

If you forget to take Etoricoxib Vir

It is important that you take Etoricoxib Vir as your doctor has indicated. If you forget a dose, just resume your normal dosing schedule the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Etoricoxib Vir

It is important that you continue taking Etoricoxib Vir unless your doctor tells you to stop.

If you have any further questions on 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 signs, stop taking Etoricoxib Vir and talk to your doctor immediately (see section2. What you need to know before taking Etoricoxib Vir):

• Difficulty breathing, chest pain, swelling of the ankles or if these worsen.
• Yellowing of the skin and eyes (jaundice), as these are signs of liver problems.
• Severe or persistent stomach pain or black stools.
• An allergic reaction, which can include skin disorders, such as ulcers or blistering, or swelling of the face, lips, tongue, or throat that can cause difficulty breathing.

During treatment with Etoricoxib Vir, the following adverse effects may occur:

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 a dental extraction)
• swelling of the legs or feet due to fluid retention (edema)
• dizziness, headache
• palpitations (rapid or irregular heartbeat), irregular heart rhythm (arrhythmia)
• high blood pressure
• wheezing or difficulty breathing (bronchospasm)
• constipation, gas (flatulence), gastritis (inflammation of the stomach lining)
• heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort, nausea, feeling of dizziness (vomiting), esophageal inflammation, mouth ulcers
• changes in blood test results related to the liver
• bruises
• weakness and fatigue, flu-like symptoms

Uncommon (may affect up to 1 in 100 people)

• gastroenteritis (inflammation of the gastrointestinal tract that affects both the stomach and the small intestine/gastric catarrh), upper respiratory tract infection, urinary tract infection
• changes in laboratory test results (decreased red blood cell count, decreased white blood cell count, decreased platelet count)
• hypersensitivity (an allergic reaction that includes the appearance of hives, which can be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, decreased mental acuity; 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
• tinnitus, vertigo (feeling of spinning while standing still)
• abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, feeling of pressure, tightness, or heaviness in the chest (angina pectoris), myocardial infarction
• flushing, stroke, transient ischemic attack, severe increase in blood pressure, inflammation of blood vessels
• cough, difficulty breathing, nasal bleeding
• abdominal distension, changes in bowel habits, 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, skin rash or itching, skin redness
• muscle cramps or spasms, muscle pain or stiffness
• high blood potassium levels, changes in blood or urine test results related to the kidneys, severe kidney disorders
• chest pain

Rare (may affect up to 1 in 1000 people)

• angioedema (an allergic reaction accompanied by swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing, which can be severe enough to require immediate medical attention, anaphylactic or anaphylactoid reactions, including shock (a severe allergic reaction that requires immediate medical attention)
• confusion, restlessness
• liver problems (hepatitis)
• low blood sodium levels
• liver failure; yellowing of the skin and eyes (jaundice)
• severe skin reactions

Reporting Adverse Effects

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

5. Storage of Etoricoxib Vir

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

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

Bottles: keep the bottle perfectly closed to protect it from moisture

Blisters: 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 point in the pharmacy. In case of 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

Composition of Etoricoxib Vir

• The active ingredient is etoricoxib.

Etoricoxib Vir 30 mg: each film-coated tablet contains 30 mg of etoricoxib.

Etoricoxib Vir 60 mg: each film-coated tablet contains 60 mg of etoricoxib.

Etoricoxib Vir 90 mg: each film-coated tablet contains 90 mg of etoricoxib.

Etoricoxib Vir 120 mg: each film-coated tablet contains 120 mg of etoricoxib.

• The other components are:

Tablet core: anhydrous dibasic calcium phosphate, microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, and magnesium stearate.

Tablet coating: hypromellose, lactose monohydrate, titanium dioxide (E-171), triacetin, aluminum lake carmine (E-132) (30, 60, and 120 mg film-coated tablets), yellow iron oxide (E-172) (30, 60, and 120 mg film-coated tablets).

Appearance of the Product and Package Contents

The Etoricoxib Vir 30 mg tablets are green-blue, round, 6.00 mm ± 0.2 mm in diameter, biconvex, film-coated, and have the inscription «443» on one side and an «L» on the other.

The Etoricoxib Vir 60 mg tablets are green, round, 8.00 mm ± 0.2 mm in diameter, biconvex, film-coated, and have the inscription «444» on one side and an «L» on the other.

The Etoricoxib Vir 90 mg tablets are white to off-white, round, 9.00 mm ± 0.2 mm in diameter, biconvex, film-coated, and have the inscription «445» on one side and an «L» on the other.

The Etoricoxib Vir 120 mg tablets are pale green, round, 10.00 mm ± 0.2 mm in diameter, biconvex, film-coated, and have the inscription «446» on one side and an «L» on the other.

Etoricoxib Vir film-coated tablets are available in Al/OPA/Al/PVC, Al/PVC/PVDC, and Al/PVC/PE/PVDC blisters, in packages of 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, and 100 film-coated tablets; and in HDPE bottles containing 2 sachets of silica gel (1 g each), with a child-resistant screw cap or lid, in packages of 30 and 90 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer:

Pharmadox Healthcare Ltd

KW20A, Kordin Industrial Park, Paola

PLA 3000, Malta

Heumann Pharma GmbH & Co. Generica KG,

Südwestpark 50, 90449

Nuremberg – Germany

Torrent Pharma (Malta) Limited

HHF 028 Hal Far Industrial Estate

Birzebbuga BBG 3000

Malta

Industrial Quimica y Farmaceutica VIR S.A.

C/ Laguna 66-68-70, Pol Industrial Urtinsa II, Alcorcón 28923

Madrid

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

Germany Etoricoxib Alembic 30/60/90/120 mg film-coated tablets

Spain Etoricoxib Vir 30/60/90/120 mg film-coated tablets EFG

Date of the last revision of this leaflet: July 2025

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/