Product Information for the Patient

Etoricoxib Vir 30 mg Film-Coated Tablets

Etoricoxib Vir 60 mg Film-Coated Tablets

Etoricoxib Vir 90 mg Film-Coated Tablets

Etoricoxib Vir 120 mg Film-Coated Tablets

Read this entire 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is Etoricoxib Vir?

•Etoricoxib Vir contains the active ingredient 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) in the joints and muscles of 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 joint disease that causes the gradual breakdown of the cartilage that cushions the ends of the bones, resulting in swelling (inflammation), pain, tenderness to the touch, 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 joint mobility in the affected joints. It can also cause inflammation in other parts of the body.

What is gout?

Gout is a disease characterized by sudden and recurrent attacks of very painful and inflamed joints, 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.

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 nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see the section on Possible side effects in 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 could be pregnant or breastfeeding (see the section on Pregnancy, breastfeeding 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 (consult your doctor or nurse if you are unsure if your blood pressure is adequately controlled)
• 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 undergone coronary revascularization, have had peripheral artery 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 ischaemic attack or TIA). Etoricoxib may slightly increase the risk of having a heart attack and a stroke, and is therefore not to be used in patients who have already had heart problems or a stroke.

If you consider that you fall into any of these cases, 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.
• 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 unsure whether you fall into any of the above situations, speak with your doctor before taking Etoricoxib Vir to check if this medicine is suitable for you.

Etoricoxib Vir works just as well in elderly patients and in younger adults. If you are over 65 years of age, your doctor will want to monitor you properly. 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

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

In particular, if you are taking any of the following medicines, your doctor may want to monitor you to check that the medicines you take work properly once you start taking Etoricoxib Vir:

• Medicines that make your blood less thick (anticoagulants) such as warfarin.
• Rifampicin (an antibiotic).
• Metotrexate (a medicine used to suppress the immune system and which is 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 called ACE inhibitors and angiotensin receptor blockers, among others, enalapril, ramipril, losartan and valsartan.
• Diuretics (tablets to eliminate fluids).
• 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 the risk of side effects).
• Hormone replacement therapy (the combination may increase the risk of side effects).
• Aspirin. The risk of stomach ulcers is higher if you take etoricoxib with aspirin.

• Aspirin for the prevention of heart attacks or strokes:

Etoricoxib 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 without first speaking with your doctor.

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

Do not takehigh dosesof aspirin or other NSAIDs while taking etoricoxib.

Taking Etoricoxib Vir with food

The onset of effect of etoricoxib may be faster if it is administered without food.

Pregnancy, breastfeeding and fertility

Pregnancy

Etoricoxib should not be used during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. If you become pregnant, stop taking this medicine and consult your doctor. Consult your doctor if you have any doubts or need more information.

Breastfeeding

The excretion of etoricoxib in breast milk is unknown. If you are breastfeeding or intend to breastfeed, consult your doctor before taking etoricoxib. You should interrupt breastfeeding during treatment with etoricoxib.

Fertility

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

Driving and operating machinery

In some patients taking etoricoxib, cases of 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.

Etoricoxib Vir contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Etoricoxib Vir contains sodium

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

Follow exactly the administration instructions of 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 should not take etoricoxib for longer than necessary. This is because the risk of myocardial infarction and cerebral infarction may increase after prolonged treatment, especially with high doses.

This medication 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:

Arthritis

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

Rheumatoid Arthritis

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

Ankylosing Spondylitis

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

Processes that involve acute pain

Etoricoxib should only be used during the acute pain period.

Gout

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

Postoperative pain after dental surgery

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

Patients with liver problems

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

• If you have a moderate liver disease, do not take more than30 mg per day.

Use in children and adolescents

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

Patients over 65 years

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

Administration form

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

If you take more Etoricoxib Vir than you should

Do not 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 Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Etoricoxib Vir

It is essential to take Etoricoxib Vir as your doctor has indicated. If you forget a dose, limit yourself to resuming the usual posological schedule the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Etoricoxib Vir

It is essential to continue taking Etoricoxib Vir, unless your doctor tells you that you can interrupt treatment.

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 experience any of these symptoms, stop taking Etoricoxib Vir and talk to your doctor immediately (see section 2. What you need to know before starting to take 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.
• Intense or persistent stomach pain or black stools.
• An allergic reaction, which may include skin disorders, such as ulcers or vesiculation, or swelling of the face, lips, tongue, or throat that may cause difficulty breathing.

During treatment with Etoricoxib Vir, the following side 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 tooth 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 difficult 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
• Bruising
• Weakness and fatigue, pseudogripal symptoms

Uncommon (may affect up to 1 in 100 people)

• Gastroenteritis (inflammation of the gastrointestinal tract affecting both the stomach and small intestine/gastric catarrh), upper respiratory tract infection, urinary tract infection
• Changes in laboratory results (decreased red blood cell count, decreased white blood cell count, decreased platelet count)
• Hypersensitivity (an allergic reaction including the appearance of hives, which may be severe enough to require immediate medical assistance)
• 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, somnolence
• Blurred vision, eye irritation and redness
• Tinnitus, vertigo (sensation of spinning while stationary)
• Abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, sensation of oppression, pressure, or heaviness in the chest (angina pectoris), myocardial infarction
• Redness, 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 ulcers
• Inflammation of the stomach lining that may be severe and cause bleeding
• Irritable bowel syndrome, pancreatitis
• Swelling of the face, skin rash or itching, skin redness
• Muscle cramps or spasms, muscle pain or stiffness
• Elevated potassium levels in the blood, changes in laboratory results or urine 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 may cause difficulty breathing or swallowing, which may be severe enough to require immediate medical assistance, anaphylactic or anaphylactoid reactions, even shock)
• Confusion, restlessness
• Liver problems (hepatitis)
• Low sodium levels in the blood
• Liver insufficiency; yellowing of the skin and 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 Usewww.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication 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

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

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

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: calcium phosphate dibasic anhydrous, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose and magnesium stearate.

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

Appearance of the product and contents of the package

Thefilm-coated tablets of Etoricoxib Vir 30 mgare blue-green coloured, round, 6.00 mm ± 0.2 mm in diameter, biconvex, film-coated and have the inscription «443» on one face and a «L» on the other.

Thefilm-coated tablets of Etoricoxib Vir 60 mgare green coloured, round, 8.00 mm ± 0.2 mm in diameter, biconvex, film-coated and have the inscription «444» on one face and a «L» on the other.

Thefilm-coated tablets of Etoricoxib Vir 90 mgare white to off-white coloured, round, 9.00 mm ± 0.2 mm in diameter, biconvex, film-coated and have the inscription «445» on one face and a «L» on the other.

Thefilm-coated tablets of Etoricoxib Vir 120 mgare pale green coloured, round, 10.00 mm ± 0.2 mm in diameter, biconvex, film-coated and have the inscription «446» on one face and a «L» on the other.

Etoricoxib Vir film-coated tablets are available in blisters of Al/OPA/Al/PVC, Al/PVC/PVDC and Al/PVC/PE/PVDC, in packs 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 (each 1 g), with a PP child-resistant closure or stopper, in packs of 30 and 90 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorisation holder:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Responsible for manufacture:

Pharmadox Healthcare Ltd

KW20A, Kordin Industrial Park, Paola

PLA 3000, Malta

Heumann Pharma GmbH & Co. Generica KG,

Südwestpark 50, 90449

Nürenberg – Germany

Torrent Pharma (UK) Limited

3rd Floor, Nexus Building, 4 Gatwick Road,

Crawley, West Sussex, RH10 9BG,

UK

Industrial Quimica y Farmaceutica VIR S.A.

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

Madrid

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

GermanyEtoricoxib Alembic 30/60/90/120 mg Filmtabletten

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

UKEtoricoxib 30/60/90/120 mg Film-coated Tablets

Last revision date of this leaflet: September 2022

For detailed and up-to-date information on this medicinal product, please consult the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/