TORIXIB 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Torixib 30 mg film-coated tablets EFG

Torixib 60 mg film-coated tablets EFG

Torixib 90 mg film-coated tablets EFG

Torixib 120 mg film-coated tablets EFG

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 the pack

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

1. What is Torixib and what is it used for

• Torixib contains the active substance etoricoxib. Torixib 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).

• Torixib 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.

• Torixib is also used for 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 breakdown of cartilage, the tissue 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 characterized by sudden, recurring 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 long joints.

2. What you need to know before you take Torixib

Do not takeTorixib

• if you are allergic to etoricoxib or any of the other ingredientsof 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 a stomach ulcer or bleeding
• if you have a severe liver disease
• if you have a 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 under control)
• if your doctor has diagnosed you with heart problemsincluding moderate or severe heart failure, angina (chest pain)
• if you have had a heart attack, revascularization surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrow or blocked arteries)
• if you have had any type of stroke(including a transient ischemic attack or a transient ischemic attack).

Etoricoxib may slightly increase your 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 at risk, do not take the tablets until you have spoken to your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting Torixib if:

• You have a history of stomach ulcersor stomach bleeding.
• You are dehydrated, for example, as a result of a prolonged illness with vomiting or diarrhea.
• You have swellingdue to fluid retention.
• You have a history of heart failureor any other form of heart disease.
• 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 a history of liver or kidney disease.
• You are being treated for an . Etoricoxib 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 etoricoxibto check if this medicine is suitable for you.

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

Taking Torixib with other medicines

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 properly once you start taking etoricoxib:

• medicines that make your blood less thick (anticoagulants), such as warfarin
• rifampicin(an antibiotic)
• methotrexate(a medicine used to suppress the immune system and often used in rheumatoid arthritis)
• cyclosporin 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 enalapriland ramipril, and losartanand 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 your risk of side effects)
• hormone replacement therapy(the combination may increase your risk of side effects)
• aspirin (acetylsalicylic acid), 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 with low doses of aspirin. If you are currently taking low doses of aspirin to prevent heart attacks or strokes, do not stop taking aspirin until you have spoken to your doctor

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

do not take high doses of aspirin or other anti-inflammatory medicines while taking etoricoxib.

Taking Torixib with food and drink

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

Pregnancy, breast-feeding and fertility

Pregnancy

Etoricoxib tablets should not be taken during pregnancy. Do not take the tablets if you are pregnant, if you think you may be pregnant, or if you are planning 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 etoricoxib is excreted in human milk. If you are breast-feeding or plan to breast-feed, consult your doctor before taking etoricoxib. If you are taking etoricoxib, do not breast-feed.

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.

Torixib contains lactose

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

Torixib contains sodium

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

3. How to take Torixib

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in 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 etoricoxib for longer than necessary. This is because the risk of heart attacks and strokes could increase after prolonged treatment, especially with high doses.

There are different doses available for this medicine, and depending on your condition, 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 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 during 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 moderate liver disease, do not take more than 30 mg per day.

Use in children and adolescents

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

Elderly patients

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

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

If you take more Torixib 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, you can also call the Toxicology Information Service, Phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Torixib

It is important that you take etoricoxib as your doctor has indicated. If you forget a dose, just resume 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 taking Torixib and talk to your doctor immediately:

• difficulty breathing, chest pain, or swelling of the ankle, or if these worsen
• yellowing of the skin and eyes (jaundice) - these are signs of liver problems
• severe or persistent stomach pain or black stools
• an allergic reaction - which can include skin problems such as ulcers or blisters, or swelling of the face, lips, tongue, or throat that can cause difficulty breathing

The following side effects may occur during treatment with etoricoxib:

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

• stomach pain

Common(may affect up to 1 in 10 people)

• 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 difficulty breathing (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(may affect up to 1 in 100 people)

• 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 cell count, decreased white blood cell count, decreased platelet count)
• hypersensitivity (allergic reaction including hives that can be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, decreased mental sharpness; 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
• ringing in the ears, vertigo (feeling of spinning while standing)
• 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 the blood, changes in blood or urine tests related to your kidneys, severe kidney problems
• chest pain

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

• 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 sodium levels in the blood
• liver disorder, 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, even if it is possible side effects that are 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 side effects, you can help provide more information on the safety of this medicine.

5. Storage of Torixib

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

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

This medicine does not require special storage conditions.

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

6. Package Contents and Additional Information

Composition of Torixib

• The active ingredient is etoricoxib.

Each 30 mg film-coated tablet contains 30 mg of etoricoxib.

Each 60 mg film-coated tablet contains 60 mg of etoricoxib.

Each 90 mg film-coated tablet contains 90 mg of etoricoxib.

Each 120 mg film-coated tablet contains 120 mg of etoricoxib.

• The other components are:

Tablet core: microcrystalline cellulose (E460), magnesium stearate (E572), sodium croscarmellose (E468), calcium hydrogen phosphate (E341)

Tablet coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518).

Appearance of the Product and Package Contents

30 mg film-coated tablets: white, round, biconvex (approximately 6 mm) engraved with "E9OX" on one side and "30" on the other.

60 mg film-coated tablets: white, round, biconvex (approximately 8 mm) engraved with "E9OX" on one side and "60" on the other.

90 mg film-coated tablets: white, round, biconvex (approximately 9 mm) engraved with "E9OX" on one side and "90" on the other.

120 mg film-coated tablets: white, round, biconvex (approximately 10 mm) engraved with "E9OX" on one side and "120" on the other.

Package Sizes

Packages of 2, 5, 7, 10, 14, 20, 28, 30, 49, 50, 84, 98, 100 tablets or multi-packages containing 98 (2 packages of 49 tablets) in blisters. Packages of 5 x 1, 50 x 1, 100 x 1 tablets in unit-dose blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U. Avda. Barcelona, 690 08970 Sant Joan Despí Barcelona

Spain

Manufacturer

Synthon Hispania S.L.

Polígono Las Salinas C/ Castelló 1

08830 Sant Boi de Llobregat

Spain

or

Synthon s.r.o. Blansko,

Brnenska 32/c.p. 597

678 01 Blansko,

Czech Republic

or

Merckle GmbH

Ludwig-Merckle-Strasse 3, 89413 Blaubeuren

Germany

This medicine is authorized in the member states of the European Economic Area under the following names:

Germany: Etarixon 30 mg Filmtabletten

Etarixon 60 mg Filmtabletten

Etarixon 90 mg Filmtabletten

Etarixon 120 mg Filmtabletten

Spain: Torixib 30 mg film-coated tablets EFG

Torixib 60 mg film-coated tablets EFG

Torixib 90 mg film-coated tablets EFG

Torixib 120 mg film-coated tablets EFG

Finland: Coxiloc 30 mg

Coxiloc 60 mg

Coxiloc 90 mg

Coxiloc 120 mg

Netherlands: Ecoxyton 30 mg tablets

Ecoxyton 60 mg tablets

Ecoxyton 90 mg tablets

Ecoxyton 120 mg tablets

Date of the Last Revision of this Prospectus:March 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