Product Information for the User

Torixib 30 mg Film-Coated Tablets

Torixib 60 mg Film-Coated Tablets

Torixib 90 mg Film-Coated Tablets

Torixib 120 mg Film-Coated Tablets

etoricoxib

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

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others 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 product information. See section 4.

1. What is Torixib and for what it is used

2. What you need to know before starting to take Torixib

3. How to take Torixib

4. Possible adverse effects

5. Storage of Torixib

6. Contents of the pack and additional information

• Torixibcontains the active ingredient etoricoxib.Torixibbelongs to a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

• Torixibhelps to reduce pain and swelling (inflammation) in the joints and muscles of people aged 16 years and over with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.

• Torixibis also used for the short-term treatment of moderate pain after dental surgery in people aged 16 years and over.

What is osteoarthritis?

Osteoarthritis is a joint disease. It causes 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 disease of the joints. It causes pain, stiffness, swelling, and progressive loss of mobility in the affected joints. It also causes 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 long joints.

Do not takeTorixib

• if you areallergic to etoricoxib or to any of the other ingredientsof this medicine (listed in section 6)
• if you areallergic to nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see Possible side effects, section 4)
• if you currently have astomach ulcerorgastrointestinal bleeding
• if you have asevere liver disease
• if you have asevere kidney disease
• if you are or may bepregnant, or arebreastfeeding your baby(see "Pregnancy, lactation and fertility")
• if you areunder 16 years of age
• if you haveinflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or colitis
• if you havehigh blood pressurethat 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 withheart problems, including heart failure (moderate or severe), angina (chest pain)
• if you have had aheart attack, revascularization surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries)
• if you have had any type ofstroke, including a transient ischemic attack or transient ischemic attack.

Etoricoxib may slightly increase your risk of heart attack and stroke, and therefore should not be used in patients who have 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 your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Torixib if:

• You have a history ofulcersorgastrointestinal bleeding.
• You aredehydrated, for example, as a result of a prolonged illness with vomiting or diarrhea.
• You haveswellingdue to fluid retention.
• You have a history ofheart failureor any other form ofheart disease.
• You have a history ofhigh 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 ofliver or kidney disease.
• You are being treated for aninfection. Etoricoxib may mask or hide fever, which is a sign of infection.
• You havediabetes, high cholesterol, or are asmoker, as these may increase your risk of heart disease.
• You are awoman trying to become pregnant.
• You areover 65 years of age.

If you are unsure whether any of the above situations affect you, speak with your doctor before taking etoricoxib to check if this medicine is suitable for you.

Etoricoxib works just as well in young and adult 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 in patients over 65 years of age.

Children and adolescents

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

Taking Torixib with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, including those obtained without a prescription.

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

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 with your doctor.

Do not take high doses of aspirin or other NSAIDs while taking etoricoxib.

Taking Torixib with food and drink

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

Pregnancy, lactation and fertility

Pregnancy

Do not take etoricoxib tablets during pregnancy. Do not take the tablets if you are pregnant, think you may be pregnant, or 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.

Lactation

We do not know if etoricoxib is excreted in human milk. If you are breastfeeding or plan to do so, consult your doctor before taking etoricoxib. If you are taking etoricoxib, do not breastfeed.

Fertility

We do not recommend using etoricoxib in women trying to become pregnant.

Driving and operating machinery

In some patients taking etoricoxib, 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.

Torixib contains lactose

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

Torixib contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; 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 stroke could increase after prolonged treatment, especially with high doses.

There are different doses available for this medication, and depending on your condition, your doctor will prescribe the tablet with the dose that is 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.

Acute Pain Situations

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, limited 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 of 3 days of treatment.

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 than 30 mg per day.

Use in Children and Adolescents

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

Older Patients

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

Administration Form

This medication is administered orally. Take the tablets once a day. Torixib can be taken with or without food.

If You Take More Torixib Than You Should

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 Toxicological Information Service, Tel. 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If You Forget to Take Torixib

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

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 develop any of these signs, stop taking Torixib and talk to your doctor immediately:

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)

Uncommon (may affect up to 1 in 100 people)

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

• angioedema (allergic reaction with swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing, which may be severe enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (severe allergic reaction requiring immediate medical attention)
• confusion, nervousness
• liver problems (hepatitis)
• low sodium levels in the blood
• liver damage, yellowing of the skin and/or 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 Pharmacovigilance of Medicines for Human Use: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. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at 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 Torixib

• The active ingredient is etoricoxib.

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

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

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

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

• The other components are:

Core of the tablet: microcrystalline cellulose (E460), magnesium stearate (E572), sodium croscarmellose (E468), dihydrogenated calcium phosphate (E341)

Film coating of the tablet: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518).

Appearance of the product and contents of the package

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

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

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

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

Pack sizes

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona

Spain

Responsible for manufacturing

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,

Republic of Czech

or

Merckle GmbH

Ludwig-Merckle-Strasse 3, 89413 Blaubeuren

Germany

This medicine is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet:March 2021

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