Torixib 90 mg film-coated tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Torixib is and what it is used for

• Torixib contains the active substance etoricoxib. Torixib belongs to a group of medicines known as selective COX-2 inhibitors. These belong to a family of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

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

• Torixib is also used for the short-term treatment of moderate pain following dental surgery in people aged 16 years and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It causes the gradual breakdown of the cartilage that cushions the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and loss of function.

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 can also cause inflammation in other parts of the body.

What is gout?

Gout is a disease characterized by sudden and recurring attacks of very painful inflammation and redness in the joints. It is caused by deposits of mineral crystals in the joint.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease affecting the spine and large joints.

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

Do not take Torixib

• if you are allergic to etoricoxib or to 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 a stomach or duodenal ulcer or gastrointestinal bleeding
• if you have severe liver disease
• if you have severe kidney disease
• if you are or may be pregnant, or are breastfeeding
• 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 that has not been controlled with treatment (consult your doctor or nurse if you are unsure whether your blood pressure is adequately controlled)
• if your doctor has diagnosed you with heart problems, including moderate or severe heart failure, or angina (chest pain)
• if you have had a myocardial infarction, surgical revascularization, or peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries)
• if you have had any type of stroke (including transient ischaemic attack or ischaemic 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 any of these situations apply to you, do not take the tablets until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Torixib if:

• You have a history of stomach ulcers or gastrointestinal bleeding.
• You are dehydrated, for example, due to a prolonged illness with vomiting or diarrhoea.
• You have swelling due to fluid retention.
• You have a history of heart failure or 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 may 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 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 unsure whether any of the above apply to you, talk to your doctor before taking etoricoxib to ensure this medicine is suitable for you.

Etoricoxib works equally well in adult and younger patients. If you are over 65, your doctor will want to monitor you appropriately. Dose adjustment is not necessary in 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 need to 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 ensure your medicines are working properly once you start taking etoricoxib:

• medicines that make your blood less sticky (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 certain types of depression)
• medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, for example enalapril and ramipril, and losartan and valsartan
• diuretics (water tablets)
• digoxin (a medicine for heart failure and irregular heartbeat)
• minoxidil (a medicine used to treat high blood pressure)
• salbutamol tablets or oral solution (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 prevention of heart attack or stroke:

Etoricoxib may be taken with low-dose aspirin. If you are currently taking low-dose aspirin to prevent heart attack or stroke, do not stop taking aspirin without first talking to your doctor.

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

Do not take high-dose aspirin or other anti-inflammatory medicines while taking etoricoxib.

Taking Torixib with food and drink

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

Pregnancy, breastfeeding and fertility

Pregnancy

Etoricoxib tablets should not be taken during pregnancy. Do not take the tablets if you are pregnant, think you may be pregnant, or plan to become pregnant. If you become pregnant, stop taking the tablets and consult your doctor. Speak to your doctor if you have any doubts or need further information.

Breastfeeding

It is not known whether etoricoxib is excreted in human breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking etoricoxib. If you are taking etoricoxib, you should not breastfeed.

Fertility

The use of etoricoxib is not recommended in women who are trying to become pregnant.

Driving and using machines

Dizziness and drowsiness have been reported in some patients taking etoricoxib.

Do not drive if you experience dizziness or drowsiness.

Do not use tools or machinery if you experience dizziness or drowsiness.

Torixib contains lactose

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

Torixib contains sodium

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

3. How to take Torixib

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Do not take more than the recommended dose for your condition. Your doctor will want to review your treatment from time to time. It is important that you use the lowest dose that controls your pain and that you do not take etoricoxib for longer than necessary. This is because the risk of heart attacks and strokes may increase after prolonged treatment, especially with high doses.

Different doses of this medicine are available, and depending on your condition, your doctor will prescribe the tablet with the dose appropriate for you.

The recommended dose is:

Osteoarthritis

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

Rheumatoid arthritis

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

Ankylosing spondylitis

The recommended dose is 60 mg once daily, increasing up 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.

Postoperative dental surgery pain

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

Patients with liver problems

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

Use in children and adolescents

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

Elderly patients

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

Method of administration

This medicine is taken 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 has recommended. If you take too many etoricoxib tablets, seek immediate medical attention.

In case of overdose or accidental ingestion, you may also call the Toxicology Information Service at phone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Torixib

It is important that you take etoricoxib as directed by your doctor. If you miss a dose, simply resume your regular dosing schedule the next day. Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

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

If you develop any of the following signs, stop taking Torixib and speak to your doctor immediately:

• difficulty breathing, chest pain or ankle swelling, 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 may include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue or throat that may cause difficulty breathing

The following adverse 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)

• dry socket (inflammation and pain following tooth extraction)
• swelling of the legs and/or feet due to fluid retention (edema)
• dizziness, headache
• palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia)
• high blood pressure
• wheezing or difficulty breathing (bronchospasm)
• constipation, flatulence (excess gas), gastritis (inflammation of the inner lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the oesophagus, 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 affecting both the stomach and small intestine / gastric flu), cold, urinary tract infection
• changes in laboratory results (reduced number of red blood cells, reduced number of white blood cells, decreased platelets)
• hypersensitivity (allergic reaction including hives, which may 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 are not there (hallucinations)
• altered taste, inability to sleep, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (sensation of spinning while standing still)
• abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, sensation of tightness, pressure or heaviness in the chest (angina pectoris), myocardial infarction
• flushing, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nosebleeds
• stomach swelling, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the inner lining of the stomach which may become severe and may cause bleeding, irritable bowel syndrome, inflammation of the pancreas
• swelling of the face, skin rash or itching, redness of the skin
• muscle cramp/spasm, muscle pain/stiffness
• elevated levels of potassium in your blood, changes in blood or urine tests related to your kidneys, serious 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 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, restlessness
• liver problems (hepatitis)
• low levels of sodium in the blood
• liver impairment, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse 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 stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Torixib

• The active substance 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 pack contents

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

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

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

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

Pack sizes

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.
Avda. Barcelona, 69
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 medicinal product 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 tabletten
Ecoxyton 60 mg tabletten
Ecoxyton 90 mg tabletten
Ecoxyton 120 mg tabletten

Date of the most recent review of this package leaflet: March 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es