Leaflet: information for the patient

Etoricoxib Combix 30 mg film-coated tablets

Etoricoxib Combix 60 mg film-coated tablets

Etoricoxib Combix 90 mg film-coated tablets

Etoricoxib Combix 120 mg film-coated tablets

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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.

1. What isEtoricoxibCombixand what it is used for

2. What you need to know before starting to takeEtoricoxibCombix

3. How to takeEtoricoxibCombix

4. Possible side effects

5. Storage ofEtoricoxibCombix

6. Contents of the pack and additional information

What is Etoricoxib?

• This medicine contains the active ingredient etoricoxib. Etoricoxib 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).

What is Etoricoxib used for?

• Etoricoxib helps 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.
• Etoricoxib is 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 disease of the joints. 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 take Etoricoxib:

• if you are allergic (hypersensitive) to etoricoxib or to any of the other ingredients of this medicine (including those listed in section6)
• if you are allergic to nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see Possible side effects, section4)
• 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 may be pregnant, or are breastfeeding your child (see "Pregnancy, breastfeeding and fertility")
• if you are under 16years of age
• if you have an 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 not sure if your blood pressure is adequately controlled)
• if your doctor has diagnosed you with heart problems, including heart failure (moderate or severe), angina (chest pain)
• if you have had a heart 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 of stroke (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 Etoricoxib if:

• You have a history of ulcers or stomach bleeding.
• You are dehydrated, for example, as a result of a prolonged illness with vomiting or diarrhea.
• 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 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 may increase your risk of heart disease.
• You are a woman trying to become pregnant.
• You are over 65years of age.

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

Etoricoxib works just as well in young and adult patients. If you are over 65years of age, your doctor will want to keep a close eye on you. No dose adjustment is necessary in patients over 65years of age.

Children and adolescents

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

Taking Etoricoxib 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 bought without a prescription.

In particular, if you are using 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:

• blood-thinning medicines (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 antagonists, for example enalapril and ramipril, and losartan and valsartan
• diuretics (tablets to help you urinate)
• 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 your risk of side effects)
• hormone replacement therapy (the combination may increase your 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 until you have spoken with your doctor

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

do not takehigh dosesof aspirin or other anti-inflammatory medicines while taking this medicine.

Taking Etoricoxib 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, 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.

Breastfeeding

We do not know if Etoricoxib is excreted in breast milk. If you are breastfeeding or plan to do so, consult your doctor before taking Etoricoxib. If you are using this medicine, do not breastfeed.

Fertility

We do not recommend using Etoricoxib in women who are trying to become pregnant.

Driving and operating machines

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 machines if you experience dizziness or somnolence.

Etoricoxib Combix contains lactose

If your doctor has told you that you are intolerant to certain sugars, consult with him before taking this medicine.

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 do 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:

Osteoarthritis

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

Rheumatoid Arthritis

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

Ankylosing Spondylitis

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

Acute Pain Situations

Etoricoxib should only be used during the period of acute pain.

Gout

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

Postoperative Pain after Dental Surgery

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

Patients with Liver Problems

• If you have a mild liver disease, do not take more than 60mg per day.
• If you have a moderate liver disease, do not take more than30mg per day.

Use in Children and Adolescents

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

Patients over 65years

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

Administration Form

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

If you take more Etoricoxib 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, Tfno. 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 forgot to take Etoricoxib

It is essential to take this medication 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 takingthis medicineand talk to your doctor immediately (see section2.What you need to know before starting to take Etoricoxib):

• 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 your stools turn black
• an allergic reaction – which can include skin problems such as ulcers or blistering, 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 10people):

• stomach pain

Common(may affect up to 1 in 10people):

• 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 heart rhythm (arrhythmia)
• high blood pressure
• shortness of breath or difficulty breathing (bronchospasm)
• constipation, gas (excessive gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort,nausea, vomiting, esophagitis (inflammation of the esophagus), mouth ulcers
• changes in blood test results related to the liver
• bruising
• weakness and fatigue, flu-like illness

Uncommon(may affect up to 1 in 100people):

• gastroenteritis (inflammation of the gastrointestinal tract affecting both the stomach and small intestine/gastric catarrh), 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 urticaria that may 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)
• alteration of taste, inability to sleep, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (sensation of spinning while standing)
• irregular heart rhythm (fibrillation), rapid heart rate, heart failure, sensation of tension, pressure, or heaviness in the chest (angina pectoris), myocardial infarction
• redness, cerebral infarction, mini-stroke (transient ischemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nasal hemorrhage
• stomach swelling, changes in bowel habits, dry mouth, stomach ulcers, severe inflammation of the stomach lining that may cause bleeding, irritable bowel syndrome, pancreatitis
• swelling of the face, skin rash or itching, skin redness
• muscle cramp/spasm, muscle pain/stiffness
• elevated potassium levels in the blood, changes in blood or urine test results related to the kidneys, severe kidney problems
• chest pain

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

• 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 alteration, 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 the Pharmacovigilance of Medicines for Human Use:https://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 packaging 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 of 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 Combix

• The active ingredient is etoricoxib. Each film-coated tablet contains 30 mg, 60 mg, 90 mg, and 120 mg of etoricoxib.
• The other components (excipients) are:

Core of the tablet:sodium laurilsulfate, microcrystalline cellulose, hydroxypropyl cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, anhydrous colloidal silica, magnesium stearate.

Coating of the tablet:lactose monohydrate, triacetin, hypromellose, and titanium dioxide (E171). The 30 mg, 60 mg, and 120 mg tablets also contain indigotin (Laca índigo carmín) (E132) and yellow iron oxide (E172).

Appearance of the product and contents of the package

Etoricoxib Combix tablets are available in 4 doses:

Etoricoxib Combix 30 mg film-coated tablets: presented in the form of smooth, film-coated, biconvex, round tablets, both sides greenish to bluish green.

Etoricoxib Combix 60 mg film-coated tablets: presented in the form of film-coated tablets with '60' engraved on one side and smooth on the other, biconvex, round, green.

Etoricoxib Combix 90 mg film-coated tablets: presented in the form of smooth, film-coated, biconvex, round tablets, both sides white to off-white.

Etoricoxib Combix 120 mg film-coated tablets: presented in the form of film-coated tablets with '120' engraved on one side and smooth on the other, biconvex, round, green.

Package sizes:

Etoricoxib Combix 30 mg, 60 mg, and 90 mg: 28 film-coated tablets.

Etoricoxib Combix 120 mg: 7 film-coated tablets.

Marketing Authorization Holder

Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Last review date of this leaflet: March 2017

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/