Etoricoxib Combix 60 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Etoricoxib Combix 30 mg film-coated tablets EFG

Etoricoxib Combix 60 mg film-coated tablets EFG

Etoricoxib Combix 90 mg film-coated tablets EFG

Etoricoxib Combix 120 mg film-coated tablets EFG

Read the 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Etoricoxib Combix is and what it is used for

What is Etoricoxib?

• This medicine contains the active substance etoricoxib. Etoricoxib belongs to a group of medicines known as 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 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.
• Etoricoxib 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 joint disease. 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 affected joints. It may also cause inflammation in other parts of the body.

What is gout?

Gout is a condition characterized by sudden and recurrent attacks of severe 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 taking Etoricoxib Combix

Do not take Etoricoxib:

• if you are allergic (hypersensitive) 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 Possible side effects, section 4)
• if you currently have a stomach or duodenal ulcer or bleeding
• if you have severe liver disease
• if you have severe kidney disease
• if you are or may be pregnant, or are breastfeeding your child (see "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 whether 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 myocardial infarction, surgical revascularization, or peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries)
• if you have had any type of stroke (including transient ischaemic attack or ischaemic stroke).

Etoricoxib may slightly increase your risk of myocardial infarction and stroke, and therefore should not be used in patients who have already had heart problems or a stroke.

If you think you fall into any of these categories, do not take the tablets until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Etoricoxib 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 situations apply to you, talk to your doctor before taking this medicine to check whether etoricoxib is suitable for you.

Etoricoxib works equally well in younger and older adult patients. If you are over 65 years of age, 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 Etoricoxib 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 thin your blood (anticoagulants), such as warfarin

• rifampicin (an antibiotic)

• methotrexate (a medicine used to suppress the immune system and often used in rheumatoid arthritis)

• cyclosporine 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, 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 adverse effects)

• hormone replacement therapy (the combination may increase your risk of adverse effects)

• acetylsalicylic acid (aspirin); the risk of stomach ulcers is higher if you take Etoricoxib with acetylsalicylic acid.

• Acetylsalicylic acid for prevention of myocardial infarction or stroke:

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

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

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

Taking Etoricoxib with food and drinks

The onset of action of Etoricoxib 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. Consult your doctor if you have any doubts or need further information.

Breastfeeding

It is not known whether Etoricoxib is excreted in human milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Etoricoxib. If you are taking this medicine, 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 somnolence have been reported in some patients taking Etoricoxib.

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 have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Etoricoxib Combix

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 to 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 may increase after long-term 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, which may be increased up to a maximum of 90 mg once daily if necessary.

Acute pain situations

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 and 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 Etoricoxib tablets.

Patients over 65 years of age

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. Etoricoxib may be taken with or without food.

If you take more Etoricoxib than you should

You must 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 medication and the amount taken. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Etoricoxib

It is important that you take this medicine exactly as your doctor has instructed. If you forget 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 experiences them.

If you develop any of the following signs, stop taking this medicine and speak to your doctor immediately (see section 2. What you need to know before taking Etoricoxib):

• 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 (excessive gas), gastritis (inflammation of the stomach lining), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the oesophagus, mouth ulcers
• changes in blood test results 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 stomach and small intestine/gastric flu), cold, urinary tract infection
• changes in laboratory results (reduced red blood cell count, reduced white blood cell count, 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, reduced 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, dizziness (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), myocardial infarction
• flushing, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nosebleed
• stomach swelling, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the stomach lining which may become severe and lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
• facial swelling, skin rash or itching, skin redness
• muscle cramp/spasm, muscle pain/stiffness
• elevated potassium levels 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 sodium levels in blood

• liver disorder, yellowing of the skin and/or eyes (jaundice)

• serious skin reactions

Reporting of adverse effects: If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Etoricoxib Combix

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to a SIGRE collection point at your pharmacy. If you are unsure how to dispose of medicines and containers you no longer need, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Etoricoxib Combix

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

Tablet core: sodium lauryl sulfate, microcrystalline cellulose, hydroxypropylcellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

Tablet coating: lactose monohydrate, triacetin, hypromellose, and titanium dioxide (E171). The 30 mg, 60 mg, and 120 mg tablets also contain indigo carmine (E132) and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Etoricoxib Combix tablets are available in 4 strengths:

Etoricoxib Combix 30 mg film-coated tablets: appear as smooth, biconvex, round, film-coated tablets, light green to bluish green in colour.

Etoricoxib Combix 60 mg film-coated tablets: appear as film-coated tablets engraved with ‘60’ on one side and smooth on the other, biconvex, round, green in colour.

Etoricoxib Combix 90 mg film-coated tablets: appear as smooth, biconvex, round, film-coated tablets, white to off-white in colour.

Etoricoxib Combix 120 mg film-coated tablets: appear as film-coated tablets engraved with ‘120’ on one side and smooth on the other, biconvex, round, green in colour.

Pack sizes:

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

Etoricoxib Combix 120 mg: 7 film-coated tablets.

Marketing Authorisation Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

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

Date of the most recent revision of this leaflet: April 2017

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/