ETORICOXIB COMBIX 120 mg FILM-COATED TABLETS

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

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

What is Etoricoxib?

• This medicine contains the active substance 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 in people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Etoricoxib is also used for short-term treatment of moderate pain following 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 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 large joints.

2. What you need to know before you take Etoricoxib Combix

Do not take Etoricoxib:

• if you are allergic (hypersensitive) to etoricoxib or 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 an ulcer or bleeding in your stomach or duodenum
• if you have severe liver disease
• if you have 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 problems, including heart failure (of moderate or severe type), angina (chest pain)
• if you have had a heart attack, revascularization surgery, peripheral arterial disease (poor circulation in your legs or feet due to narrow or blocked arteries)
• if you have had any type of stroke (including transient ischaemic attack or transient cerebral ischaemia).

Etoricoxib may slightly increase your risk of heart attack and stroke, and for this reason, it should not be used in patients who have already had heart or stroke problems.

If you think you may be at risk of these conditions, do not take the tablets until you have spoken to your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Etoricoxib if:

• You have a history of stomach ulcers or bleeding.
• You are dehydrated, for example, due to 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 65 years of age.

If you are not sure if any of the above applies to you, talk to your doctor before taking this medicineto check if etoricoxib is suitable for you.

Etoricoxib works just as well in adult and younger patients. If you are over 65 years of age, your doctor will want to keep a close check 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 Etoricoxib 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 adequately 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)
• 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 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)
• 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)
• acetylsalicylic acid (aspirin), the risk of stomach ulcers is greater if you take Etoricoxib with acetylsalicylic acid.

• Acetylsalicylic acid for the prevention of heart attacks or strokes:

Etoricoxib can be taken with low 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 talked to your doctor.

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

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

Taking Etoricoxib with food and drink

The onset of 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, 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 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 using this medicine, 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 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 have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Etoricoxib Combix

Follow exactly the instructions of administration of this medicine given to you 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 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 might increase after prolonged treatment, especially with high doses.

There are different doses available for this medicine, and depending on your disease, 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 needed.

Rheumatoid arthritis

The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily if needed.

Ankylosing spondylitis

The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily if needed.

Acute pain conditions

Etoricoxib should only be used for 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 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 moderateliver disease, you should not take more than 30mg per day.

Use in children and adolescents

Children or adolescents under 16 years of age should 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 can be taken with or without food.

If you take more Etoricoxib 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 contact the Toxicology Information Service, Tel. 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the package and the leaflet of the medicine to the healthcare professional.

If you forget to take Etoricoxib

It is important that you take this medicine as your doctor has told you. If you forget a dose, just resume your normal schedule the next day. Do not take a double dose to make up for forgotten doses.

If you have any further questions on 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 this medicine and talk to your doctor immediately (see section 2. What you need to know before you 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 stomach pain or persistent stomach pain, or if 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 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 shortness of breath (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 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 do not exist (hallucinations)
• altered taste, insomnia, numbness or tingling, somnolence
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (feeling of spinning while standing still)
• abnormal heartbeat (atrial fibrillation), rapid heartbeat, heart failure, feeling of 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 become severe and cause bleeding, irritable bowel syndrome, pancreatitis
• swelling of the face, skin rash or itching
• muscle cramp/spasm, muscle pain/stiffness
• high levels of potassium in your 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 changes, 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton after CAD. 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. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

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 ingredients (excipients) are:

Tablet core: sodium lauryl sulfate, microcrystalline cellulose, hydroxypropylcellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, anhydrous colloidal 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 Package Contents

Etoricoxib Combix tablets are available in 4 doses:

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

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

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

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

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

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 Last Revision of this Leaflet: April 2017

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/