ETORICOXIB ALTER 90 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Etoricoxib Alter 60 mg film-coated tablets EFG

Etoricoxib Alter 90 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

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

What is Etoricoxib?

• Etoricoxib contains the active substance etoricoxib. Etoricoxib belongs to a group of medications called selective COX-2 inhibitors. These belong to a family of medications 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 16 years of age and older 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 16 years of age and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It causes the gradual breakdown of cartilage that cushions the ends of 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 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 long joints.

2. What you need to know before taking Etoricoxib Alter

Do not take Etoricoxib Alter

• if you are allergic to etoricoxib or any of the other ingredients of this medication (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 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 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 adequately controlled)
• 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, surgical revascularization, peripheral arterial disease (poor circulation in the legs or feet due to narrow or blocked arteries)
• if you have had any type of stroke (including a mini-stroke, transient cerebral 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 already had heart problems or a stroke.

If you think you may be in any of these situations, do not take the tablets until you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Etoricoxib Alter if

• You have a history of stomach ulcers or 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 65 years old.

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

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

Children and adolescents

Do not give this medication to children and adolescents under 16 years of age.

Taking Etoricoxib Alter with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

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

• medications that make your blood less thick (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medication used to suppress the immune system and often used in rheumatoid arthritis)
• cyclosporin or tacrolimus (medications used to suppress the immune system)
• lithium (a medication used to treat some types of depression)
• medications used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor antagonists, such as enalapril and ramipril, and losartan and valsartan
• diuretics (water pills)
• digoxin (a medication for heart failure and irregular heartbeat)
• minoxidil (a medication used to treat high blood pressure)
• tablets or oral solution of salbutamol (a medication 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 stroke:

Etoricoxib can be taken with low dosesof aspirin. If you are currently taking low doses of aspirin to prevent heart attacks or stroke, do not stop taking aspirin until you talk to your doctor

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

do not take high dosesof aspirin or other anti-inflammatory medications while taking this medication.

Taking Etoricoxib Alter with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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 doubts or need more information.

Breastfeeding

It is not known if etoricoxib is excreted in human milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking etoricoxib. If you are using this medication, do not breastfeed.

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 drowsiness have been reported.

Do not drive if you experience dizziness or drowsiness.

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

3. How to take Etoricoxib Alter

Follow the administration instructions of this medication exactly 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 important that you use the lowest dose that controls your pain and do not take etoricoxib for longer than necessary. This is because the risk of heart attacks and strokes 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 30 mg once daily, increased to a maximum of 60 mg once daily if necessary.

Rheumatoid arthritis

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

Ankylosing spondylitis

The recommended dose is 60 mg once daily, increased 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, 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 30 mg per day.

Use in children and adolescents

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

Patients over 65 years old

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

Method of administration

This medication 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 call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and package leaflet of the medication to the healthcare professional.

If you forget to take Etoricoxib

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

If you develop any of these signs, stop taking this medication and talk to your doctor immediately (see section 2. What you need to know before taking 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 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 difficulty breathing (bronchospasm)
• constipation, gas (excess gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort, 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/gastroenteritis), 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 can 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, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (feeling of spinning while standing)
• abnormal heartbeat (atrial fibrillation), rapid heart rate, heart failure, feeling of pressure, tension, or heaviness in the chest (angina pectoris), heart attack
• flushing, stroke, mini-stroke (transient ischemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nosebleed
• stomach or intestinal swelling, changes in bowel movements, dry mouth, stomach ulcer, inflammation of the stomach lining that can be severe and can 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 the blood, changes in blood or urine tests related to the 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, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Etoricoxib Alter

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the carton and blister. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Etoricoxib Alter Composition

• The active ingredient is etoricoxib. Each film-coated tablet contains 60 mg or 90 mg of etoricoxib.
• The other components are:

Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), triacetin. The 60 mg tablet also contains yellow iron oxide (E172).

Product Appearance and Packaging Content

Etoricoxib Alter tablets are available in four doses:

60 mg: Film-coated tablets, dark green in color, round, biconvex.

90 mg: Film-coated tablets, white in color, round, biconvex.

Etoricoxib Alter is available in packages of:

60 mg: 20 and 28 film-coated tablets.

90 mg: 2, 20, and 28 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Spain Etoricoxib Alter 60 mg / 90 mg film-coated tablets EFG

Italy Etoricoxib Alter

Date of the Last Revision of this Prospectus:

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