ETORICOXIB FAIRMED 90 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Etoricoxib Fairmed 30mg film-coated tablets EFG

Etoricoxib Fairmed 60mg film-coated tablets EFG

Etoricoxib Fairmed 90mg film-coated tablets EFG

Etoricoxib Fairmed 120mg 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 questions, 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 not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Etoricoxib Fairmed and what is it used for
2. What you need to know before taking Etoricoxib Fairmed
3. How to take Etoricoxib Fairmed
4. Possible side effects
5. Storage of Etoricoxib Fairmed
6. Package contents and additional information

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

What is Etoricoxib?

• This medication contains the active ingredient 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 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.

2. What you need to know before taking Etoricoxib Fairmed

Do not take Etoricoxib:

• 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 acetylsalicylic acid and COX-2 inhibitors (see the section on Possible side effectsin 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 (see the section on 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 (see your doctor or nurse if you are not sure if your blood pressure is adequately controlled).
• if your doctor has diagnosed you with any heart condition, such as heart failure (moderate or severe), angina (chest pain).
• if you have had a heart attack, have had surgical revascularization, have had peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries).
• if you have had any type of stroke (including a transient ischemic attack or TIA). Etoricoxib may slightly increase the risk of you having a heart attack and stroke, which is why it should not be used in patients who have already had heart problems or a stroke.

If you think you are 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 Fairmed if:

• You have a history of stomach bleeding or ulcers.
• You are dehydrated, for example, as a result of prolonged episodes of vomiting or diarrhea.
• You have fluid retention.
• You have a history of heart failure or any other type of heart disease.
• You have a history of high blood pressure. Etoricoxib Fairmed may increase blood pressure in some people, especially when taken in 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 Fairmed may mask or hide fever, which is a sign of infection.
• You have diabetes, high cholesterol, or are a smoker, as these conditions may increase the risk of heart disease.
• You are a woman trying to become pregnant.
• You are over 65 years old.

If you are not sure if you are in any of the above situations, talk to your doctor before taking Etoricoxib Fairmed to check if this medication is suitable for you.

Etoricoxib Fairmed works just as well in older adult patients and in younger adults. If you are over 65 years old, your doctor will want to monitor you adequately. No dose adjustment is necessary in patients over 65 years old.

Children and adolescents

This medication is contraindicated in children and adolescents under 16 years of age.

Taking Etoricoxib Fairmed with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication, including those purchased without a prescription.

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

• Anticoagulant medications 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 inhibitorsand angiotensin receptor blockers, among others, such as enalapril, ramipril, 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 the risk of side effects).
• Hormone replacement therapy (the combination may increase the risk of side effects).
• Acetylsalicylic acid. The risk of stomach ulcers is higher if you take Etoricoxib Fairmed with acetylsalicylic acid.
• Acetylsalicylic acid for the prevention of heart attacks or strokes:

Etoricoxib Fairmed can be taken with low dosesof acetylsalicylic acid. If you are currently taking low doses of acetylsalicylic acid to prevent heart attacks or strokes, do not stop taking acetylsalicylic acid without first talking to your doctor.

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

Do not take high dosesof acetylsalicylic acid or other anti-inflammatory medications while taking Etoricoxib Fairmed.

Taking Etoricoxib Fairmed with food and drinks

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

Pregnancy, breastfeeding, and fertility

Pregnancy

Etoricoxib Fairmed should not be used during pregnancy.

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.

If you become pregnant, stop taking this medication and consult your doctor. Consult your doctor if you have any questions or need more information.

Breastfeeding

It is not known if etoricoxib is excreted in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Etoricoxib Fairmed. Breastfeeding should be interrupted during treatment with this medication.

Fertility

Etoricoxib Fairmed is not recommended for use in women trying to become pregnant.

Driving and using machines

In some patients taking Etoricoxib Fairmed, cases of 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.

This medication contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Information on sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Etoricoxib Fairmed

Follow the instructions for administration of this medication indicated by your doctor. If in 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, increasing to a maximum of 60 mg once daily if necessary.

Rheumatoid arthritis

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

Ankylosing spondylitis

The recommended dose is 60 mg once daily, increasing 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, do not take more than 60 mg per day.
• If you have moderateliver disease, do 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 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you develop any of these signs, stop taking this medicine and talk to your doctor immediately (see section2.What you need to know before you start takingEtoricoxib):

• difficulty breathing, chest pain, or swelling of the ankle, or if these worsen
• yellowish color of the skin and eyes (jaundice) - these are signs of liver problems
• severe or persistent stomach pain or black stools
• 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 frequency of possible adverse effects included below is defined according to the following convention:

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

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

Very rare (may affect up to 1 in 10,000 people)

The following adverse effects may occur during treatment with Etoricoxib:

Very common:

• stomach pain

Common:

• 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
• 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:

• gastroenteritis (inflammation of the gastrointestinal tract that affects both the stomach and the 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 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, inability to sleep, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (feeling of spinning while standing)
• abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, feeling of tension, pressure, or heaviness in the chest (angina pectoris), myocardial infarction
• flushing, stroke, transient ischemic attack (TIA), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nosebleed
• stomach swelling, changes in bowel movement habits, dry mouth, stomach ulcer, inflammation of the stomach lining that can be severe and can cause bleeding, irritable bowel syndrome, pancreatitis
• facial swelling, skin rash or itching, skin redness
• muscle cramp/spasm, muscle pain/stiffness
• high potassium levels in the blood, changes in blood or urine tests related to the kidneys, severe kidney problems
• chest pain

Rare:

• 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 alteration, yellowish color 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 that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Etoricoxib Fairmed

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

Do not use this medicine after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Blister packs: store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Etoricoxib Fairmed

• The active ingredient is etoricoxib. Each film-coated tablet contains 30 mg, 60 mg, 90 mg, or 120 mg of etoricoxib.

• The other ingredients are:

Core:microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, vegetable magnesium stearate

Coating:hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin (E1518), carnauba wax (E903).

The 30 mg, 60 mg, and 120 mg tablets also contain yellow iron oxide (E172) and indigo carmine aluminum lake (E132).

Appearance and Package Contents

Etoricoxib Fairmed is available in four presentations:

30 mg tablets:film-coated tablets, greenish-blue in color, biconvex, apple-shaped, with the mark «ET» engraved on one side and a «30» on the other.

The tablet measures approximately 6 mm in length and 5.75 mm in width.

60 mg tablets:film-coated tablets, dark green in color, biconvex, apple-shaped, with the mark «ET» engraved on one side and a «60» on the other.

The tablet measures approximately 7.4 mm in length and 7.2 mm in width.

90 mg tablets:film-coated tablets, white in color, biconvex, apple-shaped, with the mark «ET» engraved on one side and a «90» on the other.

The tablet measures approximately 8.45 mm in length and 8.25 mm in width.

120 mg tablets:film-coated tablets, white in color, biconvex, apple-shaped, with the mark «ET» engraved on one side and a «120» on the other.

The tablet measures approximately 9.2 mm in length and 8.9 mm in width.

Alu/PVC blister packs

30 mg, 60 mg, and 90 mg:

Packages containing 28 and 98 tablets.

120 mg:

Packages containing 7 and 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder:

Fairmed Healthcare GmbH

Dorotheenstr. 48

22301 Hamburg

Germany

[email protected]

Manufacturer:

Fairmed Healthcare GmbH

Maria-Goeppert-Strasse 3,

Luebeck, Schleswig-Holstein, 23562,

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands Etoricoxib generic partners 30 mg, 60 mg, 90 mg & 120 mg film-coated tablets

Spain Etoricoxib Fairmed 30 mg, 60 mg, 90 mg, and 120 mg film-coated tablets EFG

Denmark Etoricoxib Strides 30 mg, 60 mg, 90 mg & 120 mg film-coated tablets

Finland Etoricoxib Strides 30 mg, 60 mg, 90 mg & 120 mg tablets, film-coated

Norway Etoricoxib Strides 30 mg, 60 mg, 90 mg & 120 mg film-coated tablets

Sweden Etoricoxib Strides 60 mg film-coated tablets

Date of the last revision of this leaflet:09/2024.