ETORICOXIB FAIRMED 120 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 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 Fairmed and what is it used for
2. What you need to know before you take Etoricoxib Fairmed
3. How to take Etoricoxib Fairmed
4. Possible side effects
5. Storage of Etoricoxib Fairmed
6. Contents of the pack and other information

1. What is Etoricoxib Fairmed 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 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 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 gradual breakdown of the cartilage that cushions the ends of the bones. This leads to 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 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 red inflammation of the 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 you take Etoricoxib Fairmed

Do not take Etoricoxib:

• if you are allergic 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 acetylsalicylic acid and COX-2 inhibitors (see section 4, Possible side effects).
• 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 section, Pregnancy, breast-feeding, 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 controlled).
• if your doctor has diagnosed you with any heart condition, such as moderate or severe heart failure, angina (chest pain).
• if you have had a heart attack, have undergone coronary artery bypass grafting, have had peripheral arterial disease (poor circulation in your legs or feet due to narrowing or blockage of arteries).
• if you have had any type of stroke (including transient ischaemic attack or TIA). Etoricoxib may slightly increase the risk of you having a heart attack or stroke, and this is why it should not be used in patients who have already had heart or stroke problems.

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 or duodenal ulcers.
• You are dehydrated, for example, as a result of prolonged 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 taking 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 of age.

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 medicine is suitable for you.

Etoricoxib Fairmed works just as well in older adult patients as it does in younger adult patients. If you are over 65 years of age, your doctor will want to keep a closer check on you. No dose adjustment is necessary for patients over 65 years of age.

Children and adolescents

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

Taking Etoricoxib Fairmed 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 check that your medicines are working adequately once you start taking Etoricoxib Fairmed:

• Anticoagulant medicines 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, among others, such as enalapril, 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).
• Tablets or oral solution of salbutamol (a medicine 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 greater 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 medicines while taking Etoricoxib Fairmed.

Taking Etoricoxib Fairmed with food and drink

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

Pregnancy, breast-feeding, and fertility

Pregnancy

Etoricoxib Fairmed should not be used during pregnancy.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you become pregnant, stop taking this medicine and consult your doctor. Ask your doctor for advice if you have any doubts or need more information.

Breast-feeding

It is not known if etoricoxib is excreted in breast milk. If you are breast-feeding or planning to breast-feed, ask your doctor for advice before taking Etoricoxib Fairmed. Breast-feeding should be interrupted during treatment with this medicine.

Fertility

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

Driving and using machines

In some patients taking Etoricoxib Fairmed, 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.

This medicine contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Information on sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Etoricoxib Fairmed

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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 right 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 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 30mg per day.

Use in children and adolescents

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

Patient over 65 years

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, Phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the packaging 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 dosage 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 product, 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 section 2. What you need to know before you start taking Etoricoxib):

• 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 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 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, 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 (mini-stroke), 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 levels of potassium 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 disorder, 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 pharmacy's SIGRE point. 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 aluminum lake indigo carmine (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 "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 "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 "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 "120" on the other.

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

Alu/PVC blister pack

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.