Egidon

Leaflet accompanying the packaging: information for the user

Egidon, 30 mg, coated tablets

Egidon, 60 mg, coated tablets

Egidon, 90 mg, coated tablets

Egidon, 120 mg, coated tablets

Etoricoxib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Egidon and what is it used for
• 2. Important information before taking Egidon
• 3. How to take Egidon
• 4. Possible side effects
• 5. How to store Egidon
• 6. Contents of the packaging and other information

1. What is Egidon and what is it used for

What is Egidon?

• Egidon contains the active substance etoricoxib. Egidon is a medicine belonging to the group of selective cyclooxygenase-2 (COX-2) inhibitors. It belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs).

What is Egidon used for?

• Egidon helps reduce pain and swelling (inflammation) of the joints and muscles in people aged 16 and over with osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and gout.
• Egidon is also used for short-term treatment of moderate pain associated with surgical dental procedures in people aged 16 and over.

What is osteoarthritis?

Osteoarthritis is a disease that affects the joints. It occurs due to the gradual breakdown of cartilage lining the ends of bones. This causes swelling (inflammation), pain, tenderness, stiffness, and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-standing inflammatory disease of the joints. It causes pain, stiffness, swelling, and increased loss of range of motion in the joints it affects. It also causes inflammation in other parts of the body.

What is gout?

Gout is a disease characterized by sudden, recurring attacks of very painful inflammation and redness of the joints. This disease is caused by the deposition of crystalline deposits in the joint.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease of the spine and large joints.

2. Important information before taking Egidon

When not to take Egidon

• if the patient is allergic (hypersensitive) to etoricoxib or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and selective cyclooxygenase-2 (COX-2) inhibitors (see Possible side effects, section 4);
• if the patient has active peptic ulcer or bleeding from the stomach or intestines;
• if the patient has severe liver dysfunction;
• if the patient has severe kidney dysfunction;
• in pregnant or breastfeeding women, or women who may be pregnant (see Pregnancy, breastfeeding, and fertility);
• in children under 16 years of age;
• if the patient has inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or intestinal colitis;
• if the patient has uncontrolled high blood pressure (if in doubt, consult a doctor or nurse to check blood pressure);
• if the patient has ever been diagnosed with heart disease, including moderate or severe heart failure or angina pectoris (chest pain);
• if the patient has had a heart attack, undergone a bypass grafting procedure, or has peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries);
• if the patient has had any type of stroke (including mini-stroke, transient ischemic attack, TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and therefore should not be used in patients who have had heart disease or stroke.

In case of any of the above situations, consult a doctor before taking the tablets.

Warnings and precautions

Before starting to take Egidon, discuss it with a doctor or pharmacist:

• if the patient has had stomach bleeding or stomach ulcers in the past;
• if the patient is dehydrated, e.g., due to prolonged, recurring vomiting or diarrhea;
• if the patient has swelling due to fluid retention;
• if the patient has had heart failure or other heart disease in the past;
• if the patient has had high blood pressure in the past. Egidon may increase blood pressure in some people, especially after taking high doses of the medicine, so the doctor will check blood pressure from time to time;
• if the patient has had liver or kidney dysfunction in the past;
• if the patient is currently being treated for an infection. Egidon may mask fever, which is a sign of infection;
• in case of patients with diabetes, high cholesterol, or smokers. These patients have an increased risk of heart disease;
• in case of women planning to become pregnant;
• in case of patients over 65 years of age.

In case of uncertainty about any of the above situations, consult a doctor before taking Egidonto clarify whether the medicine can be taken.
Egidon is equally effective in both elderly and younger adult patients. In patients over 65 years of age, the doctor may decide on more frequent check-ups. No dose adjustment is 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.

Egidon and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those obtained without a prescription.
In case of taking any of the following medicines, the doctor may decide to monitor the patient to ensure that the treatment is proceeding correctly from the start of taking Egidon :

• blood thinners (anticoagulants), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (a medicine that suppresses the immune system, often used to treat rheumatoid arthritis);
• cyclosporine or tacrolimus (medicines that suppress the immune system);
• lithium (a medicine used to treat certain types of depression);
• medicines used to control high blood pressure and heart failure, called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, and losartan and valsartan;
• diuretics;
• digoxin (a medicine used to treat heart failure and irregular heartbeat);
• minoxidil (a medicine used to treat high blood pressure);
• salbutamol in tablet or oral solution form (a medicine used to treat asthma);
• oral contraceptives (combination may increase the risk of side effects);
• hormone replacement therapy (combination may increase the risk of side effects);
• acetylsalicylic acid, the risk of stomach ulcers is higher when taking Egidon with acetylsalicylic acid.
• acetylsalicylic acid used to prevent heart attacks or strokes: Egidon can be taken with low-doseacetylsalicylic acid.

If the patient is currently taking low-dose acetylsalicylic acid to prevent heart attacks or strokes, they should not stop taking acetylsalicylic acid without consulting a doctor;

• acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs): do not take high-doseacetylsalicylic acid or other anti-inflammatory medicines while taking Egidon.

Taking Egidon with food and drink

The effect of the medicine may start faster if Egidon is taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

Pregnancy
Egidon must not be taken during pregnancy. If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they must not take this medicine. If the patient becomes pregnant, they should stop taking the medicine and consult a doctor. In case of doubts or need for additional information, consult a doctor.
Breastfeeding
It is not known whether Egidon is excreted in breast milk. If the patient is breastfeeding or plans to breastfeed, they should consult a doctor before taking this medicine. If the patient is taking Egidon, they should not breastfeed.
Fertility
Egidon is not recommended for women planning to become pregnant.

Driving and using machines

Some patients taking Egidon have reported dizziness and drowsiness.
Do not drive if you experience dizziness or drowsiness.
Do not operate any machinery or use tools if you experience dizziness or drowsiness.

Egidon contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to take Egidon

Take this medicine always exactly as the doctor has told you. If you are not sure, consult a doctor or pharmacist.
Do not take more than the recommended dose for each condition. From time to time, consult a doctor to check the treatment. It is important to use the lowest effective dose that relieves pain, and not to take Egidon for longer than necessary. There is an increased risk of heart attacks and strokes with prolonged use of the medicine, especially in high doses.
There are different strengths of this medicine, and depending on the disease, the doctor will prescribe the tablets with the appropriate strength for the patient.
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
Etoricoxib should be used only during episodes of acute pain.
Gout
The recommended dose is 120 mg once daily; it should be used only during episodes of acute pain, for a maximum of 8 days.
Pain after surgical dental procedures
The recommended dose is 90 mg once daily, and treatment with this dose may last for a maximum of 3 days.

Patients with liver dysfunction

• In patients with mild liver dysfunction, the dose should not exceed 60 mg once daily.
• In patients with moderate liver dysfunction, the dose should not exceed 30 mg daily.

Use in children and adolescents

Egidon should not be used in children and adolescents under 16 years of age.

Elderly patients

No dose adjustment is necessary in elderly patients. As with other medicines, caution should be exercised in elderly patients.
Method of administration
Egidon is intended for oral use. The tablets should be taken once daily. Egidon can be taken with or without food.

Taking more than the recommended dose of Egidon

Never take more tablets than the doctor has recommended. If you have taken too many Egidon tablets, seek medical help immediately.

Missing a dose of Egidon

Egidon should be taken as recommended by the doctor. If a dose is missed, the next day return to the usual dosing schedule. Do not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Egidon can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking Egidon and contact a doctor immediately (see section 2 Important information before taking Egidon):

• shortness of breath, chest pain, or swelling of the ankles, or worsening of existing swelling;
• yellowing of the skin and eyes (jaundice) - these are signs of abnormal liver function;
• severe or persistent stomach pain, or black stools;
• allergic reactions, which can cause skin problems such as ulcers or blisters, or swelling of the face, lips, tongue, or throat, which can cause difficulty breathing.

The frequency of possible side effects is classified as follows:

• Very common: occurring in more than 1 in 10 patients
• Common: occurring in 1 in 100 to 1 in 10 patients
• Uncommon: occurring in 1 in 1,000 to 1 in 100 patients
• Rare: occurring in 1 in 10,000 to 1 in 1,000 patients
• Very rare: occurring in less than 1 in 10,000 patients

The following side effects may occur during treatment with Egidon:
Very common:

• stomach pain.

Common:

• dry socket (inflammation and pain after tooth extraction);
• swelling of the lower limbs and (or) feet due to fluid retention (edema);
• dizziness, headache;
• palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia);
• increased blood pressure;
• wheezing or shortness of breath (bronchospasm);
• constipation, gas (excess gas in the intestines), stomach upset (gastritis), heartburn, diarrhea, indigestion (dyspepsia), and (or) discomfort in the stomach, nausea, vomiting, esophagitis, mouth ulcers;
• changes in liver blood test results;
• bruising;
• weakness and fatigue, flu-like symptoms.

Uncommon:

• gastroenteritis (inflammation of the digestive tract, which includes both the stomach and the small intestine and (or) gastroenteritis), upper respiratory tract infection, urinary tract infection;
• changes in laboratory test results (decreased red blood cell count, decreased white blood cell count, decreased platelet count);
• hypersensitivity (allergic reaction, including hives, which can be severe enough to require immediate medical attention);
• increased or decreased appetite, weight gain;
• anxiety, depression, decreased mental performance; seeing or hearing things that do not exist (hallucinations);
• taste disorders, insomnia, numbness or tingling;
• blurred vision, eye irritation and redness;
• ringing in the ears, dizziness (feeling of spinning while at rest);
• heart rhythm disorders (atrial fibrillation), fast heartbeat, heart failure, feeling of tension, feeling of pressure or heaviness in the chest (angina pectoris), heart attack;
• hot flashes, stroke, mini-stroke (transient ischemic attack, TIA), severe increase in blood pressure, vasculitis;
• cough, shortness of breath, nosebleeds;
• bloating, change in bowel habits, dry mouth, stomach ulcers, gastritis, which can be severe and lead to bleeding, irritable bowel syndrome, pancreatitis;
• facial swelling, rash, or itching, redness of the skin;
• muscle cramps, muscle pain, or stiffness;
• high potassium levels in the blood, changes in blood or urine test results related to the kidneys, severe kidney dysfunction;
• chest pain.

Rare:

• angioedema (an allergic reaction characterized by swelling of the face, lips, tongue, and (or) throat, which can cause difficulty breathing or swallowing, which can be severe enough to require immediate medical attention); anaphylactic or anaphylactoid reactions, including shock (a severe allergic reaction that requires immediate medical attention);
• disorientation, restlessness;
• liver problems (hepatitis);
• low sodium levels in the blood;
• liver failure, yellowing of the skin and eyes (jaundice);
• severe skin reactions.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Egidon

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton. The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Egidon contains

Egidon, 30 mg, coated tablets:
The active substance is etoricoxib. Each coated tablet contains 30 mg of etoricoxib.
Egidon, 60 mg, coated tablets:
The active substance is etoricoxib. Each coated tablet contains 60 mg of etoricoxib.
Egidon, 90 mg, coated tablets:
The active substance is etoricoxib. Each coated tablet contains 90 mg of etoricoxib.
Egidon, 120 mg, coated tablets:
The active substance is etoricoxib. Each coated tablet contains 120 mg of etoricoxib.
Other ingredients are:

• Tablet core: microcrystalline cellulose (type 112), calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
• Tablet coating: 30 mg, 60 mg, 120 mg: polyvinyl alcohol, titanium dioxide (E 171), glycerol monostearate, indigo carmine (E 132), aluminum lake, yellow iron oxide (E 172), talc, sodium lauryl sulfate. 90 mg: polyvinyl alcohol, titanium dioxide (E 171), glycerol monostearate, talc, sodium lauryl sulfate.

What Egidon looks like and contents of the pack

Egidon, coated tablets are available in four strengths:
30 mg: blue-green, biconvex, coated tablet in the shape of an apple, with the inscription "30" on one side and smooth on the other, measuring 5.8 x 5.9 mm ± 7.5%.
60 mg: dark green, biconvex, coated tablet in the shape of an apple, with the inscription "60" on one side and smooth on the other, measuring 7.1 x 7.3 mm ± 7.5%.
90 mg: white, biconvex, coated tablet in the shape of an apple, with the inscription "90" on one side and smooth on the other, measuring 8.1 x 8.3 mm ± 7.5%.
120 mg: light green, biconvex, coated tablet in the shape of an apple, with the inscription "120" on one side and smooth on the other, measuring 8.9 x 9.2 mm ± 7.5%.
Aluminum/OPA/Aluminum/PVC blisters in packs containing 7, 10, 14, 20, 28, 30, 50, 98, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A
P.O. Box 3012
Larissa Industrial Area
41 500 Larissa
Greece

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

Poland: Egidon
To obtain more detailed information on this medicine, consult the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00
Date of last revision of the leaflet:20.02.2025