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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 non-steroidal anti-inflammatory drugs (NSAIDs).

What is Egidon used for?

• Egidon helps to reduce pain and swelling (inflammation) of the joints and muscles in people aged 16 and over with osteoarthritis, rheumatoid arthritis, 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 as a result of the gradual breakdown of cartilage lining the bone ends. 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 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 you are allergic (hypersensitive) to etoricoxib or any of the other ingredients of this medicine (listed in section 6);
• if you have an allergy to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and selective cyclooxygenase 2 (COX-2) inhibitors (see Possible side effects, section 4);
• if you have active stomach or intestinal ulcers or bleeding;
• if you have severe liver dysfunction;
• if you have severe kidney dysfunction;
• in pregnant or breastfeeding women, or women who may become pregnant (see Pregnancy, breastfeeding, and fertility);
• in children under 16 years of age;
• if you have inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or intestinal inflammation;
• if you have uncontrolled high blood pressure (if in doubt, consult your doctor or nurse to check your blood pressure);
• if you have ever been diagnosed by your doctor with heart problems, including heart failure (moderate or severe) or angina (chest pain);
• if you have had a heart attack, undergone a bypass grafting procedure, or have peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries);
• if you have had any type of stroke (including mini-stroke or transient ischemic attack, TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and therefore should not be used in patients with heart or stroke disease.

In the event of any of the above situations, you should consult your doctor before taking the tablets.

Warnings and precautions

Before starting to take Egidon, you should discuss it with your doctor or pharmacist:

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

In case of uncertainty as to whether any of the above situations exist, you should consult your doctor before taking Egidonto clarify whether the medicine can be taken.
Egidon is equally effective in both the elderly and younger adult patients. In patients over 65 years of age, the doctor may decide on more frequent check-ups. It is not necessary to adjust the dose in people 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

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.
In the case of taking one of the following medicines, your doctor may decide to monitor you to ensure that the treatment is going well 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 arrhythmias);
• minoxidil (a medicine used to treat high blood pressure);
• salbutamol in tablet or oral solution form (a medicine used in 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 in the prevention of heart attacks or strokes: Egidon can be taken with low-doseacetylsalicylic acid.

If you are currently taking low-dose acetylsalicylic acid to prevent heart attacks or strokes, do not stop taking acetylsalicylic acid without consulting your doctor;

• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): do not take high dosesof acetylsalicylic acid or other anti-inflammatory drugs 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 should not be taken during pregnancy. If you are pregnant, think you may be pregnant, or are planning to have a baby, do not take this medicine. If you become pregnant, stop taking the medicine and consult your doctor. If in doubt or need further information, consult your doctor.
Breastfeeding
It is not known whether Egidon is excreted in breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking this medicine. If you are taking Egidon, do not breastfeed.
Fertility
Egidon is not recommended for use in women planning a pregnancy.

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 machines 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 that the medicine is considered "sodium-free".

3. How to take Egidon

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Do not take more than the recommended dose for each condition. You should see your doctor from time to time to check your 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 with high doses.
There are different strengths of this medicine, and depending on the disease, your doctor will prescribe the strength 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
Etoricoxib should only be used during episodes of acute pain.
Gout
The recommended dose is 120 mg once daily; it should only be used 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 should not exceed 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 for oral use. The tablets should be taken once daily. Egidon can be taken with or without food.

Taking a higher dose of Egidon than recommended

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

Missing a dose of Egidon

Egidon should be taken as directed by your doctor. If you miss a dose, the next day you should return to your usual dosing schedule. Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, ask your 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 your doctor immediately (see section 2 Important information before taking Egidon):

• shortness of breath, chest pain, or swelling of the ankles or feet, 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 between 1 in 100 and 1 in 10 patients
• Uncommon: occurring in between 1 in 1,000 and 1 in 100 patients
• Rare: occurring in between 1 in 10,000 and 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 legs 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:

• gastrointestinal upset and infection (gastroenteritis, which includes both the stomach and the small and (or) large intestine), 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 movements, dry mouth, stomach ulcers, stomach inflammation, which can be severe and lead to bleeding, irritable bowel syndrome, pancreatitis;
• facial swelling, rash, or itching, redness of the skin;
• muscle spasms, muscle pain or stiffness;
• high potassium levels in the blood, changes in blood or urine test results related to kidney function, 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 those not listed in this leaflet, you should 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Egidon

The medicine should be stored out of 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:

• Core tablet: microcrystalline cellulose (type 112), calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
• 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, you should contact 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