Egidon

Leaflet attached to 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.
• In case of any doubts, you should 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 side effects 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 non-steroidal anti-inflammatory drugs (NSAIDs).

What is Egidon used for?

• Egidon helps to reduce pain and swelling (inflammatory conditions) of the joints and muscles in people aged 16 and over with osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and gout.
• Egidon is also a medicine 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 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 non-steroidal 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 women who are pregnant or may become pregnant, or are breastfeeding (see Pregnancy, breastfeeding, and fertility);
• in people under the age of 16;
• 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, the patient should consult a doctor or nurse to check blood pressure);
• if the patient has ever been diagnosed by a doctor 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 people who have had heart or stroke problems.

In the event of any of the above situations, the patient should consult a doctor before taking the tablets.

Warnings and precautions

Before starting to take Egidon, the patient should discuss it with their 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 problems in the past;
• if the patient is 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, the patient should
consult a doctor before taking Egidonto clarify whether the medicine can be taken.
Egidon is just as effective in older people as it is in 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

This medicine should not be given to children and adolescents under 16 years of age.

Egidon and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking now or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
In the case of taking one 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 (an immunosuppressive drug, often used to treat rheumatoid arthritis);
• cyclosporine or tacrolimus (immunosuppressive drugs);
• lithium (a medicine used to treat certain types of depression);
• medicines that help 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 for the prevention of heart attacks or strokes: Egidon can be taken at the same time as 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 their doctor;

• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): the patient should not take high dosesof acetylsalicylic acid or other anti-inflammatory drugs while taking Egidon.

Taking Egidon with food and drink

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

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Some patients taking Egidon have reported dizziness and drowsiness.
The patient should not drive if they experience dizziness or drowsiness.
The patient should not operate any machinery or use tools if they experience dizziness or drowsiness.

Egidon contains sodium

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

3. How to take Egidon

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The patient should not take higher doses than recommended for individual diseases. The patient should consult their doctor from time to time to monitor the treatment. It is important to use the lowest effective dose that provides pain relief, and the patient should not 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 tablets of 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 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 conditions
Etoricoxib should only be used during periods of acute pain symptoms.
Gout
The recommended dose is 120 mg once daily; it should only be used during periods 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 taken by children and adolescents under 16 years of age.

Patients over 65 years of age

No dose adjustment is necessary in patients over 65 years of age. As with other medicines, caution should be exercised in patients over 65 years of age.
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 a higher dose of Egidon than recommended

The patient should never take more tablets than the doctor has prescribed. If the patient has taken too many Egidon tablets, they should seek medical attention immediately.

Missing a dose of Egidon

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

4. Possible side effects

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

If any of the following symptoms occur, the patient should stop taking Egidon and contact their 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 manifest as 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 (rapid 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 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), rapid 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, dryness of the mucous membranes, 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 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 side effects occur, including any side effects not listed in this leaflet, the patient should tell their 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 the medicine.

5. How to store Egidon

The medicine should be stored out of sight and reach of children.
The medicine should not be taken 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 temperature requirements for the medicine.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 of the medicine is etoricoxib. Each coated tablet contains 30 mg of etoricoxib.
Egidon, 60 mg, coated tablets:
The active substance of the medicine is etoricoxib. Each coated tablet contains 60 mg of etoricoxib.
Egidon, 90 mg, coated tablets:
The active substance of the medicine is etoricoxib. Each coated tablet contains 90 mg of etoricoxib.
Egidon, 120 mg, coated tablets:
The active substance of the medicine 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%.
Blister packs of aluminum/OPA/aluminum/PVC, 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 for use in the Member States of the European Economic Area under the following names:

Poland: Egidon
To obtain more detailed information on this medicine, the patient 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