Egidon

Package leaflet: Information for the user

Egidon, 30 mg, coated tablets
Egidon, 60 mg, coated tablets
Egidon, 90 mg, coated tablets
Egidon, 120 mg, coated tablets
Etoricoxibum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Egidon is and what it is 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 pack and other information

1. What Egidon is and what it is used for

What is Egidon?

• Egidon contains the active substance etoricoxib. Egidon belongs to a group of medicines called selective inhibitors of cyclooxygenase-2 (COX-2). It belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

What is Egidon used for?

• Egidon helps reduce pain and swelling (inflammation) in the joints and muscles in people aged 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gouty arthritis.
• Egidon is also used for the short-term treatment of moderate pain following dental surgery in people aged 16 years and older.

What is osteoarthritis?
Osteoarthritis is a joint disease. It results from the gradual breakdown of the cartilage that lines the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and loss of function.

What is rheumatoid arthritis?
Rheumatoid arthritis is a long-term inflammatory joint disease. It causes pain, stiffness, swelling, and reduced range of motion in the affected joints. It may also cause 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 in the joints. This condition is caused by the deposition of crystal deposits in the joint.

What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease affecting 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 has an allergy to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, or selective inhibitors of cyclooxygenase-2 (COX-2) (see Possible side effects, section 4);
• if the patient has active peptic ulcer disease or gastrointestinal bleeding;
• if the patient has severe liver function disorders;
• if the patient has severe kidney function disorders;
• in pregnant women, women who may be pregnant, or women who are breastfeeding (see Pregnancy, breastfeeding and fertility);
• in individuals under 16 years of age;
• if the patient has inflammatory bowel disease such as Crohn's disease, ulcerative colitis, or colitis;
• if the patient has untreated high blood pressure (in case of doubt, consult a doctor or nurse to have blood pressure checked);
• if a doctor has ever diagnosed the patient with heart problems, including heart failure (moderate or severe type) or angina pectoris (chest pain);
• if the patient has had a heart attack, coronary artery bypass surgery, or peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries);
• if the patient has ever had any type of stroke (including mini-stroke, transient ischaemic 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 problems or stroke.

If any of the above situations apply, the patient should consult a doctor before taking the tablets.

Warnings and precautions

Before starting treatment with Egidon, discuss with a doctor or pharmacist if:

• the patient has previously experienced gastrointestinal bleeding or peptic ulcer disease;
• the patient is dehydrated, for example due to prolonged or recurrent vomiting or diarrhoea;
• the patient has fluid retention causing swelling (oedema);
• the patient has previously had heart failure or other heart disease;
• the patient has previously had high blood pressure. Egidon may increase blood pressure in some people, especially when high doses are used; therefore, the doctor will periodically monitor blood pressure;
• the patient has previously had liver or kidney function disorders;
• the patient is currently being treated for an infection. Egidon may mask fever, which is a symptom of infection;
• the patient has diabetes, high cholesterol levels, or is a smoker. These patients have an increased risk of heart disease;
• in women planning pregnancy;
• in individuals aged 65 years or older.

If in doubt whether any of the above conditions apply, the patient should consult a doctor before taking Egidon to determine whether the medicine can be used.

Egidon is equally effective in elderly patients and younger adult patients. In patients aged 65 years or older, the doctor may recommend more frequent check-ups. Dose adjustment is not necessary in patients aged 65 years or older.

Children and adolescents

Do not give this medicine to children and adolescents under 16 years of age.

Egidon and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines.

If the patient is taking any of the following medicines, the doctor may decide that monitoring is necessary to ensure safe and effective treatment after starting Egidon:

• anticoagulant medicines (blood thinners), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (a medicine that suppresses immune system function, often used in the treatment of rheumatoid arthritis);
• cyclosporine or tacrolimus (medicines that suppress immune system function);
• lithium (a medicine used to treat certain types of depression);
• medicines used to control high blood pressure and heart failure, known as ACE inhibitors and angiotensin receptor blockers, for example enalapril and ramipril, or losartan and valsartan;
• diuretics (water pills);
• digoxin (a medicine used in heart failure and heart rhythm disorders);
• minoxidil (a medicine used to treat high blood pressure);
• oral salbutamol tablets or oral solution (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 developing stomach ulcers is higher when Egidon is taken together with acetylsalicylic acid.
  • acetylsalicylic acid used for prevention of heart attack or stroke: Egidon may be taken together with low-dose acetylsalicylic acid.

If the patient is currently taking low-dose acetylsalicylic acid to prevent heart attack or stroke, do not stop taking acetylsalicylic acid without consulting a doctor;

• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): do not take high-dose acetylsalicylic 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 used during pregnancy. If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she must not take this medicine. If pregnancy occurs, the medicine should be discontinued immediately and the patient should contact her doctor. In case of doubt or need for further information, consult a doctor.

Breastfeeding

It is not known whether Egidon is excreted in human breast milk. If the patient is breastfeeding or planning to breastfeed, she should consult a doctor before taking this medicine. Breastfeeding must not be performed while taking Egidon.

Fertility

Use of Egidon is not recommended in women planning pregnancy.

Driving and operating machinery

Dizziness and drowsiness have been reported in some patients taking Egidon.

Do not drive if dizziness or drowsiness occurs.

Do not operate machinery or use tools if dizziness or drowsiness occurs.

Egidon contains sodium

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

3. How to take Egidon

This medicine should always be taken as directed by your doctor. If in doubt,
consult your doctor or pharmacist.
Do not take higher doses than those recommended for individual conditions. You should consult your doctor periodically
to monitor treatment. It is important to use the lowest effective dose providing pain relief, and Egidon should not be used for
longer than necessary. There is an increased risk of heart attacks and strokes with prolonged use of this medicine,
particularly at high doses.
Different strengths of this medicine are available, and depending on the condition being treated, your doctor will prescribe
tablets of an appropriate strength for the patient.
Recommended doses are as follows:
Osteoarthritis
The recommended dose is 30 mg once daily, increased if necessary to a maximum of 60 mg once daily.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, increased if necessary to a maximum of 90 mg once daily.
Ankylosing spondylitis
The recommended dose is 60 mg once daily, increased if necessary to a maximum of 90 mg once daily.
Acute pain conditions
Etoricoxib should be used only during episodes of acute pain symptoms.
Acute gout
The recommended dose is 120 mg once daily; this should be used only during episodes of acute pain, for a maximum of 8 days.
Pain following dental surgery
The recommended dose is 90 mg once daily, and treatment with this dose may last up to a maximum of 3 days.

Patients with hepatic impairment

• In patients with mild hepatic impairment, doses greater than 60 mg once daily should not be used.
• In patients with moderate hepatic impairment, doses greater than 30 mg once daily should not be used.

Use in children and adolescents
Egidon should not be used in children and adolescents under 16 years of age.
Elderly patients
Dosage adjustment is not necessary in elderly patients. However, as with other medicines, caution should be exercised in elderly patients.
Method of administration
Egidon is intended for oral use. Tablets should be taken once daily. Egidon may be taken with or without food.

If you take more Egidon than you should
Never take more tablets than prescribed by your doctor. If you have taken too many Egidon tablets, seek medical help immediately.

If you forget to take Egidon
Egidon should be taken as directed by your doctor. If you miss a dose, take your next dose at the usual time according to your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following symptoms occur, Egidon must be discontinued immediately
and you should contact your doctor without delay (see section 2 Important information before taking
Egidon):

• shortness of breath, chest pain, or development of swelling around the ankles, or worsening of existing swelling;
• yellowing of the skin or eyes (jaundice) – signs of liver dysfunction;
• severe or persistent stomach pain, or appearance of black-coloured stools;
• allergic reactions, which may manifest as skin problems such as ulcers or blisters, or swelling of the face, lips, tongue, or throat, which may cause difficulty in breathing.

The frequency of possible adverse effects is classified as follows:

• Very common: affects more than 1 in 10 patients
• Common: affects between 1 in 100 and 1 in 10 patients
• Uncommon: affects between 1 in 1,000 and 1 in 100 patients
• Rare: affects between 1 in 10,000 and 1 in 1,000 patients
• Very rare: affects less than 1 in 10,000 patients

The following adverse 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 (oedema);
• dizziness, headache;
• palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia);
• increased blood pressure;
• wheezing or shortness of breath (bronchospasm);
• constipation, flatulence (excess intestinal gas), gastritis (inflammation of the stomach lining), heartburn, diarrhoea, indigestion (dyspepsia) and/or discomfort in the stomach, nausea, vomiting, oesophagitis, oral ulcers.

Uncommon:

• gastroenteritis (inflammation of the gastrointestinal tract involving both the stomach and small intestine and/or stomach flu), upper respiratory tract infection, urinary tract infection;
• changes in laboratory test results (decreased number of red blood cells, decreased number of white blood cells, decreased number of platelets);
• hypersensitivity (allergic reaction, including urticaria, which may be severe enough to require immediate medical intervention);
• increased or decreased appetite, weight gain;
• anxiety, depression, reduced mental performance; seeing or hearing things that do not exist (hallucinations);
• taste disturbances, insomnia, numbness or tingling, drowsiness;
• blurred vision, eye irritation and redness;
• tinnitus, vertigo (spinning sensation at rest);
• heart rhythm disorders (atrial fibrillation), rapid heartbeat, heart failure, sensation of tightness, pressure or heaviness in the chest (angina pectoris), heart attack;
• hot flushes, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, vasculitis;
• cough, breathlessness, nosebleeds;
• bloating, change in bowel habits, dryness of the oral mucosa, peptic ulcer, gastritis which may be severe and lead to bleeding, irritable bowel syndrome, pancreatitis;
• facial swelling, rash or itching, skin redness;
• muscle cramps, muscle pain or stiffness;
• high potassium levels in blood, changes in blood or urine tests related to kidneys, severe kidney function impairment;
• chest pain.

Rare:

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the 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 packaging. The expiry date refers to the last day of the stated month.
No special temperature storage requirements apply.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Egidon contains
Egidon 30 mg, film-coated tablets:
The active substance is etoricoxib. Each film-coated tablet contains 30 mg of etoricoxib.
Egidon 60 mg, film-coated tablets:
The active substance is etoricoxib. Each film-coated tablet contains 60 mg of etoricoxib.
Egidon 90 mg, film-coated tablets:
The active substance is etoricoxib. Each film-coated tablet contains 90 mg of etoricoxib.
Egidon 120 mg, film-coated tablets:
The active substance is etoricoxib. Each film-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), glyceryl monostearate, indigo carmine (E 132), aluminium lake, yellow iron oxide (E 172), talc, sodium lauryl sulfate.
  90 mg: polyvinyl alcohol, titanium dioxide (E 171), glyceryl monostearate, talc, sodium lauryl sulfate.

What Egidon looks like and contents of the pack
Egidon film-coated tablets are available in four strengths:
30 mg: bluish-green, biconvex film-coated tablet in the shape of an apple, imprinted with the number "30" on one side and plain on the other, dimensions 5.8 x 5.9 mm ± 7.5%.
60 mg: dark green, biconvex film-coated tablet in the shape of an apple, imprinted with the number "60" on one side and plain on the other, dimensions 7.1 x 7.3 mm ± 7.5%.
90 mg: white, biconvex film-coated tablet in the shape of an apple, imprinted with the number "90" on one side and plain on the other, dimensions 8.1 x 8.3 mm ± 7.5%.
120 mg: light green, biconvex film-coated tablet in the shape of an apple, imprinted with the number "120" on one side and plain on the other, dimensions 8.9 x 9.2 mm ± 7.5%.

Aluminium/OPA/Aluminium/PVC foil blisters in packs containing 7, 10, 14, 20, 28, 30, 50, 98 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Egidon

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00