Edolox

Leaflet attached to the packaging: information for the user

Edolox, 30 mg, coated tablets

Edolox, 60 mg, coated tablets

Edolox, 90 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.
• If you have any doubts, consult your 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 Edolox and what is it used for
• 2. Important information before taking Edolox
• 3. How to take Edolox
• 4. Possible side effects
• 5. How to store Edolox
• 6. Contents of the packaging and other information

1. What is Edolox and what is it used for

What is Edolox?

• Edolox contains the active substance etoricoxib. Edolox 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 Edolox used for?

• Edolox helps 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.
• Edolox 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 bone ends. This causes swelling (inflammation), pain, tenderness, stiffness, and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-lasting inflammatory disease of the joints. It causes pain, stiffness, swelling, and limited mobility of the affected joints. 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 Edolox

When not to take Edolox:

• in pregnant or breastfeeding women, or women who may become pregnant (see subsection Pregnancy, breastfeeding, and fertility);
• in people under 16 years of age;

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

Warnings and precautions

Before starting to take Edolox, discuss it with your doctor or pharmacist:

• in people with diabetes, high cholesterol, or smokers. These patients are at increased risk of heart disease;

in case of women planning to become pregnant;

• in people over 65 years of age.

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

Children and adolescents

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

Edolox and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
In the case of using 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 Edolox:

• 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 drug 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 drug used to treat heart failure and arrhythmias);
• minoxidil (a drug used to treat high blood pressure);
• salbutamol in tablet or oral solution form (a drug 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 Edolox with acetylsalicylic acid;
• acetylsalicylic acid used for the prevention of heart attacks or strokes: Edolox can be taken at the same time as a low dose of acetylsalicylic acid. If you are currently taking low dosesof acetylsalicylic acid to prevent a heart attack or stroke, 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 Edolox.

Edolox with food and drink

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

Pregnancy, breastfeeding, and fertility

Pregnancy
Edolox should not be used in pregnant women. A pregnant woman or a woman who may be pregnant or is planning to become pregnant should not take this medicine. If pregnancy occurs, stop taking the medicine and consult a doctor. In case of doubt or need for additional information, consult a doctor.
Breastfeeding
It is not known whether Edolox is excreted in breast milk. If breastfeeding or planning to breastfeed, consult a doctor before taking Edolox. If taking Edolox, do not breastfeed.
Fertility
It is not recommended to take Edolox in women planning to become pregnant.

Driving and using machines

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

Edolox contains sodium

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

3. How to take Edolox

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Do not take more than the recommended dose for each condition. Consult your doctor from time to time to check the treatment. It is important to use the smallest effective dose that relieves pain and not to take Edolox 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.
Recommended dose
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 may last for a maximum of 3 days.

Patients with liver dysfunction

• In patients with mild liver dysfunction, do not take a dose higher than 60 mg once daily.
• In patients with moderateliver dysfunction, do not take a dose higher than 30 mg per day.

Use in children and adolescents

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

Elderly patients

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

Taking a higher dose of Edolox than recommended

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

Missing a dose of Edolox

Edolox should be taken as prescribed by your doctor. If you miss a dose, the next day return to your 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 your doctor or pharmacist.

4. Possible side effects

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

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

• 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, 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 less than 1 in 10 patients
Uncommon:
occurring in less than 1 in 100 patients
Rare:
occurring in less than 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 Edolox:

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, irregular heartbeat (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;
• bruises;
• weakness and fatigue, flu-like symptoms.

Uncommon:

• gastrointestinal inflammation (gastroenteritis, which affects 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), 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, blood vessel inflammation;
• 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 disease (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 side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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. 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 Edolox

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
There are no special precautions for storing the medicine at a certain temperature. 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 Edolox contains

The active substance of Edolox is etoricoxib.
Each coated tablet contains 30 mg, 60 mg, or 90 mg of etoricoxib.
The other ingredients are:
Core of the tablet: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
Coating of the tablet:
Edolox 30 mg, 60 mg:polyvinyl alcohol, titanium dioxide (E 171), glycerol monostearate, indigo carmine aluminum lake (E 132), yellow iron oxide (E 172), talc, sodium lauryl sulfate
Edolox 90 mg:polyvinyl alcohol, titanium dioxide (E 171), glycerol monostearate, talc, sodium lauryl sulfate.

What Edolox looks like and what the pack contains

Edolox is available in three strengths:
30 mg:blue-green coated tablets, apple-shaped, biconvex, with the inscription "30" on one side and smooth on the other, 5.8 x 5.9 mm in size ± 7.5%.
60 mg:dark green coated tablets, apple-shaped, biconvex, with the inscription "60" on one side and smooth on the other, 7.1 x 7.3 mm in size ± 7.5%.
90 mg:white coated tablets, apple-shaped, biconvex, with the inscription "90" on one side and smooth on the other, 8.1 x 8.3 mm in size ± 7.5%.
Aluminum/OPA/Aluminum/PVC blisters in a cardboard box.
Pack sizes:
30 mg:2, 7, 14, 20, 28, 49 coated tablets or a collective packaging containing 98 coated tablets (2 blisters of 49 coated tablets each)
60 mg and 90 mg:2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100 coated tablets or a collective packaging containing 98 coated tablets (2 blisters of 49 coated tablets each).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.,
P.O. Box 3012 Larisa Industrial Area, Larisa, 41004
Greece

Date of last revision of the leaflet: 12/2020