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

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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. 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 to 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.
• Edolox 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-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:

• if the patient is allergic to etoricoxib or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and selective cyclooxygenase 2 (COX-2) inhibitors (see section 4. Possible side effects);
• if the patient has active peptic ulcer or gastrointestinal bleeding;
• 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 subsection 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 inflammation;
• if the patient has uncontrolled high blood pressure (in case of doubt, consult a doctor or nurse to check blood pressure);
• if the patient has ever been diagnosed with heart disorders, 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 disorders.

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

Warnings and precautions

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

• if the patient has a history of stomach bleeding or stomach ulcers;
• 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 a history of heart failure or other heart disease;
• if the patient has a history of high blood pressure. Edolox 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 a history of liver or kidney dysfunction;
• if the patient is currently being treated for an infection. Edolox may mask fever, which is a symptom of infection;
• in the case of people with diabetes, high cholesterol, or people who smoke. These patients are at increased risk of heart disease;

in the case of women planning to become pregnant;

• in the case of people over 65 years of age.

In case of doubt as to whether any of the above situations exist, 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 the case of patients over 65 years of age, the doctor may decide on more frequent check-ups. It is not necessary to adjust the dosage in patients over 65 years of age.

Children and adolescents

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

Edolox and other medicines

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, 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 (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 that help control high blood pressure and heart failure, called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, as well as losartan and valsartan;
• diuretics;
• digoxin (a medicine used to treat heart failure and heart rhythm disorders);
• 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 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 action of the medicine may start faster if Edolox is taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

Pregnancy
Edolox should not be taken by women who are pregnant. A pregnant woman or a woman who may be pregnant or is planning to become pregnant should not take this medicine. If you become pregnant, stop taking the medicine and contact your doctor. If you have any doubts or need further information, contact your doctor.
Breastfeeding
It is not known whether Edolox is excreted in breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking Edolox. If you are taking Edolox, do not breastfeed.
Fertility
It is not recommended to take Edolox in women who are planning to become pregnant.

Driving and using machines

Some patients taking the medicine 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

This medicine should always be taken according to the doctor's instructions. If you have any doubts, consult a doctor or pharmacist.
Do not take higher doses than recommended for individual diseases. From time to time, consult a doctor to monitor 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 after 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.
Recommended dose
Osteoarthritis
The recommended dose is 30 mg once a day, increased to a maximum of 60 mg once a day if necessary.
Rheumatoid arthritis
The recommended dose is 60 mg once a day, increased to a maximum of 90 mg once a day if necessary.
Ankylosing spondylitis.
The recommended dose is 60 mg once a day, increased to a maximum of 90 mg once a day if necessary.
Acute pain
Etoricoxib should only be used during episodes of acute pain.
Gout
The recommended dose is 120 mg once a day; 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 a day, 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 a day.
• 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 taken by children and adolescents under the age of 16.

Elderly patients

No dose adjustment is necessary in 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 a day. Edolox can be taken with or without food.

Taking a higher dose of Edolox than recommended

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

Missing a dose of Edolox

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

4. Possible side effects

Like all medicines, this medicine 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 worsening of existing swelling;
• yellowing of the skin and eyes (jaundice) - these are symptoms of abnormal liver function;
• severe or persistent stomach pain, or black stools;
• allergic reactions, which can manifest as 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 lower limbs 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), gastritis (inflammation of the stomach lining), 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:

• gastritis and enteritis (inflammation of the digestive tract, which includes both the stomach and the small intestine and (or) gastroenteritis), upper respiratory tract infections, urinary tract infections;
• changes in laboratory test results (decrease in red blood cell count, decrease in white blood cell count, decrease in 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, transient ischemic attack (mini-stroke), severe increase in blood pressure, vasculitis;
• cough, shortness of breath, nosebleeds;
• bloating, change in bowel movements, dryness of the oral mucosa, 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 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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, 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

The medicine should be stored out of 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 entry 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 instructions 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 the medicine 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, aluminum indigo 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 packaging contains

Edolox is available in three strengths:
30 mg:blue-green coated tablets, apple-shaped, convex on both sides, 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 coated tablets, apple-shaped, convex on both sides, with the inscription "60" on one side and smooth on the other, measuring 7.1 x 7.3 mm ± 7.5%.
90 mg:white coated tablets, apple-shaped, convex on both sides, with the inscription "90" on one side and smooth on the other, measuring 8.1 x 8.3 mm ± 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)
60 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).
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