Edolox

Leaflet accompanying the packaging: information for the user

Edolox, 30 mg, coated tablets

Edolox, 60 mg, coated tablets

Edolox, 90 mg, coated tablets

Etoricoxib

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 used for the 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 colitis;
• if the patient has uncontrolled high blood pressure (in case of doubt, the doctor or nurse should be consulted to check blood pressure);
• if the patient has ever been diagnosed 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 doctor should be consulted before taking the tablets.

Warnings and precautions

Before starting to take Edolox, the doctor or pharmacist should be consulted:

• if the patient has a history of stomach ulcers or stomach bleeding;
• 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 sign 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 people over 65 years of age.

In case of doubt about any of the above situations, the doctor should be consulted before taking Edolox to clarify whether the medicine can be taken.

Children and adolescents

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

Edolox and other medicines

The doctor or pharmacist should be informed about all medicines being taken or recently taken, as well as any medicines planned to be taken, including those available without a prescription.

• 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 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 low-dose acetylsalicylic acid is currently being taken to prevent heart attacks or strokes, it should not be stopped without consulting a doctor;
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): high doses of acetylsalicylic acid or other anti-inflammatory drugs should not be taken 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. In the event of pregnancy, the medicine should be stopped and a doctor consulted. In case of doubt or need for additional information, a doctor should be consulted.
Breastfeeding
It is not known whether Edolox is excreted in breast milk. In the case of breastfeeding or planning to breastfeed, a doctor should be consulted before taking Edolox. Edolox should not be taken while breastfeeding.
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. Vehicles should not be driven if dizziness and drowsiness occur.

Edolox contains sodium

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

3. How to take Edolox

This medicine should always be taken as directed by the doctor. In case of doubt, the doctor or pharmacist should be consulted.

Do not take more than the recommended dose for each condition. The doctor should be consulted from time to time 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 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.

Recommended dose

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
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, the dose should not exceed 60 mg once daily.
• In patients with moderateliver dysfunction, the dose should not exceed 30 mg daily.

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 daily. 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. In case of taking too many Edolox tablets, medical help should be sought immediately.

Missing a dose of Edolox

Edolox should be taken as directed by the doctor. If a dose is missed, the next day the usual dosing schedule should be resumed. A double dose should not be taken to make up for the missed dose.

In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

If any of the following symptoms occur, Edolox should be stopped and a doctor consulted 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:

occur in more than 1 in 10 patients

Common:

occur in less than 1 in 10 patients

Uncommon:

occur in less than 1 in 100 patients

Rare:

occur in less than 1 in 1,000 patients

Very rare:

occur 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;
• bruising;
• 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, drowsiness;
• 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), severe increase in blood pressure, vasculitis;
• cough, shortness of breath, nosebleeds;
• bloating, change in bowel movements, dry mouth, 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 any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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, more information can be collected on the safety of the 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 stated.

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. The pharmacist should be asked how to dispose of medicines that are no longer used. 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:

microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.

Coating:

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, biconvex, 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, biconvex, 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, biconvex, 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.

Package sizes:

30 mg:2, 7, 14, 20, 28, 49 coated tablets or a collective package 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 package containing 98 coated tablets (2 blisters of 49 coated tablets each)

Not all package 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