Edolox

Package leaflet: Information for the user

Edolox, 30 mg, coated tablets
Edolox, 60 mg, coated tablets
Edolox, 90 mg, coated tablets
Etoricoxib
Read this leaflet carefully before taking this medicine because it contains important information for you.

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

Contents of the leaflet

1. What Edolox is and what it is used for
2. What you need to know before taking Edolox
3. How to take Edolox
4. Possible side effects
5. How to store Edolox
6. Contents of the pack and other information

1. What Edolox is and what it is used for

What is Edolox?

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

What is Edolox used for?

• Edolox 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.
• Edolox 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 occurs due to gradual breakdown of the cartilage that lines the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and reduced mobility.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long-term inflammatory disease affecting the joints. It causes pain, stiffness, swelling, and limits movement 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 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 nonsteroidal 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 disease or gastrointestinal bleeding;
• if the patient has severe liver function impairment;
• if the patient has severe renal function impairment;
• in pregnant women, women who may be pregnant, or breastfeeding women (see subsection 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 check blood pressure);
• if the patient has ever been diagnosed by a doctor 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 ischemic attack TIA). Etoricoxib may slightly increase the risk of heart attack and stroke and therefore should not be used in individuals who have experienced heart problems or stroke.

If any of the above conditions apply, consult a doctor before taking the tablets.
Warnings and precautions
Before starting treatment with Edolox, discuss the following with your doctor or pharmacist:

• if the patient has previously experienced stomach bleeding or peptic ulcer disease;

• if the patient is dehydrated, for example due to prolonged recurrent vomiting or diarrhea;

• if the patient has fluid retention causing swelling (edema);

• if the patient has previously had heart failure or other heart disease;

• if the patient has previously had high blood pressure. Edolox may increase blood pressure in some individuals, especially when high doses are used; therefore, the doctor will periodically monitor blood pressure;

• if the patient has previously had liver or kidney function disorders;

• if the patient is currently being treated for an infection. Edolox may mask fever, which is a symptom of infection;

• in patients with diabetes, high cholesterol levels, or who are tobacco smokers. These patients have an increased risk of heart disease;

• in women planning pregnancy;

• in individuals over 65 years of age.

If in doubt whether any of the above conditions apply, consult a doctor before taking Edolox to determine whether the medicine can be used.
Edolox is equally effective in elderly patients and younger adult patients. In patients over 65 years of age, the doctor may recommend more frequent check-ups. Dose adjustment is not necessary in 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
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use, including those available without a prescription.
If any of the following medicines are being used, the doctor may decide that monitoring is necessary to ensure safe and effective treatment with Edolox:

• anticoagulant medicines (blood thinners), such as warfarin;
• rifampicin (antibiotic);
• methotrexate (immunosuppressive medicine, often used in the treatment of rheumatoid arthritis);
• cyclosporine or tacrolimus (immunosuppressive medicines);
• lithium (used in the treatment of 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;
• digoxin (used in heart failure and heart rhythm disorders);
• minoxidil (used in the treatment of high blood pressure);
• oral salbutamol tablets or oral solution (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 Edolox is taken together with acetylsalicylic acid;
  • acetylsalicylic acid used for prevention of heart attack or stroke: Edolox may be taken together with low-dose acetylsalicylic acid. If you are currently taking low-dose acetylsalicylic acid to prevent heart attack or stroke, do not stop taking it without consulting your doctor;
  • acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs): do not use high doses of acetylsalicylic acid or other anti-inflammatory medicines 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 must not be used during pregnancy. Pregnant women, women who may be pregnant, or women planning pregnancy must not use this medicine. If pregnancy occurs, discontinue the medicine and contact your doctor. In case of doubt or need for further information, consult your doctor.
Breastfeeding
It is unknown whether Edolox is excreted in breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before using Edolox. Breastfeeding is not allowed while taking Edolox.
Fertility
Use of Edolox is not recommended in women planning pregnancy.
Driving and operating machinery
Dizziness and drowsiness have been reported in some patients taking this medicine. Do not drive if dizziness or drowsiness occurs.
Do not operate any machinery or use tools if dizziness or drowsiness occurs.
Edolox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
3. How to take Edolox
This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Do not take higher doses than recommended for specific conditions. Periodically consult your doctor to monitor treatment. It is important to use the lowest effective dose providing pain relief and not to use Edolox for longer than necessary. The risk of heart attack and stroke increases with prolonged use, especially at high doses.
Different strengths of this medicine are available, and depending on the condition, your doctor will prescribe the appropriate strength for you.
Recommended dose
Osteoarthritis
The recommended dose is 30 mg once daily, increased if necessary up to a maximum of 60 mg once daily.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, increased if necessary up to a maximum of 90 mg once daily.
Ankylosing spondylitis
The recommended dose is 60 mg once daily, increased if necessary up to a maximum of 90 mg once daily.
Acute pain episodes
Etoricoxib should be used only during episodes of acute pain.
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 after dental surgery
The recommended dose is 90 mg once daily; treatment with this dose may last up to 3 days.
Patients with hepatic impairment

• In patients with mild hepatic impairment, the dose should not exceed 60 mg once daily.
• In patients with moderate hepatic impairment, the dose should not exceed 30 mg per day.

Use in children and adolescents
Edolox must not be used in children and adolescents under 16 years of age.
Elderly patients
Dose adjustment is not necessary in elderly patients. As with other medicines, caution should be exercised in elderly patients.
Method of administration
Edolox is for oral use. Tablets should be taken once daily. Edolox can be taken with or without food.
Taking more Edolox than prescribed
Never take more tablets than prescribed by your doctor. If an overdose is taken, seek immediate medical help.
Missed dose
Take Edolox as prescribed by your doctor. If a dose is missed, resume the usual dosing schedule the next day. Do not take a double dose to make up for a missed dose.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If any of the following symptoms occur, discontinue Edolox immediately and
contact your doctor without delay (see section 2. Important information before taking
Edolox):

• Shortness of breath, chest pain, or development of swelling around the ankles, or worsening of existing swelling;
• Yellowing of the skin and eyes (jaundice) – signs of liver dysfunction;
• Severe or persistent stomach pain, or appearance of black-coloured stools;
• Hypersensitivity reactions, which may present as skin problems such as ulcers,

blisters, or swelling of the face, lips, tongue, or throat, which may cause difficulty
in breathing.
The frequency of possible adverse reactions is classified as follows:
Very common: affects more than 1 in 10 patients
Common: affects less than 1 in 10 patients
Uncommon: affects less than 1 in 100 patients
Rare: affects less than 1 in 1,000 patients
Very rare: affects less than 1 in 10,000 patients

The following adverse reactions 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 (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;
• Changes in blood test results related to the liver;
• Bruising;
• Weakness and fatigue, flu-like symptoms.

Uncommon:

• Gastroenteritis (inflammation of the gastrointestinal tract affecting both the stomach and small intestine, and/or stomach flu), upper respiratory tract infection, urinary tract infection;
• Changes in laboratory test results (reduced number of red blood cells, reduced number of white blood cells, reduced 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 are not real (hallucinations);
• Taste disturbances, insomnia, numbness or tingling sensations, 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 (inflammation of blood vessels);
• 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 disorders;
• 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 disorders (hepatitis);
• Low sodium levels in blood;
• Liver failure, yellowing of the skin and eyes (jaundice);
• Severe skin reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicinal product Edolox

Keep the medicine 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 stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
There are no special storage temperature requirements. 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 required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Edolox contains
The active substance is etoricoxib.
Each coated tablet contains 30 mg, 60 mg, or 90 mg of etoricoxib, respectively.
Other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
Tablet coating:
Edolox 30 mg, 60 mg: polyvinyl alcohol, titanium dioxide (E 171), glyceryl monostearate, indigo carmine aluminium lake (E 132), yellow iron oxide (E 172), talc, sodium lauryl sulfate.
Edolox 90 mg: polyvinyl alcohol, titanium dioxide (E 171), glyceryl monostearate, talc, sodium lauryl sulfate.

What Edolox looks like and contents of the pack
Edolox tablets are available in three strengths:
30 mg: bluish-green coated tablets, shaped like an apple cross-section, biconvex, with the imprint "30" on one side and smooth on the other, measuring 5.8 x 5.9 mm ± 7.5%.
60 mg: dark green coated tablets, shaped like an apple cross-section, biconvex, with the imprint "60" on one side and smooth on the other, measuring 7.1 x 7.3 mm ± 7.5%.
90 mg: white coated tablets, shaped like an apple cross-section, biconvex, with the imprint "90" on one side and smooth on the other, measuring 8.1 x 8.3 mm ± 7.5%.

Packaging: Aluminium/OPA/Aluminium/PVC blisters in a cardboard box.
Pack sizes:
30 mg: 2, 7, 14, 20, 28, 49 coated tablets or a multipack containing 98 coated tablets (2 blisters with 49 coated tablets each).
60 mg and 90 mg: 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100 coated tablets or a multipack containing 98 coated tablets (2 blisters with 49 coated tablets each).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
Poland

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