Etuxor

Package leaflet: Information for the patient

Etuxor, 60 mg, coated tablets
etoricoxib
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as 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 a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Etuxor is and what it is used for

What is Etuxor?
Etuxor contains the active substance etoricoxib. Etuxor is a medicine belonging to the group of selective inhibitors of cyclooxygenase-2 (COX-2). It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
What is Etuxor used for?
Etuxor helps reduce pain and swelling (inflammation) in the joints and muscles in people aged 16 years and older with osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and gouty arthritis.
Etuxor 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 as a result of the gradual breakdown of cartilage lining the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and impaired function.
What is rheumatoid arthritis?
Rheumatoid arthritis is a chronic 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 crystalline 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 Etuxor

When not to take Etuxor:

• if the patient is allergic to etoricoxib or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has active peptic ulcer disease or gastrointestinal bleeding
• if the patient is allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, or selective cyclooxygenase-2 (COX-2) inhibitors (see Possible side effects, section 4)
• in women who are pregnant, may be pregnant, or are breastfeeding (see "Pregnancy, breastfeeding and fertility")
• if the patient has severe liver disease
• if the patient has severe kidney disease
• 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 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 untreated high blood pressure (if in doubt, consult a doctor or nurse to have blood pressure checked)
• 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 in doubt whether any of the above conditions apply,
consult a doctor before taking this medicine.
Warnings and precautions
Before starting treatment with Etuxor, discuss 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 or recurrent vomiting or diarrhoea
• if the patient has swelling due to fluid retention
• if the patient has previously had heart failure or other heart disease
• if the patient has previously had high blood pressure. Etuxor may increase blood pressure in some individuals, especially when high doses are used; therefore, the doctor will monitor blood pressure periodically.
• if the patient has previously had liver or kidney function disorders
• if the patient is currently being treated for an infection. Etuxor may mask fever, which is a sign of infection.
• in patients with diabetes, high cholesterol levels, or who smoke. These patients have an increased risk of heart disease.
• in women planning pregnancy
• in individuals aged 65 years or older.

If unsure whether any of the above conditions apply,
consult a doctor before taking Etuxor to determine whether the medicine can be used.
Etuxor is equally effective in elderly patients and younger adult patients. For patients aged 65 years or older, the doctor may recommend more frequent check-ups. Dose adjustment is not necessary for patients aged 65 years or older.
Children and adolescents
Do not give this medicine to children and adolescents under 16 years of age.
Etuxor with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription.
In particular, when using any of the following medicines, the doctor may decide that monitoring is necessary to ensure safe and effective treatment after starting Etuxor:

• anticoagulants (blood thinners), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine that suppresses immune system function, commonly used in the treatment of rheumatoid arthritis)
• cyclosporine or tacrolimus (immunosuppressive medicines)
• 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 tablets)
• 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 adverse effects)
• hormone replacement therapy (combination may increase the risk of adverse effects)
• acetylsalicylic acid (aspirin) – the risk of stomach ulcers is higher when Etuxor is taken together with aspirin
• aspirin used for prevention of heart attack or stroke: Etuxor may be taken together with low-dose aspirin. If currently taking low-dose aspirin to prevent heart attack or stroke, do not stop taking aspirin without consulting your doctor;
• aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs): do not take high-dose aspirin or other anti-inflammatory medicines while taking Etuxor. Taking Etuxor with food and drink The effect of the medicine may start faster if Etuxor is taken on an empty stomach.

Pregnancy, breastfeeding and fertility
Pregnancy
Etuxor must not be used in women who are pregnant. A woman who is pregnant, may be pregnant, or is planning pregnancy must not take this medicine. If pregnancy occurs, stop taking the medicine and contact a doctor. If in doubt or if additional information is needed, consult a doctor.
Breastfeeding
It is not known whether Etuxor is excreted in human breast milk. If breastfeeding or planning to breastfeed, consult a doctor before taking Etuxor. Breastfeeding is not permitted while taking Etuxor.
Effect on fertility
Use of Etuxor is not recommended in women planning pregnancy.
Driving and using machines
Dizziness and drowsiness have been reported in some patients taking Etuxor. Do not drive if dizziness or drowsiness occurs.
Do not operate machinery or use tools if dizziness or drowsiness occurs.
Etuxor contains lactose
This medicine contains 1.6 mg of lactose (as lactose monohydrate) in a 60 mg tablet. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Other excipients
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 Etuxor

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Do not take more than the recommended dose for each condition. The treatment should be reviewed
periodically by your doctor. It is important to use the lowest effective dose that provides pain relief,
and Etuxor should not be used for longer than necessary. Prolonged use of this medicine, especially
at high doses, increases the risk of heart attacks and strokes.
This medicinal product is available in various strengths, and depending on the condition being
treated, your doctor will prescribe the appropriate strength for the patient.

Recommended dose:
Osteoarthritis
The recommended dose is 30 mg once daily, which may be increased to a maximum of 60 mg once daily, if needed.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, which may be increased to a maximum of 90 mg once daily, if needed.
Ankylosing spondylitis
The recommended dose is 60 mg once daily, which may be increased to a maximum of 90 mg once daily, if needed.
Acute pain
Etoricoxib should be used only during episodes of acute pain.
Gouty arthritis
The recommended dose is 120 mg once daily; this dose should be used only during episodes of acute pain, for a maximum of 8 days.
Postoperative dental pain
The recommended dose is 90 mg once daily; treatment with this dose may last up to a maximum of 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 once daily.

Use in children and adolescents
Etuxor must not be used in children and adolescents under 16 years of age.

Elderly patients
Dosage adjustment is not usually required in elderly patients. As with other medicines, caution should be exercised in elderly patients.

Method of administration
Etuxor is intended for oral use. Tablets should be taken once daily.
Etuxor may be taken with food or independently of meals.

Overdose
Never take more tablets than prescribed by your doctor. If you have taken too many Etuxor tablets, seek immediate medical attention.

Missed dose
It is important to take Etuxor exactly as prescribed by your doctor. If you miss a dose, take the next dose the following day according to your usual 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, stop using Etuxor immediately
and contact your doctor without delay (see section 2 “Important information before
using Etuxor”):

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

The following adverse effects may occur during treatment with Etuxor:

Very common ( may occur in more than 1 in 10 people )

• stomach pain

Common ( may occur in up to 1 in 10 people )

• dry socket (inflammation and pain after tooth extraction)
• swelling of the lower limbs and/or feet due to fluid retention (edema)
• 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, diarrhea, indigestion (dyspepsia) and/or discomfort in the stomach, nausea, vomiting, esophagitis, oral ulcers
• changes in blood test results related to the liver
• bruising
• weakness and fatigue, flu-like symptoms

Uncommon ( may occur in up to 1 in 100 people )

• 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 (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, drowsiness
• blurred vision, eye irritation and redness
• tinnitus, vertigo (spinning sensation at rest)
• heart rhythm disorders (atrial fibrillation), rapid heartbeat, heart failure, feeling of tightness, pressure or heaviness in the chest (angina), heart attack
• hot flushes, stroke, mini-stroke (transient ischemic attack), severe increase in blood pressure, vasculitis (inflammation of blood vessels)
• cough, breathlessness, nosebleeds
• bloating, change in bowel habits, dryness of the oral mucosa, gastric ulcer, inflammation of the stomach lining 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 ( may occur in up to 1 in 1000 people )

• angioedema (an allergic reaction characterized by swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing, which may be severe enough to require immediate medical intervention); anaphylactic or anaphylactoid reactions, including shock (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 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Etuxor

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
No special storage precautions apply.
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 Etuxor contains

• The active substance is etoricoxib. Each coated tablet contains 60 mg of etoricoxib.
• The other ingredients are: Tablet core: Calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, sodium croscarmellose (E 468), hydroxypropylcellulose (E 463), magnesium stearate. Tablet coating: Hypromellose 2910, lactose monohydrate, titanium dioxide (E 171), triacetin, indigo carmine (E 132) (aluminium lake), iron oxide yellow (E 172).

What Etuxor looks like and contents of the pack
Etuxor tablets are available in one strength:
60 mg: green, round, biconvex tablets, 8 mm in diameter, with the imprint “444” on one side and “L” on the other side.
Pack size: 30 tablets in blister packs.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer/Importer
Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
24100 Salo
Finland

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]