Etuxor

Package Leaflet: Information for the Patient

Etuxor, 60 mg, coated tablets

etoricoxib

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Etuxor and what is it 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 is Etuxor and what is it used for

What is Etuxor?

Etuxor contains the active substance etoricoxib. Etuxor is a medicine belonging to a group of selective cyclooxygenase-2 (COX-2) inhibitors. It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

What is Etuxor used for?

Etuxor helps to reduce pain and swelling (inflammation) of joints and muscles in people aged 16 years and older with osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and gout. Etuxor is also used for short-term treatment of moderate pain associated with dental surgery in people aged 16 years and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It occurs when the cartilage covering the end of the bones breaks down, leading to inflammation, pain, tenderness, stiffness, and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term inflammatory disease of the joints. It causes pain, stiffness, swelling, and can also cause inflammation in other parts of the body.

What is gout?

Gout is a disease that causes sudden, recurring attacks of very painful inflammation and redness in the joints. It 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 Etuxor

When not to take Etuxor:

• if you are allergic to etoricoxib or any of the other ingredients of this medicine (listed in section 6)
• if you have active stomach or intestinal ulcers or bleeding
• if you have allergic reactions to nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin or selective cyclooxygenase-2 (COX-2) inhibitors (see Possible side effects, section 4)
• in women who are pregnant, think they may be pregnant, or are breast-feeding (see Pregnancy, breast-feeding, and fertility)
• if you have severe liver disease
• if you have severe kidney disease
• in people under 16 years of age
• if you have inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
• if you have been diagnosed with heart problems, including heart failure (moderate or severe) or angina (chest pain)
• if you have high blood pressure that is not well-controlled
• if you have had a heart attack, bypass surgery, or peripheral artery disease (poor circulation to the legs)
• if you have had any type of stroke (including mini-stroke or transient ischaemic attack). Etoricoxib may slightly increase the risk of heart attack and stroke, and should not be used in people who have had these conditions.

If you are not sure if any of these conditions apply to you, consult your doctor before taking Etuxor.

Warnings and precautions

Before taking Etuxor, tell your doctor or pharmacist:

• if you have had stomach or intestinal ulcers or bleeding in the past
• if you are dehydrated, for example due to prolonged vomiting or diarrhea
• if you have swelling due to fluid retention
• if you have had heart failure or other heart problems in the past
• if you have had high blood pressure in the past. Etuxor may increase blood pressure in some people, especially when taken in high doses, so your doctor will check your blood pressure from time to time.
• if you have had liver or kidney problems in the past
• if you are currently being treated for an infection. Etuxor may mask the signs of an infection, such as fever.
• if you have diabetes, high cholesterol, or are a smoker. These people are at a higher risk of heart disease.
• if you are planning to become pregnant
• if you are over 65 years of age. If you are not sure if any of these conditions apply to you, consult your doctor before taking Etuxor.

Etuxor is just as effective in older people as it is in younger adults. In people over 65 years, your doctor may want to check on you more often.

Children and adolescents

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

Etuxor with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, including those obtained without a prescription.

• blood-thinning medicines (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine that suppresses the immune system, often used to treat rheumatoid arthritis)
• cyclosporin or tacrolimus (medicines that suppress the immune system)
• lithium (a medicine used to treat certain types of depression)
• medicines used to treat high blood pressure and heart failure, called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, and losartan and valsartan
• diuretics (water tablets)
• digoxin (a medicine used to treat heart failure and irregular heartbeat)
• minoxidil (a medicine used to treat high blood pressure)
• salbutamol tablets or oral solution (a medicine used to treat asthma)
• oral contraceptives (the combination may increase the risk of side effects)
• hormone replacement therapy (the combination may increase the risk of side effects)
• aspirin (the risk of stomach ulcers is higher when Etuxor is taken with aspirin)
• aspirin for the prevention of heart attack or stroke: Etuxor can be taken with low-dose aspirin. If you are currently taking low-dose aspirin to prevent heart attack or stroke, do not stop taking it without talking to your doctor;
• aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs): do not take high doses of aspirin or other anti-inflammatory medicines while taking Etuxor.

Taking Etuxor with food and drink

The effect of the medicine may start sooner if Etuxor is taken on an empty stomach.

Pregnancy, breast-feeding, and fertility

Pregnancy
Etuxor must not be used during pregnancy. Women who are pregnant, think they may be pregnant, or are planning to become pregnant should not take this medicine. If you become pregnant, stop taking the medicine and consult your doctor. If you have any further questions, ask your doctor.
Breast-feeding
It is not known if Etuxor passes into breast milk. If you are breast-feeding or planning to breast-feed, consult your doctor before taking Etuxor. If you are taking Etuxor, do not breast-feed.
Fertility
Etuxor is not recommended for women who are planning to become pregnant.

Driving and using machines

Some patients taking Etuxor have experienced dizziness and drowsiness. Do not drive or operate machinery if you experience dizziness or drowsiness.

Etuxor contains lactose

This medicine contains 1.6 mg of lactose (as lactose monohydrate) per 60 mg tablet. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Other excipients

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

3. How to take Etuxor

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Do not take more than the recommended dose for each condition. Your doctor may want to check your treatment from time to time. It is important to use the lowest effective dose for the shortest duration possible to reduce the risk of heart attack and stroke, especially in patients with cardiovascular risk factors.

The recommended dose is:

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 acute painful periods.
Gout
The recommended dose is 120 mg once daily; it should only be used during acute painful periods, for a maximum of 8 days.
Pain after dental surgery
The recommended dose is 90 mg once daily, and treatment with this dose should not exceed 3 days.

Patients with liver problems

• in patients with mild liver problems, the dose should not exceed 60 mg once daily.
• in patients with moderate liver problems, the dose should not exceed 30 mg once daily.

Use in children and adolescents

Etuxor should not be used in children and adolescents under 16 years.

Elderly

No dose adjustment is necessary for elderly patients. As with other medicines, caution should be exercised in elderly patients.

Method of administration

Etuxor is for oral use. The tablets should be taken once daily.
Etuxor can be taken with or without food.

Overdose

Never take more tablets than your doctor has recommended. If you have taken more Etuxor than you should, contact a doctor or hospital for advice.

Missed dose

It is important to take Etuxor as instructed by your doctor. If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• shortness of breath, chest pain, or swelling of the feet or ankles, or worsening of existing swelling
• yellowing of the skin and eyes (jaundice) - these are signs of liver problems
• severe or persistent stomach pain, or black tarry stools
• allergic reactions, including skin problems such as ulcers, blisters, or swelling of the face, lips, tongue, or throat, which may cause difficulty breathing. The following side effects may occur during treatment with Etuxor:

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

• stomach pain.

Common (may affect up to 1 in 10 people)

• dry socket (inflammation and pain after tooth extraction)
• swelling of the legs or feet due to fluid retention (edema)
• dizziness, headache
• palpitations (rapid or irregular heartbeat), irregular heartbeat (arrhythmia)
• high blood pressure
• wheezing or shortness of breath (bronchospasm)
• constipation, gas (excess wind), 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 (may affect up to 1 in 100 people)

• gastroenteritis (inflammation of the stomach and intestines), upper respiratory tract infection, urinary tract infection
• changes in blood test results (decreased red blood cells, decreased white blood cells, decreased platelets)
• hypersensitivity (allergic reaction, including hives, which may be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, decreased mental ability; seeing or hearing things that are not there (hallucinations)
• taste disturbances, insomnia, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, dizziness (feeling of spinning while standing still)
• heart rhythm disturbances (atrial fibrillation), rapid heartbeat, heart failure, feeling of tightness, heaviness, or pressure in the chest (angina), heart attack
• hot flushes, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, blood vessel inflammation
• cough, breathlessness, nosebleeds
• bloating, change in bowel movements, dry mouth, stomach ulcers, gastritis, which can be severe and lead to bleeding, irritable bowel syndrome, pancreatitis
• face swelling, rash, or itching
• muscle spasms, muscle pain or stiffness
• high levels of potassium in the blood, changes in blood or urine test results related to kidney problems, severe kidney problems
• chest pain.

Rare (may affect up to 1 in 1,000 people)

• angioedema (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 attention); anaphylactic or anaphylactoid reactions, including shock (severe allergic reaction that requires immediate medical attention)
• confusion, anxiety
• liver problems (hepatitis)
• low levels of sodium in the blood
• liver failure, yellowing of the skin and eyes (jaundice)
• severe skin reactions.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Etuxor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Etuxor contains

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

What Etuxor looks like and contents of the pack

Etuxor is available in one strength:
60 mg: green, round, biconvex tablets, 8 mm in diameter, with the marking "444" on one side and "L" on the other.
Pack sizes: 30 tablets in blisters.

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 medicine, contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

Date of last revision of the leaflet: