Xaleba

Package leaflet: Information for the user

Xaleba, 30 mg, coated tablets
Xaleba, 60 mg, coated tablets
Xaleba, 90 mg, coated tablets
Xaleba, 120 mg, coated tablets
Etoricoxib
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Xaleba is and what it is used for

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

When not to use Xaleba:

• 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, or selective cyclooxygenase-2 (COX-2) inhibitors (see Possible side effects, section 4);
• if the patient has active peptic ulcer disease or gastrointestinal bleeding;
• if the patient has severe hepatic impairment;
• if the patient has severe renal impairment;
• in women who are pregnant, who may be pregnant, or who are breastfeeding (see 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 (if in doubt, consult a doctor or nurse to have blood pressure checked);
• if the patient has ever been diagnosed by a doctor with heart problems, including heart failure (moderate or severe) or angina (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 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 any of the above conditions apply, consult a doctor before taking Xaleba tablets.

Warnings and precautions
Before starting treatment with Xaleba, discuss with your doctor or pharmacist if:

• the patient has previously had gastrointestinal bleeding or peptic ulcer disease;
• the patient is dehydrated, for example due to prolonged or recurrent vomiting or diarrhoea;
• the patient has oedema due to fluid retention;
• the patient has previously had heart failure or other heart disease;
• the patient has previously had high blood pressure. Etoricoxib may increase blood pressure in some individuals, especially when high doses are used; therefore, your doctor may periodically monitor your blood pressure;
• the patient has previously had liver or kidney dysfunction;
• the patient is currently being treated for an infection. Etoricoxib may mask fever, which is a symptom of infection;
• the patient has diabetes, high cholesterol levels, or is a smoker. These patients have an increased risk of heart disease;
• in women planning pregnancy;
• in individuals over 65 years of age.

If you are unsure whether any of the above situations apply, you should consult your doctor before using Xaleba to determine whether the medicine can be used.
Etoricoxib is equally effective in elderly patients and younger adult patients. For patients over 65 years of age, the doctor may recommend more frequent follow-up visits. Dose adjustment is not necessary in patients over 65 years of age.

Children and adolescents
Do not give this medicine to children or adolescents under 16 years of age.

Xaleba and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines.
If you are taking any of the following medicines, your doctor may decide to monitor you to ensure treatment is proceeding safely after starting Xaleba:

• anticoagulants (blood-thinning medicines), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (a medicine that suppresses immune system function, often used in the treatment of rheumatoid arthritis);
• cyclosporine or tacrolimus (medicines that suppress immune system function);
• 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, as well as 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 or oral solution (a medicine used in asthma);
• oral contraceptives (concomitant use may increase the risk of adverse effects);
• hormone replacement therapy (concomitant use may increase the risk of adverse effects);
• acetylsalicylic acid – the risk of gastric ulcers is higher when Xaleba is taken together with acetylsalicylic acid;
  • acetylsalicylic acid used for prevention of heart attack or stroke: Xaleba 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 non-steroidal anti-inflammatory drugs (NSAIDs): do not take high doses of acetylsalicylic acid or other anti-inflammatory medicines while taking Xaleba.

Xaleba with food and drink
The effect of the medicine may start more quickly if Xaleba is taken on an empty stomach.

Pregnancy, breastfeeding and fertility
Pregnancy
Xaleba must not be used in women who are pregnant. A woman who is pregnant, may be pregnant, or is planning pregnancy must not use this medicine. If pregnancy occurs, 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 Xaleba is excreted in human breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking Xaleba. Breastfeeding is not permitted while taking Xaleba.

Fertility
Use of Xaleba is not recommended in women planning pregnancy.

Driving and using machines
Dizziness and drowsiness have been reported in some patients taking etoricoxib.
Do not drive if you experience dizziness or drowsiness.
Do not operate machinery or tools if you experience dizziness or drowsiness.

Xaleba contains lactose
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

Xaleba contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Xaleba

This medicine should always be used exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
Do not take more than the recommended dose for each condition. You should consult your doctor regularly to monitor your treatment. It is important to use the lowest effective dose that provides pain relief, and Xaleba 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 different strengths, and depending on the condition being treated, your doctor will prescribe the appropriate strength for you.

Recommended dose:

Osteoarthritis
The recommended dose is 30 mg once daily, increased if necessary to a maximum of 60 mg once daily.

Rheumatoid arthritis
The recommended dose is 60 mg once daily, increased if necessary to a maximum of 90 mg once daily.

Ankylosing spondylitis
The recommended dose is 60 mg once daily, increased if necessary to a maximum of 90 mg once daily.

Acute pain conditions
Etoricoxib should only be used during episodes of acute pain.

Acute gouty arthritis
The recommended dose is 120 mg once daily; this should only be used during an acute painful attack, for a maximum of 8 days.

Post-dental surgical pain
The recommended dose is 90 mg once daily, and treatment at this dose should not exceed 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
Xaleba must not be used in children and adolescents under 16 years of age.

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

Method of administration
Xaleba is for oral use. Tablets should be taken once daily. Xaleba can be taken with or without food.

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

Missed dose of Xaleba
Take Xaleba exactly as prescribed by your doctor. If you miss a dose, take the next dose at your usual time. 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, stop taking Xaleba and
contact your doctor immediately (see section 2 Important information before taking Xaleba)

• Shortness of breath, chest pain, or development or worsening of swelling around the ankles;
• Yellowing of the skin or eyes (jaundice) – these are signs of liver dysfunction;
• Severe or persistent stomach pain, or black stools;
• Hypersensitivity reactions, which may present as skin problems such as ulcers, blisters, or swelling of the face, lips, tongue, or throat, possibly causing breathing difficulties.

The following adverse reactions may occur during treatment with Xaleba:
Very common (affects more than 1 in 10 people):

• Stomach pain.

Common (affects 1 in 100 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, 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 (affects 1 in 1,000 to 1 in 100 people):

• 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, somnolence;
• 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 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 impairment;
• Chest pain.

Rare (affects 1 in 10,000 to 1 in 1,000 people):

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

5. How to store XALEBA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
No special storage requirements.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Xaleba contains

• The active substance is etoricoxib. Each coated tablet contains 30 mg, 60 mg, 90 mg or 120 mg of etoricoxib.
• The other ingredients are:
  Tablet core: microcrystalline cellulose, magnesium stearate, sodium croscarmellose, anhydrous calcium hydrogen phosphate.
  Tablet coating: lactose monohydrate, hypromellose 15 mPa·s, titanium dioxide (E171), triacetin.

What Xaleba looks like and contents of the pack
Xaleba tablets are available in four strengths:
30 mg white, round, biconvex tablets (approximately 6 mm) with "E9OX" engraved on one side and "30" on the other side.
60 mg white, round, biconvex tablets (approximately 8 mm) with "E9OX" engraved on one side and "60" on the other side.
90 mg white, round, biconvex tablets (approximately 9 mm) with "E9OX" engraved on one side and "90" on the other side.
120 mg white, round, biconvex tablets (approximately 10 mm) with "E9OX" engraved on one side and "120" on the other side.

Pack sizes: 2, 5, 7, 10, 14, 20, 28, 30, 49, 50, 84, 98, 100 tablets or a "multi" pack containing 98 tablets (2 packs of 49 tablets each).
Blister packs in unit dose packaging: 5 x 1, 50 x 1, 100 x 1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Accord Healthcare Limited
Sage House 319 Pinner Road
North Harrow HA1 4HF, Middlesex
United Kingdom

Manufacturer/Importer:
Synthon Hispania S.L.
Calle Castello 1
Poligono Las Salinas
Sant Boi De Llobregat
08830 Barcelona
Spain

Synthon s.r.o.
Brněnská 32/cp. 597
678 01 Blansko
Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names: