Xaleba

Leaflet accompanying the packaging: 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

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Xaleba and what is it 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 packaging and other information

1. What is Xaleba and what is it used for

• Xaleba contains the active substance etoricoxib. Xaleba 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).
• Xaleba helps to reduce pain and swelling (inflammatory conditions) of the joints and muscles in people aged 16 and over with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Xaleba is also a medicine used for 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 bone ends. 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 increased loss of range of motion in the joints it affects. 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 Xaleba

When not to take Xaleba:

• if the patient is allergic to etoricoxib or any of the other ingredientsof 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 Possible side effects, section 4);
• if the patient has active peptic ulceror gastrointestinal bleeding;
• if the patient has severe liver dysfunction;
• if the patient has severe kidney dysfunction;
• in women who are pregnantor may be pregnant, or breastfeeding(see Pregnancy, breastfeeding, and fertility);
• in people under 16 years of age;
• if the patient has inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or enteritis;
• if the patient has uncontrolled high blood pressure. Etoricoxib 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 ever been diagnosed with heart problems, 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). Etoricoxib may slightly increase the risk of heart attack and stroke, and therefore should not be used in people who have had heart problems or stroke. In case of the above situations, before taking the tablets, consult a doctor.

Warnings and precautions

Before starting to take Xaleba, discuss it with your doctor or pharmacist:

• if the patient has a history of stomach bleedingor stomach ulcers;
• 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 failureor other heart disease;
• if the patient has a history of high blood pressure. Etoricoxib 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 . Etoricoxib may mask fever, which is a sign of infection;
• in the case of people with diabetes, high cholesterol, or smokers. These people are at increased risk of heart disease.
• in the case of women planning to become pregnant;
• in the case of people over 65 years of age.

In case of uncertainty as to whether any of the above situations occur, consult a doctor before taking Xalebato clarify whether the medicine can be taken.
Etoricoxib is equally effective in both elderly and younger adult patients. In the case of patients over 65, the doctor may decide on more frequent check-ups. No dose adjustment is necessary in people over 65.

Children and adolescents

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

Xaleba and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.
In the case of taking one of the following medicines, the doctor may decide to monitor the patient to ensure that the treatment is proceeding correctly from the start of taking Xaleba :

• blood thinners (anticoagulants), such as warfarin;
• rifampicin(an antibiotic);
• methotrexate(a medicine that suppresses the immune system, often used to treat rheumatoid arthritis);
• cyclosporine or tacrolimus(medicines that suppress the immune system);
• 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, ramipril, and losartan, valsartan;
• diuretics;
• digoxin(a medicine used to treat heart failure and arrhythmias);
• minoxidil(a medicine used to treat high blood pressure);
• salbutamolin tablet or oral solution form (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);
• acetylsalicylic acid, the risk of stomach ulcers is higher when taking Xaleba with acetylsalicylic acid;
• acetylsalicylic acid used for the prevention of heart attacks or strokes: Xaleba can be taken at the same time as a low dose of acetylsalicylic acid. If you are currently taking low doses of acetylsalicylic acid to prevent a heart attack or stroke, do not stop taking acetylsalicylic acid 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 drugs while taking Xaleba.

Xaleba with food and drink

The effect of the medicine may start faster if Xaleba is taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

Pregnancy
Xaleba must not be taken by women who are pregnant. A pregnant woman or a woman who may be pregnant or is planning to become pregnant must not take this medicine. If you become pregnant, stop taking the medicine and contact your doctor. In case of doubts or need for additional information, contact your doctor.
Breastfeeding
It is not known whether Xaleba is excreted in breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking Xaleba. If you are taking Xaleba, do not breastfeed.
Fertility
Xaleba is not recommended for women who are planning to become pregnant.

Driving and using machines

Some patients taking etoricoxib have reported dizziness and drowsiness.
Do not drive vehicles if you experience dizziness and drowsiness.
Do not operate any machinery or use tools if you experience dizziness and drowsiness.

Xaleba contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Xaleba contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is essentially 'sodium-free'.

3. How to take Xaleba

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. From time to time, consult your doctor to check the treatment. It is important to use the smallest effective dose that relieves pain and not to take Xaleba for longer than necessary. There is an increased risk of heart attacks and strokes with prolonged use of the medicine, especially with high doses.
There are different strengths of this medicinal product, 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 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 conditions

Etoricoxib should only be used during periods of acute pain.
Gout
The recommended dose is 120 mg once daily; it should only be used during periods 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, do not take more than 60 mg once daily.
• In patients with moderate liver dysfunction, do not take more than 30 mg daily.

Use in children and adolescents

Xaleba must not be taken by children and adolescents under 16 years of age.

Elderly patients

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

Method of administration

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

Taking a higher dose of Xaleba than recommended

Never take more tablets than your doctor has prescribed. If you have taken too many Xaleba tablets, seek medical attention immediately.

Missing a dose of Xaleba

Xaleba should be taken as prescribed by your doctor. If you miss a dose, the next day return to your usual dosing schedule. Do not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• shortness of breath, chest pain, or swelling of the ankles, 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 following side effects may occur during treatment with Xaleba:
Very common(occurring in more than 1 in 10 patients) :

• stomach pain.

Common(occurring in 1 in 100 to 1 in 10 patients) :

• dry socket (inflammation and pain after tooth extraction);
• swelling of the lower limbs and (or) feet due to fluid retention (edema);
• dizziness, headache;
• palpitations, irregular heartbeat;
• increased blood pressure;
• wheezing, shortness of breath;
• constipation, gas, stomach upset, heartburn, diarrhea, indigestion, and (or) discomfort in the stomach, nausea, vomiting, esophagitis;
• changes in liver blood test results;
• bruising;
• weakness and fatigue, flu-like symptoms.

Uncommon(occurring in 1 in 1000 to 1 in 100 patients) :

• gastrointestinal inflammation (inflammation of the digestive tract, which includes both the stomach and the small intestine and (or) gastritis), upper respiratory tract infection, urinary tract infection;
• changes in blood 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;
• 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;
• bloating, change in bowel habits, dry mouth, stomach ulcers, stomach inflammation, which can be severe and lead to bleeding, irritable bowel syndrome, pancreatitis;
• facial swelling, rash, or itching;
• muscle cramps, muscle pain or stiffness;
• high potassium levels in the blood, changes in blood or urine test results related to kidney function, severe kidney dysfunction;
• chest pain.

Rare(occurring in 1 in 10,000 to 1 in 1000 patients) :

• 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, anxiety;
• 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 you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, you can help provide more information on the safety of this medicine.

5. How to store XALEBA

Keep this medicine out of the 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 month.
There are no special storage requirements.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Xaleba contains

• The active substance of Xaleba 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 is available in four strengths:
30 mg white, round, biconvex tablets (about 6 mm) with "E9OX" engraved on one side and "30" on the other.
60 mg white, round, biconvex tablets (about 8 mm) with "E9OX" engraved on one side and "60" on the other.
90 mg white, round, biconvex tablets (about 9 mm) with "E9OX" engraved on one side and "90" on the other.
120 mg white, round, biconvex tablets (about 10 mm) with "E9OX" engraved on one side and "120" on the other.
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).
Packs containing single-dose blisters: 5 x 1, 50 x 1, 100 x 1 tablets.
Not all pack sizes may be marketed.

Marketing authorization 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/čp. 597
678 01 Blansko
Czech Republic

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: December 2021