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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 a group of medicines called nonsteroidal 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 (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and gout.
• Xaleba is also a medicine used for short-term treatment of moderate pain associated with dental surgery 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-standing inflammatory disease of the joints. It causes pain, stiffness, swelling, and increased loss 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 you are allergic to etoricoxib or any of the other ingredientsof this medicine (listed in section 6).
• if you have hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and selective cyclooxygenase-2 (COX-2) inhibitors (see Possible side effects, section 4);
• if you have active peptic ulceror gastrointestinal bleeding;
• if you have severe liver dysfunction;
• if you have severe kidney dysfunction;
• in women during pregnancyor in women who may be pregnantor breastfeeding(see Pregnancy, breastfeeding, and fertility);
• in people under 16 years of age;
• if you have inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or intestinal inflammation;
• if you have uncontrolled high blood pressure. Etoricoxib may increase blood pressure in some people, especially after taking high doses of the medicine, so your doctor will check your blood pressure from time to time;
• if you have ever been diagnosed by a doctor with heart problems, including heart failure (moderate or severe) or angina pectoris (chest pain);
• if you have had a heart attack, undergone a bypass grafting procedure, or have peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries);
• if you have had any type of stroke (including a mini-stroke, transient ischemic attack, TIA). 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. If any of the above conditions occur, you should consult your doctor before taking the tablets.

Warnings and precautions

Before starting treatment with Xaleba, you should discuss it with your doctor or pharmacist:

• if you have had stomach bleedingor stomach ulcersin the past;
• if you are dehydrated, e.g., due to prolonged, recurring vomiting or diarrhea;
• if you have swelling due to fluid retention;
• if you have had heart failureor other heart diseasein the past;
• if you have had high blood pressurein the past. Etoricoxib may increase blood pressure in some people, especially after taking high doses of the medicine, so your doctor will check your blood pressure from time to time;
• if you have had liver or kidney dysfunctionin the past;
• if you are 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 pregnancy;
• in the case of people over 65 years of age.

In case of uncertainty as to whether any of the above conditions exist, you should consult your doctor before taking Xalebato clarify whether the medicine can be taken.
Etoricoxib is equally effective in both elderly and younger adult patients. In patients over 65 years of age, the doctor may decide on more frequent check-ups. It is not necessary to adjust the dose in people over 65 years of age.

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 the medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.
In the case of taking any of the following medicines, your doctor may decide to monitor you 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 with a low dose of acetylsalicylic acid. If you are currently taking low doses of acetylsalicylic acid to prevent heart attacks or strokes, do not stop taking acetylsalicylic acid without consulting your doctor;
• acetylsalicylic acid and other nonsteroidal 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 action of the medicine may start faster if Xaleba is taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

Pregnancy
Xaleba should not be taken by women during pregnancy. A pregnant woman or a woman who may be pregnant or is planning to become pregnant should not take this medicine. If you become pregnant, stop taking the medicine and contact your doctor. If you have any doubts or need further information, you should contact your doctor.
Breastfeeding
It is not known whether Xaleba is excreted in breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking Xaleba. If you are taking Xaleba, you should not breastfeed.
Fertility
Xaleba is not recommended for use in women planning pregnancy.

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 diagnosed with an intolerance to some sugars, you should 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

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should ask your doctor or pharmacist.
Do not take more than the prescribed dose for each condition. You should see your doctor from time to time to check the treatment. It is important to use the lowest effective dose to relieve 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, your doctor will prescribe the tablets with the appropriate strength for you.
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 episodes of acute pain.
Gout
The recommended dose is 120 mg once daily; it should only be used during episodes of acute pain, for a maximum of 8 days.
Pain after dental surgery
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, the dose should not exceed 60 mg once daily.
• In patients with moderate liver dysfunction, the dose should not exceed 30 mg daily.

Use in children and adolescents

Xaleba should 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 intended 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, you should seek medical attention immediately.

Missing a dose of Xaleba

Xaleba should be taken as prescribed by your doctor. If you miss a dose, you should return to your usual dosing schedule the next day. Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, you should ask 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, you should 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 feet, 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 (arrhythmia);
• increased blood pressure;
• wheezing, shortness of breath (bronchospasm);
• constipation, gas (excess gas in the intestines), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia), and (or) discomfort in the stomach, nausea, vomiting, esophagitis, oral ulcers;
• changes in liver-related blood test results;
• bruising;
• weakness and fatigue, flu-like symptoms.

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

• gastroenteritis (inflammation of the digestive tract, which includes both the stomach and the small intestine and (or) gastroenteritis), upper respiratory tract infection, urinary tract infection;
• changes in laboratory 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);
• arrhythmias (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, nosebleeds;
• bloating, change in bowel movements, dry mouth, stomach ulcers, gastritis, 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 liver or kidney function test results;
• 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, restlessness;
• 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 those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
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

The medicine should be stored 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 month.
There are no special storage requirements.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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 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 the inscription "E9OX" on one side and "30" on the other side.
60 mg white, round, biconvex tablets (about 8 mm) with the inscription "E9OX" on one side and "60" on the other side.
90 mg white, round, biconvex tablets (about 9 mm) with the inscription "E9OX" on one side and "90" on the other side.
120 mg white, round, biconvex tablets (about 10 mm) with the inscription "E9OX" 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).
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