XAZAL 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Xazal 5 mg film-coated tablets

For adults and children from 6 years of age

Levocetirizine dihydrochloride

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Xazal and what is it used for
2. What you need to know before you take Xazal
3. How to take Xazal
4. Possible side effects
5. 5. Storage of Xazal

Contents of the pack and further information

1. What is Xazal and what is it used for

The active substance of Xazal is levocetirizine dihydrochloride. Xazal is an antiallergic medicine.

For the treatment of symptoms associated with:

• Allergic rhinitis (including persistent allergic rhinitis);

Urticaria.

2. What you need to know before you take Xazal

Do not take Xazal

• If you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine or any of the other ingredients of Xazal (listed in section 6).
• If you have severe kidney disease that requires dialysis.

Warnings and precautions

Consult your doctor or pharmacist before taking Xazal.

If you have any condition that makes it difficult to empty your urinary bladder (such as spinal cord injury or enlarged prostate), please inform your doctor.

If you are epileptic or have a risk of convulsions, please consult your doctor as the use of Xazal may worsen the crises.

If you are going to have an allergy test, ask your doctor if you should stop taking Xazal a few days before. This medicine may affect the results of the allergy test.

Children

Xazal is not recommended for children under 6 years of age, as the film-coated tablets do not allow for dose adjustment.

Other medicines and Xazal

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Taking Xazal with food, drinks, and alcohol

Caution is recommended if you take Xazal and alcohol or other substances that act on the brain at the same time. In sensitive patients, taking Xazal with alcohol or other substances that act on the brain may cause additional decreased attention and decreased performance.

Xazal can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Some patients treated with Xazal may experience drowsiness, fatigue, and exhaustion. Be careful if you are going to drive or use machinery until you know how this medication affects you. However, in special tests performed in healthy people, no alterations in attention, reaction capacity, and driving ability were detected after taking levocetirizine at the recommended dose.

Xazal contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Xazal

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults and children from 6 years of age is one tablet per day.

Special dosing instructions for specific populations:

Renal and hepatic impairment

Patients with renal impairment should receive a lower dose according to the severity of their kidney disease, and in children, the dose will also be chosen based on body weight; the dose will be decided by your doctor.

Patients with severe kidney disease that requires dialysis should not take Xazal.

Patients with only hepatic impairment should take the normal prescribed dose.

Patients with hepatic and renal impairment should take a lower dose based on the severity of their kidney disease, and in children, the dose will be based on body weight; the dose to be taken will be determined by your doctor.

Patient over 65 years of age

In elderly patients, it is not necessary to adjust the dose if their renal function is normal.

Use in children

Xazal is not recommended for children under 6 years of age.

How and when should you take Xazal?

For oral use only

Xazal tablets should be swallowed whole with water and can be taken with or without food.

How long should your treatment with Xazal last?

The duration of treatment depends on the type, duration, and course of the symptoms and will be determined by your doctor.

If you take more Xazal than you should

If you take more Xazal than you should, in adults, it may cause drowsiness. In children, it may initially cause agitation and restlessness followed by drowsiness.

In case of overdose or accidental ingestion of Xazal, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 915 620 420.

If you forget to take Xazal

If you have forgotten to take Xazal, or if you take a lower dose than prescribed by your doctor, do not take a double dose to make up for the forgotten doses. Continue taking your normal dose when it is due.

If you stop taking Xazal

Stopping treatment should not have negative effects. However, rarely, intense itching (pruritus) may appear when stopping Xazal, even when these symptoms were not present at the start of treatment. The symptoms may disappear spontaneously. In some cases, the symptoms may be intense and require restarting treatment. The symptoms usually disappear when treatment is restarted.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Common: may affect up to 1 in 10 people

Dry mouth, headache, fatigue, and drowsiness.

Uncommon: may affect up to 1 in 100 people

Exhaustion and abdominal pain.

Frequency not known: cannot be estimated from the available data

Other side effects have also been reported, such as palpitations, increased heart rate (tachycardia), convulsions, tingling, dizziness, syncope, tremor, dysgeusia (alteration of taste), sensation of rotation or movement, visual disturbances, blurred vision, oculogyric crisis (uncontrolled circular movements of the eyes), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, urticaria (swelling, redness, and itching of the skin), skin eruption, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucination, depression, insomnia, recurrent thoughts or concern with suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.

Intense itching (pruritus) when stopping treatment.

If you experience the first signs of a hypersensitivity reaction, stop taking Xazal and inform your doctor immediately. The symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or throat, difficulty breathing or swallowing (chest tightness or wheezing), hives, sudden drop in blood pressure that can lead to collapse or shock, which can be fatal.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Xazal

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging and label after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Xazal

• The active substance is levocetirizine dihydrochloride.
• Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol 400.

Appearance of the product and pack contents

The film-coated tablets are white or almost white, oval, and have the mark "Y" engraved on one of their faces.

They are packaged in blisters of 1, 2, 4, 5, 7, 10, 2x10, 10x10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 70, 90, and 100 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder

UCB Pharma, S.A.

Plaza de Manuel Gómez Moreno, s/n,

Edificio Bronce, Planta 5

28020 Madrid.

Manufacturer

Aesica Pharmaceuticals S.r.l

Via Praglia 15, I-10044 Pianezza (TO)

Italy

Poland>

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria: Xyzall Belgium: Xyzall

Cyprus: Xyzal

Czech Republic: Xyzal

Denmark: Xyzal

Estonia: Xyzal

Finland: Xyzal

France: Xyzall

Germany: Xusal

Greece: Xozal

Hungary: Xyzal 5 mg filmtabletta

Ireland: Xyzal

Italy: Xyzal

Latvia: Xyzal

Lithuania: Xyzal

Luxembourg: Xyzall

Malta: Xyzal

Netherlands: Xyzal

Norway: Xyzal

Poland: Xyzal

Portugal: Xyzal

Slovakia: Xyzal

Slovenia: Xyzal

Spain: Xazal

United Kingdom: Xyzal

Date of last revision of this package leaflet: 07/2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es