Package Insert: Patient Information

Xazal 0.5 mg/ml Oral Solution

For adults and children 2 years and older

Levocetirizine dihydrochloride

Contents of the package and additional information

The active ingredient of Xazal is levocetirizine dihydrochloride.

Xazal is an antihistamine medication.

For the treatment of signs of illness (symptoms) associated with:

• Allergic rhinitis (including persistent allergic rhinitis);

Urticaria.

Do not take Xazal

• if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other components of this medication (listed in section6).
• if you have severe kidney disease that requires dialysis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Xazal.

If you have any condition that prevents you from emptying your bladder (such as spinal cord damage or enlarged prostate), please inform your doctor.

If you are epileptic or at risk of seizures, please consult your doctor as the use of Xazal may worsen the seizures.

If you are scheduled for an allergy test, ask your doctor if you need to stop taking Xazal several days beforehand. This medication may affect the results of the allergy test.

Children

Xazal is not recommended for children under 2 years old.

Other medications and Xazal

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Taking Xazal with food, drinks, and alcohol

Caution is advised if Xazal is taken at the same time as alcohol or other agents that act on the brain.

In sensitive patients, taking Xazal with alcohol or other medications that act on the brain may cause additional decreased attention and performance.

Xazal can be taken both on an empty stomach and with 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 medication.

Driving and operating machinery

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

Xazal contains sodium, liquid maltitol, methyl parahydroxybenzoate, and propyl parahydroxybenzoate

• This medication contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

• This medication contains liquid maltitol. If your doctor has told you that you have intolerance to certain sugars, consult with them before taking Xazal.

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults and adolescents 12 years and older: 10 ml of solution once a day.

Special dosing instructions for specific populations

Renal and hepatic insufficiency

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

Patients with severe kidney disease requiring dialysis should not take Xazal.

Patients with only hepatic insufficiency can take the normal prescription dose.

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

Patients 65 years of age and older

In elderly patients, no dose adjustment is necessary if their renal function is normal.

Use in children

Children between 6 and 12 years: 10 ml of solution once a day

Children between 2 and 6 years: 2.5 ml of solution twice a day.

Xazal is not recommended for children under 2 years.

How and when to take Xazal

Only administer orally.

A oral syringe is included in the packaging. The solution can be taken undiluted or diluted in a glass of water.

Xazal can be taken both on an empty stomach and with food.

Oral syringe handling

Insert the oral syringe into the bottle and push the plunger up to the mark corresponding to the dose in milliliters (ml) prescribed by your doctor. For use in children under 6 years, the total daily dose is 5 ml divided into two doses per day, which is measured by extracting 2.5 ml of solution from the bottle (according to the syringe graduation).

Extract the oral syringe from the bottle and empty the contents into a spoon or a glass of water by pushing the plunger down. Take the medication immediately after dilution.

Clear the plunger with water after each use.

How long should your Xazal treatment last?

The duration of treatment depends on the type, duration, and course of 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.

If you think you have taken an overdose of Xazal, inform your doctor, who will decide on the action to take or call the Toxicological Information Service 915 620 420.

If you forget to take Xazal

If you have forgotten to take Xazal, or if you take a dose lower than prescribed by your doctor, do not take a double dose to compensate for the missed dose. Take the next dose at your scheduled time.

If you interrupt Xazal treatment

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Frequent: may affect up to 1 in 10 people

Dry mouth, headache, fatigue, and drowsiness/drowsiness

Rare: may affect up to 1 in 100 people

Exhaustion and abdominal pain

Unknown frequency: cannot be estimated from available data

Other adverse effects that have been described include palpitations, increased heart rate (tachycardia), seizures, paresthesia, dizziness, syncope, tremor, dysgeusia (alteration of the sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, ocular crisis (uncontrolled circular movements of the eyes), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), urticaria (swelling, redness, and itching of the skin), skin rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucination, depression, insomnia, recurrent thoughts or concern about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.

Intense itching when treatment is interrupted.

Stop taking Xazal at the first signs of hypersensitivity reaction and inform your doctor. Symptoms of hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or throat, difficulty breathing or swallowing (chest tightness or wheezing), hoarseness, sudden decrease in blood pressure that may lead to collapse or shock, which can be fatal.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use 3months after opening the packaging for the first time.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Composition of Xazal

The active ingredient is levocetirizine dihydrochloride.

1 ml of oral solution contains 0.5 mg of levocetirizine dihydrochloride as the active ingredient.

The other components (excipients) are sodium acetate trihydrate, glacial acetic acid, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), 85% glycerol, liquid maltitol (E965), sodium saccharin, tutti frutti aroma (triacetin (E1518), benzaldehyde, orange oil, vanillin, ethyl butyrate, concentrated orange oil, isoamyl acetate, allyl hexanoate, gamma-undecalactone, citral, geraniol, citronellol, alpha-tocopherol (E307)), purified water.

Appearance of the product and contents of the package

The oral solution is transparent and colorless, and is presented in a glass bottle with a white polypropylene child-resistant cap. The solution bottle is presented in a cardboard box that also contains a 10 ml oral syringe.

Package sizes: 75 ml, 150 ml, and 200 ml.

Only some package sizes may be commercially available.

Marketing Authorization Holder

UCB Pharma, S.A.

Plaza de Manuel Gómez Moreno, s/n

Edificio Bronce, 5th floor

28020 Madrid

Responsible for manufacturing

Aesica Pharmaceuticals S.r.l

Via Praglia 15, I-10044 Pianezza (TO)

Italy

<UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom>

<Phoenix Pharma Polska Sp. z o.o., ul. Rajdowa 9 Konotopa, 05-850 Ozarów Mazowiecki, Poland>

j 14, DK-2300 København S, Denmark>

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Belgium: Xyzall

Cyprus: Xyzal

Czech Republic: Xyzal

Denmark: Xyzal

Estonia: Xyzal

Finland: Xyzal

France: Xyzall

Germany: Levocetirizin Saft

Greece: Xozal

Hungary: XYZAL 0.5 mg/ml oral solution

Ireland: Xyzal

Italy: Xyzal

Latvia: Xyzal

Lithuania: Xyzal

Luxembourg: Xyzall

Malta: Xyzal

Netherlands: Xyzal

Norway: Xyzal

Poland: Xyzal

Portugal: Xyzal

Slovakia: Xyzal 0.5 mg/ml oral solution

Slovenia: Xyzal

Spain: Xazal

United Kingdom: Xyzal

Last review date of this leaflet: 07/2022

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es