XAZAL 0.5 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Xazal 0.5 mg/ml Oral Solution

For adults and children from 2 years of age

Levocetirizine dihydrochloride

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

Keep this 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 signs of illness 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 leaflet. See section 4.

Contents of the pack and other information

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. 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 this medicine (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 bladder (such as a damaged spinal cord 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 need to 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 2 years of age.

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 at the same time as alcohol or other substances that act on the brain.

In sensitive patients, taking Xazal simultaneously with alcohol or other medicines that act on the brain may cause additional decreased attention and reduced 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 conducted in healthy individuals, no alterations in attention, reaction capacity and driving ability were detected after taking levocetirizine at the recommended dose.

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

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

• This medicine contains liquid maltitol. If your doctor has told you that you have an intolerance to some sugars, consult them before taking Xazal.

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

3. How to take Xazal

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

The recommended dose is:

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

Special dosing instructions for specific populations

Renal and hepatic impairment

Patient 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.

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

Patient with only hepatic impairment may take the normal prescribed dose.

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

Patient from 65 years of age

In elderly patients, it is not necessary to adjust the dose 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 of age.

How and when to take Xazal

Administer only by oral route.

An oral syringe is attached to the packaging. The solution can be taken undiluted or diluted in a glass of water.

Xazal can be taken with or without food.

Handling the oral syringe

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 of age, the total daily dose is 5 ml divided into two doses a day, measuring each time 2.5 ml of solution from the bottle (according to the syringe graduation).

Remove the oral syringe from the bottle and empty its contents into a spoon or a glass of water by pressing the plunger down. Take the medicine immediately after dilution.

Rinse the plunger with water after each use.

How long should your treatment with Xazal last

The duration of the treatment depends on the type, duration and course of the symptoms, and it is your doctor who must determine it.

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 the action to take or call the Toxicology Information Service 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 dose. Take the next dose at the scheduled time.

If you stop taking Xazal

Stopping treatment should not have negative effects. However, it may rarely cause intense itching (pruritus) 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 further questions on 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 been reported such as palpitations, increased heart rate (tachycardia), convulsions, tingling, dizziness, syncope, tremor, dysgeusia (altered sense 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 about 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. 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 leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: 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.

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.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Xazal

The active substance is levocetirizine dihydrochloride.

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

The other ingredients (excipients) are sodium acetate trihydrate, glacial acetic acid, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), glycerol 85%, liquid maltitol (E965), sodium saccharin, tutti frutti flavor (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 pack contents

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

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

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

This medicine is authorised in the Member States of the European Economic Area under 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 belsoleges oldat

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 peroralny roztok

Slovenia: Xyzal

Spain: Xazal

United Kingdom: Xyzal

Date of last revision of this leaflet: 07/2022

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