Xazal 0.5 mg/ml oral solution
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Xazal 0.5 mg/ml oral solution
For adults and children from 2 years of age
Levocetirizine dihydrochloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Keep this leaflet as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Xazal is and what it is used for
- What you need to know before taking Xazal
- How to take Xazal
- Possible side effects
- How to store Xazal
Contents of the pack and other information
1. What Xazal is and what it is used for
The active substance in Xazal is levocetirizine dihydrochloride.
Xazal is an antiallergic medicine.
For the treatment of signs of disease (symptoms) associated with:
- Allergic rhinitis (including persistent allergic rhinitis);
Urticaria.
2. What you need to know before taking Xazal
Do not take Xazal
- if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other components of this medicine (listed in section 6).
- if you have severe kidney disease requiring dialysis.
Warnings and precautions
Talk to your doctor or pharmacist before taking Xazal.
If you have any condition that impairs your ability to empty the urinary bladder (such as spinal cord damage or enlarged prostate), please inform your doctor.
If you have epilepsy or are at risk of seizures, please consult your doctor, as the use of Xazal may worsen seizures.
If you are scheduled for allergy testing, ask your doctor whether you should stop treatment with Xazal several days beforehand. This medicine may affect the results of allergy tests.
Children
The use of Xazal is not recommended in children under 2 years of age.
Other medicines and Xazal
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Xazal with food, drinks and alcohol
Caution is advised when taking Xazal together with alcohol or other agents acting on the brain.
In sensitive patients, taking Xazal simultaneously with alcohol or other medicines acting on the brain may cause further reduction in attention capacity and performance.
Xazal can be taken either on an empty stomach or with food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you might 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/sedation, fatigue, and exhaustion. Exercise caution when driving or operating machinery until you know how this medicine affects you. However, in special tests conducted in healthy individuals, no impairment of attention, reaction ability, or driving skills was detected after taking levocetirizine at the recommended dose.
Xazal contains sodium, maltitol liquid, methyl parahydroxybenzoate and propyl parahydroxybenzoate
-
This medicine contains less than 23 mg of sodium (1 mmol) per ml; hence, it is essentially “sodium-free”.
-
This medicine contains liquid maltitol. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking Xazal.
Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).
3. How to take Xazal
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
- Adults and adolescents aged 12 years and older: 10 ml of solution once daily.
Special dosage instructions for specific populations
Renal and hepatic impairment
Patients with renal impairment should receive a reduced dose according to the severity of their kidney disease, and in children the dose will also be selected based on body weight; the dose will be determined by your doctor.
Patients with severe kidney disease requiring dialysis must not take Xazal.
Patients with hepatic impairment alone may take the normal prescribed dose.
Patients with both hepatic and renal impairment should take a reduced dose according to the severity of their kidney disease, and in children the dose will also depend on body weight; the dose will be determined by your doctor.
Patients aged 65 years and older
Dose adjustment is not necessary in elderly patients if renal function is normal.
Use in children
Children between 6 and 12 years: 10 ml of solution once daily.
Children between 2 and 6 years: 2.5 ml of solution twice daily.
Administration of Xazal is not recommended in children under 2 years of age.
How and when to take Xazal?
For oral use only.
An oral syringe is provided with the package. The solution may be taken undiluted or diluted in a glass of water.
Xazal may be taken either on an empty stomach or with food.
Handling of the oral syringe
Insert the oral syringe into the bottle and pull the plunger up to the mark corresponding to the prescribed dose in millilitres (ml). For use in children under 6 years of age, the total daily dose is 5 ml, divided into two doses; measure each time 2.5 ml of solution from the bottle (according to the syringe graduations).
Remove the oral syringe from the bottle and empty the 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 treatment depends on the type, duration and course of symptoms, and must be determined by your doctor.
If you take more Xazal than you should
If you take more Xazal than you should, somnolence may occur in adults. In children, initial agitation and restlessness may occur, followed by somnolence.
If you think you have taken an overdose of Xazal, inform your doctor, who will decide on the necessary action, or call the Toxicology Information Service at 915 620 420.
If you forget to take Xazal
If you forget 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 missed dose. Take the next dose at the scheduled time.
If you stop taking Xazal
Stopping treatment should not have negative effects. However, rarely, pruritus (intense itching) may occur when stopping Xazal, even if these symptoms were not present at the start of treatment. Symptoms may resolve spontaneously. In some cases, symptoms may be severe and require restarting treatment. Symptoms usually resolve when treatment is restarted.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Common: may affect up to 1 in 10 people
Dry mouth, headache, fatigue, and drowsiness/sleepiness
Uncommon: may affect up to 1 in 100 people
Exhaustion and abdominal pain
Frequency not known: cannot be estimated from the available data
Other adverse effects have been reported, such as palpitations, increased heart rate (tachycardia), seizures, tingling sensations, dizziness, fainting, tremor, dysgeusia (altered sense of taste), sensation of spinning or movement, visual disturbances, blurred vision, oculogyric crisis (involuntary circular eye movements), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, urticaria (skin swelling, redness, and itching), skin rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurrent thoughts or concerns about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.
Pruritus (intense itching) upon discontinuation of treatment.
At the first signs of a hypersensitivity reaction, stop taking Xazal 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), hives, sudden drop in blood pressure which may lead to collapse or shock, any of which could be fatal.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse 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 stated on the container and label after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Do not use more than 3 months after first opening the container.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the container and other information
Composition of Xazal
The active substance is levocetirizine dihydrochloride.
1 ml of oral solution contains 0.5 mg of levocetirizine dihydrochloride as the active substance.
The other components (excipients) are sodium acetate trihydrate, glacial acetic acid, methyl 4-hydroxybenzoate (E218), propyl 4-hydroxybenzoate (E216), glycerol 85%, liquid maltitol (E965), sodium saccharin, tutti frutti flavour (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 container
The oral solution is clear and colourless, and is supplied in a glass bottle with a white child-resistant polypropylene cap. The bottle is contained in a cardboard box which also includes a 10 ml oral syringe.
Pack sizes: 75 ml, 150 ml and 200 ml.
Only some pack sizes may be marketed.
Marketing Authorization Holder
UCB Pharma, S.A.
Plaza de Manuel Gómez Moreno, s/n
Edificio Bronce, Planta 5
28020 Madrid, Spain
Manufacturer
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>
<ExtractumPharma Co.Ltd, IV Korzet 6, Kunfeherto, 6413, Hungary>
<Phoenix Pharma Polska Sp. z o.o., ul. Rajdowa 9 Konotopa, 05-850 Ozarów Mazowiecki, Poland>
<UCB Pharma AS, Haakon VIIs gate 6, NO-0161 Oslo, Norway>
<UCB Pharma B.V., Hoge Mosten 2 A1, 4822 NH, Breda, Netherlands>
<UCB Nordic A/S, Edvard Thomsens Vej 14, DK-2300 København S, Denmark>
<UCB Pharma SA, Chemin Du Foriest 1, Braine-L’alleud, 1420, Belgium>
This medicinal product is authorized in the European Economic Area member states 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
Slovak Republic: Xyzal 0,5 mg/ml peroralny roztok
Slovenia: Xyzal
Spain: Xazal
United Kingdom: Xyzal
Date of the most recent revision of this leaflet: 07/2022
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es