Xyzal 0.5 mg/ml oral solution

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Xyzal 0.5 mg/ml oral solution
Levocetirizini dihydrochloridum
For adults and children aged 2 years and older
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of Contents:

1. What Xyzal is and what it is used for
2. Important information before taking Xyzal
3. How to take Xyzal
4. Possible side effects
5. How to store Xyzal
6. Contents of the pack and other information

1. What Xyzal is and what it is used for

The active substance in Xyzal is levocetirizine dihydrochloride.
Xyzal is an antiallergic medicine.
Xyzal is used to treat symptoms associated with:

• allergic rhinitis (including perennial allergic rhinitis);
• urticaria.

2. Important information before using Xyzal

When not to use Xyzal

• if the patient is allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe kidney disease requiring dialysis.

Warnings and precautions
Before starting Xyzal, discuss this with your doctor or pharmacist.
If the patient has difficulty emptying the bladder (in conditions such as: spinal cord injury or benign prostatic hyperplasia), medical advice should be sought.
Xyzal may increase the risk of seizures; therefore, consult a doctor if the patient has epilepsy or a risk of seizures.
If the patient has planned allergy testing, ask the doctor whether the patient should stop taking Xyzal a few days before the tests. Xyzal may affect the results of allergy tests.
Children
Xyzal is not recommended for infants and young children under 2 years of age.
Xyzal and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking Xyzal with food, drink and alcohol
Exercise caution when taking Xyzal together with alcohol or other substances affecting brain function.
In sensitive patients, concomitant use of Xyzal with alcohol or other substances affecting brain function may additionally reduce alertness and reaction ability.
Xyzal may be taken during or between meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Some patients treated with Xyzal may experience drowsiness, fatigue, and exhaustion. Caution is advised when driving or operating machinery until the patient's response to the medicine is known. However, specific tests conducted in healthy individuals after taking levocetirizine at the recommended dose did not show any effect of the medicine on attention, reaction ability, or ability to drive.
Xyzal contains sodium, liquid maltitol, methyl parahydroxybenzoate and propyl parahydroxybenzoate

• The medicine contains less than 1 mmol (23 mg) of sodium per ml; therefore, the medicine is considered "sodium-free".
• The medicine contains liquid maltitol (E 965). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before using Xyzal.
• Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (including delayed-type reactions).

3. How to use Xyzal medicine

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Recommended dose:
Adults and adolescents over 12 years of age: 10 ml of solution once daily.
Dosing in special patient groups:
Renal and hepatic impairment
In patients with renal impairment, dose reduction may be necessary depending on the severity of kidney disease; in children, the dose should also be adjusted according to body weight; the doctor will determine the appropriate dose.
Xyzal must not be used in patients with severe renal disease requiring dialysis.
Patients with hepatic impairment only should usually receive the recommended dose.
In patients with both hepatic and renal impairment, a lower dose may be required depending on the severity of renal disease; in children, the dose should also be adjusted according to body weight; the doctor will determine the appropriate dose.
Elderly patients (65 years and older)
Dose adjustment is not necessary in elderly patients if renal function is normal.
Use in children
Children aged 6 to 12 years: 10 ml of solution once daily.
Children aged 2 to 6 years: 2.5 ml of solution twice daily.
Xyzal is not recommended for infants and young children under 2 years of age.
How and when to take Xyzal medicine?
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.
Xyzal may be taken with or between meals.
Instructions for use of the oral syringe
Insert the oral syringe into the bottle and pull the plunger to the mark on the scale corresponding to the dose prescribed by the doctor in millilitres (ml). For children under 6 years of age, the daily dose of 5 ml given in two divided doses should be measured by drawing 2.5 ml of solution from the bottle twice daily (the dose must be accurately measured using the syringe with scale).
Remove the oral syringe from the bottle and empty its contents onto a spoon or into a glass of water by pressing the plunger. The medicine should be taken orally immediately after dilution.
After each use, rinse the syringe with water.

How long should Xyzal be taken?
The duration of treatment depends on the type, duration and severity of the disease symptoms and is determined by the doctor.
Taking more than the recommended dose of Xyzal
In adults, taking more than the recommended dose of Xyzal may cause drowsiness. In children, initial excitation and restlessness, especially motor restlessness, may occur, followed by drowsiness.
If an overdose of Xyzal is suspected, consult a doctor, who will decide what actions should be taken.
Missed dose of Xyzal
If a dose of Xyzal is missed or a lower than recommended dose is taken, do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
Stopping Xyzal treatment
Stopping treatment with Xyzal should not cause harmful effects. However, in rare cases, itching (intense pruritus) may occur after discontinuation of Xyzal, even if these symptoms were not present before starting treatment. These symptoms may resolve spontaneously. In some cases, symptoms may be severe and treatment may need to be resumed. Symptoms should resolve upon resumption of treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.

Frequent: may occur in less than 1 in 10 patients
Dry mouth, headache, fatigue, and drowsiness

Uncommon: may occur in less than 1 in 100 patients
Exhaustion and abdominal pain

Frequency not known: cannot be estimated from the available data
Other adverse reactions reported include: palpitations, increased heart rate, convulsions, tingling, dizziness, fainting, tremor, taste disturbances (altered taste perception), sensation of spinning or swaying, visual disturbances, blurred vision, rotatory eye movements (uncontrolled circular eye movements), painful or difficult urination, inability to completely empty the bladder, swelling, itching, rash, urticaria (skin swelling, redness, and itching), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, restlessness and aggressive behavior, hallucinations, depression, insomnia, recurring suicidal thoughts or interest in suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea. Itching (intense pruritus) after discontinuation of the medicine.

If the first symptoms of hypersensitivity reactions occur, discontinue use of Xyzal and inform your doctor. Symptoms of hypersensitivity reactions may include: swelling of the lips, tongue, face, and (or) throat, difficulty breathing or swallowing (chest tightness or wheezing), urticaria, sudden drop in blood pressure leading to collapse or shock, which may lead to death.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Xyzal

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use more than 3 months after the first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Xyzal contains

• The active substance is levocetirizine dihydrochloride. 1 ml of oral solution contains 0.5 mg of levocetirizine dihydrochloride.
• The other ingredients are: sodium acetate trihydrate, glacial acetic acid, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), glycerol 85%, maltitol liquid (E 965), sodium saccharin, fruit flavour (triacetin (E 1518), benzaldehyde, orange oil, vanillin, ethyl butyrate, orange oil concentrate, isopentyl acetate, allyl caproate, gamma-undecalactone, citral, geraniol, citronellol, alpha-tocopherol (E 307)), purified water.

What Xyzal looks like and contents of the pack
The oral solution is a clear, colourless solution contained in a glass bottle with a white
polypropylene child-resistant closure. The bottle containing the solution is placed in a cardboard
box, which also contains an oral syringe.
Pack sizes: 200 ml.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in the Czech Republic, the country of export:
UCB s.r.o.
Jankovcova 1518/2, 170 00 Prague 7, Czech Republic
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., 6413 Kunfehértó, IV. körzet 6., Hungary
Phoenix Pharma Polska Sp. z o.o., ul. Rajdowa 9, Konotopa, 05-850 Ożarów Mazowiecki, Poland
UCB Pharma GmbH, Alfred-Nobel-Straße 10, 40789 Monheim, Germany
UCB Pharma B.V, Hoge Mosten 2 A1, 4822 NH, Breda, Netherlands
UCB Pharma AS, Haakon VIIs gate 6, NO-0161 Oslo, Norway
UCB Nordic A/S, Edvard Thomsens Vej 14, DK-2300 Copenhagen S, Denmark
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Relabelled and/or repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in the Czech Republic, the country of export: 24/202/06-C
Parallel Import Licence Number: 180/18
This medicinal product is authorised in 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 belsőleges 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