Xyzal 0.5 mg/ml oral solution

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• 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. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Xyzal 0.5 mg/ml oral solution (hereinafter: 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 chronic allergic rhinitis);
• urticaria.

2. Important information before taking Xyzal

When not to take Xyzal

• 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 renal impairment (severe renal failure with creatinine clearance less than 10 ml/min).

Warnings and precautions
Before starting treatment with Xyzal, discuss it with your doctor or pharmacist.
If you have difficulty emptying your bladder (e.g. due to spinal cord injury or benign prostatic hyperplasia), consult your doctor.
Xyzal may increase the frequency of epileptic seizures; therefore, consult your doctor if you have epilepsy or are at risk of seizures.
If you are scheduled for allergy testing, ask your doctor whether you should stop taking Xyzal several days before the test. Xyzal may affect the results of allergy tests.
Children
Xyzal is not recommended for infants and children under 2 years of age.
Xyzal with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan 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 with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Some patients treated with Xyzal may experience drowsiness, fatigue, or exhaustion. Exercise caution when driving or operating machinery until you know how you react to the medicine. However, specific tests conducted in healthy volunteers taking levocetirizine at the recommended dose did not show any effect on attention, reaction ability, or driving skills.
Xyzal contains sodium, liquid maltitol, methyl parahydroxybenzoate, and propyl parahydroxybenzoate

• The medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. the medicine is considered "sodium-free".
• The medicine contains liquid maltitol. If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before using Xyzal.
• Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) may cause allergic reactions (including delayed-type reactions).

3. How to use Xyzal

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 impaired renal function, a 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 dose will be determined by the doctor.
Xyzal must not be used in patients with severe renal impairment.
Patients with hepatic impairment alone 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 dose will be determined by the doctor.
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
This medicine is 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 during or between meals.
Instructions for using the oral syringe
Place the oral syringe into the bottle and pull the plunger to the mark on the scale corresponding to the prescribed dose in millilitres (ml). For children under 6 years of age, the daily dose of 5 ml administered 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 medicinal product 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.
Use of 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
Discontinuation of Xyzal should not cause harmful effects. However, in rare cases, itching (intense pruritus) may occur after stopping 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 all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Common: may affect less than 1 in 10 people
Dry mouth, headache, fatigue and drowsiness.
Uncommon: may affect less than 1 in 100 people
Exhaustion and abdominal pain.
Frequency not known: cannot be estimated from the available data
Other adverse reactions have also been reported, such as: 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 behaviour,
hallucinations, depression, insomnia, recurring thoughts of suicide or interest in suicide, nightmares,
hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhoea. Itching
(intense pruritus) after discontinuation of the medicine.
If the first symptoms of hypersensitivity reactions occur, treatment with Xyzal should be
discontinued and the doctor should be informed. 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,
pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be
collected.

5. How to store Xyzal 0,5 mg/ml oral solution

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

6. Contents of the packaging 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, Tutti frutti flavour (triacetin (E 1518), benzaldehyde, orange oil, vanillin, ethyl butyrate, concentrated orange oil, isoamyl 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 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in the Czech Republic, the country of export: 24/202/06-C
Parallel import authorisation number: 422/17
This medicinal product is authorised for marketing 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 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