Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Xyzal, 5 mg, film-coated tablets
Levocetirizini dihydrochloridum
For adults and children aged 6 years and older
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet to be able to read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are identical.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Xyzal is and what it is used for
Important information before taking Xyzal
How to take Xyzal
Possible side effects
How to store Xyzal
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 function disorders (severe renal impairment with creatinine clearance less than 10 ml/min).

Warnings and precautions
Before starting to use Xyzal, consult your doctor or pharmacist.
If the patient has difficulty emptying the bladder (e.g. due to spinal cord injury or benign prostatic hyperplasia), medical advice should be sought.
Xyzal may increase the frequency of epileptic seizures; therefore, consult a doctor if the patient has epilepsy or is at risk of seizures.
If the patient is scheduled for allergy testing, ask the doctor whether the patient should stop taking Xyzal several days before the test. Xyzal may affect the results of allergy tests.
Children
Xyzal coated tablets are not recommended for children under 6 years of age, as appropriate dose adjustment is not possible with this formulation.
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 can 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, somnolence, fatigue and exhaustion. Exercise caution when driving or operating machinery until the patient's response to the medicine is known. 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 monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Xyzal

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose of the medicine in adults and children aged 6 years and older is 1 tablet per day.
Dosage 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 impaired liver function 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 kidney 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)
In elderly patients, dosage adjustment is not necessary if renal function is normal.
Use in children
Xyzal tablets are not recommended for children under 6 years of age.
How and when to take Xyzal
This medicine is for oral use only.
Xyzal tablets should be swallowed whole with water. The medicine may be taken with or without food.
How long to take Xyzal
The duration of treatment depends on the type, duration, and severity of the disease symptoms and is determined by the doctor.
Taking more Xyzal than recommended
In adults, taking a higher than recommended dose of Xyzal may cause drowsiness. In children, initial symptoms may include hyperactivity and restlessness, especially motor restlessness, 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. In such a case, take the next dose at the usual time.
Stopping Xyzal treatment
Stopping treatment with Xyzal should not cause harmful effects. However, in rare cases, pruritus (intense itching) 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. These 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 will experience them.
Common: may occur in less than 1 in 10 patients
Dry mouth, headache, fatigue and drowsiness/sleepiness
Uncommon: may occur in less than 1 in 100 patients
Feeling of exhaustion and abdominal pain
Frequency not known: cannot be estimated based on 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, nystagmus (involuntary rhythmic eye movement), 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, recurrent suicidal thoughts 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 a doctor should be informed immediately. 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 circulatory 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 a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables further collection of information on the safety of the medicine.

5. How to store Xyzal

Keep the 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 instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Xyzal contains

The active substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
Other components of the medicine are: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate; coating: hypromellose, titanium dioxide (E 171) and macrogol.

What Xyzal looks like and contents of the pack
Xyzal is a white or almost white, oval film-coated tablet with the letter "Y" on one side.
The pack contains 10, 20, 30 or 40 film-coated tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization Holder in Romania, the country of export:
UCB Pharma GmbH
Alfred-Nobel-Str. 10
40789 Monheim
Germany
Manufacturer:
Aesica Pharmaceuticals S.r.l.
Via Praglia 15
I-10044 Pianezza (TO)
Italy
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Romania, the country of export: 2074/2009/10
Parallel Import Authorization Number: 396/22
This medicinal product is authorized for marketing in the European Economic Area member states under the following trade names:
Austria Xyzall
Belgium Xyzall
Czech Republic Xyzal
Cyprus Xyzal
Denmark Xyzal
Estonia Xyzal
Finland Xyzal
France Xyzall
Hungary Xyzal 5 mg filmtabletta
Germany Xusal
Greece Xosal
Ireland Xyzal
Italy Xyzal
Latvia Xyzal
Lithuania Xyzal
Luxembourg Xyzall
Malta Xyzal
Netherlands Xyzal
Norway Xyzal
Poland Xyzal
Portugal Xyzal
Slovakia Xyzal
Slovenia Xyzal
Spain Xazal
United Kingdom Xyzal