Patient Information Leaflet

Caution! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Xyzal (Xyzall), 5 mg, film-coated tablets
Levocetirizini dihydrochloridum
For adults and children aged 6 years and older
Xyzal and Xyzall are different brand names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

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 disease requiring dialysis.

Warnings and precautions
Before starting to use Xyzal, discuss this with your doctor or pharmacist.
If the patient may have difficulty emptying the bladder (in conditions such as spinal cord injury or benign prostatic hyperplasia), consult a doctor.
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 has planned 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 with 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 use.

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 baby, 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, or 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 receiving levocetirizine at the recommended dose did not show any effect of the medicine on attention, reaction ability, or driving performance.

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 take Xyzal

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose 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 reduced dose 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 disease requiring dialysis.
Patients with impaired hepatic 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 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)
In elderly patients, dose 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
For oral use only.
Xyzal tablets should be swallowed whole with water. The medicine may be taken during or between meals.
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.
Overdose of Xyzal
In adults, taking a higher than recommended dose of Xyzal may cause drowsiness. In children, initial symptoms may include restlessness and hyperactivity, 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 this case, take the next dose at the usual time.
Stopping Xyzal
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 restarted. 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 everyone experiences 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 from available data
Other adverse reactions have also been reported, such as: palpitations, increased heart rate, convulsions, tingling, dizziness, fainting, tremor, taste disturbances (altered sense of taste), 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 urinary bladder, swelling, itching, rash, urticaria (swelling, redness, and itching of the skin), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, restlessness and aggressive behavior, hallucinations, depression, insomnia, recurring thoughts of suicide or suicidal ideation, nightmares, hepatitis, liver function abnormalities, vomiting, increased appetite, nausea, and diarrhea.

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 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, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 helps to provide more information on the safety of the medicine.

5. How to store Xyzal

Keep this medicine out of the 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 packaging and other information

What Xyzal contains

The active substance is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E 171), and polyethylene glycol 400.

What Xyzal looks like and contents of the pack
Xyzal is a white or almost white, oval-shaped coated tablet with the logo Y on one side.
The pack contains 10, 20, 30 or 100 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Belgium, the country of export:
UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium

Manufacturer:
UCB Pharma SA, Chemin Du Foriest 1, Braine-L’alleud, 1420, Belgium
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 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 København 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

Belgium (country of export) marketing authorisation number: BE228505
Parallel import authorisation number: 154/25

This medicinal product is authorised for sale in the European Economic Area under the following 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 Xozal
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