Xyzal

Patient Information Leaflet

Warning! Keep this leaflet. Information on the outer 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 for future reference.
• If you have any questions, 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 others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your 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 antihistamine 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 has difficulty emptying the bladder (in conditions such as spinal cord injury or benign prostatic hyperplasia), consult a doctor.
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 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 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 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, or exhaustion. Exercise caution when driving or operating machinery until the patient's response to the medicine is known. However, specific studies conducted in healthy volunteers taking 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 use Xyzal

This medicine should always be used according to the instructions given by the doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose for 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 kidney 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 liver function alone should usually receive the standard recommended dose.
In patients with both hepatic and renal impairment, a lower dose may be necessary 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)
Dosage adjustment is not necessary in elderly patients 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 symptoms and is determined by the doctor.
Taking more Xyzal than recommended
In adults, taking more than the 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 immediately to determine 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. Instead, 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 it may be necessary to resume treatment. Symptoms should resolve after resuming 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/somnolence.

Uncommon: may occur in less than 1 in 100 patients
Feeling of exhaustion and abdominal pain.

Frequency unknown: cannot be estimated from available data
Other adverse reactions reported include: 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 bladder, swelling, itching, rash, urticaria (skin swelling, redness and itching), shortness of breath, weight gain, muscle pain, joint pain, agitation 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, discontinue use of Xyzal and inform your doctor 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 this 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 the sewage system or in 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.
• Other components of the medicine are: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, and the coating Opadry Y-1-7000 (hypromellose, titanium dioxide (E 171), polyethylene glycol 400).

What Xyzal looks like and contents of the pack
Xyzal is a white or almost white, oval coated tablet with the logo Y on one side.
The packaging contains 10, 20, 30 or 100 coated tablets.
For more detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing Authorisation numbers in Romania, the country of export: 2074/2009/10
2074/2009/03
2074/2009/04
2074/2009/11
2074/2009/12
2074/2009/13
2074/2009/14
2074/2009/15
2074/2009/16
Parallel Import Authorisation number: 259/23
This medicine is authorised for sale in the European Economic Area countries 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