Xyzal

Package leaflet: Information for the patient

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

• Keep this leaflet, so that you can read it again if necessary.
• 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. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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 treatment with Xyzal, discuss this with your doctor or pharmacist.
If the patient has difficulty emptying the bladder (e.g. due to 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 a few 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, has recently taken, or 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 abilities.
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, fatigue, tiredness or exhaustion. Caution should be exercised 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 lactose monohydrate
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 as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose of the medicine 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 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 liver function alone should usually receive the 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)
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.
Taking more Xyzal than recommended
In adults, taking more than the recommended dose of Xyzal may cause drowsiness. In children, initial symptoms may include excitation 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 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, 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 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/sleepiness.

Uncommon: may occur in less than 1 in 100 patients
Feeling of 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 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 (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, stop taking Xyzal and inform your doctor. Symptoms of hypersensitivity reactions may include: swelling of 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 Adverse Drug Reactions of the 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
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 container. The expiry date refers to the last day of the specified month.
No special storage instructions apply.
Medicines should 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 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, 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 film-coated tablet with the logo Y on one side.
The pack contains 30 film-coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder 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:
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 Romania, the country of export: 2074/2009/10
Parallel import authorisation number: 112/23
This medicinal product is authorised for supply 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