Xizal

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Xyzal (Xozal), 5 mg, coated tablets

Levocetirizine dihydrochloride
For adults and children from 6 years of age
Xyzal and Xozal are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Xyzal and what is it 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 packaging and other information

1. What is Xyzal and what is it used for

The active substance of 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 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 taking Xyzal, you should discuss it with your doctor or pharmacist.
If the patient may have difficulty emptying the bladder (in conditions such as spinal cord injury or prostate enlargement), they should consult a doctor.
Xyzal may exacerbate seizure attacks, so the patient should consult a doctor if they have epilepsy or a risk of seizures.
If the patient is scheduled to undergo allergy tests, they should ask their doctor if they 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 it is not possible to adjust the dose appropriately for this form of the medicine.

Xyzal and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Taking Xyzal with food, drink, and alcohol

The patient should be cautious when taking Xyzal with alcohol or other substances that affect brain function.
In sensitive patients, taking Xyzal with alcohol or other substances that affect brain function may cause additional decreased alertness and reaction ability.
Xyzal can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Some patients taking Xyzal may experience drowsiness, dizziness, fatigue, and exhaustion. The patient should be cautious when driving or operating machinery until they know how the medicine affects them. However, special tests conducted with healthy volunteers after taking levocetirizine at the recommended dose did not show any effect on attention, reaction ability, or driving ability.

Xyzal contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Xyzal

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The recommended dose of Xyzal for adults and children aged 6 years and older is 1 tablet per day.

Dosing in special patient groups:

Kidney and liver function disorders
In patients with kidney function disorders, it may be necessary to reduce the dose of Xyzal, depending on the severity of the kidney disease; in children, the dose should also be adjusted according to body weight; the dose of Xyzal will be determined by the doctor.
Xyzal should not be taken by patients with severe kidney disease requiring dialysis.
Patients with liver function disorders only should take the usual recommended dose of Xyzal.
In patients with both liver and kidney function disorders, a lower dose may be necessary, depending on the severity of the kidney disease; in children, the dose should also be adjusted according to body weight; the dose of Xyzal will be determined by the doctor.
Patients over 65 years of age
In elderly patients, there is no need to adjust the dose if kidney function is normal.

Use in children

Xyzal tablets are not recommended for children under 6 years of age.

How and when to take Xyzal?

Xyzal is for oral use only.
Xyzal tablets should be swallowed whole with water. The medicine can 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 a higher dose of Xyzal than recommended

In adults, if a higher dose of Xyzal than recommended is taken, drowsiness may occur. In children, initial excitement and restlessness, especially motor restlessness, may occur, followed by drowsiness.
If an overdose of Xyzal is suspected, the patient should consult a doctor, who will decide what actions should be taken.

Missing a dose of Xyzal

If a dose of Xyzal is missed or a lower dose than recommended by the doctor is taken, a double dose should not be taken to make up for the missed dose. In such cases, the next dose should be taken at the usual time.

Stopping Xyzal treatment

Stopping Xyzal treatment should not cause any harmful effects. However, in rare cases, itching (intense itching) may occur after stopping Xyzal treatment, even if these symptoms did not occur before starting treatment. These symptoms may resolve on their own. In some cases, these symptoms may be intense and treatment may need to be resumed. These symptoms should resolve after treatment is resumed.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xyzal can cause side effects, although not everybody gets them.
Common:may affect up to 1 in 10 people
Dry mouth, headache, fatigue, and drowsiness/dizziness.
Uncommon:may affect up to 1 in 100 people
Feeling of exhaustion and abdominal pain.
Frequency not known:cannot be estimated from the available data
Other side effects have also been reported, such as: palpitations, increased heart rate, seizures, tingling, dizziness, fainting, tremors, taste disturbances (altered taste perception), feeling of spinning or swaying, vision disturbances, blurred vision, rotational eye movements (uncontrolled circular eye movement), painful or difficult urination, inability to fully empty the bladder, swelling, itching, rash, urticaria (swelling, redness, and itching of the skin), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, excitement and aggressive behavior, hallucinations, depression, insomnia, recurring suicidal thoughts or interest in suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.
Itching (intense itching) after stopping Xyzal treatment.
If the patient experiences any symptoms of a hypersensitivity reaction, they should stop taking Xyzal and tell their doctor. Symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face, and (or) throat, difficulty breathing or swallowing (tightness in the chest or wheezing), urticaria, sudden drop in blood pressure leading to fainting or shock, which can be life-threatening.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xyzal

The medicine should be stored 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 month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Xyzal contains

• The active substance of Xyzal is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients of Xyzal are: microcrystalline cellulose, lactose monohydrate, silica colloidal anhydrous, magnesium stearate, hypromellose (E 464), titanium dioxide (E 171), and macrogol 400.

What Xyzal looks like and what the packaging contains

Xyzal is a white or almost white, oval, coated tablet with the logo Y on one side.
The packaging contains 10, 20, 30, 40 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

UCB A.E.
Ag. Dimitriou 63
174 56 Alimos, Greece

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 Greece, the country of export:855/7-01-2014

Parallel import authorization number: 41/23

This medicine is authorized in the Member States of 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 film-coated tablet
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
Date of leaflet approval: 10.03.2023
[Information about the trademark]