Xizal

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. 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.

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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. Package contents 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 problems (severe renal impairment with creatinine clearance less than 10 ml/min).

Warnings and precautions

Before starting to take Xyzal, the patient should discuss it with their doctor or pharmacist.
If the patient may have difficulty emptying their bladder (in conditions such as spinal cord injury or prostate enlargement), they should consult their doctor.
Xyzal may increase the frequency of epileptic seizures, so the patient should consult their doctor if they have epilepsy or are at risk of seizures.
If the patient is scheduled to undergo allergy testing, they should ask their doctor if they 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 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 drowsiness and impaired ability to react.
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 of the medicine on attention, reaction time, or ability to drive.

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 as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose of Xyzal for adults and children over 6 years of age is 1 tablet per day.

Dosing in special patient groups:

Kidney and liver problems
Patients with kidney problems may need 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 doctor will determine the dose.
Xyzal should not be taken by patients with severe kidney problems.
Patients with liver problems only should take the usual recommended dose of Xyzal.
Patients with both liver and kidney problems may need to take a lower dose depending on the severity of the kidney disease; in children, the dose should also be adjusted according to body weight; the doctor will determine the dose.
Elderly patients (65 years and older)
There is no need to adjust the dose for elderly patients if their 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?

The medicine 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 treatment period 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, taking a higher dose of Xyzal than recommended may cause drowsiness. In children, it may initially cause excitement and restlessness, especially motor restlessness, and then drowsiness.
If an overdose of Xyzal is suspected, the patient should consult their doctor, who will decide what actions to take.

Missing a dose of Xyzal

If a dose of Xyzal is missed or a lower dose than recommended by the doctor is taken, the patient should not take a double dose to make up for the missed dose. Instead, they should take the next dose at the usual time.

Stopping Xyzal treatment

Stopping Xyzal treatment should not cause any harm. 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 the patient has any further doubts about taking this medicine, they should consult their 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 inform their doctor. Symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face, and (or) throat, difficulty breathing or swallowing (chest tightness 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 inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 side effects can help gather more information on the safety of the medicine.

5. How to store Xyzal

The medicine should be stored out of sight and reach of children.
The medicine should not be used 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. Package contents 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 the medicine 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 package contains

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

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
License number in Greece, the country of export: 855/7-01-2014

Parallel import license number: 7/23

This medicinal product 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
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
Date of leaflet approval: 11.01.2023
[Information about the trademark]