Xizal

Package Leaflet: Information for the Patient

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

Xyzal, 5 mg, film-coated tablets

Levocetirizine dihydrochloride
For adults and children from 6 years of age

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 you experience any side effects, including those not listed in this leaflet, tell your 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 pack 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 you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine or any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney problems (severe renal impairment with creatinine clearance less than 10 ml/min).

Warnings and precautions

Before taking Xyzal, discuss it with your doctor or pharmacist.
If you may have difficulty emptying your bladder (in conditions such as spinal cord injury or prostate enlargement), consult your doctor.
Xyzal may increase the frequency of epileptic seizures, so consult your doctor if you have epilepsy or are at risk of seizures.
If you are scheduled to undergo allergy testing, ask your doctor if you should stop taking Xyzal a few days before the test. Xyzal may affect the results of allergy tests.

Children

Xyzal film-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

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Taking Xyzal with food, drink, and alcohol

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 reaction.
Xyzal can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Xyzal contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Xyzal

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
The recommended dose of Xyzal for adults and children from 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.
Patients with severe kidney problems should not take Xyzal.
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 over)
There is no need to adjust the dose in elderly patients if kidney function is normal.

Use in children

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

How and when to take Xyzal?

Xyzal is for oral use only.
Swallow the tablets whole with water. Xyzal 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 you suspect that you have taken a higher dose of Xyzal than recommended, consult your doctor, who will decide what actions should be taken.

Missing a dose of Xyzal

If you miss a dose of Xyzal or take a lower dose than recommended by your doctor, do not take a double dose to make up for the missed dose. Instead, 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 may require restarting treatment. These symptoms should resolve after restarting treatment.
If you have any further doubts about taking this medicine, 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), 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, hives (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 you notice the first symptoms of an allergic reaction, stop taking Xyzal and tell your doctor. Allergic reaction symptoms may include: swelling of the mouth, tongue, face, and (or) throat, difficulty breathing or swallowing (chest tightness or wheezing), hives, sudden drop in blood pressure leading to fainting or shock, which can be life-threatening.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Xyzal

Keep the 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 month.
No special precautions for storage are necessary.
Medicines should 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 pack and other information

What Xyzal contains

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

What Xyzal looks like and contents of the pack

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

Marketing authorization 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:

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 Romania, the country of export:2074/2009/10

Parallel import authorization number: 396/22

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 filmtabletta
Germany Xusal
Greece Xosal
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
United Kingdom Xyzal
Date of revision of the leaflet: 26.10.2022
[Information about the trademark]