Xizal 0,5 mg/ml roztvur doustni

Package Leaflet: Information for the Patient

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

Xyzal, 0.5 mg/ml, Oral Solution

Levocetirizine Dihydrochloride
For adults and children from 2 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 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 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 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, 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 risk of 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 is not recommended for infants and young children under 2 years of age.

Xyzal and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or 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 reaction time.
Xyzal can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

Xyzal contains sodium, liquid maltitol, methyl parahydroxybenzoate, and propyl parahydroxybenzoate

• The medicine contains less than 1 mmol (23 mg) of sodium per ml, which means it is considered "sodium-free".
• The medicine contains liquid maltitol (E 965). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Xyzal.
• Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possible late reactions).

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 is:
Adults and adolescents over 12 years of age: 10 ml of solution once a day.

Dosing in special patient groups:

Renal and hepatic impairment
In patients with renal impairment, the dose may need to be reduced 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 of the medicine.
Xyzal should not be taken by patients with severe kidney disease requiring dialysis.
Patients with only hepatic impairment should take the usual recommended dose of the medicine.
In patients with both hepatic and renal impairment, 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 doctor will determine the dose of the medicine.
Elderly patients (65 years and over)
In elderly patients, there is no need to adjust the dose if kidney function is normal.

Use in children

Children from 6 to 12 years of age: 10 ml of solution once a day.
Children from 2 to 6 years of age: 2.5 ml of solution twice a day.
Xyzal is not recommended for infants and young children under 2 years of age.

How and when to take Xyzal?

The medicine is for oral use only.
An oral syringe is included with the packaging. The solution can be taken undiluted or diluted in a glass of water.
Xyzal can be taken with or without food.
How to use the oral syringe
Place the oral syringe in the bottle and pull the plunger to the mark on the scale corresponding to the dose prescribed by the doctor in milliliters (ml). For children under 6 years of age, the daily dose of 5 ml given in two divided doses should be measured by withdrawing 2.5 ml of solution from the bottle twice a day (the dose should be measured accurately using the syringe with the scale).
Remove the oral syringe from the bottle and empty its contents onto a spoon or into a glass of water by pressing the plunger. The medicine should be taken orally immediately after dilution.
After each use, the syringe should be rinsed with water.

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, 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 their 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, the patient should not take a double dose to make up for the missed dose. The next dose should be taken at the usual time.

Stopping Xyzal

Stopping Xyzal should not cause any harmful effects. However, in rare cases, itching (intense itching) may occur after stopping Xyzal, 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 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
Uncommon: may affect up to 1 in 100 people
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.
If the patient experiences any symptoms of an allergic reaction, they should stop taking Xyzal and tell their doctor. Symptoms of an allergic reaction may include: swelling of the lips, 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 this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Do not use after 3 months from the date of first opening.
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 pack and other information

What Xyzal contains

• The active substance is levocetirizine dihydrochloride. 1 ml of oral solution contains 0.5 mg of levocetirizine dihydrochloride.
• The other ingredients are: sodium acetate trihydrate, glacial acetic acid, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), glycerol 85%, liquid maltitol (E 965), sodium saccharin, fruit flavor (triacetin (E 1518), benzaldehyde, orange oil, vanillin, ethyl butyrate, orange oil concentrate, allyl caproate, gamma-undecalactone, citral, geraniol, citronellol, alpha-tocopherol (E 307)), purified water.

What Xyzal looks like and contents of the pack

The oral solution is a clear and colorless solution in a glass bottle with a white polypropylene child-resistant closure. The bottle with the solution is placed in a cardboard box, which also contains an oral syringe.
Pack sizes: 200 ml.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

UCB s.r.o.
Jankovcova 1518/2, 170 00 Prague 7, Czech Republic

Manufacturer:

Aesica Pharmaceuticals S.r.l, Via Praglia 15, I-10044 Pianezza (TO), Italy
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom
ExtractumPharma Co. Ltd., 6413 Kunfehértó, IV. körzet 6., Hungary
Phoenix Pharma Polska Sp. z o.o., ul. Rajdowa 9, Konotopa, 05-850 Ożarów Mazowiecki, Poland
UCB Pharma GmbH, Alfred-Nobel-Straße 10, 40789 Munich, Germany
UCB Pharma B.V, Hoge Mosten 2 A1, 4822 NH, Breda, Netherlands
UCB Pharma AS, Haakon VIIs gate 6, NO-0161 Oslo, Norway
UCB Nordic A/S, Edvard Thomsens Vej 14, DK-2300 Kodaň S, Denmark

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:24/202/06-C
Parallel import authorization number:180/18

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Xyzall
Cyprus: Xyzal
Czech Republic: Xyzal
Denmark: Xyzal
Estonia: Xyzal
Finland: Xyzal
France: Xyzall
Germany: Levocetirizin Saft
Greece: Xozal
Hungary: XYZAL 0.5 mg/ml oral solution
Ireland: Xyzal
Italy: Xyzal
Latvia: Xyzal
Lithuania: Xyzal
Luxembourg: Xyzall
Malta: Xyzal
Netherlands: Xyzal
Norway: Xyzal
Poland: Xyzal
Portugal: Xyzal
Slovakia: Xyzal 0.5 mg/ml oral solution
Slovenia: Xyzal
Spain: Xazal
United Kingdom: Xyzal
Date of leaflet approval: 01.03.2023
[Information about the trademark]