Xizal 0,5 mg/ml roztvur doustni

Package Leaflet: Information for the Patient

Xyzal, 0.5 mg/ml, Oral Solution

Levocetirizine Dihydrochloride
For adults and children from 2 years of age

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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 disease requiring dialysis.

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 risk of seizures, so consult your doctor if you have a history of seizures 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 should not be given to infants and young children under 2 years of age.

Xyzal and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might 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 time.
Xyzal can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Some patients taking Xyzal may experience drowsiness, fatigue, and exhaustion.
Be cautious when driving or operating machinery until you know how Xyzal affects you. However, special tests conducted with healthy volunteers 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. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking Xyzal.
• Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) may cause allergic reactions (possible late reactions).

3. How to take Xyzal

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years: 10 ml of solution once daily.

Dosing in special patient groups:

Kidney and liver function disorders
In patients with kidney function disorders, 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 dose will be determined by your 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 will be determined by your doctor.
Elderly patients (65 years and over)
No dose adjustment is necessary in elderly patients with normal kidney function.

Use in children

Children from 6 to 12 years: 10 ml of solution once daily.
Children from 2 to 6 years: 2.5 ml of solution twice daily.
Xyzal should not be given to infants and young children under 2 years of age.

How and when to take Xyzal?

This medicine is for oral use only.
A measuring syringe is provided with the pack. 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 measuring syringe
Place the syringe in the bottle and pull the plunger to the mark on the syringe that corresponds to the dose in milliliters (ml) prescribed by your doctor. For children under 6 years, the daily dose of 5 ml given in two divided doses should be measured by taking 2.5 ml of solution twice daily (the dose should be measured accurately using the syringe with the scale).
Remove the syringe from the bottle and empty its contents onto a spoon or into a glass of water by pressing the plunger. The medicinal product should be taken orally immediately after dilution.
After each use, rinse the syringe with water.

How long to take Xyzal?

The duration of treatment depends on the type, duration, and severity of the disease symptoms and is determined by your 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. Take the next dose at the usual time.

Stopping Xyzal treatment

Stopping treatment with Xyzal 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 it may be necessary to resume treatment. These symptoms should resolve after resuming treatment.
If you have any further questions about taking this medicine, ask 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
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 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 lips, 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 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 Monitoring, 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Xyzal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of that month.
There are no special storage precautions for this medicine.
Do not use after 3 months from the date of first opening.
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 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, Tutti frutti flavor (triacetin (E1518), benzaldehyde, orange oil, vanillin, ethyl butyrate, orange oil concentrate, isoamyl acetate, allyl caproate, gamma-undecalactone, citral, geraniol, citronellol, alpha-tocopherol (E307)), 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 containing a measuring syringe.
Pack sizes: 200 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder
VEDIM Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Tel. +48 22 696 99 20
Manufacturer:
Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza (TO), Italy
Importer:
UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom
ExtractumPharma Zrt., H-6413 Kunfehértó, IV. körzet 6, Hungary
PHOENIX Pharma Polska Sp z o.o., ul. Rajdowa 9, Konotopa, 05-850 Ożarów Mazowiecki
United Drug Distributors Ireland Limited, United Drug House, Magna Drive,
Magna Business Park, Citywest Road, Dublin 24, Ireland
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 København S, Denmark
UCB Pharma SA, Chemin Du Foriest 1, Braine-l’alleud, 1420, Belgium

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 last revision of the leaflet:December 2023