Xizal

Package Leaflet: Information for the Patient

Xyzal, 5 mg, Film-Coated Tablets

Levocetirizine Dihydrochloride
For adults and children from 6 years of age

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

• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

• 1. What Xyzal is and what it is used for
• 2. Before you take 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 Xyzal is and what it is 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. Before you take 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, you should 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), you should consult your doctor.
Xyzal may increase the risk of seizures, so you should consult your doctor if you have a history of seizures or are at risk of seizures.
If you are scheduled to undergo allergy testing, you should 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 age group.

Xyzal and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about 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 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 tiredness. 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 an effect on attention, reaction time, or driving ability.

Xyzal contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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 of Xyzal for adults and children aged 6 years and above is 1 tablet daily.

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 renal impairment; 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 renal impairment requiring dialysis.
Patients with hepatic impairment only should take the usual recommended dose.
In patients with both hepatic and renal impairment, a lower dose may be necessary depending on the severity of the renal impairment; 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 needed in elderly patients with normal renal function.

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 and is determined by your doctor.

Overdose of Xyzal

In adults, in case of overdose, Xyzal may cause drowsiness. In children, initially, there may be excitement and restlessness, especially agitation, followed by drowsiness.
If you think you have taken too much Xyzal, contact your doctor, who will decide what actions should be taken.

Missed 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 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 may require restarting treatment. These symptoms should resolve after restarting treatment.
If you have any further questions on the use of this product, 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/drowsiness
Uncommon: may affect up to 1 in 100 people
Feeling of tiredness 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, urticaria (swelling, redness, and itching of the skin), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, agitation 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 any of 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 (tightness in the chest or wheezing), rash, 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 any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Medicinal Product 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.
By reporting side effects, you can help provide 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 which is stated on the blister and carton after “EXP” and “Expiry Date”. The expiry date refers to the last day of that month.
There are no special storage requirements.
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. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, silicon dioxide, magnesium stearate, hypromellose (E 464), titanium dioxide (E 171), and macrogol 400.

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 7, 14, 21, 28, or 100 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
VEDIM Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Phone: +48 22 696 99 20
Manufacturer:
Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza (TO), Italy
Importer:
PHOENIX Pharma Polska Sp z o.o., ul. Rajdowa 9, Konotopa, 05-850 Ożarów Mazowiecki
UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom
ExtractumPharma Zrt., H-6413 Kunfehértó, IV. körzet 6, Hungary
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:

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 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
United Kingdom Xyzal
Date of last revision of the leaflet: December 2023