Xizal

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. 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

Before Taking the Medication, Read the Leaflet Carefully

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those 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. 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 medication.
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 medication (listed in section 6),
• if the patient has severe kidney disease requiring dialysis.

Warnings and precautions

Before taking Xyzal, consult a doctor or pharmacist.
If the patient may have difficulty emptying the bladder (in conditions such as spinal cord injury or prostate enlargement), consult a doctor.
Xyzal may exacerbate seizure attacks, so consult a doctor if the patient has epilepsy or a risk of seizures.
If the patient is scheduled to undergo allergy tests, ask the doctor if the patient should stop taking Xyzal a few days before the tests. Xyzal may affect the results of allergy tests.

Children

It is not recommended to give Xyzal film-coated tablets to children under 6 years of age, as it is not possible to adjust the dose appropriately for this form of the medication.

Xyzal and other medications

Tell the doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans 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 ability.
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 a doctor or pharmacist before taking this medication.

Driving and operating machinery

Some patients taking Xyzal may experience drowsiness, fatigue, and exhaustion. Be cautious when driving or operating machinery until the patient's reaction to the medication is known. However, special tests conducted with healthy volunteers after taking levocetirizine at the recommended dose did not show any effect on attention, reaction ability, or driving ability.

Xyzal contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medication.

3. How to take Xyzal

This medication should always be taken as directed by a doctor or pharmacist. In case of doubts, consult a 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 function disorders
In patients with kidney function disorders, the dose of Xyzal 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 a 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 a doctor.
Patients over 65 years of age
In patients over 65 years of age, there is no need to adjust the dose if kidney function is normal.

Administration to children

It is not recommended to give Xyzal tablets to children under 6 years of age.

How and when to take Xyzal?

The medication is for oral use only.
Xyzal tablets should be swallowed whole with water. The medication 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 a 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 restlessness and agitation, especially motor agitation, followed by drowsiness.
In case of suspected overdose, consult a 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 a doctor is taken, 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.
In case of any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, 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 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, 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 the patient experiences any symptoms of an allergic reaction, they should stop taking Xyzal and inform their doctor. Symptoms of an allergic 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 those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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
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 medication.

5. How to store Xyzal

Keep the medication out of sight and reach of children.
Do not use this medication 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.
Medications should not be disposed of via wastewater or household waste containers. Ask a pharmacist how to dispose of unused medications. 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 anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E 171), and macrogol
• 400.

What Xyzal looks like and what the pack contains

Xyzal is a white or almost white, oval, film-coated tablet with a logo Y on one side.
The pack contains 30 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:

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
Authorization number in Romania, the country of export: 2074/2009/10

Parallel import authorization number: 112/23

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 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

Date of leaflet approval: 12.06.2023

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