Xizal Allergi

Leaflet attached to the packaging: patient information

Xyzal Allergy, 5 mg, coated tablets

Levocetirizine dihydrochloride
For adults, adolescents, and children from 6 years of age

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Xyzal Allergy and what is it used for
• 2. Important information before taking Xyzal Allergy
• 3. How to take Xyzal Allergy
• 4. Possible side effects
• 5. How to store Xyzal Allergy
• 6. Contents of the pack and other information

1. What is Xyzal Allergy and what is it used for

The active substance of Xyzal Allergy is levocetirizine dihydrochloride.
Xyzal Allergy is an antiallergic medicine.
Xyzal Allergy is used to treat symptoms associated with:

• allergic rhinitis (including chronic allergic rhinitis);
• urticaria.

The symptoms of allergic rhinitis include itching, redness and tearing of the eyes, nasal discharge, sneezing, and itching of the nose.
Xyzal Allergy is indicated for use in adults, adolescents, and children from 6 years of age.
If after 3 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Xyzal Allergy

When not to take Xyzal Allergy

• if the patient is hypersensitive to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or other substances with a similar chemical structure to piperazine 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 Allergy, 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 Allergy may increase the severity of epileptic 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 Allergy a few days before the test. Xyzal Allergy may affect the results of allergy tests.

Children

Xyzal Allergy 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 Allergy and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

Taking Xyzal Allergy with food, drink, and alcohol

Care should be taken when taking Xyzal Allergy with alcohol or other substances that affect brain function.
In sensitive patients, taking Xyzal Allergy with alcohol or other substances that affect brain function may cause additional drowsiness and impaired reaction time.
Xyzal Allergy 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 their doctor or pharmacist before taking this medicine.

Driving and using machines

Some patients taking Xyzal Allergy may experience drowsiness, fatigue, and exhaustion. Care should be taken when driving or operating machinery until the patient knows how they react to the medicine. 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 Allergy contains lactose

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

3. How to take Xyzal Allergy

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The recommended dose of Xyzal Allergy for adults, adolescents, and children from 6 years of age is 1 tablet per day.

Dosing in special patient groups:

Kidney and liver impairment
In patients with kidney impairment, the dose of Xyzal Allergy 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 the doctor.
Xyzal Allergy should not be taken by patients with severe kidney disease requiring dialysis.
Patients with liver impairment only should take the usual recommended dose of Xyzal Allergy.
In patients with both liver and kidney 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 dose will be determined by the doctor.
Elderly patients (65 years and over)
No dose adjustment is necessary in elderly patients with normal kidney function.

Use in children

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

How and when to take Xyzal Allergy?

The medicine is for oral use only.
The Xyzal Allergy tablet should be swallowed whole with water. The medicine can be taken with or without food.

How long to take Xyzal Allergy?

The duration of treatment depends on the type, duration, and severity of the disease symptoms and is determined by the doctor. The patient should consult their doctor or pharmacist.
The medicine should not be taken for more than 10 days without consulting a doctor. If after 3 days of taking the medicine there is no improvement or the patient feels worse, they should contact their doctor.

Taking a higher dose of Xyzal Allergy than recommended

In adults, if a higher dose of Xyzal Allergy 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 Allergy is suspected, the patient should consult their doctor, who will decide what actions should be taken.

Missing a dose of Xyzal Allergy

If a dose of Xyzal Allergy 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. Instead, the next dose should be taken at the usual time.

Stopping Xyzal Allergy

Stopping Xyzal Allergy should not cause any harmful effects. However, in rare cases, itching (intense itching) may occur after stopping Xyzal Allergy, 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 treatment may need to be restarted. 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 Allergy can cause side effects, although not everybody gets them.
If the patient experiences any symptoms of an allergic reaction, they should stop taking Xyzal Allergy and inform their doctor. Symptoms of an allergic reaction may include:
swelling of the mouth, tongue, face, and (or) throat, difficulty breathing or swallowing (tightness in the chest or wheezing), urticaria, a sudden drop in blood pressure leading to fainting or shock, which can be life-threatening.
Common: may affect up to 1 in 10 people
Dry mouth, headache, fatigue, and drowsiness or somnolence
Uncommon: may affect up to 1 in 100 people
Feeling of exhaustion and abdominal pain
Frequency not known: frequency cannot be estimated from the available data
Hypersensitivity, including anaphylactic shock
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, edema, itching, rash, urticaria (swelling, redness, and itching of the skin), skin eruptions, dyspnea, weight gain, muscle pain, joint pain, excitement and aggressive behavior, hallucinations, depression, insomnia, recurrent suicidal thoughts or interest in suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.
Itching (intense itching) after stopping Xyzal Allergy.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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, 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 Allergy

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the blister and carton after "EXP".
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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Xyzal Allergy contains

• The active substance of Xyzal Allergy is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients of the medicine are: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, and the coating Opadry Y-1-7000, which contains: hypromellose (E 464), titanium dioxide (E 171), and macrogol 400.

What Xyzal Allergy looks like and contents of the pack

Xyzal Allergy is a white or almost white, oval, coated tablet with the logo Y on one side.
The pack contains 10 coated tablets.

Marketing authorization holder and manufacturer/importer

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:
PHOENIX Pharma Polska Sp. z o.o., ul. Rajdowa 9, Konotopa, 05-850 Ożarów Mazowiecki

Date of last revision of the leaflet: