Package leaflet: Information for the patient

Xyzal Allergy, 5 mg, film-coated tablets
Levocetirizini dihydrochloridum
For adults, adolescents and children aged 6 years and older
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet:

What Xyzal Allergy is and what it is used for
Important information before taking Xyzal Allergy
How to take Xyzal Allergy
Possible side effects
How to store Xyzal Allergy
Contents of the pack and other information

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

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

allergic rhinitis (including perennial allergic rhinitis);
urticaria.

Symptoms of allergic rhinitis include itching, redness and watering of the eyes, nasal discharge, sneezing and nasal itching.
Xyzal Allergy is indicated for use in adults, adolescents and children aged 6 years and older.
If there is no improvement after 3 days, or if you feel worse, you should consult your doctor.

2. Important information before using Xyzal Allergy

When not to use Xyzal Allergy

if the patient is allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, substances with a chemical structure similar 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 starting treatment with Xyzal Allergy, consult your doctor or pharmacist.
If the patient may have difficulty emptying the bladder (e.g. due to spinal cord injury or benign prostatic hyperplasia), medical advice should be sought.
Xyzal Allergy may increase the frequency of epileptic seizures; therefore, consult a doctor if the patient has epilepsy or is at risk of seizures.
If the patient has planned allergy testing, consult the doctor whether use of Xyzal Allergy should be discontinued several days before the test. Xyzal Allergy may affect the results of allergy tests.
Children
It is not recommended to administer Xyzal Allergy coated tablets to children under 6 years of age, as appropriate dose adjustment is not possible with this formulation.
Xyzal Allergy and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to use.
Use of Xyzal Allergy with food, drink and alcohol
Exercise caution when taking Xyzal Allergy together with alcohol or other substances affecting brain function.
In sensitive patients, concomitant use of Xyzal Allergy with alcohol or other substances affecting brain function may additionally reduce alertness and reaction ability.
Xyzal Allergy may be taken during or between meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Some patients treated with Xyzal Allergy may experience drowsiness, somnolence, fatigue, and exhaustion. Caution should be exercised when driving or operating machinery until the patient's response to the medicine is known. However, specific tests conducted in healthy volunteers taking levocetirizine at the recommended dose did not show any effect of the medicine on attention, reaction ability, or driving performance.
Xyzal Allergy contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Xyzal Allergy

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose of the medicine in adults, adolescents and children aged 6 years and older is 1 tablet per day.

Dosing in special patient groups:
Renal and hepatic impairment
In patients with impaired renal function, a dose reduction may be necessary depending on the severity of renal disease. In children, the dose should also be adjusted according to body weight; the dose will be determined by the doctor.
Xyzal Allergy must not be used in patients with severe renal disease requiring dialysis.
Patients with hepatic impairment alone should usually receive the recommended dose.
In patients with both hepatic and renal impairment, a reduced dose may be necessary depending on the severity of renal 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 older)
No dose adjustment is necessary in elderly patients if renal function is normal.

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

How and when to take Xyzal Allergy
For oral use only.
Xyzal Allergy tablets should be swallowed whole with water. The medicine may be taken during or between meals.

How long to take Xyzal Allergy
The duration of treatment depends on the type, duration and severity of symptoms, and is determined by the doctor. Consult your doctor or pharmacist.
Do not use the medicine for longer than 10 days without consulting a doctor. If there is no improvement after 3 days of treatment, or if symptoms worsen, contact your doctor.

Use of a higher than recommended dose of Xyzal Allergy
In adults, taking a higher than recommended dose of Xyzal Allergy may cause drowsiness. In children, initial excitation and restlessness, especially motor restlessness, may occur, followed by drowsiness.
If an overdose of Xyzal Allergy is suspected, consult a doctor who will decide on the necessary actions.

Missed dose of Xyzal Allergy
If a dose of Xyzal Allergy is missed or a lower than recommended dose has been 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 Allergy
Discontinuation of Xyzal Allergy should not cause harmful effects. However, in rare cases, itching (intense pruritus) may occur after stopping Xyzal Allergy, even if these symptoms were not present before starting treatment. These symptoms may resolve spontaneously. In some cases, symptoms may be severe and treatment may need to be resumed. These symptoms should resolve upon resumption of treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the first symptoms of hypersensitivity reactions occur, discontinue use of Xyzal Allergy and inform your doctor. Symptoms of hypersensitivity reactions 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 collapse or shock, which may lead to death.

Common: may occur in less than 1 in 10 patients
Dry mouth, headache, fatigue and drowsiness or somnolence

Uncommon: may occur in less than 1 in 100 patients
Feeling of exhaustion and abdominal pain

Frequency not known: frequency cannot be estimated from available data
Hypersensitivity, including anaphylactic shock

Other adverse reactions reported include: palpitations, increased heart rate, seizures, tingling, dizziness, fainting, tremor, taste disturbances (altered taste perception), sensation of spinning or swaying, visual disturbances, blurred vision, rotatory eye movements (involuntary circular eye movements), painful or difficult urination, inability to completely 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, restlessness and aggressive behaviour, hallucinations, depression, insomnia, recurring suicidal thoughts or interest in suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhoea.

Itching (intense pruritus) after discontinuation of the medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Xyzal Allergy

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Xyzal Allergy contains

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

What Xyzal Allergy looks like and contents of the pack
Xyzal Allergy is white or almost white, oval, film-coated tablets with the letter Y on one side.
The pack contains 10 film-coated tablets.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation 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