Zenaro

Package Leaflet: Information for the Patient

Zenaro, 5 mg, Film-Coated Tablets

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

• Keep this package 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, 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Zenaro and what is it used for

The active substance of Zenaro is levocetirizine dihydrochloride. Zenaro is an antiallergic medicine.
It is used for the treatment of symptoms associated with:

• allergic rhinitis, including chronic allergic rhinitis,
• urticaria (hives).

The medicine is intended for adults, adolescents, and children from 6 years of age.

2. Important information before taking Zenaro

When not to take Zenaro

• 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 problems requiring dialysis (estimated glomerular filtration rate below 15 ml/min).

Warnings and precautions

If you may have difficulty emptying your bladder (in conditions such as spinal cord injury or prostate enlargement), you should discuss this with your doctor or pharmacist before taking Zenaro.
Zenaro 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 whether you should stop taking Zenaro a few days before the test. This medicine may affect the results of allergy tests.

Children

Zenaro film-coated tablets are not recommended for children under 6 years of age, as it is not possible to adjust the dose with this formulation.

Zenaro and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Zenaro with food, drink, and alcohol

Be cautious when taking Zenaro with alcohol or other substances that affect brain function.
In sensitive patients, taking Zenaro with alcohol or other substances that affect brain function may cause additional drowsiness and impaired reaction time.
Zenaro can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Some patients taking Zenaro may experience drowsiness, fatigue, tiredness, and exhaustion. Be cautious when driving or operating machinery until you know how you react to the medicine. Special studies conducted with healthy volunteers after taking levocetirizine at the recommended dose did not show an effect on concentration, reaction time, or driving ability.

Zenaro contains lactose monohydrate and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Zenaro

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

The recommended dose for adults, adolescents, and children over 6 years of age is one film-coated tablet per day.
Dosing recommendations for special patient groups
In patients with kidney problems, 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.
Zenaro should not be taken by patients with severe kidney problems.
Patients with liver problems only should take the usual recommended dose.
In patients with both liver and kidney problems, 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.
In elderly patients (65 years and over), there is no need to adjust the dose if kidney function is normal.

How to take Zenaro

The medicine is for oral use only.
Swallow the tablets whole with water. The tablets can be taken with or without food.

How long to take Zenaro

The duration of treatment depends on the type, duration, and severity of the disease and is determined by your doctor.

Overdose of Zenaro

In adults, if a higher dose than recommended is taken, drowsiness may occur. In children, initial excitement and restlessness may occur, followed by drowsiness.
If you suspect that you have taken a higher dose than recommended, contact your doctor, who will decide what actions should be taken.

Missed dose of Zenaro

If you miss a dose 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 treatment with Zenaro

Stopping treatment with Zenaro should not cause any harm. However, in rare cases, itching (intense itching) may occur after stopping treatment with Zenaro, 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and seek immediate medical attention if you experience any of the following symptoms of an allergic reaction (hypersensitivity): swelling of the mouth, tongue, face, and (or) throat, or difficulty swallowing, along with skin rash, causing redness, swelling, and itching, difficulty breathing, a sudden drop in blood pressure leading to fainting or shock, which can be life-threatening.
The following side effects have been reported during treatment with levocetirizine (the active substance of Zenaro):

• Common (may affect up to 1 in 10 people): dry mouth, headache, fatigue, drowsiness, and (or) somnolence

Uncommon (may affect up to 1 in 100 people):

• exhaustion, abdominal pain

Frequency not known (cannot be estimated from the available data):

• 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 (pruritus), rash, urticaria (hives, redness, and itching of the skin), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, excitement and aggressive behavior, hallucinations, depression, insomnia, recurrent suicidal thoughts or suicidal ideation, nightmares, hepatitis, liver function disorders, vomiting, increased appetite, nausea, and diarrhea. Itching (intense itching) after stopping treatment with Zenaro.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl You can also report side effects to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zenaro

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original package to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging after 'EXP'. The expiry date refers to the last day of the month.
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 Zenaro contains

The active substance is levocetirizine dihydrochloride, 5 mg in each film-coated tablet.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (Type A), anhydrous colloidal silica, magnesium stearate, hypromellose 2910/5, macrogol 6000, talc, titanium dioxide (E171).

What Zenaro looks like and contents of the pack

Zenaro is almost white, elongated, biconvex film-coated tablets with 'e' embossed on one side.
Immediate packaging: Aluminum/Aluminum blister or PVC/Aclar/Aluminum blister or PVC/Aclar/PVC/Aluminum blister.
Outer packaging: cardboard box.

Pack sizes

The pack sizes are 7, 20, 28, 50, 90, 100 film-coated tablets.
This means 1 or 4 blisters, each containing 7 film-coated tablets, in one cardboard box, along with the patient information leaflet, or 2, 5, 9, or 10 blisters, each containing 10 film-coated tablets, in one cardboard box, along with the patient information leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

For further information, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
Phone: +48 22 375 92 00
Date of last revision of the leaflet:February 2025