Zenaro

Package leaflet: Information for the patient

Zenaro, 5 mg, film-coated tablets
Levocetirizini dihydrochloridum
Please read the entire leaflet carefully before using this medicine, because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Zenaro is and what it is 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 Zenaro is and what it is used for

The active substance in Zenaro is levocetirizine dihydrochloride. Zenaro is an antiallergic medicine. It is used to treat symptoms associated with:

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

This medicine is intended for adults, adolescents, and children aged 6 years and older.

2. Important information before using Zenaro

When not to use Zenaro

• If the patient is allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has severe kidney function impairment requiring dialysis (estimated glomerular filtration rate below 15 ml/min).

Warnings and precautions
If the patient has difficulty emptying the bladder (in conditions such as spinal cord injury or benign prostatic hyperplasia), consult a doctor or pharmacist before starting treatment with Zenaro.
Zenaro may increase the risk of seizures. Therefore, consult a doctor if the patient has epilepsy or is at risk of seizures.
If the patient has planned allergy testing, ask the doctor whether the patient should stop taking Zenaro a few days before the tests. This medicine may affect the results of allergy tests.

Children
Zenaro coated tablets are not recommended for children under 6 years of age, because appropriate dose adjustment is not possible with this formulation.

Zenaro with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Zenaro, food, drink and alcohol
Exercise caution when taking Zenaro together with alcohol or other substances affecting brain function.
In sensitive patients, concomitant use of Zenaro with alcohol or other substances affecting brain function may additionally reduce alertness and reaction abilities.
Zenaro may be taken with or without food.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Some patients treated with Zenaro may experience drowsiness, somnolence, fatigue, or exhaustion. Exercise caution when driving or operating machinery until the patient's response to the medicine is known. Specific studies conducted in healthy volunteers receiving levocetirizine at the recommended dose did not show any effect of the medicine on concentration, reaction ability, or driving performance.

Zenaro contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Zenaro

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Dosage
The recommended dose for adults, adolescents, and children above 6 years of age is 1 coated tablet
per day.
Dosage recommendations for specific patient groups
In patients with impaired renal function, dose reduction may be necessary depending on the
severity of kidney disease. In children, the dose should also be adjusted according to body weight.
The physician will determine the appropriate dose.
Zenaro must not be used in patients with severe renal impairment.
Patients with liver function disorders alone should usually receive the standard recommended dose.
In patients with both hepatic and renal function disorders, a lower dose may be required depending
on the severity of kidney disease. In children, the dose should also be adjusted according to body
weight. The physician will determine the appropriate dose.
In elderly patients aged 65 years and older, dosage adjustment is not necessary if renal function is
normal.
Use in children
Zenaro is not recommended for use in children under 6 years of age.
How to take Zenaro
For oral use only.
Tablets should be swallowed whole with water. Tablets may be taken with or without food.
Duration of treatment with Zenaro
The treatment duration depends on the type, duration, and severity of disease symptoms and is
determined by the physician.
Use of a higher than recommended dose of Zenaro
In adults, administration of a higher than recommended dose of Zenaro may cause drowsiness. In
children, initial excitation and restlessness may occur, followed by drowsiness.
If an overdose of Zenaro is suspected, consult a physician immediately to determine the necessary
actions.
Missed dose of Zenaro
If a dose of Zenaro is missed or a lower than prescribed dose is taken, do not take a double dose to
make up for the missed dose. Instead, take the next dose at the usual time.
Discontinuation of Zenaro
Discontinuation of Zenaro should not cause harmful effects. However, in rare cases, pruritus (intense
itching) may occur after stopping Zenaro, even if these symptoms were not present before starting
treatment. These symptoms may resolve spontaneously. In some cases, symptoms may be severe
and treatment re-initiation may be necessary. These symptoms should resolve upon resumption of
treatment.
If you have any further questions about the use of this medicine, consult your physician or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment should be discontinued and immediate medical advice sought if the first signs of hypersensitivity (allergic reaction) to Zenaro occur. Symptoms of hypersensitivity include: swelling of the oral cavity, tongue, face and (or) throat or difficulty swallowing, accompanied by a skin reaction causing local redness, swelling and itching, breathing difficulties, sudden drop in blood pressure leading to collapse or shock, which may result in death.

The following adverse reactions have been observed during treatment with levocetirizine (the active substance in the medicine):

Common (may affect fewer than 1 in 10 people):

• dry mouth, headache, fatigue, drowsiness and (or) somnolence

Uncommon (may affect fewer than 1 in 100 people):

• exhaustion, abdominal pain

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

• palpitations, increased heart rate, convulsions, paraesthesia, dizziness, fainting, tremor, taste disturbances (altered taste perception), sensation of spinning or swaying,
  visual disturbances, blurred vision, nystagmus (uncontrolled circular eye movements), painful or difficult urination, inability to completely empty the bladder, swelling, itching (pruritus), rash, urticaria (skin swelling, redness and itching), skin eruptions, dyspnoea, weight gain, muscle pain, joint pain, restlessness and aggressive behaviour, hallucinations, depression, insomnia, recurrent suicidal thoughts or suicidal ideation, nightmares, hepatitis, hepatic function abnormalities, 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 not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
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 authorisation holder or its representative in Poland.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Zenaro

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date (EXP):". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 coated tablet.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch
(Type A), colloidal anhydrous silica, magnesium stearate, hypromellose 2910/5,
macrogol 6000, talc, titanium dioxide (E171).

What Zenaro looks like and contents of the pack
Zenaro is an almost white, elongated, biconvex coated tablet with the letter "e" engraved on one side.
Immediate packaging: Aluminium/Aluminium blister or PVC/Aclar/Aluminium blister or
PVC/Aclar/PVC/Aluminium blister.
Outer packaging: cardboard box.

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

Marketing Authorisation Holder and Manufacturer
Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For more detailed information, please contact the representative of the
responsible entity in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00