Cezera

Package leaflet: information for the patient

Warning! Keep the leaflet! Information on the immediate packaging is in a foreign language.
Cezera
5 mg, coated tablets
Levocetirizini dihydrochloridum
Please read the following instructions carefully before using the medicine, as they contain
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Cezera is and what it is used for

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

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

2. Important information before using Cezera

When not to use Cezera:

• 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 renal disease requiring dialysis.

Warnings and precautions
Before starting treatment with Cezera, discuss this with your doctor or pharmacist.
If the patient may have difficulties in emptying the bladder (in conditions such as: spinal cord injury or benign prostatic hyperplasia), medical advice should be sought.
Cezera may increase the frequency of epileptic seizures; therefore, consult your 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 discontinue Cezera a few days before the tests. The medicine may influence the results of allergy tests.
Children
Administration of Cezera coated tablets is not recommended in children under 6 years of age, because appropriate dose adjustment is not possible with this formulation.
Cezera with other medicines
Inform 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.
Cezera with food, drink and alcohol
Exercise caution when taking Cezera together with alcohol or other substances affecting brain function.
In sensitive patients, concomitant use of Cezera with alcohol or other substances affecting brain function may additionally reduce alertness and reaction ability.
Cezera may be taken with or without food.
Pregnancy and breastfeeding
During pregnancy or breastfeeding, or if the woman suspects she may be pregnant or is planning a pregnancy, consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Some patients taking Cezera may experience drowsiness and/or somnolence, fatigue, and exhaustion. Exercise caution when driving or operating machinery until your reaction to the medicine is known. However, specific tests conducted in healthy subjects did not reveal impairment of concentration, reaction ability, or driving skills after administration of levocetirizine at the recommended dose.
Cezera contains monohydrate lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Cezera

This medicine should always be used according to the doctor's instructions. If in doubt, consult your
doctor or pharmacist.
The recommended dose for adults and children aged 6 years and older is one tablet per day.
Dosage in special patient groups:
Renal and hepatic impairment
In patients with impaired renal function, the dose of the medicine may be reduced depending on the
degree of renal impairment. In children, the dose should also be adjusted according to body weight; the doctor will determine the dose.
Cezera must not be used in patients with severe renal disease requiring dialysis.
Patients with hepatic impairment alone should usually receive the standard dose.
In patients with both hepatic and renal impairment, the dose of the medicine may be reduced depending on the degree of renal impairment, and in children the dose will additionally be adjusted according to body weight; the doctor will determine the dose.
Elderly patients (65 years and older)
Dosage adjustment is not necessary in elderly patients if renal function is normal.
Use in children
Cezera is not recommended for use in children under 6 years of age.
How and when to take Cezera
For oral use only.
Tablets should be swallowed whole with water. Tablets may be taken with or without food.
How long to take Cezera
The duration of treatment depends on the type, duration and severity of the disease symptoms and is determined by the doctor.
Overdose of Cezera
In adults, taking a higher than recommended dose of Cezera may cause drowsiness.
In children, initial excitation and restlessness may occur, followed by drowsiness.
If a higher than recommended dose of Cezera has been taken, contact your doctor, who will decide what actions should be taken.
Missed dose of Cezera
If a dose of Cezera is missed or a lower than recommended dose has been taken, do not take a double dose to make up for the missed dose. In this case, take the next dose at the usual time.
Discontinuation of Cezera
Stopping treatment with Cezera should not cause harmful effects. However, in rare cases, itching (intense pruritus) may occur after discontinuation of Cezera, even if these symptoms were not present before starting treatment. These symptoms may resolve spontaneously. In some cases, symptoms may be severe and it may be necessary to resume treatment. These symptoms should resolve after resuming 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.
Common adverse reactions (may occur in up to 1 in 10 patients):
Dry mouth, headache, fatigue, drowsiness and (or) somnolence.
Uncommon adverse reactions (may occur in up to 1 in 100 patients):
Exhaustion, abdominal pain.
Adverse reactions with unknown frequency (frequency cannot be estimated from
the available data):
Other adverse reactions have also been reported, such as: palpitations, increased heart rate,
seizure attacks, tingling and numbness, dizziness, fainting, tremors, 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 urinary bladder, swelling, itching, rash, urticaria (swelling, redness and itching of the skin), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, aggression or agitation, hallucinations, depression, insomnia, recurring suicidal thoughts or morbid preoccupation with suicide, nightmares, hepatitis, abnormal liver function test results, vomiting, increased appetite, nausea and diarrhoea. Itching (intense pruritus) upon discontinuation of Cezera.
If first signs of hypersensitivity reactions occur, treatment with Cezera should be discontinued immediately and medical advice should be sought. Symptoms of hypersensitivity reactions may include: swelling of the lips, tongue, face and (or) throat, breathing or swallowing difficulties (chest tightness or wheezing), urticaria, sudden drop in blood pressure leading to collapse or shock, which may be fatal.
Reporting of adverse reactions
If any adverse reactions occur, including any 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, 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Cezera

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Cezera contains

• The active substance is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate. Coating: monohydrate lactose, hypromellose 6cP, titanium dioxide (E 171), macrogol 3000 and triacetin. See section 2. "Cezera contains monohydrate lactose".

What Cezera looks like and contents of the pack
The tablets are coated, white, round, biconvex with bevelled edges.
Packaging: 20, 30 and 90 coated tablets in blisters, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto, Slovenia
Manufacturer:
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto, Slovenia
TAD Pharma GmbH
Heinz-Lohmann-Str. 5
27472 Cuxhaven, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in the Czech Republic, country of export: 24/247/08-C
Parallel import authorisation number: 68/21