Cezera

Package Leaflet: Information for the Patient

Cezera, 5 mg, Film-Coated Tablets

Levocetirizine Dihydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

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

Table of Contents of the Leaflet

• 1. What is Cezera and What is it Used For
• 2. Important Information Before Taking Cezera
• 3. How to Take Cezera
• 4. Possible Side Effects
• 5. How to Store Cezera
• 6. Package Contents and Other Information

1. What is Cezera and What is it Used For

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

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

2. Important Information Before Taking Cezera

When Not to Take Cezera:

• 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 disease requiring dialysis.

Warnings and Precautions

Before taking Cezera, discuss it with your doctor or pharmacist.
If you may have difficulty emptying your bladder (in conditions such as spinal cord injury or prostate enlargement), consult your doctor.
Cezera may exacerbate seizure attacks, so consult your doctor if you have epilepsy or a risk of seizures.
If you are scheduled to undergo allergy testing, ask your doctor if you should stop taking Cezera a few days before the test. The medicine may affect the results of allergy tests.

Children

Cezera film-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.

Cezera and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Cezera with Food, Drink, and Alcohol

Be cautious when taking Cezera with alcohol or other substances that affect brain function.
In sensitive patients, taking Cezera with alcohol or other substances that affect brain function may cause additional decreased alertness and reaction ability.
Cezera can be taken with or without food.

Pregnancy and Breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and Using Machines

Some patients taking Cezera may experience drowsiness and (or) fatigue, tiredness, and exhaustion. Be cautious when driving or operating machinery until you know how the medicine affects you. However, special tests conducted in healthy individuals did not show any impairment of concentration, reaction ability, or driving ability after taking levocetirizine at the recommended dose.

Cezera Contains Lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to Take Cezera

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The recommended dose for adults and children over 6 years is one tablet per day.

Dosing in Special Patient Groups:

Kidney and Liver Impairment
In patients with kidney impairment, the dose of Cezera may be reduced depending on the degree of kidney impairment. In children, the dose should also be adjusted according to body weight; the doctor will determine the dose of the medicine.
Cezera should not be taken by patients with severe kidney disease requiring dialysis.
Patients with only liver impairment should take the usual dose.
In patients with both kidney and liver impairment, the dose of Cezera may be reduced depending on the degree of kidney impairment, and in children, the dose will also be adjusted according to body weight; the doctor will determine the dose of the medicine.
Elderly Patients (65 Years and Over)
No dose adjustment is necessary for elderly patients with normal kidney function.

Use in Children

Cezera is not recommended for children under 6 years of age.

How and When to Take Cezera

Cezera is for oral use only.
Swallow the tablets whole with water. The tablets can 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.

Taking More than the Recommended Dose of Cezera

In adults, if a higher dose of Cezera is taken than recommended, drowsiness may occur.
In children, initial excitement and restlessness may occur, followed by drowsiness.
If you take more Cezera than you should, contact your doctor, who will decide what actions to take.

Missing a Dose of Cezera

If you miss a dose of Cezera 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 Cezera Treatment

Stopping Cezera treatment should not cause any harmful effects. However, in rare cases, itching (intense itching) may occur after stopping Cezera treatment, 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, Cezera can cause side effects, although not everybody gets them.

Common Side Effects (May Affect Up to 1 in 10 People):

Dry mouth, headache, fatigue, drowsiness, and (or) somnolence.

Uncommon Side Effects (May Affect Up to 1 in 100 People):

Exhaustion, abdominal pain.

Side Effects of Unknown Frequency (Frequency Cannot be Estimated from the Available Data):

Other side effects have also been reported, such as: palpitations, increased heart rate, seizure attacks, tingling and numbness, dizziness, fainting, tremors, taste disturbances (altered taste perception), 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, shortness of breath, weight gain, muscle pain, joint pain, aggression or excitement, hallucinations, depression, insomnia, recurrent suicidal thoughts or morbid preoccupation with suicide, nightmares, hepatitis, abnormal liver function test results, vomiting, increased appetite, nausea, and diarrhea. Itching (intense itching) after stopping Cezera treatment.
If you experience the first symptoms of a hypersensitivity reaction, stop taking Cezera immediately and contact your doctor. Symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face, and (or) throat, breathing or swallowing difficulties (chest tightness or wheezing), urticaria, sudden decrease in blood pressure leading to collapse or shock, which can be fatal.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 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 after "EXP". The expiry date refers to the last day of that month.
The batch number is stated on the packaging after "Lot".
There are no special storage precautions.
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. Package Contents and Other Information

What Cezera Contains

• The active substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate in the tablet core; lactose monohydrate, hypromellose 6cP, titanium dioxide (E171), macrogol 3000, and triacetin in the tablet coating. See section 2 "Cezera contains lactose".

What Cezera Looks Like and Contents of the Package

The tablets are film-coated, white, round, biconvex with beveled edges.
Packaging:20, 28, 30, and 90 film-coated tablets in blisters in a cardboard box

Marketing Authorization Holder:

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-Straße 5, 27472 Cuxhaven, Germany
To obtain more detailed information on the names of medicinal products in other EU member states, please contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of Last Revision of the Leaflet:14.03.2024