Cezera 5 mg film-coated tablets – levocetirizine for allergic rhinitis and urticaria

Cezera contains levocetirizine dihydrochloride, an anti-allergy medicine (systemic antihistamine, piperazine derivative). Levocetirizine is the R-enantiomer of cetirizine and blocks peripheral H1 receptors, relieving allergy symptoms.

In Serbia it is authorised as 5 mg film-coated tablets in packs of 10 tablets (KRKA, Novo Mesto, Slovenia; marketing authorisation holder KRKA-FARMA d.o.o. Belgrade). It is taken once a day.

What is Cezera used for and how is it taken correctly?

Key facts about the medicine

What is Cezera used for?

Cezera is intended for the symptomatic treatment of:

• allergic rhinitis, including persistent allergic rhinitis;
• urticaria (hives).

The medicine relieves allergy symptoms (e.g. sneezing, runny nose, itching) but does not treat the cause of the allergy.

How is it used and dosed?

• Adults and children aged 6 years and over: 1 tablet (5 mg) once daily.
• Swallow the tablet whole with water, with or without food.
• The duration of treatment depends on the type, duration and course of the condition and is decided by the doctor.

This is the general dosage from the leaflet – your dose and treatment duration are determined by your doctor.

Special patient groups

• Children under 6 years: the film-coated tablets are not recommended because the dose cannot be adjusted.
• Elderly (65 years and over): no dose change if kidney function is normal.
• Liver impairment only: usual dose.
• Kidney impairment: the dosing interval is adjusted according to creatinine clearance (in children also according to body weight):

Contraindications – when the medicine must not be used

• allergy to levocetirizine dihydrochloride, cetirizine, hydroxyzine, any other piperazine derivative or any of the excipients
• severe kidney impairment – creatinine clearance below 10 mL/min

Warnings and precautions

• Problems emptying the bladder (e.g. spinal cord injury, enlarged prostate) – ask your doctor for advice.
• Epilepsy or risk of convulsions – the medicine may worsen seizures.
• Before allergy skin tests, ask your doctor whether to stop treatment several days beforehand, as the medicine affects the results.
• Intense itching (pruritus) may occur after stopping the medicine, even if it was not present before.
• The medicine contains lactose – if you have an intolerance to some sugars, talk to your doctor.

Interactions with other medicines, food and drink

• Alcohol and medicines acting on the brain (e.g. sedatives) may further reduce alertness and performance in sensitive people – avoid alcohol and use caution with such medicines.
• The medicine can be taken with or without food.
• Tell your doctor or pharmacist about all medicines you take, including those bought without a prescription.

Pregnancy and breast-feeding

If you are pregnant, breast-feeding or planning pregnancy, ask your doctor before taking the medicine. According to the SmPC, use of levocetirizine during pregnancy may be considered if necessary (a large amount of data for cetirizine does not indicate harm to the baby). Levocetirizine probably passes into breast milk, so caution is needed in breast-feeding women.

Driving and using machines

Some patients may feel drowsy, tired and weak. Before driving or using machines, check how the medicine affects you. In special tests in healthy people, the recommended dose did not impair alertness or driving ability.

Possible side effects

• Common: dry mouth, headache, fatigue, drowsiness.
• Uncommon: exhaustion, abdominal pain.
• Frequency not known: palpitations and fast heartbeat, convulsions, pins and needles, dizziness, fainting, tremor, taste disturbance, visual problems and blurred vision, uncontrolled eye movements, painful or difficult urination and incomplete bladder emptying, swelling, itching, rash, hives, shortness of breath, weight gain, muscle and joint pain, aggressive behaviour or agitation, hallucinations, depression, insomnia, suicidal thoughts, nightmares, hepatitis and abnormal liver function, vomiting, increased appetite, nausea, diarrhoea; intense itching after stopping treatment.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: adults may become more drowsy; children may first become agitated and restless, then drowsy. Tell your doctor immediately.
• Missed dose: do not take a double dose; take the next dose at the usual time.
• Stopping treatment: should not have harmful effects, but intense itching may rarely occur, which may resolve by itself or require restarting the medicine – ask your doctor.

Related information

For additional care and support with allergy symptoms, see also the Anti-allergy preparations category – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: levocetirizine dihydrochloride 5 mg per tablet (4.21 mg levocetirizine).
• Excipients – core: lactose monohydrate; microcrystalline cellulose (E460); colloidal anhydrous silica; magnesium stearate (E572); coating (Opadry White 33G28707): lactose monohydrate; hypromellose 6cP; titanium dioxide (E171); macrogol 3000; triacetin (E1518).
• Pack: carton with 1 blister (OPA/Al/PVC-Al or PVC/PVDC-Al) of 10 film-coated tablets.
• Marketing authorisation holder: KRKA-FARMA D.O.O. BEOGRAD, Jurija Gagarina 26/V/II, Belgrade. Manufacturer: KRKA D.D., NOVO MESTO, Šmarješka cesta 6, Novo Mesto, Slovenia.

Storage

• This medicine does not require any special storage conditions.
• Keep out of the sight and reach of children.
• Do not use after the expiry date (shelf life: 3 years).

Frequently asked questions

Does Cezera cause drowsiness?

Drowsiness and fatigue are common side effects, but not everyone gets them. Check how the medicine affects you before driving and avoid alcohol.

Can Cezera be given to children?

The 5 mg film-coated tablets are for adults and children from 6 years (1 tablet a day). They are not recommended for children under 6 because the dose cannot be adjusted.

Should Cezera be stopped before allergy tests?

Yes, the medicine can affect the results of skin tests. Ask your doctor how many days beforehand to stop treatment.

Why does my skin itch after I stop taking the medicine?

According to the leaflet, intense itching may rarely occur after stopping treatment, even if it was not present before. It usually passes by itself; if it is severe, contact your doctor.

Sources

• ALIMS – Summary of Product Characteristics Cezera®, 5 mg, film-coated tablets (Serbian)
• ALIMS – Patient leaflet Cezera®, 5 mg, film-coated tablets (August 2020, Serbian)

Sources checked on: 24 October 2026.