Lazine film-coated tablets 5 mg 3 blisters of 10 pcs.

• active ingredient: levocetirizine;
• 1 tablet contains levocetirizine dihydrochloride 5 mg;
• excipients: microcrystalline cellulose, colloidal anhydrous silica, lactose monohydrate, magnesium stearate, OpadryWhite YS-1-7003 (hypromellose (E 464), titanium dioxide (E 171), polysorbate, macrogol 400).

• hypersensitivity to the active substance, cetirizine, hydroxyzine or to any other piperazine derivatives, as well as to any excipient of the medicinal product;
• severe chronic renal failure (creatinine clearance <10 ml/min).

Immune system disorders: hypersensitivity, including anaphylaxis.

Nutrition and metabolism disorders: increased appetite.

On the part of the psyche: aggression, agitation, hallucinations, depression, insomnia, suicidal thoughts, terrible dreams. 

Nervous system: convulsions, paresthesias, dizziness, fainting, tremor, dysgeusia.

From the organs of hearing and balance: vertigo.

On the part of the organs of vision: visual impairment, blurred vision.

Cardiac: palpitations, tachycardia.

Respiratory, thoracic and mediastinal disorders: dyspnea.

Gastrointestinal: nausea, vomiting, diarrhea.

Hepatobiliary disorders: hepatitis.

Renal and urinary disorders: dysuria, urinary retention.

Skin and subcutaneous tissue disorders: angioedema, persistent drug eruptions, pruritus, rash, urticaria.

Musculoskeletal, connective tissue and bone disorders: myalgia, arthralgia.

General disorders and administration site conditions: edema.

Research results: weight gain, abnormal liver function tests.

The drug is prescribed to adults and children aged 6 years and older orally in a daily dose of 5 mg once a day.

Take the tablet with food or on an empty stomach, without chewing, with a small amount of water.

Duration of use: Patients with intermittent allergic rhinitis (duration of symptoms less than 4 days per week or less than 4 weeks) should be treated according to the disease and history; treatment can be stopped if symptoms disappear and can be resumed again if symptoms recur. In case of persistent allergic rhinitis (duration of symptoms more than 4 days per week or more than 4 weeks) the patient may be offered continuous therapy during the period of contact with allergens. In chronic diseases (chronic allergic rhinitis, chronic urticaria) the duration of treatment is up to 1 year (data are available from clinical studies using the racemate).

Use during pregnancy or breastfeeding

Levocetirizine is contraindicated during pregnancy.

Cetirizine, the racemate of levocetirizine, has been shown to be excreted in human milk. Therefore, it is likely that levocetirizine is excreted in breast milk. Adverse reactions associated with levocetirizine may occur in breastfed infants. Therefore, if necessary, breast-feeding should be discontinued.

Children

The drug in tablet form should not be used in children under 6 years of age, as this dosage form does not allow for the necessary correction of the dosage regimen. For this category of patients, the use of levocetirizine in a dosage form suitable for use in pediatrics is recommended.

Ability to influence reaction speed when driving or using other mechanisms

Comparative clinical trials have not revealed any evidence that levocetirizine at the recommended dose impairs mental alertness, reaction time or the ability to drive.

However, some patients may experience drowsiness, fatigue and asthenia during treatment with levocetirizine. Therefore, patients who intend to drive vehicles, engage in potentially hazardous activities or operate machinery should take into account their reaction to the drug.

Symptoms of overdose: may include drowsiness in adults; children may initially experience agitation and restlessness, then drowsiness.

Treatment. In case of symptoms of overdose, symptomatic and supportive therapy is recommended. Gastric lavage should be considered shortly after administration. There is no specific antidote. Hemodialysis is not effective in removing levocetirizine from the body.

Store in the original packaging at a temperature not exceeding 25 ºС, out of the reach of children.