Cetrine syrup 2.5 mg/5 ml bottle of 50 ml

• active ingredient: levocetirizine dihydrochloride;
• 5 ml of syrup contains levocetirizine dihydrochloride 2.5 mg;
• Excipients: sugar; methyl parahydroxybenzoate (E 218); propyl parahydroxybenzoate (E 216); disodium edetate; sodium citrate; anhydrous citric acid; sorbitol solution, non-crystallizing (E 420); glycerin; sunset yellow FCF (E 110); orange flavor RS 15215; purified water.

Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, to any other piperazine derivatives or to any other excipient of the drug.

Severe chronic renal failure (creatinine clearance < 10 ml/min).

Immune system disorders: frequency unknown: hypersensitivity, including anaphylaxis.

Nutrition and metabolism disorders: frequency unknown: increased appetite.

Nervous system: frequency unknown: drowsiness, headache, fatigue, weakness, asthenia, convulsions, paresthesia, dizziness, fainting, tremor, dysgeusia.

Psychiatric: frequency unknown: sleep disturbances, agitation, hallucinations, depression, aggression, insomnia, suicidal thoughts, nightmares.

Cardiac disorders: frequency unknown: palpitations, tachycardia.

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

From the side of the organs of hearing and balance: frequency unknown: vertigo.

Hepatobiliary disorders: frequency unknown: hepatitis.

Renal and urinary disorders: frequency unknown: dysuria, urinary retention.

Respiratory, thoracic and mediastinal disorders: frequency unknown: shortness of breath.

On the part of the digestive tract: frequency unknown: nausea, vomiting, diarrhea, constipation, dry mouth, abdominal pain.

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

The drug is prescribed to adults and children aged 2 years and older.

The drug can be taken regardless of food intake.

Recommended doses:

• adults and adolescents aged 12 years and over: the recommended daily dose of the drug is 5 mg (10 ml) once a day;
• Children aged 2 to 6 years: the recommended daily dose of the drug is 2.5 mg (5 ml). This dose should be administered as 1.25 mg (2.5 ml) 2 times a day;
• Children aged 6 to 12 years: the recommended daily dose of the drug is 5 mg (10 ml) once a day.

Patients with intermittent allergic rhinitis (symptoms present for less than 4 days per week or less than 4 weeks per year) should be treated according to the course of the disease and the history: treatment can be stopped if the symptoms disappear and can be resumed if the symptoms recur. In case of persistent allergic rhinitis (symptoms present for more than 4 days per week or more than 4 weeks per year), the patient can be offered continuous therapy during the period of contact with allergens. There is clinical experience with levocetirizine for a treatment period of at least 6 months. 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

If necessary, the use of levocetirizine during pregnancy may be considered.

Caution should be exercised when prescribing levocetirizine to breastfeeding women.

Children

The use of levocetirizine in children under 2 years of age is not recommended due to limited data in this age group.

The drug should be used in children over 2 years of age.

Ability to influence reaction speed when driving vehicles or other mechanisms

Patients who intend to drive, engage in potentially hazardous activities, or operate machinery should take into account their reaction to the drug.

Symptoms: Symptoms of overdose may include drowsiness in adults and initial agitation and increased irritability followed by drowsiness in children.

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

Interaction studies (including studies with CYP3A4 inducers) have not been conducted with levocetirizine. Studies with cetirizine (racemate) have shown that concomitant use with antipyrine, azithromycin, cimetidine, diazepam, erythromycin, glipizide, ketoconazole or pseudoephedrine does not cause clinically significant adverse interactions. With concomitant use with theophylline (400 mg daily), a small decrease (by 16%) in the total clearance of levocetirizine was observed (theophylline distribution was not changed). In a study of multiple doses of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the extent of cetirizine exposure increased by approximately 40%, while the distribution of ritonavir was slightly changed (-11%) with concomitant use of cetirizine.

Eating does not affect the extent of absorption of the drug, but reduces the rate of its absorption.

Concomitant use of cetirizine or levocetirizine and alcohol or other central nervous system depressants in susceptible patients may cause additional impairment of alertness and ability to perform work.

Storage conditions

Store in original packaging at a temperature not exceeding 30 ° C. Keep out of the reach of children.