Sezonia

Release Forms:

The composition 1 tablet:

  • active substance: levocetirizine;
  • 1 tablet contains levocetirizine dihydrochloride in terms of 100% substance 5 mg;
  • excipients: microcrystalline cellulose; lactose monohydrate; anhydrous colloidal silicon dioxide; magnesium stearate; coating: hypromellose; polyethylene glycol 6000; titanium dioxide (E171).

Dosage form. Film-coated tablets.

Basic physical and chemical properties: round tablets with a biconvex surface, film-coated white or almost white.

10 tablets in a blister; 1, 2, 3, or 10 glitter in a cardboard box.

10 tablets in a blister; 1, 2, 3, or 10 glitter in a cardboard box.

Indications for use.

Antihistamines for systemic use. Piperazine derivatives. Symptomatic treatment of allergic rhinitis (including annual allergic rhinitis) and urticaria.

Contraindications

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).
Rare hereditary conditions of galactose intolerance, lactase deficiency or impaired absorption of glucose and galactose.
The period of pregnancy or lactation.

Method of application.

The drug is administered orally, regardless of food intake. The tablet must be swallowed whole with a little water. It is recommended to apply the daily dose at one time.
The drug is prescribed for adults and children from 6 years of age.

Recommended doses
Adults and children over 12 years of age: the daily dose is 5 mg (1 film-coated tablet) once a day.

Elderly patients
Elderly patients with normal renal function do not need a dose adjustment.
Dose adjustment is recommended for elderly patients with moderate to severe renal impairment.
Patients with impaired renal function
For patients with impaired renal function, the dose should be calculated taking into account the degree of impaired renal function (creatinine clearance).
For children with impaired renal function, the dose of the drug should be adjusted individually, taking into account the patient’s renal clearance and body weight.
There are no specific data regarding the use of children with impaired renal function.
Patients with impaired liver function
Patients with exclusively hepatic impairment do not need dosage adjustment. For patients with hepatic and renal impairment, adjust the dosage in accordance with the above table.
Pediatric population
For children from 6 to 12 years old: the recommended daily dose is 5 mg (1 film-coated tablet).
For children from 2 to 6 years old, it is impossible to adjust the dose of the drug in this dosage form (film-coated tablet). It is recommended to take levocetirizine in a different dosage form suitable for pediatric use.
Duration of use
Patients with recurrent allergic rhinitis (duration of symptoms of the disease is less than 4 days per week or for less than 4 weeks per year) should be treated according to the disease and history; treatment can be discontinued if symptoms disappear and can be restored if symptoms recur. In the case of persistent allergic rhinitis (the duration of the symptoms of the disease is more than 4 days per week and for more than 4 weeks per year) during the period of contact with allergens, the patient may be offered continuous therapy. There is clinical experience with levocetirizine for a minimum 6-month treatment period. In chronic diseases (chronic allergic rhinitis, chronic urticaria), the duration of treatment is up to 1 year (data from clinical studies of the use of racemate).

Children.
The drug in the form of tablets is not used in children under 6 years of age, since this dosage form does not make it possible to carry out the necessary dosage adjustment. For this category of patients, it is recommended to prescribe levocetirizine in another dosage form suitable for use in pediatrics.