Reksalti - antipsychotic means (neuroleptic) for treatment of schizophrenia.

Each tablet contains

:

• active ingredient: brekspiprazol 4 mg;
• excipients: lactoses monohydrate of 47.4 mg / 45.4 mg, starch of corn 20.0 mg / 20.0 mg, cellulose of microcrystalline 10.0 mg / 10.0 mg, a hypro rod low-substituted 10.0 mg / 10.0 with mg, a hypro rod of 1.0 mg / 1.0 in mg, magnesium stearate of 0.6 mg / 0.6 in mg;
• film cover: Opadray 03A420002 of yellow 3.0 mg (gipromelloz 2910, talc, titan dioxide (E171), ferrous oxide yellow (E172)).

Contraindication

• Hypersensitivity to a brekspiprazol or any component as a part of medicine.
• Hereditary intolerance of a galactose, insufficiency of lactase, glucose galactose absorption disturbance.
• Children's and teenage age up to 18 years (safety and efficiency are not established).
• Use of medicament for patients with the established slow metabolism connected with activity of an isoenzyme of CYP2D6 accepting strong/moderate inhibitors of an isoenzyme CYP3A4.
• Use of medicament for the patients accepting strong/moderate inhibitors of an isoenzyme CYP2D6 in combination with strong/moderate inhibitors of an isoenzyme CYP3A4.

  Side effect

  Most frequent undesirable reactions the akathisia (5.6%) and increase in body weight (3.9%) were li>.

  Route of administration

  Drug Reksalti is taken inside once a day irrespective of meal.

  Recommended initial dose of medicament makes 1 mg in the period of 1-4 day once a day. Range of the recommended doses is from 2 mg to 4 mg once a day. The dose is increased to 2 mg in the period of 5-7 day once a day, and then increase up to 4 mg for the 8th day depending on the clinical response of the patient to treatment and shipping of treatment once a day. The maximum recommended dose makes 4 mg a day.

  Use at pregnancy and during breastfeeding

  Use of the medicament Reksalti is not recommended to

  Feature of use

  by

  at pregnant women and at the women of childbearing age who are not using contraceptive.

  needs to make the decision on the termination of breastfeeding or on termination/refusal of Reksalti's therapy, considering advantage of breastfeeding for the child and advantage of therapy for mother.

  Children

  Efficiency and safety of a brekspiprazol at children and teenagers up to 18 years are not established to

  by

  .

  Influence on ability to run vehicles, mechanisms

  Brekspiprazol has small or moderate impact on ability to drive the car and to work with mechanisms owing to possible effects from nervous system, for example, of development of sedation and/or dizziness which are frequent undesirable reactions at use of a brekspiprazol.

  Overdose

  Gastric lavage and purpose of the means causing vomiting can be useful right after overdose. It is necessary to conduct the ECG a research and at identification of the extended interval of QT to appoint cardiomonitoring.

  Is recommended to carry out by

  maintenance therapy directed to maintenance of passability of airways, oxygenation and ventilation of the lungs, symptomatic therapy. Careful medical observation and monitoring have to be carried out up to recovery of the patient.

  Intake of activated carbon and sorbitol (50 g / 240 ml) inside in an hour after oral administration of a brekspiprazol in a dose of 2 mg lowered Cmax and AUC of a brekspiprazol approximately by 5%-23% and for 31%-39%, respectively. However, sufficient information on therapeutic opportunities of use of activated carbon for treatment of overdose of a brekspiprazol is absent.

  Information on efficiency of a hemodialysis at overdose of a brekspiprazol is absent, but it is improbable that the hemodialysis will be useful at overdose as it brekspiprazol considerably contacts proteins of plasma.

  Storage conditions

  At a temperature not above 30 °C.

  to Store

  out of children's reach.