Instruction for use: Calixta

Dosage form: capsules

Active substance: Mirtazapine*

ATX

N06AX11 Mirtazapin

Pharmacological groups:

Antidepressant

The nosological classification (ICD-10)

F32 Depressive episode: Adynamic subdepression; Astheno-adynamic subdepressive states; Asthenoadressive disorder; Astheno-depressive disorder; Asthenodepressive state; Astheno-depressive state; Major Depressive Disorder; Vyaloapatichesky depression with retardation; Double Depression; Depressive pseudodement; Depressive illness; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive disorders; Depressive syndrome; Depressive syndrome larviated; Depressive syndrome in psychoses; Depressed masks; Depression; Depression Depletion; Depression with the phenomena of inhibition within the framework of cyclothymia; Depression is smiling; Involutional depression; Involutionary melancholy; Involutional depression; Manic-depressive disorder; Masked Depression; Melancholic Attack; Neurotic depression; Neurotic depression; Shallow Depression; Organic depression; Organic depressive syndrome; Simple depression; Simple melancholic syndrome; Psychogenic depression; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Reactive depression; Recurrent depression; Seasonal depressive syndrome; Severostatic depression; Senile Depression; Symptomatic Depression; Somatogenic depression; Cyclotymic depression; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F33 Recurrent depressive disorder: Major depressive disorder; Secondary depression; Double Depression; Depressive pseudodement; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive syndrome; Depressed masks; Depression; Depression is smiling; Involutional depression; Involutional depression; Masked Depression; Melancholic Attack; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

Composition

Tablets covered with a film membrane 1 tab.

active substance:

mirtazapine 15 mg; 30 mg; 45 mg

auxiliary substances: lactose monohydrate - 44,4 / 88,8 / 133,2 mg; corn starch - 8/56/84 mg; giprolose - 15/30/45 mg; MCC - 15/30/45 mg; pregelatinized starch - 15/30/45 mg; talc - 1,4 / 2,8 / 4,2 mg; magnesium stearate - 0.7 / 1.4 / 2.1 mg; silicon dioxide colloidal - 0.5 / 1 / 1.5 mg

membrane film: hypromellose (5cps) - 2.4 / 4.8 / 7.2 mg; macrogol 6000 - 0.2 / 0.4 / 0.6 mg; titanium dioxide - 0.25 (0.5 / 1.05 mg; talc - 0.05 / 0.1 / 0.15 mg; ferric iron oxide yellow (E172) (for dosages of 15 and 30 mg) - 0.1 / 0.15 mg; ferric oxide red oxide (E172) (for a dosage of 30 mg) - 0.05 mg

Pharmachologic effect

Pharmacological action - antidepressant.

Dosing and Administration

Inside, not liquid, squeezed a small amount of liquid.

Adults. The effective daily dose is usually from 15 to 45 mg; initial - 15 or 30 mg.

Special patient groups

Elderly patients. The recommended dose is similar to that for adult patients. To achieve a satisfactory effect and to ensure safety, an increase in the dose to elderly patients should be carried out under the direct supervision of a physician.

Impaired renal function. The clearance of mirtazapine may be reduced in patients with moderate or severe renal impairment (Cl creatinine <40 mL / min). This should be taken into account when appointing Calixta® to this group of patients.

Violation of the function of the liver. The clearance of mirtazapine may be reduced in patients with impaired hepatic function. This should be taken into account in the appointment of Calixt® to this group of patients, especially in cases of severe impairment of liver function. The use of mirtazapine in this group of patients has not been studied.

Calixta ® can be taken once a day, preferably at the same time, at bedtime, or twice a day, dividing the daily dose into two doses (morning and night, the higher dose should be taken at night). Treatment should be continued for as long as possible for 4-6 months until the symptoms disappear completely; after that it can be gradually canceled.

Mirtazapine begins to exert its effect usually after 1-2 weeks of treatment. Treatment with an adequate dose should lead to a positive result within 2-4 weeks. If there is insufficient clinical response to treatment, the dose may be increased to the maximum (45 mg). If there is no response to treatment for an additional 2-4 weeks, it should be discontinued.

Release form

Tablets, film-coated, 15 mg. For 30 tablets. in an aluminum / PVC / PVDC blister. 1 bl. placed in a cardboard box.

Tablets, film-coated, 30, 45 mg. For 15 tables, in an aluminum / PVC / PVDC blister. 2 bl. placed in a cardboard box.

Conditions of leave from pharmacies

On prescription.

Storage conditions for Calixta

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of Calixta

3 years.

Do not use after the expiry date printed on the package.