Instruction for use: Stimuloton

Dosage form: coated tablets

Active substance: Sertaline*

ATX

N06AB06 Sertalin

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

F40.0 Agoraphobia: Fear of open space; Fear of being in a crowd

F41.0 Panic disorder [episodic paroxysmal anxiety]: Panic state; Panic attack; Panic; Panic disorders

F41.2 Mixed anxiety and depressive disorder: Depression with anxiety-depressive components; Mixed anxiety-depressive conditions; Anxiety Depression; Anxious and depressing mood; Anxiety-depressive state; Anxious-depressive conditions; Anxiety-depressive syndrome; Anxious-Neurotic Conditions

F42 Obsessive-compulsive disorder: Obsessive-compulsive syndrome; Obsessive compulsive states; Obsessive-compulsive syndrome; The Obsession Syndrome; The obsession neurosis; Obsessive-compulsive neurosis; Obsessions

F43.1 Post-traumatic stress disorder: Combat fatigue; Catastrophe Syndrome; The survivor's syndrome; Traumatic isolation; Traumatic neurosis; Traumatic syndrome; Post-Traumatic Stress Disorder

Composition

Tablets covered with a film membrane 1 tab.

active substance:

sertraline hydrochloride 55.95 mg; 111.9 mg

(equivalent to 50 and 100 mg sertraline, respectively)

auxiliary substances: magnesium stearate - 2/4 mg; giprolose (hydroxypropylcellulose) - 6.05 (12.1 mg; sodium carboxymethyl starch (type A) - 20/40 mg; calcium hydrophosphate dihydrate - 24/48 mg; MCC - 45/90 mg

membrane film: Macrogol 6000 - 800 mcg / 1.6 mg; titanium dioxide C.I. 77891 (EEC 171) 1.3 / 2.6 mg; hypromellose - 2.9 / 5.8 mg

Pharmachologic effect

Pharmacological action - antidepressant.

Dosing and Administration

Inside, 1 time per day (morning or evening).

Adult treatment for depression and obsessive-compulsive disorder: The usual dose is 50 mg 1 time per day.

To reduce the frequency and severity of side effects in patients with panic disorders or post-traumatic stress disorders, it is recommended to start treatment with a dose of 25 mg once a day and after 1 week increase the dose to 50 mg once a day.

With an unsatisfactory therapeutic effect and good tolerability, the daily dose can be increased by 50 mg for several weeks to a maximum daily dose of 200 mg. Therapeutic effect may occur within 7 days. However, usually for a full manifestation of antidepressant effect it takes from 2 to 4 weeks. With obsessive-compulsive disorder, the therapeutic effect develops even more slowly. For maintenance therapy, the minimum effective dose should be given.

Children aged 13-18 years with obsessive-compulsive disorder: Stimuloton® should be prescribed starting at a dose of 50 mg / day. For children with obsessive-compulsive disorder at the age of 6-12 years, an initial dose of 25 mg per day is recommended, which after 1 week can be increased to 50 mg per day. With an unsatisfactory therapeutic response, you can then increase the dose weekly at 50 mg / day to a maximum daily dose of 200 mg. However, in order to avoid an overdose with a dose increase of more than 50 mg, it should be borne in mind that the body weight in children is less than in adults. With prolonged maintenance therapy, the lowest effective doses should be given.

Special Groups

There is no need for dose adjustment for elderly patients.

Patients with impaired liver function require special attention in the treatment of sertraline. If the liver function is severely impaired, the dose of the drug should be reduced or the intervals between doses should be increased.

In patients with impaired renal function, no special dose selection is required.

Release form

Tablets, film-coated, 50 mg. For 10 tab. in a blister of PVC / PVDC / aluminum foil. 1, 2 or 3 blisters in a cardboard box.

Tablets, film-coated, 100 mg. According to Table 14. in a blister of PVC / PVDC / aluminum foil. 1 or 2 blisters in a cardboard bundle.

Conditions of leave from pharmacies

On prescription.

Conditions of leave from pharmacies

On prescription.

Storage conditions for Stimuloton

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of Stimuloton

5 years.

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