Instruction for use: Egolanza

Dosage form: tablets

Active substance: Olanzapine*

ATX

N05AH03 Olanzapine

Pharmacological group:

Neuroleptics

The nosological classification (ICD-10)

F20 Schizophrenia: Schizophrenic conditions; Exacerbation of schizophrenia; Schizophrenia; Chronic schizophrenia; Dementia praecox; Bleuler's disease; Psychotic discordant; Dementia early; The febrile form of schizophrenia; Chronic schizophrenic disorder; Psychosis of the schizophrenic type; Acute form of schizophrenia; Acute schizophrenic disorder; Cerebral Organic Insufficiency in Schizophrenia; Acute attack of schizophrenia; Schizophrenic psychosis; Acute schizophrenia; Sluggish schizophrenia; Sluggish schizophrenia with apathoabulic disorders; Acute stage of schizophrenia with excitation

F30 Manic episode: Manic-depressive disorder; Manic agitation; Manic state; Manic conditions; A manic condition; Manic syndrome; Acute manic syndrome

F30.1 Mania without psychotic symptoms

F30.2 Mania with psychotic symptoms: Delusional mania

F31 Bipolar affective disorder: Mood disorders bipolar; Affective bipolar psychosis; Manic-melancholic psychosis; Intermittent psychosis; Circular psychosis; Cyclophrenia; Bipolar disorders; Bipolar psychosis; Affective insanity; Manic-depressive syndrome; Psycho Manic-Depressive; Depressive episode of bipolar disorder

Composition

Tablets covered with a film membrane 1 tab.

active substance:

olanzapine dihydrochloride trihydrate 7.03 mg; 14.06 mg

(equivalent to 5 mg, 10 mg of olanzapine, respectively)

Excipients

core: MCC - 40,99 / 81,97 mg; lactose monohydrate - 40.98 (81.97 mg; giprolose (hydroxypropylcellulose) - 5/10 mg; crospovidone - 5/10 mg; magnesium stearate - 1/2 mg

membrane film: hypromellose - 1,4 / 2,4 mg; dye quinoline yellow - 0.014 / 0.023 mg; Opadry Y-1-7000 white - 2.79 / 4.68 mg: hypromellose - 62.5%; titanium dioxide - 31.25%; Macrogol 400 - 6.25%

Pharmachologic effect

Pharmacological action - antipsychotic.

Dosing and Administration

Inside, regardless of food intake, once - 5-20 mg / day.

In schizophrenia in adults, the recommended initial dose is 10 mg / day.

In acute mania associated with bipolar disorders, adults - 15 mg / day (1 time) as monotherapy or 10 mg / day (1 time) in combination with drugs Li + or valproic acid (maintenance therapy at the same dose).

Prevention of recurrence of bipolar disorder: the recommended initial dose is 10 mg per day. Patients who previously received olanzapine to treat a manic episode should continue treatment at the same dose to prevent relapse. In the presence of a new manic, mixed or depressive episode, taking olanzapine should be continued (if necessary, specifying the dose); In the presence of clinical indications should additionally prescribe drugs to eliminate mood disorders.

In the treatment of schizophrenia, a manic episode, as well as to prevent the recurrence of bipolar disorder, the daily dose can be subsequently adjusted in the range of 5 to 20 mg, taking into account the clinical state of the individual patient. Dose correction beyond the recommended dose as the initial dose is recommended only after careful clinical analysis, and should generally be performed at intervals of at least 24 hours.

Before stopping taking olanzapine, you should gradually reduce the dose.

The maximum daily dose of olanzapine is 20 mg.

Elderly patients

A lower initial dose (5 mg per day) is not mandatory for all patients, but is possible for patients aged 65 years and older with clinical indications.

Impaired renal and / or liver function

For such patients, it may be necessary to reduce the initial dose (up to 5 mg per day). For moderate hepatic insufficiency (cirrhosis, class A or B by Child-Pugh), an initial dose of 5 mg should be given and increased with caution.

Floor

Women should be prescribed the drug in the same doses as men.

Smokers

Smokers should be given the drug at the same doses as non-smokers.

In the presence of more than one factor that can cause a slowdown in metabolism (female, elderly, non-smokers), the need to reduce the initial dose to 5 mg / day should be considered. If necessary, further increase in dose with caution.

Release form

Tablets, film-coated, 5 mg, 10 mg. By 7 tab. in a blister of the combined film "cold" (polyamide / aluminum foil / PVC) // aluminum foil. 4 blisters in a cardboard box.

Conditions of leave from pharmacies

On prescription.

Storage conditions of the drug Egolanza

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Egolanza

5 years.

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