Instruction for use: Ridonex

Dosage form: film-coated tablets

Active substance: Risperidone*

ATX

N05AX08 Risperidone

Pharmacological group:

Neuroleptics

The nosological classification (ICD-10)

F06.3 Organic mood disorders [affective]: Secondary affective symptoms; Organic depression; Affective disorders; Depressed mood with elements of anxiety

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

F28 Other Inorganic Psychotic Disorders: Affective psychoses; Involutional psychosis; Psychoinstrumental; Psychic senile; Senile psychosis; Structural Involutionary Psychosis; Static psychosis

F29 Inorganic psychosis, unspecified: Childhood psychoses; Psychomotor agitation in psychoses; Hallucinatory-delusional disorders; Hallucinatory-delusional syndrome; Intoxication psychosis; Manic-delusional disorders; Manic chronic psychosis; Manic psychosis; Acute psychosis; paranoid psychosis; Paranoid psychosis; Subacute psychosis; Presenile psychosis; Psychosis; Intoxicating psychosis; Psychosis is paranoid; Psychosis in children; Reactive psychosis; Chronic psychosis; Chronic hallucinatory psychosis; Chronic psychosis; Chronic psychotic disorder; Schizophrenic psychosis

F31.1 Bipolar affective disorder, current episode of mania without psychotic symptoms: Mania in bipolar disorders

F31.2 Bipolar affective disorder, current episode of mania with psychotic symptoms: Manic episode of bipolar disorder; Mania in bipolar disorders

F39 Mood disturbance [affective], unspecified: Affective disorder; Affective disorders; Dysphoric states; Dysphoric disorder; Psychoemotional Disorder; Affective disorders; Emotional-labile upset; Cyclotimic personality

Composition

Tablets covered with a film membrane 1 tab.

active substance:

risperidone 1 mg; 2 mg; 4 mg

Excipients

core: sodium lauryl sulfate - 0.4 / 0.4 / 0.4 mg; silicon dioxide colloidal - 0,44 / 0,44 / 0,44 mg; hypromellose - 1,5 / 1,5 / 1,5 mg; Magnesium stearate - 2.26 / 2.26 / 2.26 mg; pregelatinized starch - 6/6/6 mg; MCC - 41.7 / 41.7 / 41.7 mg; lactose monohydrate 96.7 (95.7) 93.7 mg

film sheath: Opadry II yellow 85F32072 / 85F32069 / 85F23450 (iron oxide red (E172, CI 77491) - 0.0004 / 0.0004 / 0.02 mg, iron oxide yellow (E172, CI 77492) - 0.14 / 0 , 4968 / 0.2484 mg, titanium dioxide (E171, CI 77891) 0.8596 / 0.5028 / 0.7316 mg, talc 0.592 / 0.592 / 0.592 mg macrogol 0.808 / 0.808 / 0.808 mg, polyvinyl alcohol - 1.6 / 1.6 / 1.6 mg) - 4/4/4 mg

Pharmachologic effect

Pharmacological action - antipsychotic, neuroleptic.

Dosing and Administration

Inside, adults and children over 15 years - 1 or 2 times a day.

Schizophrenia. The initial dose is 2 mg / day. On the 2nd day - up to 4 mg / day. From this moment the dose can either be kept at the same level, or, if necessary, individually adjusted in the range of 4-6 mg / day.

Doses above 10 mg / day did not show higher efficacy compared with smaller doses and could cause extrapyramidal symptoms.

The maximum dose is 16 mg / day.

Bipolar disorder in mania. The initial dose is 2 mg / day for 1 dose. Increase in the dose (by 1 mg / day) - not more often than every other day. The optimal dose is 1-6 mg / day.

Impaired renal and hepatic function. In the presence of kidney and liver disease, regardless of the indication, it is necessary to apply half of the initial and subsequent doses.

Release form

Tablets, film-coated, 1 mg, 2 mg and 4 mg. In the blister of PVC / PVDH-film and aluminum foil for 10 pcs. 2 blisters in a cardboard box.

Conditions of leave from pharmacies

On prescription.

Conditions for storage of Ridonex

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Ridonex

3 years.

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