Instruction for use: Servitel

Dosage form: film coated tablets

Active substance: Quetiapine*

ATX

N05AH04 Quetiapine

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

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

Composition

Tablets covered with a film membrane 1 tab.

active substance:

quetiapine hemifumarate 28.78 / 115.13 / 230.27 mg

(equivalent to 25, 100 or 200 mg of quetiapine)

auxiliary substances: hypromellose - 1,4 / 5,6 / 11,2 mg; calcium hydrogen phosphate dihydrate 3.5 / 14/28 mg; lactose monohydrate - 7/28/56 mg; corn starch - 13,82 / 55,27 / 110,54 mg; carboxymethyl starch sodium - 3,5 / 14/28 mg; magnesium stearate - 0.89 / 3.56 / 7.11 mg; MCC - 7.94 / 31.75 / 63.5 mg; talc - 1.75 / 7/14 mg; silicon dioxide colloidal - 1.42 / 5.69 / 11.38 mg

film for 25 mg: Opadry pink 02B34304 (iron oxide red (E172) 0.031 mg, iron oxide yellow oxide (E172) 0.028 mg, hypromellose 2910 (E464) 1.25 mg, titanium dioxide (E171) - 0.56 mg, macrogol 400 - 0.125 mg, dye "Sunset Sunset" yellow (E110) - 0.003 mg) - 2 mg

(for 100 mg): Opadry yellow 02B32696 (iron oxide pigment yellow (El72) 0.25 mg, hypromellose 2910 (E464) 5 mg, titanium dioxide (E171) 2.25 mg, macrogol 400 0, 5 mg), 8 mg

film membrane (for 200 mg): Opadry white 20A28735 (giprolose (E463) 3.59 mg, hypromellose 2910 (E464) 3.59 mg, titanium dioxide (E171) 3.51 mg, talc 1.31 mg ) - 12 mg

Pharmachologic effect

Pharmacological action - antipsychotic, neuroleptic.

Dosing and Administration

Inside, regardless of food intake.

Adults

Treatment of schizophrenia. Servitor® is prescribed 2 times a day. The daily dose for the first 4 days of therapy is: 1 st - 50 mg, 2 - 100 mg, 3 - 200 mg, 4 - 300 mg. Starting from the 4th day, the dose should be selected to clinically effective, which usually ranges from 300 to 450 mg / day. Depending on the clinical effect and individual patient tolerance, the dose may vary from 150 to 750 mg / day. The maximum recommended daily dose is 750 mg

Treatment of manic episodes in the structure of bipolar disorder. Servitel® is used as a monotherapy or in combination with drugs that have a normotimic effect.

Servitel® is prescribed 2 times a day. The daily dose for the first 4 days of therapy is: 1 st - 100 mg, 2 - 200 mg, 3 - 300 mg, 4 - 400 mg. In the future, by the 6th day of therapy, the daily dose of the drug can be increased to 800 mg. An increase in the daily dose should not exceed 200 mg per day. Depending on the clinical effect and individual patient tolerance.

Release form

Film-coated tablets, 25 mg. For 30 tablets. in PVC / aluminum blister. 2 bl. placed in a cardboard box.

Tablets, film-coated, 100 mg and 200 mg. According to Table 15. in PVC / aluminum blister. 4 bl. placed in a cardboard box.

Conditions of leave from pharmacies

On prescription.

Storage conditions of the drug Servitel

At temperatures not higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Servitel

3 years.

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