Quetiapine (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

N05AH04 (Quetiapine)

Active Substance

Quetiapine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antipsychotic drug (neuroleptic)

Pharmacotherapeutic Group

Antipsychotic (neuroleptic) agent

Pharmacological Action

Quetiapine is an atypical antipsychotic drug that exhibits a higher affinity for serotonin (hydroxytryptamine) receptors (5HT₂) than for dopamine D₁ and D₂ receptors in the brain.

Quetiapine also has a more pronounced affinity for histamine and alpha₁-adrenergic receptors and a lesser affinity for alpha₂-adrenergic receptors. No significant affinity of quetiapine for muscarinic and benzodiazepine receptors was found. In standard tests, Quetiapine exhibits antipsychotic activity.

Pharmacokinetics

When taken orally, Quetiapine is well absorbed from the gastrointestinal tract and is actively metabolized in the liver. The main metabolites found in plasma do not have significant pharmacological activity.

Food intake does not significantly affect the bioavailability of quetiapine. T_1/2 is about 7 hours. Approximately 83% of quetiapine is bound to plasma proteins.

The pharmacokinetics of quetiapine are linear, and no differences in pharmacokinetic parameters are observed between men and women.

The average clearance of quetiapine in elderly patients is 30-50% lower than in patients aged 18 to 65 years.

The average plasma clearance of quetiapine is approximately 25% lower in patients with severe renal impairment (creatinine clearance less than 30 ml/min/1.73 m²) and in patients with liver damage, but interindividual clearance values are within the range corresponding to healthy volunteers. Approximately 73% of quetiapine is excreted in the urine and 21% in the feces. Less than 5% of quetiapine is not metabolized and is excreted unchanged by the kidneys or in the feces. CYP3A4 has been identified as the key isoenzyme for the cytochrome P450-mediated metabolism of quetiapine.

In a pharmacokinetic study of quetiapine at various doses, the administration of quetiapine before or simultaneously with ketoconazole led to an average increase in C_max and the area under the concentration-time curve (AUC) of quetiapine by 235% and 522%, respectively, as well as a decrease in the clearance of quetiapine by an average of 84%. The T_1/2 of quetiapine increased, but T_max did not change.

Quetiapine and some of its metabolites have weak inhibitory activity against cytochrome P450 isoenzymes 1A2, 2C9, 2C19, 2D6, and 3A4, but only at concentrations 10-50 times higher than those observed at the commonly used effective dose of 300-450 mg/day.

Based on in vitro results, it is not expected that the concomitant use of quetiapine with other drugs will lead to clinically significant inhibition of cytochrome P450-mediated metabolism of other drugs.

Indications

Acute and chronic psychoses, including schizophrenia;
Manic episodes in the structure of bipolar disorder.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
F20	Schizophrenia
F21	Schizotypal disorder
F22	Chronic delusional disorders
F23	Acute and transient psychotic disorders
F25	Schizoaffective disorders
F29	Unspecified nonorganic psychosis
F30	Manic episode
F31	Bipolar affective disorder

ICD-11 code	Indication
6A20.Z	Schizophrenia, unspecified episode
6A21.Z	Schizoaffective disorder, unspecified
6A22	Schizotypal disorder
6A23.Z	Acute and transient psychotic disorder, unspecified
6A24.Z	Delusional disorder, unspecified
6A2Z	Schizophrenia or other primary psychotic disorders, unspecified
6A60.Z	Bipolar type I disorder, unspecified
6A61.Z	Bipolar type II disorder, unspecified
6A6Z	Bipolar or similar disorder, unspecified
6A8Z	Affective disorders, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Adults

Acute and chronic psychoses, including schizophrenia

The daily dose for the first 4 days of therapy is: Day 1 – 50 mg, Day 2 – 100 mg, Day 3 – 200 mg, Day 4 – 300 mg. Starting from the 4th day, the dose should be adjusted to a clinically effective dose, which is usually in the range of 300 to 450 mg/day. Depending on the clinical effect and individual tolerance, the dose can vary from 150 to 750 mg/day.

Treatment of manic episodes in the structure of bipolar disorder

Quetiapine is used as monotherapy or as adjunctive therapy for mood stabilization.

The daily dose for the first 4 days of therapy is: Day 1 – 100 mg, Day 2 – 200 mg, Day 3 – 300 mg, Day 4 – 400 mg. Further, by the 6th day of therapy, the daily dose of the drug can be increased to 800 mg. The increase in the daily dose should not exceed 200 mg per day.

Depending on the clinical effect and individual tolerance, the dose can vary from 200 to 800 mg/day. The usual effective dose is from 400 to 800 mg/day.

For the treatment of schizophrenia, the maximum recommended daily dose of quetiapine is 750 mg; for the treatment of manic episodes in the structure of bipolar disorder, the maximum recommended daily dose of quetiapine is 800 mg/day.

In elderly patients, the initial dose of quetiapine is 25 mg/day. The dose should be increased daily by 25-50 mg until an effective dose is reached, which is likely to be lower than in young patients.

In patients with renal or hepatic impairment, it is recommended to start therapy with quetiapine at 25 mg/day. It is recommended to increase the dose daily by 25-50 mg until an effective dose is reached.

Adverse Reactions

The most common adverse reactions associated with the drug are: drowsiness (17.5%), dizziness (10%), constipation (9%), dyspepsia (6%), orthostatic hypotension and tachycardia (7%), dry mouth (7%), increased activity of “liver” enzymes in the blood serum (6%), increased concentration of cholesterol and triglycerides in the blood plasma.

Taking quetiapine may be accompanied by the development of moderate asthenia, rhinitis and dyspepsia, and weight gain (mainly in the first weeks of treatment). Quetiapine can cause orthostatic hypotension (accompanied by dizziness), tachycardia, and in some patients – fainting; these side reactions mainly occur during the initial dose titration period (see the “Special Precautions” section). Therapy with quetiapine is associated with a small dose-dependent decrease in the concentration of thyroid hormones, in particular, total T4 and free T4. The maximum decrease in total and free T4 was recorded at the 2nd and 4th week of quetiapine therapy, without a further decrease in hormone concentration during long-term treatment. Subsequently, there were no signs of clinically significant changes in the concentration of thyroid-stimulating hormone.

With long-term use of quetiapine, there is a potential for the development of tardive dyskinesia. If symptoms of tardive dyskinesia occur, it is necessary to reduce the dose or discontinue further treatment with quetiapine. With abrupt withdrawal of high doses of antipsychotic drugs, the following acute reactions (“withdrawal” syndrome) may be observed: nausea, vomiting, rarely – insomnia.

Cases of exacerbation of psychotic symptoms and the appearance of involuntary movement disorders (akathisia, dystonia, dyskinesia) are possible. Therefore, it is recommended to discontinue the drug gradually.

Below are the adverse reactions observed with the use of quetiapine, distributed by organs and systems.

Nervous system disorders: drowsiness, dizziness, headache, anxiety, asthenia, hostility, agitation, insomnia, akathisia, tremor, seizures, depression, paresthesia, neuroleptic malignant syndrome (hyperthermia, muscle rigidity, changes in mental status, lability of the autonomic nervous system, increased creatine phosphokinase activity), restless legs syndrome.

Cardiovascular system disorders: orthostatic hypotension, tachycardia, QT interval prolongation.

Digestive system disorders: dry oral mucosa, nausea, vomiting, abdominal pain, diarrhea or constipation, increased activity of “liver” transaminases, jaundice, hepatitis.

Respiratory system disorders: pharyngitis, rhinitis.

Allergic reactions: skin rash, eosinophilia, angioedema, Stevens-Johnson syndrome, anaphylactic reactions.

Laboratory parameters: leukopenia, neutropenia, hypercholesterolemia, hypertriglyceridemia, decreased T4 concentration (first 4 weeks), hyperglycemia.

Other: back pain, chest pain, low-grade fever, weight gain (mainly in the first weeks of treatment), myalgia, dry skin, visual impairment, including blurred vision, decompensation of pre-existing diabetes mellitus, priapism, galactorrhea.

Contraindications

Hypersensitivity to any component of the drug;
Concomitant use with CYP3A4 inhibitors, such as HIV protease inhibitors, azole antifungal drugs, erythromycin, clarithromycin, nefazodone;
Children under 18 years of age;
Lactation period.

Use with caution in patients with cardiovascular and cerebrovascular diseases or other conditions predisposing to arterial hypotension; in the elderly; with hepatic insufficiency; history of seizures; pregnancy.

Use in Pregnancy and Lactation

Use with caution during pregnancy. Contraindicated during lactation.

Use in Hepatic Impairment

In patients with hepatic impairment, it is recommended to start therapy with quetiapine at 25 mg/day. It is recommended to increase the dose daily by 25-50 mg until an effective dose is reached.

Use in Renal Impairment

In patients with renal impairment, it is recommended to start therapy with quetiapine at 25 mg/day. It is recommended to increase the dose daily by 25-50 mg until an effective dose is reached.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Geriatric Use

Special Precautions

Quetiapine can cause orthostatic hypotension, especially during the initial dose titration period (observed more often in elderly patients than in young patients). No relationship has been identified between the use of quetiapine and an increase in the QT_c interval. However, caution should be exercised when using quetiapine concomitantly with drugs that prolong the QT_c interval, especially in the elderly. During treatment, if the neutrophil count falls below 1000/µl, quetiapine should be discontinued.

If orthostatic hypotension develops during treatment with the drug, it is necessary to reduce the dose or conduct dose titration more slowly. The drug is not indicated for the treatment of psychosis associated with dementia. If symptoms of tardive dyskinesia develop, the dose of the drug should be reduced or the drug should be gradually discontinued. Symptoms of tardive dyskinesia may worsen or even appear after discontinuation of the drug.

In case of development of neuroleptic malignant syndrome, the drug should be discontinued.

Considering that Quetiapine mainly affects the central nervous system, the drug should be used with caution in combination with other drugs that depress the central nervous system, or with alcohol. In children, adolescents, and young adults (under 24 years of age) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when prescribing Quetiapine or any other antidepressants to children, adolescents, and young adults (under 24 years of age), the risk of suicide should be weighed against the benefits of their use. In short-term studies in people over 24 years of age, the risk of suicide was not increased, and in people over 65 years of age it was somewhat reduced. Any depressive disorder itself increases the risk of suicide. Therefore, during treatment with antidepressants, all patients should be monitored for early detection of behavioral disorders or changes, as well as suicidal tendencies.

Effect on ability to drive vehicles and operate machinery

Quetiapine may cause drowsiness, so during treatment, patients are advised to refrain from driving vehicles and engaging in activities that require increased concentration and speed of psychomotor reactions.

Overdose

Data on quetiapine overdose are limited. Cases of taking quetiapine in doses exceeding 20 g have been described without fatal consequences and with full recovery, however, there are reports of extremely rare cases of quetiapine overdose leading to death or coma.

Symptoms may be a consequence of the enhancement of known pharmacological effects of the drug, such as drowsiness and excessive sedation, tachycardia and decreased blood pressure.

Treatment: there are no specific antidotes for quetiapine. In cases of overdose, gastric lavage (after intubation, if the patient is unconscious), administration of activated charcoal and laxatives to remove unabsorbed quetiapine is possible, however, the effectiveness of these measures has not been studied. Symptomatic therapy and measures aimed at maintaining respiratory function, cardiovascular system, ensuring adequate oxygenation and ventilation are indicated. Medical supervision and monitoring should continue until the patient has fully recovered.

Drug Interactions

With the simultaneous use of drugs that have a potent inhibitory effect on the CYP3A4 isoenzyme (such as azole antifungals and erythromycin, clarithromycin, nefazodone), the plasma concentration of quetiapine increases, so their simultaneous use with quetiapine is contraindicated. With the simultaneous use of quetiapine with drugs that induce the liver enzyme system, such as carbamazepine, a decrease in the plasma concentration of the drug is possible, which may require an increase in the dose of quetiapine, depending on the clinical effect. In a pharmacokinetic study of quetiapine at various doses, its use before or simultaneously with carbamazepine (a liver enzyme inducer) led to a significant increase in the clearance of quetiapine. Such an increase in the clearance of quetiapine reduced the AUC by an average of 13% compared to the use of quetiapine without carbamazepine. The simultaneous use of quetiapine with another inducer of liver microsomal enzymes – phenytoin, also led to an increase in the clearance of quetiapine. With the simultaneous use of quetiapine and phenytoin (or other inducers of liver enzymes, such as barbiturates, rifampicin), an increase in the dose of quetiapine may be required. A dose reduction of quetiapine may also be required upon discontinuation of phenytoin or carbamazepine or another inducer of the liver enzyme system or replacement with a drug that does not induce liver microsomal enzymes (for example, valproic acid).

The pharmacokinetics of lithium preparations do not change with the simultaneous use of quetiapine.

Quetiapine did not cause induction of liver enzyme systems involved in the metabolism of antipyrine. The pharmacokinetics of quetiapine do not change significantly with simultaneous use with antipsychotic drugs – risperidone or haloperidol. However, the simultaneous administration of quetiapine and thioridazine led to an increase in the clearance of quetiapine. CYP3A4 is the key enzyme involved in the cytochrome P450-mediated metabolism of quetiapine. The pharmacokinetics of quetiapine do not change significantly with the simultaneous use of cimetidine, which is a P450 inhibitor.

The pharmacokinetics of quetiapine did not change significantly with the simultaneous use of imipramine (CYP2D6 inhibitor) or fluoxetine (CYP3A4 and CYP2D6 inhibitor). Drugs that depress the central nervous system and ethanol increase the risk of developing side effects of quetiapine.

Storage Conditions

Keep out of reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Quetiapine [Atoll LLC (Russia)]
Film-coated tablets, 25 mg: 10, 20, 25, 30, 40, 50, 60, 70, 75, 80, 90, 100, 120, 125, 130, 140, 150, 160, 175, 180, 200, 210, 225, 240, 250, 270, 300, 350, 400, 450, or 500 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Quetiapine

Film-coated tablets, 25 mg: 10, 20, 25, 30, 40, 50, 60, 70, 75, 80, 90, 100, 120, 125, 130, 140, 150, 160, 175, 180, 200, 210, 225, 240, 250, 270, 300, 350, 400, 450, or 500 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is almost white.

	1 tab.
Quetiapine fumarate	28.78 mg,
Equivalent to quetiapine content	25 mg

Excipients: microcrystalline cellulose – 34.15 mg, lactose monohydrate – 13.545 mg, calcium hydrogen phosphate dihydrate – 9.5 mg, povidone K-25 – 4.275 mg, sodium carboxymethyl starch – 3.8 mg, magnesium stearate – 0.95 mg.

Film coating composition hypromellose – 1.375 mg, titanium dioxide – 0.75 mg, macrogol 4000 – 0.375 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
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20 pcs. – contour cell packs (5) – cardboard packs.
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20 pcs. – contour cell packs (9) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
25 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (2) – cardboard packs.
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25 pcs. – contour cell packs (4) – cardboard packs.
25 pcs. – contour cell packs (5) – cardboard packs.
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25 pcs. – contour cell packs (7) – cardboard packs.
25 pcs. – contour cell packs (8) – cardboard packs.
25 pcs. – contour cell packs (9) – cardboard packs.
25 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – contour cell packs (7) – cardboard packs.
30 pcs. – contour cell packs (8) – cardboard packs.
30 pcs. – contour cell packs (9) – cardboard packs.
30 pcs. – contour cell packs (10) – cardboard packs.
50 pcs. – contour cell packs (1) – cardboard packs.
50 pcs. – contour cell packs (2) – cardboard packs.
50 pcs. – contour cell packs (3) – cardboard packs.
50 pcs. – contour cell packs (4) – cardboard packs.
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50 pcs. – contour cell packs (7) – cardboard packs.
50 pcs. – contour cell packs (8) – cardboard packs.
50 pcs. – contour cell packs (9) – cardboard packs.
50 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
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70 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Quetiapine [Atoll LLC (Russia)]
Film-coated tablets, 100 mg: 10, 20, 25, 30, 40, 50, 60, 70, 75, 80, 90, 100, 120, 125, 130, 140, 150, 160, 175, 180, 200, 210, 225, 240, 250, 270, 300, 350, 400, 450, or 500 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Quetiapine

Film-coated tablets, 100 mg: 10, 20, 25, 30, 40, 50, 60, 70, 75, 80, 90, 100, 120, 125, 130, 140, 150, 160, 175, 180, 200, 210, 225, 240, 250, 270, 300, 350, 400, 450, or 500 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is almost white.

	1 tab.
Quetiapine fumarate	115.13 mg,
Equivalent to quetiapine content	100 mg

Excipients: microcrystalline cellulose – 27.1 mg, lactose monohydrate – 10.72 mg, calcium hydrogen phosphate dihydrate – 19 mg, povidone K-25 – 8.55 mg, sodium starch glycolate – 7.6 mg, magnesium stearate – 1.9 mg.

Film coating composition hypromellose – 2.75 mg, titanium dioxide – 1.5 mg, macrogol 4000 – 0.75 mg.

Quetiapine [Atoll LLC (Russia)]
Film-coated tablets, 150 mg: 10, 20, 25, 30, 40, 50, 60, 70, 75, 80, 90, 100, 120, 125, 130, 140, 150, 160, 175, 180, 200, 210, 225, 240, 250, 270, 300, 350, 400, 450, or 500 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Quetiapine

Film-coated tablets, 150 mg: 10, 20, 25, 30, 40, 50, 60, 70, 75, 80, 90, 100, 120, 125, 130, 140, 150, 160, 175, 180, 200, 210, 225, 240, 250, 270, 300, 350, 400, 450, or 500 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a score on one side; the core on the cross-section is almost white.

	1 tab.
Quetiapine fumarate	172.7 mg,
Equivalent to quetiapine content	150 mg

Excipients: microcrystalline cellulose – 66.55 mg, lactose monohydrate – 26.4 mg, calcium hydrogen phosphate dihydrate – 33 mg, povidone K-25 – 14.85 mg, sodium starch glycolate – 13.2 mg, magnesium stearate – 3.3 mg.

Film coating composition hypromellose – 4.4 mg, titanium dioxide – 2.4 mg, macrogol 4000 – 1.2 mg.

Quetiapine [Atoll LLC (Russia)]
Film-coated tablets, 200 mg: 10, 20, 25, 30, 40, 50, 60, 70, 75, 80, 90, 100, 120, 125, 130, 140, 150, 160, 175, 180, 200, 210, 225, 240, 250, 270, 300, 350, 400, 450, or 500 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Quetiapine

Film-coated tablets, 200 mg: 10, 20, 25, 30, 40, 50, 60, 70, 75, 80, 90, 100, 120, 125, 130, 140, 150, 160, 175, 180, 200, 210, 225, 240, 250, 270, 300, 350, 400, 450, or 500 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is almost white.

	1 tab.
Quetiapine fumarate	230.26 mg,
Equivalent to quetiapine content	200 mg

Excipients: microcrystalline cellulose – 54.2 mg, lactose monohydrate – 21.44 mg, calcium hydrogen phosphate dihydrate – 38 mg, povidone K-25 – 17.1 mg, sodium starch glycolate – 15.2 mg, magnesium stearate – 3.8 mg.

Film coating composition hypromellose – 5.5 mg, titanium dioxide – 3 mg, macrogol 4000 – 1.5 mg.

Quetiapine [Atoll LLC (Russia)]
Film-coated tablets, 300 mg: 10, 20, 25, 30, 40, 50, 60, 70, 75, 80, 90, 100, 120, 125, 130, 140, 150, 160, 175, 180, 200, 210, 225, 240, 250, 270, 300, 350, 400, 450, or 500 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Quetiapine

Film-coated tablets, 300 mg: 10, 20, 25, 30, 40, 50, 60, 70, 75, 80, 90, 100, 120, 125, 130, 140, 150, 160, 175, 180, 200, 210, 225, 240, 250, 270, 300, 350, 400, 450, or 500 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is almost white.

	1 tab.
Quetiapine fumarate	345.4 mg,
Equivalent to quetiapine content	300 mg

Excipients: microcrystalline cellulose – 133.1 mg, lactose monohydrate – 52.8 mg, calcium hydrogen phosphate dihydrate – 66 mg, povidone K-25 – 29.7 mg, sodium starch glycolate – 26.4 mg, magnesium stearate – 6.6 mg.

Film coating composition: hypromellose – 8.8 mg, titanium dioxide – 4.8 mg, macrogol 4000 – 2.4 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (7) – cardboard packs.
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10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
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20 pcs. – contour cell packaging (8) – cardboard packs.
20 pcs. – contour cell packaging (9) – cardboard packs.
20 pcs. – contour cell packaging (10) – cardboard packs.
25 pcs. – contour cell packaging (1) – cardboard packs.
25 pcs. – contour cell packaging (2) – cardboard packs.
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25 pcs. – contour cell packaging (8) – cardboard packs.
25 pcs. – contour cell packaging (9) – cardboard packs.
25 pcs. – contour cell packaging (10) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
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30 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – contour cell packaging (6) – cardboard packs.
30 pcs. – contour cell packaging (7) – cardboard packs.
30 pcs. – contour cell packaging (8) – cardboard packs.
30 pcs. – contour cell packaging (9) – cardboard packs.
30 pcs. – contour cell packaging (10) – cardboard packs.
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50 pcs. – contour cell packaging (8) – cardboard packs.
50 pcs. – contour cell packaging (9) – cardboard packs.
50 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
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100 pcs. – jars (1) – cardboard packs.

Film coating composition AquaPolish^® D blue – 5 mg [hypromellose (hydroxypropyl methylcellulose) – 2.5 mg, glycerol (glycerin) – 0.25 mg, microcrystalline cellulose – 0.5 mg, talc – 0.73 mg, Candurin silver shine dye – 0.9 mg, indigo carmine dye – 0.12 mg].

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.

Quetiapine Canon [Canonpharma Production, CJS (Russia)]
Film-coated tablets, 200 mg: 30 or 60 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Quetiapine Canon

Film-coated tablets, 200 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets blue with a pearlescent sheen, round, biconvex; on the cross-section – a core of almost white color.

	1 tab.
Quetiapine fumarate (quetiapine hemifumarate)	230.27 mg,
Equivalent to quetiapine content	200 mg

Excipients: hyprolose (hydroxypropylcellulose Klucel LF) – 7 mg, calcium hydrogen phosphate dihydrate – 31.75 mg, calcium stearate – 3.28 mg, pregelatinized corn starch – 17.2 mg, magnesium stearate – 2 mg, sodium starch glycolate – 3.5 mg, microcrystalline cellulose (type 101) – 25 mg.

Film coating composition AquaPolish^® D blue – 8 mg [hypromellose (hydroxypropyl methylcellulose) – 4 mg, glycerol (glycerin) – 0.4 mg, microcrystalline cellulose – 0.8 mg, talc – 1.17 mg, Candurin silver shine dye – 1.44 mg, indigo carmine dye – 0.19 mg].

Quetiapine Canon [Canonpharma Production, CJS (Russia)]
Film-coated tablets, 300 mg: 30 or 60 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Quetiapine Canon

Film-coated tablets, 300 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets blue with a pearlescent sheen, round, biconvex; on the cross-section – a core of almost white color.

	1 tab.
Quetiapine fumarate (quetiapine hemifumarate)	345.4 mg,
Equivalent to quetiapine content	300 mg

Excipients: hypromellose (hydroxypropyl methylcellulose Klucel LF) – 11 mg, calcium hydrogen phosphate dihydrate – 39.28 mg, calcium stearate – 4.72 mg, pregelatinized corn starch – 20 mg, magnesium stearate – 3 mg, sodium starch glycolate – 4.6 mg, microcrystalline cellulose (type 101) – 32 mg.

Film coating composition: AquaPolish^® D blue – 12 mg [hypromellose (hydroxypropyl methylcellulose) – 6 mg, glycerol (glycerin) – 0.6 mg, microcrystalline cellulose – 1.2 mg, talc – 1.76 mg, Candurin silver shine dye – 2.16 mg, indigo carmine dye – 0.28 mg].

Quetiapine Canon Prolong [Canonpharma Production, CJS (Russia)]
Film-coated tablets, 150 mg: 30 or 60 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Quetiapine Canon Prolong

Film-coated tablets, 150 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Extended-release film-coated tablets blue, round, biconvex, on the cross-section – a core of almost white color.

	1 tab.
Quetiapine fumarate (quetiapine hemifumarate)	172.69 mg,
Equivalent to quetiapine content	150 mg

Excipients: hypromellose (hydroxypropyl methylcellulose) – 156 mg, lactose monohydrate – 56.75 mg, magnesium stearate – 7.8 mg, sodium citrate – 70.01 mg, microcrystalline cellulose – 56.75 mg.

Film coating composition Opadry II blue – 16 mg including polyvinyl alcohol – 6.4 mg, macrogol (polyethylene glycol) – 3.232 mg, talc – 2.368 mg, titanium dioxide – 3.28 mg, indigo carmine dye – 0.688 mg, Allura Red AC dye – 0.032 mg.

10 pcs. – contour cell packs (PVC/PVDC/aluminum foil) (3) – cardboard packs.
10 pcs. – contour cell packs (PVC/PVDC/aluminum foil) (6) – cardboard packs.
15 pcs. – contour cell packs (PVC/PVDC/aluminum foil) (2) – cardboard packs.
15 pcs. – contour cell packs (PVC/PVDC/aluminum foil) (4) – cardboard packs.

Quetiapine Canon Prolong [Canonpharma Production, CJS (Russia)]
Film-coated tablets, 200 mg: 30 or 60 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Quetiapine Canon Prolong

Film-coated tablets, 200 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Extended-release film-coated tablets blue, round, biconvex, on the cross-section – a core of almost white color.

	1 tab.
Quetiapine fumarate (quetiapine hemifumarate)	230.26 mg,
Equivalent to quetiapine content	200 mg

Excipients: hypromellose (hydroxypropyl methylcellulose) – 180 mg, lactose monohydrate – 52.87 mg, magnesium stearate – 9 mg, sodium citrate – 75 mg, microcrystalline cellulose – 52.87 mg.

Film coating composition Opadry II blue – 18 mg including polyvinyl alcohol – 7.2 mg, macrogol (polyethylene glycol) – 3.636 mg, talc – 2.662 mg, titanium dioxide – 3.69 mg, indigo carmine dye – 0.774 mg, Allura Red AC dye – 0.036 mg.

Quetiapine Canon Prolong [Canonpharma Production, CJS (Russia)]
Film-coated tablets, 300 mg: 30 or 60 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Quetiapine Canon Prolong

Film-coated tablets, 300 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Extended-release film-coated tablets blue, oval, biconvex, on the cross-section – a core of almost white color.

	1 tab.
Quetiapine fumarate (quetiapine hemifumarate)	345.38 mg,
Equivalent to Quetiapine content	300 mg

Excipients: hypromellose (hydroxypropyl methylcellulose) – 225 mg, lactose monohydrate – 38.06 mg, magnesium stearate – 13.5 mg, sodium citrate – 90 mg, microcrystalline cellulose – 38.06 mg.

Film coating composition Opadry II blue – 23 mg including polyvinyl alcohol – 9.2 mg, macrogol (polyethylene glycol) – 4.646 mg, talc – 3.404 mg, titanium dioxide – 4.715 mg, indigo carmine dye – 0.989 mg, Allura Red AC dye – 0.046 mg.

Quetiapine Canon Prolong [Canonpharma Production, CJS (Russia)]
Film-coated tablets, 400 mg: 30 or 60 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Quetiapine Canon Prolong

Film-coated tablets, 400 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Extended-release film-coated tablets blue, oval, biconvex, on the cross-section – a core of almost white color.

	1 tab.
Quetiapine fumarate (quetiapine hemifumarate)	460.51 mg,
Equivalent to quetiapine content	400 mg

Excipients: hypromellose (hydroxypropyl methylcellulose) – 270 mg, lactose monohydrate – 26.74 mg, magnesium stearate – 16.01 mg, sodium citrate – 100 mg, microcrystalline cellulose – 26.74 mg.

Film coating composition opadry II blue – 28 mg including polyvinyl alcohol – 11.2 mg, macrogol (polyethylene glycol) – 5.656 mg, talc – 4.144 mg, titanium dioxide – 5.74 mg, indigo carmine dye – 1.204 mg, Allura Red AC dye – 0.056 mg.

Quetiapine Prolong-Alium [Aliym, JSC (Russia)]
Extended-release film-coated tablets, 150 mg: 10 or 60 pcs.
Extended-release film-coated tablets, 200 mg: 10 or 60 pcs.
Extended-release film-coated tablets, 300 mg: 10 or 60 pcs.
Extended-release film-coated tablets, 400 mg: 10 or 60 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Forms

	Quetiapine Prolong-Alium	Extended-release film-coated tablets, 150 mg: 10 or 60 pcs.
		Extended-release film-coated tablets, 200 mg: 10 or 60 pcs.
		Extended-release film-coated tablets, 300 mg: 10 or 60 pcs.
		Extended-release film-coated tablets, 400 mg: 10 or 60 pcs.

Dosage Form, Packaging, and Composition

Extended-release film-coated tablets white or almost white, biconvex, oblong in shape, with rounded ends; on the cross-section the core is white or almost white.

	1 tab.
Quetiapine fumarate	172.69 mg,
Equivalent to quetiapine content	150 mg

Excipients: lactose monohydrate, microcrystalline cellulose type 101, sodium citrate dihydrate, hypromellose (hydroxypropyl methylcellulose), colloidal anhydrous hydrophobic silicon dioxide, magnesium stearate.

Coating composition: Opadry II 85F48105 white [polyvinyl alcohol, partially hydrolyzed, macrogol, talc, titanium dioxide].

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Extended-release film-coated tablets from yellow to yellow-brown, biconvex, oblong in shape, with rounded ends; on the cross-section the core is white or almost white.

	1 tab.
Quetiapine fumarate	230.26 mg,
Equivalent to quetiapine content	200 mg

Coating composition: Opadry II 85F38111 yellow [polyvinyl alcohol, partially hydrolyzed, macrogol, titanium dioxide, talc, iron oxide yellow dye, iron oxide red dye, iron oxide black dye].

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Extended-release film-coated tablets from yellow to yellow-brown, biconvex, oblong in shape, with rounded ends; on the cross-section the core is white or almost white.

	1 tab.
Quetiapine fumarate	345.38 mg,
Equivalent to quetiapine content	300 mg

Coating composition: Opadry II 85F38111 yellow [polyvinyl alcohol, partially hydrolyzed, macrogol, titanium dioxide, talc, iron oxide yellow dye, iron oxide red dye, iron oxide black dye].

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Extended-release film-coated tablets white or almost white, biconvex, oblong in shape, with rounded ends; on the cross-section the core is white or almost white.

	1 tab.
Quetiapine fumarate	460.5 mg,
Equivalent to quetiapine content	400 mg

Coating composition: Opadry II 85F48105 white [polyvinyl alcohol, partially hydrolyzed, macrogol, talc, titanium dioxide].

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Quetiapine Stada [Stada Arzneimittel, AG (Germany)]
Film-coated tablets, 100 mg: 60 pcs.

Marketing Authorization Holder

Stada Arzneimittel, AG (Germany)

Manufactured By

MATRIX Laboratories, Limited (India)

Labeled By

NYCOMED PHARMA, Sp. z.o.o. (Poland)

Dosage Form

Quetiapine Stada

Film-coated tablets, 100 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Quetiapine	100 mg

10 pcs. – blisters (6) – cardboard packs.

Quetiapine Stada [Stada Arzneimittel, AG (Germany)]
Film-coated tablets, 25 mg: 60 pcs.

Marketing Authorization Holder

Stada Arzneimittel, AG (Germany)

Manufactured By

MATRIX Laboratories, Limited (India)

Labeled By

NYCOMED PHARMA, Sp. z.o.o. (Poland)

Dosage Form

Quetiapine Stada

Film-coated tablets, 25 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Quetiapine	25 mg

10 pcs. – blisters (6) – cardboard packs.

Quetiapine Stada [Stada Arzneimittel, AG (Germany)]
Film-coated tablets, 200 mg: 60 pcs.

Marketing Authorization Holder

Stada Arzneimittel, AG (Germany)

Manufactured By

MATRIX Laboratories, Limited (India)

Labeled By

NYCOMED PHARMA, Sp. z.o.o. (Poland)

Dosage Form

Quetiapine Stada

Film-coated tablets, 200 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Quetiapine	200 mg

10 pcs. – blisters (6) – cardboard packs.

Quetiapine Sun [Sun Pharmaceutical Industries, Ltd. (India)]
Film-coated tablets, 25 mg: 30, 50, or 60 pcs.

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

Dosage Form

Quetiapine Sun

Film-coated tablets, 25 mg: 30, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Quetiapine	25 mg

10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.

Quetiapine Sun [Sun Pharmaceutical Industries, Ltd. (India)]
Film-coated tablets, 100 mg: 50 pcs.

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

Dosage Form

Quetiapine Sun

Film-coated tablets, 100 mg: 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Quetiapine	100 mg

10 pcs. – blisters made of PVC/aluminum foil (3) – cardboard packs.
10 pcs. – blisters made of PVC/aluminum foil (5) – cardboard packs.
10 pcs. – blisters made of PVC/aluminum foil (6) – cardboard packs.

Quetiapine Sun [Sun Pharmaceutical Industries, Ltd. (India)]
Film-coated tablets, 200 mg: 50 pcs.

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

Dosage Form

Quetiapine Sun

Film-coated tablets, 200 mg: 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Quetiapine	200 mg

Quetiapine Sun [Sun Pharmaceutical Industries, Ltd. (India)]
Film-coated tablets, 300 mg: 30, 50, or 60 pcs.

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

Dosage Form

Quetiapine Sun

Film-coated tablets, 300 mg: 30, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Quetiapine	300 mg

Quetiapine-Alium [Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)]
Film-coated tablets, 25 mg: 10, 15, 20, 30, 40, 45, 60, 90, 100, 120, 150, 180, 200, 240, 300, or 360 pcs.
Film-coated tablets, 100 mg: 10, 15, 20, 30, 40, 45, 60, 90, 100, 120, 150, 180, 200, 240, 300, or 360 pcs.
Film-coated tablets, 200 mg: 10, 15, 20, 30, 40, 45, 60, 90, 100, 120, 150, 180, 200, 240, 300, or 360 pcs.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Forms

	Quetiapine-Alium	Film-coated tablets, 25 mg: 10, 15, 20, 30, 40, 45, 60, 90, 100, 120, 150, 180, 200, 240, 300, or 360 pcs.
		Film-coated tablets, 100 mg: 10, 15, 20, 30, 40, 45, 60, 90, 100, 120, 150, 180, 200, 240, 300, or 360 pcs.
		Film-coated tablets, 200 mg: 10, 15, 20, 30, 40, 45, 60, 90, 100, 120, 150, 180, 200, 240, 300, or 360 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink, biconvex, oblong in shape with rounded ends, with a score; on cross-section, the core is white or almost white.

	1 tab.
Quetiapine fumarate	28.78 mg,
Equivalent to quetiapine content	25 mg

Excipients: microcrystalline cellulose, lactose monohydrate, sodium carboxymethyl starch (sodium starch glycolate), hypromellose (hydroxypropylcellulose), magnesium stearate.

Shell composition: hypromellose (hydroxypropylcellulose), macrogol 6000 (polyethylene glycol 6000), titanium dioxide, azorubine dye (carmoisine).

Film-coated tablets yellow, round, biconvex; on cross-section, the core is white or almost white.

	1 tab.
Quetiapine fumarate	115.13 mg,
Equivalent to quetiapine content	100 mg

Excipients: microcrystalline cellulose, lactose monohydrate, sodium carboxymethyl starch (sodium starch glycolate), hypromellose (hydroxypropylcellulose), magnesium stearate.

Shell composition: hypromellose (hydroxypropylcellulose), macrogol 6000 (polyethylene glycol 6000), titanium dioxide, yellow iron oxide dye.

Film-coated tablets white, biconvex, oblong in shape with rounded ends, with a score; on cross-section, the core is white or almost white.

	1 tab.
Quetiapine fumarate	230.26 mg,
Equivalent to quetiapine content	200 mg

Excipients: microcrystalline cellulose, lactose monohydrate, sodium carboxymethyl starch (sodium starch glycolate), hypromellose (hydroxypropylcellulose), magnesium stearate.

Shell composition: hypromellose (hydroxypropylcellulose), macrogol 6000 (polyethylene glycol 6000), titanium dioxide.

Quetiapine-Vertex [Vertex, JSC (Russia)]
Film-coated tablets, 25 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Quetiapine-Vertex

Film-coated tablets, 25 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on cross-section, the core is white or almost white.

	1 tab.
Quetiapine	25 mg

Excipients: microcrystalline cellulose – 8.718 mg, lactose monohydrate – 4.5 mg, sodium carboxymethyl starch – 3.5 mg, povidone K-30 – 2 mg, talc – 1.25 mg, colloidal silicon dioxide – 0.75 mg, magnesium stearate – 0.5 mg.

Film coating composition: hypromellose – 0.9 mg, talc – 0.3 mg, titanium dioxide – 0.165 mg, macrogol 4000 – 0.135 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.

Quetiapine-Vertex [Vertex, JSC (Russia)]
Film-coated tablets, 100 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Quetiapine-Vertex

Film-coated tablets, 100 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on cross-section, the core is white or almost white.

	1 tab.
Quetiapine	100 mg

Excipients: microcrystalline cellulose – 34.87 mg, lactose monohydrate – 18 mg, sodium carboxymethyl starch – 14 mg, povidone K-30 – 8 mg, talc – 5 mg, colloidal silicon dioxide – 3 mg, magnesium stearate – 2 mg.

Film coating composition: hypromellose – 3.6 mg, talc – 1.2 mg, titanium dioxide – 0.66 mg, macrogol 4000 – 0.54 mg.

Quetiapine-Vertex [Vertex, JSC (Russia)]
Film-coated tablets, 200 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Quetiapine-Vertex

Film-coated tablets, 200 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on cross-section, the core is white or almost white.

	1 tab.
Quetiapine	200 mg

Excipients: microcrystalline cellulose – 69.74 mg, lactose monohydrate – 36 mg, sodium carboxymethyl starch – 28 mg, povidone K-30 – 16 mg, talc – 10 mg, colloidal silicon dioxide – 6 mg, magnesium stearate – 4 mg.

Film coating composition: hypromellose – 7.2 mg, talc – 2.4 mg, titanium dioxide – 1.32 mg, macrogol 4000 – 1.08 mg.

Quetiapine-Vertex [Vertex, JSC (Russia)]
Film-coated tablets, 300 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Quetiapine-Vertex

Film-coated tablets, 300 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on cross-section, the core is white or almost white.

	1 tab.
Quetiapine	300 mg

Excipients: microcrystalline cellulose – 104.61 mg, lactose monohydrate – 54 mg, sodium carboxymethyl starch – 42 mg, povidone K-30 – 24 mg, talc – 15 mg, colloidal silicon dioxide – 9 mg, magnesium stearate – 6 mg.

Film coating composition: hypromellose – 10.8 mg, talc – 3.6 mg, titanium dioxide – 1.98 mg, macrogol 4000 – 1.62 mg.

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.
20 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – contour cell blisters (1) – cardboard packs.
30 pcs. – contour cell blisters (2) – cardboard packs.
30 pcs. – contour cell blisters (3) – cardboard packs.

Quetiapine-Vial [Vial, LLC (Russia)]
Film-coated tablets, 25 mg: 48 or 50 pcs.
Film-coated tablets, 100 mg: 30 or 60 pcs.
Film-coated tablets, 200 mg: 20 pcs.

Marketing Authorization Holder

Vial, LLC (Russia)

Manufactured By

Vifitech, CJSC (Russia)

Dosage Forms

	Quetiapine-Vial	Film-coated tablets, 25 mg: 48 or 50 pcs.
		Film-coated tablets, 100 mg: 30 or 60 pcs.
		Film-coated tablets, 200 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets red-brown in color, round, biconvex, with a score on one side; the cross-section shows a red-brown coating and a white or almost white core.

	1 tab.
Quetiapine fumarate	28.78 mg,
Equivalent to quetiapine content	25 mg

Excipients: lactose monohydrate – 30.22 mg, microcrystalline cellulose – 30 mg, sodium carboxymethyl starch – 5 mg, povidone K30 – 3.5 mg, magnesium stearate – 1 mg.

Coating composition: talc – 0.6 mg, titanium dioxide – 0.6 mg, povidone K30 – 0.46 mg, macrogol 6000 – 0.42 mg, polysorbate 80 – 0.54 mg, triacetin – 0.36 mg, yellow iron oxide – 0.3 mg, red iron oxide – 0.32 mg.

24 pcs. – blisters (2) – cardboard packs.
50 pcs. – containers (1) – cardboard packs.

Film-coated tablets light yellow in color, round, biconvex, with a score on one side; the cross-section shows a light yellow coating and a white or almost white core.

	1 tab.
Quetiapine fumarate	115.13 mg,
Equivalent to quetiapine content	100 mg

Excipients: lactose monohydrate – 120.87 mg, microcrystalline cellulose – 60 mg, sodium carboxymethyl starch – 20 mg, povidone K30 – 10 mg, magnesium stearate – 4 mg.

Coating composition: talc – 1.65 mg, titanium dioxide – 1.65 mg, povidone K30 – 1.32 mg, macrogol 6000 – 1.15 mg, polysorbate 80 – 1.52 mg, triacetin – 1 mg, yellow iron oxide – 1.71 mg.

10 pcs. – blisters (3) – cardboard packs.
30 pcs. – containers (1) – cardboard packs.
60 pcs. – containers (1) – cardboard packs.

Film-coated tablets light yellow in color, oblong, biconvex, with a score on one side; the cross-section shows a light yellow coating and a white or almost white core.

	1 tab.
Quetiapine fumarate	230.26 mg,
Equivalent to quetiapine content	200 mg

Excipients: lactose monohydrate – 241.74 mg, microcrystalline cellulose – 120 mg, sodium carboxymethyl starch – 40 mg, povidone K30 – 22 mg, magnesium stearate – 10 mg.

Coating composition: talc – 2.97 mg, titanium dioxide – 2.97 mg, povidone K30 – 2.38 mg, macrogol 6000 – 2.07 mg, polysorbate 80 – 2.74 mg, triacetin – 1.80 mg, yellow iron oxide – 3.07 mg.

10 pcs. – blisters (2) – cardboard packs.
20 pcs. – containers (1) – cardboard packs.

Medixlife (Author)

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