Mastodon

Fluvoxamine (Tablets) Instructions for Use

ATC Code

N06AB08 (Fluvoxamine)

Active Substance

Fluvoxamine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antidepressant

Pharmacotherapeutic Group

Psychoanaleptics; antidepressants; selective serotonin reuptake inhibitors

Pharmacological Action

Antidepressant. The mechanism of action is associated with the selective inhibition of serotonin reuptake by neurons of the brain and is characterized by a minimal effect on noradrenergic transmission.

Fluvoxamine has a weak ability to bind to α- and β-adrenergic receptors, histamine, m-cholinergic receptors, dopamine, and serotonin receptors.

Indications

Treatment and prevention of depressions, treatment of symptoms of obsessive-compulsive disorders.

ICD codes

ICD-10 code Indication
F31 Bipolar affective disorder
F32 Depressive episode
F33 Recurrent depressive disorder
F41.2 Mixed anxiety and depressive disorder
F42 Obsessive-compulsive disorder
ICD-11 code Indication
6A60.Z Bipolar type I disorder, unspecified
6A61.Z Bipolar type II disorder, unspecified
6A6Z Bipolar or similar disorder, unspecified
6A70.Z Single episode depressive disorder, unspecified
6A71.Z Recurrent depressive disorder, unspecified
6A73 Mixed depressive and anxiety disorder
6B20.Z Obsessive-compulsive disorder, unspecified
6C9Z Disruptive behavior or dissocial 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

The dosage is set individually. At the beginning of treatment, the daily dose is 50-100 mg (it is recommended to take it at night). If the effect is insufficient, the daily dose can be increased to 150-200 mg. The maximum daily dose is 300 mg. If the daily dose is more than 100 mg, it should be divided into 2-3 doses.

In accordance with the official WHO recommendations, treatment with antidepressants should be continued for at least 6 months after the cure of a depressive episode.

Adverse Reactions

From the digestive system often – nausea, sometimes accompanied by vomiting (usually disappears within the first 2 weeks of treatment); possible – constipation, anorexia, dyspepsia, diarrhea, unpleasant sensations in the epigastric region, dry mouth, feeling of discomfort; rarely – increased activity of liver enzymes, predominantly in elderly patients – transient hyponatremia (in some cases due to the syndrome of inappropriate ADH secretion, disappears after discontinuation of fluvoxamine).

From the CNS possible drowsiness, dizziness, headache, insomnia, anxiety, psychomotor agitation, feeling of fear, tremor, feeling of discomfort, asthenia; after abrupt withdrawal of fluvoxamine, in rare cases, headache, nausea, dizziness, feeling of fear were observed.

From the cardiovascular system possible slight decrease in heart rate (by 2-6 beats/min), palpitations, tachycardia.

Other possible increased sweating, change in body weight.

Some of the above side effects may be symptoms of depression and are not caused by the action of fluvoxamine.

Contraindications

Severe liver dysfunction, simultaneous use of MAO inhibitors, children under 8 years of age, hypersensitivity to fluvoxamine.

Use in Pregnancy and Lactation

If it is necessary to use fluvoxamine during pregnancy, the expected benefit of therapy for the mother and the possible risk to the fetus should be assessed.

Fluvoxamine should not be used during lactation, as this active substance is excreted in small amounts in breast milk.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction.

Patients with hepatic insufficiency should be started on Fluvoxamine at low doses under strict medical supervision.

If symptoms due to increased activity of liver enzymes appear, Fluvoxamine should be discontinued.

Use in Renal Impairment

Patients with renal insufficiency should be started on Fluvoxamine at low doses under strict medical supervision.

Pediatric Use

Contraindicated in children under 8 years of age.

Geriatric Use

In elderly patients, the dose of fluvoxamine should always be increased more slowly and with greater caution.

Special Precautions

In depression, there is usually a high probability of a suicide attempt, which may persist until sufficient remission is achieved.

Use with caution in patients with a history of seizures. If an epileptic seizure develops, treatment with fluvoxamine should be discontinued.

Patients with hepatic or renal insufficiency should be started on Fluvoxamine at low doses under strict medical supervision.

If symptoms due to increased activity of liver enzymes appear, Fluvoxamine should be discontinued.

In elderly patients, the dose of fluvoxamine should always be increased more slowly and with greater caution.

There are reports of the development of ecchymoses and purpura with the use of selective serotonin reuptake inhibitors. In view of this, such drugs should be prescribed with caution, especially simultaneously with drugs that affect platelet functions (for example, with atypical antipsychotics and phenothiazines, many tricyclic antidepressants, NSAIDs, including acetylsalicylic acid), as well as to patients with a history of bleeding.

Alcohol consumption is not allowed during treatment.

Due to the lack of clinical experience, Fluvoxamine is not recommended for the treatment of depression in children.

Effect on the ability to drive vehicles and operate machinery

Fluvoxamine should be used with caution in patients whose activities require concentration and high speed of psychomotor reactions until the individual response to treatment is finally determined.

Treatment with MAO inhibitors should be discontinued 2 weeks before starting fluvoxamine.

Fluvoxamine may slow down the elimination of drugs metabolized with the participation of liver microsomal enzymes.

Drug Interactions

When used simultaneously with MAO inhibitors, there is a possibility of developing serotonin syndrome, especially when used simultaneously with irreversible non-selective MAO inhibitors.

When used simultaneously, the plasma concentration of alprazolam, bromazepam, diazepam increases and their side effects are enhanced due to the fact that Fluvoxamine inhibits the metabolism of these benzodiazepines.

When used simultaneously, the plasma concentration of amitriptyline, clomipramine, imipramine, maprotiline, trimipramine increases, which is probably due to the fact that Fluvoxamine is a non-competitive inhibitor of the CYP1A2 isoenzyme, which is involved in the process of N-demethylation of these antidepressants.

When used simultaneously with buspirone, a decrease in its effectiveness is possible; with valproic acid – an increase in the effects of valproic acid is possible; with warfarin – an increase in the plasma concentration of warfarin and the appearance of a risk of bleeding is possible; with galantamine – the likelihood of increased side effects of galantamine increases; with haloperidol – the plasma concentration of lithium increases.

When used simultaneously, the plasma concentration of carbamazepine increases, which is due to the inhibition of its metabolism in the liver, mainly due to the suppression of the activity of the CYP2D6 isoenzyme under the influence of fluvoxamine.

When used simultaneously, the plasma concentration of clozapine significantly increases, which in some patients is accompanied by the development of toxic effects of clozapine.

When used simultaneously, a decrease in the clearance of caffeine and an increase in its effects is possible. This interaction is due to the fact that Fluvoxamine significantly inhibits the CYP1A2 isoenzyme, which is the main enzyme responsible for the metabolism of caffeine.

When used simultaneously with metoclopramide, a case of extrapyramidal disorders has been described.

When used simultaneously with olanzapine, the plasma concentration of olanzapine increases; with propranolol – the plasma concentration of propranolol increases, which is probably due to the inhibition by fluvoxamine of the cytochrome P450 system isoenzymes involved in the metabolism of propranolol.

When used simultaneously with theophylline, the plasma concentration of theophylline increases, which leads to the development of toxic reactions. This interaction is due to the fact that Fluvoxamine significantly inhibits the CYP1A2 isoenzyme, which is the main enzyme responsible for the metabolism of theophylline.

When used simultaneously, the clearance of tolbutamide and its metabolites decreases, which is due to the inhibition of the CYP2C9 isoenzyme.

There are isolated reports of increased side effects of phenytoin when used simultaneously with fluvoxamine.

When used simultaneously, the metabolism of quinidine slows down and its clearance decreases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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

Marketing Authorization Holder

Geneffic, LLC (Russia)

Manufactured By

Advanced Pharma, LLC (Russia)

Dosage Forms

Bottle Rx Icon Fluvoxamine Film-coated tablets, 50 mg: 20, 30, 40, 50, 60, or 80 pcs.
Film-coated tablets, 100 mg: 20, 30, 40, 50, 60, or 80 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from white to almost white, round, biconvex.

1 tab.
Fluvoxamine maleate 50 mg

Excipients : mannitol – 151.5 mg, corn starch – 40 mg, pregelatinized starch – 6 mg, sodium stearyl fumarate – 1.75 mg, colloidal silicon dioxide – 0.75 mg.

Shell composition white film coating – 7 mg (polyvinyl alcohol – 45%, titanium dioxide (E171) – 30%, macrogol 4000 – 11%, talc – 11%, soy lecithin – 3%).

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (8) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.

Film-coated tablets from white to almost white, round, biconvex.

1 tab.
Fluvoxamine maleate 100 mg

Excipients : mannitol – 303 mg, corn starch – 80 mg, pregelatinized starch – 12 mg, sodium stearyl fumarate – 3.5 mg, colloidal silicon dioxide – 1.5 mg.

Shell composition white film coating – 14 mg (polyvinyl alcohol – 45%, titanium dioxide (E171) – 30%, macrogol 4000 – 11%, talc – 11%, soy lecithin – 3%).

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (8) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Forms

Bottle Rx Icon Fluvoxamine Film-coated tablets, 50 mg: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 22, 24, 26, 28, 30, 33, 36, 39, 40, 42, 44, 45, 48, 50, 52, 55, 56, 60, 65, 66, 70, 72, 75, 77, 78, 80, 84, 88, 90, 91, 96, 98, 99, 100, or 104 pcs. etc.
Film-coated tablets, 100 mg: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 22, 24, 26, 28, 30, 33, 36, 39, 40, 42, 44, 45, 48, 50, 52, 55, 56, 60, 65, 66, 70, 72, 75, 77, 78, 80, 84, 88, 90, 91, 96, 98, 99, 100, or 104 pcs. etc.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, flat-cylindrical, with a bevel and a score on one side.

1 tab.
Fluvoxamine maleate 50 mg

Excipients: mannitol – 152 mg, corn starch – 40 mg, pregelatinized starch – 6 mg, sodium stearyl fumarate – 1.8 mg, colloidal silicon dioxide – 0.8 mg.

Film coating composition Opadry white (hypromellose – 55.41 %, macrogol 6000 – 20.27 %, titanium dioxide – 20.27 %, talc – 4.05 %) – 7.4 mg.

1 pc. – contour cell packs – cardboard packs.
1 pc. – contour cell packs (2) – cardboard packs.
1 pc. – contour cell packs (3) – cardboard packs.
1 pc. – contour cell packs (4) – cardboard packs.
1 pc. – contour cell packs (5) – cardboard packs.
1 pc. – contour cell packs (6) – cardboard packs.
1 pc. – contour cell packs (7) – cardboard packs.
1 pc. – contour cell packs (8) – cardboard packs.
1 pc. – contour cell packs (9) – cardboard packs.
1 pc. – contour cell packs (10) – cardboard packs.
2 pcs. – contour cell packs – cardboard packs.
2 pcs. – contour cell packs (2) – cardboard packs.
2 pcs. – contour cell packs (3) – cardboard packs.
2 pcs. – contour cell packs (4) – cardboard packs.
2 pcs. – contour cell packs (5) – cardboard packs.
2 pcs. – contour cell packs (6) – cardboard packs.
2 pcs. – contour cell packs (7) – cardboard packs.
2 pcs. – contour cell packs (8) – cardboard packs.
2 pcs. – contour cell packs (9) – cardboard packs.
2 pcs. – contour cell packs (10) – cardboard packs.
3 pcs. – contour cell packs – cardboard packs.
3 pcs. – contour cell packs (2) – cardboard packs.
3 pcs. – contour cell packs (3) – cardboard packs.
3 pcs. – contour cell packs (4) – cardboard packs.
3 pcs. – contour cell packs (5) – cardboard packs.
3 pcs. – contour cell packs (6) – cardboard packs.
3 pcs. – contour cell packs (7) – cardboard packs.
3 pcs. – contour cell packs (8) – cardboard packs.
3 pcs. – contour cell packs (9) – cardboard packs.
3 pcs. – contour cell packs (10) – cardboard packs.
4 pcs. – contour cell packs – cardboard packs.
4 pcs. – contour cell packs (2) – cardboard packs.
4 pcs. – contour cell packs (3) – cardboard packs.
4 pcs. – contour cell packs (4) – cardboard packs.
4 pcs. – contour cell packs (5) – cardboard packs.
4 pcs. – contour cell packs (6) – cardboard packs.
4 pcs. – contour cell packs (7) – cardboard packs.
4 pcs. – contour cell packs (8) – cardboard packs.
4 pcs. – contour cell packs (9) – cardboard packs.
4 pcs. – contour cell packs (10) – cardboard packs.
5 pcs. – contour cell packs – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (3) – cardboard packs.
5 pcs. – contour cell packs (4) – cardboard packs.
5 pcs. – contour cell packs (5) – cardboard packs.
5 pcs. – contour cell packs (6) – cardboard packs.
5 pcs. – contour cell packs (7) – cardboard packs.
5 pcs. – contour cell packs (8) – cardboard packs.
5 pcs. – contour cell packs (9) – cardboard packs.
5 pcs. – contour cell packs (10) – cardboard packs.
6 pcs. – contour cell packs – cardboard packs.
6 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (3) – cardboard packs.
6 pcs. – contour cell packs (4) – cardboard packs.
6 pcs. – contour cell packs (5) – cardboard packs.
6 pcs. – contour cell packs (6) – cardboard packs.
6 pcs. – contour cell packs (7) – cardboard packs.
6 pcs. – contour cell packs (8) – cardboard packs.
6 pcs. – contour cell packs (9) – cardboard packs.
6 pcs. – contour cell packs (10) – cardboard packs.
7 pcs. – contour cell packs – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (6) – cardboard packs.
7 pcs. – contour cell packs (7) – cardboard packs.
7 pcs. – contour cell packs (8) – cardboard packs.
7 pcs. – contour cell packs (9) – cardboard packs.
7 pcs. – contour cell packs (10) – cardboard packs.
8 pcs. – contour cell packs – cardboard packs.
8 pcs. – contour cell packs (2) – cardboard packs.
8 pcs. – contour cell packs (3) – cardboard packs.
8 pcs. – contour cell packs (4) – cardboard packs.
8 pcs. – contour cell packs (5) – cardboard packs.
8 pcs. – contour cell packs (6) – cardboard packs.
8 pcs. – contour cell packs (7) – cardboard packs.
8 pcs. – contour cell packs (8) – cardboard packs.
8 pcs. – contour cell packs (9) – cardboard packs.
8 pcs. – contour cell packs (10) – cardboard packs.
9 pcs. – contour cell packs – cardboard packs.
9 pcs. – contour cell packs (2) – cardboard packs.
9 pcs. – contour cell packs (3) – cardboard packs.
9 pcs. – contour cell packs (4) – cardboard packs.
9 pcs. – contour cell packs (5) – cardboard packs.
9 pcs. – contour cell packs (6) – cardboard packs.
9 pcs. – contour cell packs (7) – cardboard packs.
9 pcs. – contour cell packs (8) – cardboard packs.
9 pcs. – contour cell packs (9) – cardboard packs.
9 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs – 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.
11 pcs. – contour cell packs – cardboard packs.
11 pcs. – contour cell packs (2) – cardboard packs.
11 pcs. – contour cell packs (3) – cardboard packs.
11 pcs. – contour cell packs (4) – cardboard packs.
11 pcs. – contour cell packs (5) – cardboard packs.
11 pcs. – contour cell packs (6) – cardboard packs.
11 pcs. – contour cell packs (7) – cardboard packs.
11 pcs. – contour cell packs (8) – cardboard packs.
11 pcs. – contour cell packs (9) – cardboard packs.
11 pcs. – contour cell packs (10) – cardboard packs.
12 pcs. – contour cell packs – cardboard packs.
12 pcs. – contour cell packs (2) – cardboard packs.
12 pcs. – contour cell packs (3) – cardboard packs.
12 pcs. – contour cell packs (4) – cardboard packs.
12 pcs. – contour cell packs (5) – cardboard packs.
12 pcs. – contour cell packs (6) – cardboard packs.
12 pcs. – contour cell packs (7) – cardboard packs.
12 pcs. – contour cell packs (8) – cardboard packs.
12 pcs. – contour cell packs (9) – cardboard packs.
12 pcs. – contour cell packs (10) – cardboard packs.
13 pcs. – contour cell packs – cardboard packs.
13 pcs. – contour cell packs (2) – cardboard packs.
13 pcs. – contour cell packs (3) – cardboard packs.
13 pcs. – contour cell packs (4) – cardboard packs.
13 pcs. – contour cell packs (5) – cardboard packs.
13 pcs. – contour cell packs (6) – cardboard packs.
13 pcs. – contour cell packs (7) – cardboard packs.
13 pcs. – contour cell packs (8) – cardboard packs.
13 pcs. – contour cell packs (9) – cardboard packs.
13 pcs. – contour cell packs (10) – cardboard packs.
14 pcs. – contour cell packs – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (3) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – contour cell packs (5) – cardboard packs.
14 pcs. – contour cell packs (6) – cardboard packs.
14 pcs. – contour cell packs (7) – cardboard packs.
14 pcs. – contour cell packs (8) – cardboard packs.
14 pcs. – contour cell packs (9) – cardboard packs.
14 pcs. – contour cell packs (10) – cardboard packs.
15 pcs. – contour cell packs – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (3) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (5) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.
15 pcs. – contour cell packs (7) – cardboard packs.
15 pcs. – contour cell packs (8) – cardboard packs.
15 pcs. – contour cell packs (9) – cardboard packs.
15 pcs. – contour cell packs (10) – cardboard packs.
16 pcs. – contour cell packs – cardboard packs.
16 pcs. – contour cell packs (2) – cardboard packs.
16 pcs. – contour cell packs (3) – cardboard packs.
16 pcs. – contour cell packs (4) – cardboard packs.
16 pcs. – contour cell packs (5) – cardboard packs.
16 pcs. – contour cell packs (6) – cardboard packs.
16 pcs. – contour cell packs (7) – cardboard packs.
16 pcs. – contour cell packs (8) – cardboard packs.
16 pcs. – contour cell packs (9) – cardboard packs.
16 pcs. – contour cell packs (10) – cardboard packs.
17 pcs. – contour cell packs – cardboard packs.
17 pcs. – contour cell packs (2) – cardboard packs.
17 pcs. – contour cell packs (3) – cardboard packs.
17 pcs. – contour cell packs (4) – cardboard packs.
17 pcs. – contour cell packs (5) – cardboard packs.
17 pcs. – contour cell packs (6) – cardboard packs.
17 pcs. – contour cell packs (7) – cardboard packs.
17 pcs. – contour cell packs (8) – cardboard packs.
17 pcs. – contour cell packs (9) – cardboard packs.
17 pcs. – contour cell packs (10) – cardboard packs.
18 pcs. – contour cell packs – cardboard packs.
18 pcs. – contour cell packs (2) – cardboard packs.
18 pcs. – contour cell packs (3) – cardboard packs.
18 pcs. – contour cell packs (4) – cardboard packs.
18 pcs. – contour cell packs (5) – cardboard packs.
18 pcs. – contour cell packs (6) – cardboard packs.
18 pcs. – contour cell packs (7) – cardboard packs.
18 pcs. – contour cell packs (8) – cardboard packs.
18 pcs. – contour cell packs (9) – cardboard packs.
18 pcs. – contour cell packs (10) – cardboard packs.
19 pcs. – contour cell packs – cardboard packs.
19 pcs. – contour cell packs (2) – cardboard packs.
19 pcs. – contour cell packs (3) – cardboard packs.
19 pcs. – contour cell packs (4) – cardboard packs.
19 pcs. – contour cell packs (5) – cardboard packs.
19 pcs. – contour cell packs (6) – cardboard packs.
19 pcs. – contour cell packs (7) – cardboard packs.
19 pcs. – contour cell packs (8) – cardboard packs.
19 pcs. – contour cell packs (9) – cardboard packs.
19 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (7) – cardboard packs.
20 pcs. – contour cell packs (8) – cardboard packs.
20 pcs. – contour cell packs (9) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – bottles – cardboard packs.
20 pcs. – bottles – cardboard packs.
25 pcs. – bottles – cardboard packs.
30 pcs. – bottles – cardboard packs.
35 pcs. – bottles – cardboard packs.
40 pcs. – bottles – cardboard packs.
45 pcs. – bottles – cardboard packs.
50 pcs. – bottles – cardboard packs.
55 pcs. – bottles – cardboard packs.
60 pcs. – bottles – cardboard packs.
65 pcs. – bottles – cardboard packs.
70 pcs. – bottles – cardboard packs.
75 pcs. – bottles – cardboard packs.
80 pcs. – bottles – cardboard packs.
85 pcs. – bottles – cardboard packs.
90 pcs. – bottles – cardboard packs.
95 pcs. – bottles – cardboard packs.
100 pcs. – bottles – cardboard packs.
110 pcs. – bottles – cardboard packs.
120 pcs. – bottles – cardboard packs.
130 pcs. – bottles – cardboard packs.
140 pcs. – bottles – cardboard packs.
150 pcs. – bottles – cardboard packs.
160 pcs. – bottles – cardboard packs.
170 pcs. – bottles – cardboard packs.
180 pcs. – bottles – cardboard packs.
190 pcs. – bottles – cardboard packs.
200 pcs. – bottles – cardboard packs.

Film-coated tablets white or almost white, oval, biconvex, with a bevel and a score on one side.

1 tab.
Fluvoxamine maleate 100 mg

Excipients: mannitol – 303 mg, corn starch – 80 mg, pregelatinized starch – 12 mg, sodium stearyl fumarate – 3.5 mg, colloidal silicon dioxide – 1.5 mg.

Film coating composition Opadry yellow (hypromellose – 60 %, macrogol 4000 – 8 %, titanium dioxide – 25.6 %, yellow iron oxide dye – 6.4 %) – 10.1 mg.

1 pc. – contour cell packaging – cardboard packs.
1 pc. – contour cell packaging (2) – cardboard packs.
1 pc. – contour cell packaging (3) – cardboard packs.
1 pc. – contour cell packaging (4) – cardboard packs.
1 pc. – contour cell packaging (5) – cardboard packs.
1 pc. – contour cell packaging (6) – cardboard packs.
1 pc. – contour cell packaging (7) – cardboard packs.
1 pc. – contour cell packaging (8) – cardboard packs.
1 pc. – contour cell packaging (9) – cardboard packs.
1 pc. – contour cell packaging (10) – cardboard packs.
2 pcs. – contour cell packaging – cardboard packs.
2 pcs. – contour cell packaging (2) – cardboard packs.
2 pcs. – contour cell packaging (3) – cardboard packs.
2 pcs. – contour cell packaging (4) – cardboard packs.
2 pcs. – contour cell packaging (5) – cardboard packs.
2 pcs. – contour cell packaging (6) – cardboard packs.
2 pcs. – contour cell packaging (7) – cardboard packs.
2 pcs. – contour cell packaging (8) – cardboard packs.
2 pcs. – contour cell packaging (9) – cardboard packs.
2 pcs. – contour cell packaging (10) – cardboard packs.
3 pcs. – contour cell packaging – cardboard packs.
3 pcs. – contour cell packaging (2) – cardboard packs.
3 pcs. – contour cell packaging (3) – cardboard packs.
3 pcs. – contour cell packaging (4) – cardboard packs.
3 pcs. – contour cell packaging (5) – cardboard packs.
3 pcs. – contour cell packaging (6) – cardboard packs.
3 pcs. – contour cell packaging (7) – cardboard packs.
3 pcs. – contour cell packaging (8) – cardboard packs.
3 pcs. – contour cell packaging (9) – cardboard packs.
3 pcs. – contour cell packaging (10) – cardboard packs.
4 pcs. – contour cell packaging – cardboard packs.
4 pcs. – contour cell packaging (2) – cardboard packs.
4 pcs. – contour cell packaging (3) – cardboard packs.
4 pcs. – contour cell packaging (4) – cardboard packs.
4 pcs. – contour cell packaging (5) – cardboard packs.
4 pcs. – contour cell packaging (6) – cardboard packs.
4 pcs. – contour cell packaging (7) – cardboard packs.
4 pcs. – contour cell packaging (8) – cardboard packs.
4 pcs. – contour cell packaging (9) – cardboard packs.
4 pcs. – contour cell packaging (10) – cardboard packs.
5 pcs. – contour cell packaging – cardboard packs.
5 pcs. – contour cell packaging (2) – cardboard packs.
5 pcs. – contour cell packaging (3) – cardboard packs.
5 pcs. – contour cell packaging (4) – cardboard packs.
5 pcs. – contour cell packaging (5) – cardboard packs.
5 pcs. – contour cell packaging (6) – cardboard packs.
5 pcs. – contour cell packaging (7) – cardboard packs.
5 pcs. – contour cell packaging (8) – cardboard packs.
5 pcs. – contour cell packaging (9) – cardboard packs.
5 pcs. – contour cell packaging (10) – cardboard packs.
6 pcs. – contour cell packaging – cardboard packs.
6 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (3) – cardboard packs.
6 pcs. – contour cell packaging (4) – cardboard packs.
6 pcs. – contour cell packaging (5) – cardboard packs.
6 pcs. – contour cell packaging (6) – cardboard packs.
6 pcs. – contour cell packaging (7) – cardboard packs.
6 pcs. – contour cell packaging (8) – cardboard packs.
6 pcs. – contour cell packaging (9) – cardboard packs.
6 pcs. – contour cell packaging (10) – cardboard packs.
7 pcs. – contour cell packaging – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (3) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (5) – cardboard packs.
7 pcs. – contour cell packaging (6) – cardboard packs.
7 pcs. – contour cell packaging (7) – cardboard packs.
7 pcs. – contour cell packaging (8) – cardboard packs.
7 pcs. – contour cell packaging (9) – cardboard packs.
7 pcs. – contour cell packaging (10) – cardboard packs.
8 pcs. – contour cell packaging – cardboard packs.
8 pcs. – contour cell packaging (2) – cardboard packs.
8 pcs. – contour cell packaging (3) – cardboard packs.
8 pcs. – contour cell packaging (4) – cardboard packs.
8 pcs. – contour cell packaging (5) – cardboard packs.
8 pcs. – contour cell packaging (6) – cardboard packs.
8 pcs. – contour cell packaging (7) – cardboard packs.
8 pcs. – contour cell packaging (8) – cardboard packs.
8 pcs. – contour cell packaging (9) – cardboard packs.
8 pcs. – contour cell packaging (10) – cardboard packs.
9 pcs. – contour cell packaging – cardboard packs.
9 pcs. – contour cell packaging (2) – cardboard packs.
9 pcs. – contour cell packaging (3) – cardboard packs.
9 pcs. – contour cell packaging (4) – cardboard packs.
9 pcs. – contour cell packaging (5) – cardboard packs.
9 pcs. – contour cell packaging (6) – cardboard packs.
9 pcs. – contour cell packaging (7) – cardboard packs.
9 pcs. – contour cell packaging (8) – cardboard packs.
9 pcs. – contour cell packaging (9) – cardboard packs.
9 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging – 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.
10 pcs. – contour cell packaging (8) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
11 pcs. – contour cell packaging – cardboard packs.
11 pcs. – contour cell packaging (2) – cardboard packs.
11 pcs. – contour cell packaging (3) – cardboard packs.
11 pcs. – contour cell packaging (4) – cardboard packs.
11 pcs. – contour cell packaging (5) – cardboard packs.
11 pcs. – contour cell packaging (6) – cardboard packs.
11 pcs. – contour cell packaging (7) – cardboard packs.
11 pcs. – contour cell packaging (8) – cardboard packs.
11 pcs. – contour cell packaging (9) – cardboard packs.
11 pcs. – contour cell packaging (10) – cardboard packs.
12 pcs. – contour cell packaging – cardboard packs.
12 pcs. – contour cell packaging (2) – cardboard packs.
12 pcs. – contour cell packaging (3) – cardboard packs.
12 pcs. – contour cell packaging (4) – cardboard packs.
12 pcs. – contour cell packaging (5) – cardboard packs.
12 pcs. – contour cell packaging (6) – cardboard packs.
12 pcs. – contour cell packaging (7) – cardboard packs.
12 pcs. – contour cell packaging (8) – cardboard packs.
12 pcs. – contour cell packaging (9) – cardboard packs.
12 pcs. – contour cell packaging (10) – cardboard packs.
13 pcs. – contour cell packaging – cardboard packs.
13 pcs. – contour cell packaging (2) – cardboard packs.
13 pcs. – contour cell packaging (3) – cardboard packs.
13 pcs. – contour cell packaging (4) – cardboard packs.
13 pcs. – contour cell packaging (5) – cardboard packs.
13 pcs. – contour cell packaging (6) – cardboard packs.
13 pcs. – contour cell packaging (7) – cardboard packs.
13 pcs. – contour cell packaging (8) – cardboard packs.
13 pcs. – contour cell packaging (9) – cardboard packs.
13 pcs. – contour cell packaging (10) – cardboard packs.
14 pcs. – contour cell packaging – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (3) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – contour cell packaging (5) – cardboard packs.
14 pcs. – contour cell packaging (6) – cardboard packs.
14 pcs. – contour cell packaging (7) – cardboard packs.
14 pcs. – contour cell packaging (8) – cardboard packs.
14 pcs. – contour cell packaging (9) – cardboard packs.
14 pcs. – contour cell packaging (10) – cardboard packs.
15 pcs. – contour cell packaging – cardboard packs.
15 pcs. – contour cell packaging (2) – cardboard packs.
15 pcs. – contour cell packaging (3) – cardboard packs.
15 pcs. – contour cell packaging (4) – cardboard packs.
15 pcs. – contour cell packaging (5) – cardboard packs.
15 pcs. – contour cell packaging (6) – cardboard packs.
15 pcs. – contour cell packaging (7) – cardboard packs.
15 pcs. – contour cell packaging (8) – cardboard packs.
15 pcs. – contour cell packaging (9) – cardboard packs.
15 pcs. – contour cell packaging (10) – cardboard packs.
16 pcs. – contour cell packaging – cardboard packs.
16 pcs. – contour cell packaging (2) – cardboard packs.
16 pcs. – contour cell packaging (3) – cardboard packs.
16 pcs. – contour cell packaging (4) – cardboard packs.
16 pcs. – contour cell packaging (5) – cardboard packs.
16 pcs. – contour cell packaging (6) – cardboard packs.
16 pcs. – contour cell packaging (7) – cardboard packs.
16 pcs. – contour cell packaging (8) – cardboard packs.
16 pcs. – contour cell packaging (9) – cardboard packs.
16 pcs. – contour cell packaging (10) – cardboard packs.
17 pcs. – contour cell packaging – cardboard packs.
17 pcs. – contour cell packaging (2) – cardboard packs.
17 pcs. – contour cell packaging (3) – cardboard packs.
17 pcs. – contour cell packaging (4) – cardboard packs.
17 pcs. – contour cell packaging (5) – cardboard packs.
17 pcs. – contour cell packaging (6) – cardboard packs.
17 pcs. – contour cell packaging (7) – cardboard packs.
17 pcs. – contour cell packaging (8) – cardboard packs.
17 pcs. – contour cell packaging (9) – cardboard packs.
17 pcs. – contour cell packaging (10) – cardboard packs.
18 pcs. – contour cell packaging – cardboard packs.
18 pcs. – contour cell packaging (2) – cardboard packs.
18 pcs. – contour cell packaging (3) – cardboard packs.
18 pcs. – contour cell packaging (4) – cardboard packs.
18 pcs. – contour cell packaging (5) – cardboard packs.
18 pcs. – contour cell packaging (6) – cardboard packs.
18 pcs. – contour cell packaging (7) – cardboard packs.
18 pcs. – contour cell packaging (8) – cardboard packs.
18 pcs. – contour cell packaging (9) – cardboard packs.
18 pcs. – contour cell packaging (10) – cardboard packs.
19 pcs. – contour cell packaging – cardboard packs.
19 pcs. – contour cell packaging (2) – cardboard packs.
19 pcs. – contour cell packaging (3) – cardboard packs.
19 pcs. – contour cell packaging (4) – cardboard packs.
19 pcs. – contour cell packaging (5) – cardboard packs.
19 pcs. – contour cell packaging (6) – cardboard packs.
19 pcs. – contour cell packaging (7) – cardboard packs.
19 pcs. – contour cell packaging (8) – cardboard packs.
19 pcs. – contour cell packaging (9) – cardboard packs.
19 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging – 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.
20 pcs. – contour cell packaging (6) – cardboard packs.
20 pcs. – contour cell packaging (7) – cardboard packs.
20 pcs. – contour cell packaging (8) – cardboard packs.
20 pcs. – contour cell packaging (9) – cardboard packs.
20 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – bottles – cardboard packs.
20 pcs. – bottles – cardboard packs.
25 pcs. – bottles – cardboard packs.
30 pcs. – bottles – cardboard packs.
35 pcs. – bottles – cardboard packs.
40 pcs. – bottles – cardboard packs.
45 pcs. – bottles – cardboard packs.
50 pcs. – bottles – cardboard packs.
55 pcs. – bottles – cardboard packs.
60 pcs. – bottles – cardboard packs.
65 pcs. – bottles – cardboard packs.
70 pcs. – bottles – cardboard packs.
75 pcs. – bottles – cardboard packs.
80 pcs. – bottles – cardboard packs.
85 pcs. – bottles – cardboard packs.
90 pcs. – bottles – cardboard packs.
95 pcs. – bottles – cardboard packs.
100 pcs. – bottles – cardboard packs.
110 pcs. – bottles – cardboard packs.
120 pcs. – bottles – cardboard packs.
130 pcs. – bottles – cardboard packs.
140 pcs. – bottles – cardboard packs.
150 pcs. – bottles – cardboard packs.
160 pcs. – bottles – cardboard packs.
170 pcs. – bottles – cardboard packs.
180 pcs. – bottles – cardboard packs.
190 pcs. – bottles – cardboard packs.
200 pcs. – bottles – cardboard packs.

Marketing Authorization Holder

Kronopharm, LLC (Russia)

Manufactured By

Canonpharma Production, CJS (Russia)

Dosage Forms

Bottle Rx Icon Fluvoxamine Kpoho Film-coated tablets 50 mg
Film-coated tablets 100 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

1 tab.
Fluvoxamine maleate 50 mg

10 pcs. – contour cell packaging (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – contour cell packaging (3 pcs.) – cardboard packs (30 pcs.) – By prescription
15 pcs. – jars – cardboard packs (15 pcs.) – By prescription
15 pcs. – contour cell packaging – cardboard packs (15 pcs.) – By prescription
15 pcs. – contour cell packaging (2 pcs.) – cardboard packs (30 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
30 pcs. – contour cell packaging – cardboard packs (30 pcs.) – By prescription
60 pcs. – jars – cardboard packs (60 pcs.) – By prescription

Film-coated tablets

1 tab.
Fluvoxamine 100 mg

10 pcs. – contour cell packaging (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – contour cell packaging (3 pcs.) – cardboard packs (30 pcs.) – By prescription
15 pcs. – jars – cardboard packs (15 pcs.) – By prescription
15 pcs. – contour cell packaging – cardboard packs (15 pcs.) – By prescription
15 pcs. – contour cell packaging (2 pcs.) – cardboard packs (30 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
60 pcs. – jars – cardboard packs (60 pcs.) – By prescription

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Forms

Bottle Rx Icon Fluvoxamine Organica Film-coated tablets 50 mg: 10, 20, 30, 40, 50, 60, or 80 pcs.
Film-coated tablets 100 mg: 10, 20, 30, 40, 50, 60, or 80 pcs.

Dosage Form, Packaging, and Composition

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

1 tab.
Fluvoxamine maleate 50 mg

Excipients: mannitol E421, corn starch, pregelatinized corn starch, povidone K25, sodium stearyl fumarate, colloidal silicon dioxide (aerosil).
Coating composition hypromellose (hydroxypropylmethylcellulose) 2910, titanium dioxide, macrogol (polyethylene glycol) 6000, talc.

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 (8) – cardboard packs.

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

1 tab.
Fluvoxamine maleate 100 mg

Excipients: mannitol E421, corn starch, pregelatinized corn starch, povidone K25, sodium stearyl fumarate, colloidal silicon dioxide (aerosil).
Coating composition hypromellose (hydroxypropylmethylcellulose) 2910, titanium dioxide, macrogol (polyethylene glycol) 6000, talc.

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 (8) – cardboard packs.

Marketing Authorization Holder

Pharmasintez, JSC (Russia)

Dosage Forms

Bottle Rx Icon Fluvoxamine Pharmasintez Film-coated tablets, 50 mg: 10, 20, 30, 40, 50, 60, or 80 pcs.
Film-coated tablets, 100 mg: 10, 20, 30, 40, 50, 60, or 80 pcs.

Dosage Form, Packaging, and Composition

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

1 tab.
Fluvoxamine maleate 50 mg

Excipients: mannitol – 151.5 mg, corn starch – 40 mg, pregelatinized starch – 6 mg, sodium stearyl fumarate – 1.75 mg, colloidal silicon dioxide – 0.75 mg.

Film coating composition Hypromellose E15 – 2.8 mg, macrogol 6000 – 1 mg, talc – 0.2 mg, calcium carbonate – 1 mg.

Core tablet mass – 250 mg.
Film-coated tablet mass – 255 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 (8) – cardboard packs.

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

1 tab.
Fluvoxamine maleate 100 mg

Excipients: mannitol – 303 mg, corn starch – 80 mg, pregelatinized starch – 12 mg, sodium stearyl fumarate – 3.5 mg, colloidal silicon dioxide – 1.5 mg.

Film coating composition Hypromellose E15 – 5.6 mg, macrogol 6000 – 2 mg, talc – 0.4 mg, calcium carbonate – 2 mg.

Core tablet mass – 500 mg.
Film-coated tablet mass – 510 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 (8) – cardboard packs.

Table of Contents

→ TABLE OF CONTENTS