Iffiflok^® (Tablets) Instructions for Use

Marketing Authorization Holder

Salvus, LLC (Russia)

Manufactured By

Advanced Pharma, LLC (Russia)

ATC Code

N06AB08 (Fluvoxamine)

Active Substance

Fluvoxamine (Rec.INN WHO registered)

Dosage Forms

	Iffiflok®	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.

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

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

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

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

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

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

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

Clinical-Pharmacological Group

Antidepressant

Pharmacotherapeutic Group

Antidepressant, selective serotonin reuptake inhibitor

Pharmacological Action

Antidepressant.

The mechanism of action is associated with 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

Dosage Regimen

Is set individually.

At the beginning of treatment, the daily dose is 50-100 mg (it is recommended to take 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 in the first 2 weeks of treatment); possibly – constipation, anorexia, dyspepsia, diarrhea, unpleasant sensations in the epigastric region, dry mouth, feeling of discomfort; rarely – increased activity of liver enzymes, mainly 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, headache, nausea, dizziness, feeling of fear were rarely observed.

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

Other increased sweating, change in body weight are possible.

Some of the above side effects may be symptoms of depression and are not due to 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, because this active substance is excreted in small amounts in breast milk.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction.

Patients with hepatic insufficiency at the beginning of treatment with Fluvoxamine should be prescribed 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 at the beginning of treatment with Fluvoxamine should be prescribed 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, as a rule, there is 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 at the beginning of treatment with Fluvoxamine should be prescribed 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 ecchymosis 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 mechanisms

In patients whose activities are associated with the need for concentration and high speed of psychomotor reactions, Fluvoxamine should be used with caution until the final determination of the individual response to treatment.

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

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

Drug Interactions

With simultaneous use with MAO inhibitors, there is a possibility of developing serotonin syndrome, especially with simultaneous use with irreversible non-selective MAO inhibitors.

With simultaneous use, the concentration in blood plasma of alprazolam, bromazepam, diazepam increases and their side effects are enhanced due to the fact that Fluvoxamine inhibits the metabolism of these benzodiazepines.

With simultaneous use, the concentration in blood plasma 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, with the participation of which the process of N-demethylation of these antidepressants occurs.

With simultaneous use 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 concentration of warfarin in blood plasma and the appearance of the risk of bleeding is possible; with galantamine – the likelihood of increased side effects of galantamine increases; with haloperidol – the concentration of lithium in blood plasma increases.

With simultaneous use, the concentration of carbamazepine in blood plasma 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.

With simultaneous use, the concentration of clozapine in blood plasma significantly increases, which in some patients is accompanied by the development of toxic effects of clozapine.

With simultaneous use, a decrease in the clearance of caffeine and an increase in its effects are 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.

With simultaneous use with metoclopramide, a case of extrapyramidal disorders has been described.

With simultaneous use with olanzapine, the concentration of olanzapine in blood plasma increases; with propranolol – the concentration of propranolol in blood plasma increases, which is probably due to the inhibition by fluvoxamine of the cytochrome P450 system isoenzymes involved in the metabolism of propranolol.

With simultaneous use with theophylline, the concentration of theophylline in blood plasma 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.

With simultaneous use, 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.

With simultaneous use, 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.