Феварин®

General characteristics. Structure:

Active agent: a fluvoksamina a maleate — 50, 100 mg

excipients: Mannitolum — 152,0 mg (303,0 mg), starch corn — 40,0 mg (80,0 mg), starch prezhelatinizirovanny — 6,0 mg (12,0 mg), the sodium stearylfumarating — 1,8 mg (3,5 mg), silicon dioxide colloid — 0,8 mg (1,5 mg)

cover: a gipromelloza — 4,1 mg (5,6 mg), a macrogoal of 6000 — 1,5 mg (2,0 mg), talc — 0,3 mg (0,4 mg), titanium dioxide (E171) — 1,5 mg (2,1 mg).

Description:

Tablets "50 mg":

Tablets are film coated, round biconvex white color with risky on the one hand, with an engraving 291 on both sides from risks.

Tablets "100 mg":

Tablets are film coated, oval biconvex white color with risky on the one hand, with an engraving 313 on both sides from risks.

Pharmacological properties:

Pharmacodynamics. Researches on linkng with receptors showed what флувоксамин is powerful inhibitor of the return serotonin reuptake both in vitro, and in vivo with the minimum affinity to serotoninovy receptors. Its ability to communicate with α-and β-adrenoceptors, histamine, m-holino or dopamine receptors insignificant.

Fluvoksamin has high affinity to σ1 — to receptors, acting as their agonist.

Pharmacokinetics. Absorption

After intake флувоксамин it is completely soaked up from digestive tract. The maximum concentration of drug in a blood plasma are noted in 3-8 hours after reception. Absolute bioavailability makes 53% after primary metabolism in a liver. The concomitant use of a fluvoksamin with food does not influence pharmacokinetics.

Distribution

Linkng of a fluvoksamin with proteins of plasma makes 80% (in vitro). Distribution volume — 25 l/kg.

Metabolism

Metabolism of a fluvoksamin happens, mainly, in a liver. Though the isoenzyme 2D6 of P 450 cytochrome is the basic in metabolism of a fluvoksamin, concentration of drug in a blood plasma at persons with reduced function of this isoenzyme is not much higher, than at persons with normal metabolism.

The average plasma elimination half-life of blood making for a single dose of 13-15 hours increases a little at multiple dose (17-22 hours), and equilibrium concentration in a blood plasma is, as a rule, reached within 10-14 days.

Fluvoksamin is exposed to biotransformation in a liver (mainly, by oxidizing demethylation) at least to nine metabolites which are removed through kidneys. Two main metabolites have insignificant pharmacological activity. Other metabolites probably pharmacological are inactive.

Fluvoksamin considerably inhibits P450 1A2 cytochrome and P450 2C19, moderately inhibits tsitokhroma of P450 2C9, P450 2D6 and P450 3A4.

The pharmacokinetics of a single dose of a fluvoksamin is linear. Equilibrium concentration of a fluvoksamin is higher, than concentration of a single dose, and this disproportion is more expressed at higher daily doses.

Special groups of patients

The pharmacokinetics of a fluvoksamin is identical at healthy people, elderly and patients with a renal failure. Metabolism of a fluvoksamin is reduced at patients with liver diseases.

Equilibrium concentration of a fluvoksamin in plasma is twice higher at children (at the age of 6-11 years), than at teenagers (at the age of 12-17 years). Concentration of drug in a blood plasma at teenagers are similar to concentration at adults.

Indications to use:

— depressions of various genesis

— obsessivno-compulsive frustration

Route of administration and doses:

Pill of a fluvoksamin should be taken inside, without chewing, washing down with water. The tablet can be divided into two equal parts.

Depressions

Adults

The recommended starting dose for adults makes 50 or 100 mg (once, in the evening). Gradual increase in a dose to level effective is recommended.

The effective daily dose making usually 100 mg is selected individually depending on reaction of the patient to treatment. The daily dose can reach 300 mg. Daily doses over 150 mg should be distributed on several receptions.

According to official WHO recommendations, treatment by antidepressants should be continued, at least, within 6 months of remission after a depressive episode.

For prevention of a recurrence of a depression about 100 mg of the drug Fevarin® once a day, daily are recommended to accept.

Children

Due to the lack of clinical experience of Fevarin® it is not recommended to apply to treatment of depressions at children up to 18 years.

Obsessivno-kompulsivnye Frustration (OKF)

Adults

The recommended starting dose for adults sostavyat 50 mg of the drug Fevarin® a day within 3-4 days. The effective daily dose makes, as a rule, from 100 to 300 mg. Doses should be raised gradually to achievement of an effective daily dose which should not exceed 300 mg at adults. Doses to 150 mg can be accepted once in days, it is desirable in the evening. Daily doses over 150 mg are recommended to be distributed on 2 or 3 receptions.

Children are more senior than 8 years and teenagers

The initial dose makes 25 mg/days on one reception. Maintenance dose of 50 — 200 mg/days. At treatment of ROC at children aged from 8 up to 18 years the daily dose should not exceed 200 mg. Daily doses over 100 mg are recommended to be distributed on 2 or 3 receptions.

At the good therapeutic answer to drug treatment can be continued by means of individually picked up daily dose. If improvement is not reached in 10 weeks, then treatment fluvoksaminy should be reconsidered. Still system researches which could answer a question of how treatment fluvoksaminy can long be carried out were not organized, however obsessivno-compulsive frustration have chronic character and therefore it is possible to consider expedient treatment extension fluvoksaminy over 10 weeks at the patients who well answered this drug. Selection of the minimum effective maintenance dose has to be carried out with care in an individual order. It is periodically necessary to estimate need for treatment again. Some clinical physicians recommend carrying out the accompanying psychotherapy at the patients who well answered pharmacotherapy.

Syndrome of "cancellation" after phase-out of a fluvoksamin

It is necessary to avoid sharp drug withdrawal. At the treatment termination fluvoksaminy it is necessary to reduce gradually a dose within at least 1-2 weeks for decrease in risk of a syndrome of "cancellation" (see the section "Side Effects" and "Special Instructions"). In case of intolerable symptoms after a dose decline or after cancellation of treatment it is possible to consider a question of resuming of treatment in earlier recommended dose. Later the doctor can begin a dose decline, however more gradually again.

Treatment of patients with a liver or renal failure should be begun with low doses under strict medical control.

Features of use:

As well as at use of other psychotropic drugs, during treatment the drug Fevarin® does not recommend to consume alcohol.

Suicide / suicide thoughts or clinical aggravation of symptoms

The depression is connected with the increased risk of suicide thoughts, self-damages and attempts of a suicide (suicide behavior). This risk remains before considerable improvement of a state. As improvement can not occur within the first several weeks of treatment or longer, patients have to be under careful observation before emergence of such improvement.

In clinical practice increase in risk of a suicide at early stages of recovery is eurysynusic.

Other mental disorders for which treatment appoint флувоксамин can be also connected with the increased risk of suicide acts. Besides, these states can accompany a deep depression. Therefore patients with other mental disorders have to be under careful observation.

It is known that patients with suicide behavior in the anamnesis or substantially showing suicide thinking, before an initiation of treatment have bigger risk of suicide thoughts or suicide attempts and have to be observed carefully during treatment.

Careful observation of the patients who especially have high risk has to accompany medicinal therapy especially at its early stages and after changes of a dose.

It is necessary to warn patients (and carrying out care of them) about need to trace any clinical aggravation of symptoms, suicide behavior or suicide thoughts, unusual changes of behavior, and to address immediately for consultation the specialist at emergence of such symptoms.

Children's population

Fluvoksamin should not be applied to treatment of children and teenagers up to 18 years except for patients with obsessivno-compulsive frustration. Because of a lack of clinical experience of use of a fluvoksamin for children for treatment of a depression it cannot be recommended. In the clinical trials conducted among children and teenagers the suicide caused behavior (suicide attempts and thoughts) and hostility (mainly aggression, oppositional behavior and anger) were observed more often at the patients receiving antidepressant in comparison with the receiving placebos. If on the basis of clinical requirement the decision on treatment is made, for the patient careful observation regarding emergence of suicide symptoms has to be established.

Besides, the long-term data on safety for children and teenagers concerning growth, development and formation of cognitive behavior no.

Adults (from 18 to 24 years)

Placebo meta-analysis - controlled clinical trials of antidepressants at adult patients with mental disorders revealed the increased risk of suicide behavior at reception of antidepressants in comparison with placebo at patients more young than 25 years. At purpose of a fluvoksamin it is necessary to correlate risk of a suicide and advantage of its use.

Elderly patients

The data obtained at treatment of patients of advanced age and younger patients confirm lack of clinically significant distinctions between the daily doses which were usually applied at them. Nevertheless, increase in doses of drug at elderly patients has to be carried out always more slowly and with bigger care.

Akathisia / psychomotor excitement

Development of the akathisia connected with reception of a fluvoksamin is characterized by subjectively unpleasant and painful concern. The need to move often was followed by inability to sit or stand quietly. Development of such state is most probable within the first several weeks of treatment. Increase in a dose of drug at patients with such symptoms can worsen their state.

Treatment of the patients having a liver or renal failure should be begun with low doses and such patients have to be under strict medical control. In rare instances treatment fluvoksaminy can lead to the increase in activity of liver enzymes most of which often is followed by the corresponding clinical symptoms and in such cases of Fevarin® has to be cancelled.

Frustration of a nervous system

It is necessary to show care at purpose of drug the patient with spasms in the anamnesis. It is necessary to avoid purpose of a fluvoksamin at patients with unstable epilepsy, and patients with stable epilepsy have to be under strict control. Treatment by the drug Fevarin® has to be stopped if there are epileptic attacks or their frequency increases.

Exceptional cases of development of a serotoninovy syndrome or state, similar to a malignant antipsychotic syndrome which can be connected with reception of a fluvoksamin, especially in a combination with other serotonergichesky and/or antipsychotic medicines are described. As these syndromes can lead to potentially life-threatening states, the shown hyperthermia, muscle tension, a myoclonus, lability of an autonomous nervous system with possible fast changings of the vital parameters (pulse, breath, the ABP, etc.), changes of the mental status, including confusion, irritability, the extreme agitation reaching a delirium or a coma — in such cases treatment fluvoksaminy has to be stopped and the corresponding symptomatic treatment has to be begun.

Disorders of metabolism and food

As well as at use of other selective serotonin reuptake inhibitors, emergence of a hyponatremia which is exposed to involution, after cancellation of a fluvoksamin is in rare instances possible. Some cases were caused by a syndrome of insufficient secretion of antidiuretic hormone. Generally these cases were observed at elderly patients.

Control over glucose level in blood (i.e. a hyperglycemia, a hypoglycemia, disturbance of tolerance to glucose), especially at early stages of treatment can be broken. In case of purpose of a fluvoksamin, dose adjustment of anti-diabetic drugs can be required by patients with a diabetes mellitus in the anamnesis.

The most often observed symptom connected using the drug Fevarin® is the nausea which sometimes is followed by vomiting. This side effect, as a rule, disappears within the first two weeks of treatment.

Disturbance from an organ of sight

It was reported about cases of development of a mydriasis at use of SIOZS, such as флувоксамин. Therefore patients with the increased intraocular pressure or to patients of group of the increased risk of acute closed-angle glaucoma флувоксамин should appoint with care.

Hematologic disturbances

There are messages on such intradermal hemorrhages as ecchymomas and a purpura, and also other hemorrhagic manifestations (for example, gastrointestinal bleeding or gynecologic bleeding) observed at use of selective serotonin reuptake inhibitors. It is necessary to show care at purpose of these medicines at the elderly patients and patients who are at the same time receiving the drugs operating on platelet function (for example, atypical antipsychotic means and fenotiazina, many tricyclic antidepressants, acetylsalicylic acid, nonsteroid antiinflammatory medicines) or the drugs increasing risk of development of bleedings and also at patients with bleedings in the anamnesis or inclined to bleedings (for example, with thrombocytopenia or disturbance of coagulation).

Cardiac disturbances

Increase in risk of lengthening of an interval of QT/Bouveret's of ventricular disease like "pirouette" at a combination therapy of a fluvoksamin with terfenadiny or astemizoly or tsizapridy, in connection with increase of concentration of the last in a blood plasma. Therefore флувоксамин it is not necessary to appoint together with these drugs.

Fluvoksamin can cause insignificant decrease in ChSS (on 2-6 beats per minute).

Electroconvulsive therapy (EST)

Experience of a clinical use of a fluvoksamin against the background of EST is limited therefore such therapy has to be carried out with care.

Cancellation reactions

At the termination of reception of a fluvoksamin development of a syndrome of "cancellation" is possible though the available data of preclinical and clinical trials did not reveal emergence of dependence on treatment fluvoksaminy. The most frequent symptoms noted in case of drug withdrawal: dizziness, sensitivity disturbances (including paresthesias, visual frustration and feeling current rush), backfilling disturbances (including sleeplessness and bright dreams) excitement, irritability, confusion of consciousness, emotional lability, a headache, nausea and/or vomiting, diarrhea, perspiration, a heart consciousness, a tremor and alarm (see the section "Side effects").

The majority of these symptoms have poorly or moderately expressed character and are stopped independently, however some patients can have them heavy and/or long. Similar symptoms usually arise during the first several days after the treatment termination. For this reason it is recommended to reduce gradually a dose of a fluvoksamin before full cancellation according to a condition of the patient (see the section "Route of Administration and Doses").

Mania/hypomania

Fluvoksamin it is necessary to use with care at patients with a mania/hypomania in the anamnesis. At development in the patient of a maniacal phase it is necessary to stop use of a fluvoksamin.

Ability to driving and use of cars and

mechanisms.

Феварин®, appointed to healthy volunteers in doses to 150 mg, did not influence or rendered

insignificant influence on ability to driving by the car and control of cars.

At the same time there are messages on the drowsiness noted during treatment

fluvoksaminy. In this regard, it is recommended to show care to

final definition of the individual answer to drug.

Side effects:

Some side effects observed at conduct of clinical trials often were connected with a disease, but not with the drug Fevarin® which is carried out by treatment.

All reactions are distributed on systems of bodies and frequency of development: frequent (> 1% and <10%); not frequent (> 0,1% and <1%); rare (> 0,01% and <0,1%); frequency is not known.

Frequent                    Not frequent                     Rare                               Frequency is not known
 
Disturbances from blood and lymphatic system
 
                                                                                             bleedings (for example, gastrointestinal
                                                                                             bleedings, gynecologic bleedings,
                                                                                             ecchymoma, purpura)
Disturbances from endocrine system
 
                                                                                             giperprolaktinemiya, syndrome of inadequate products
                                                                                             antidiuretic hormone
Disturbances from a metabolism and food
anorexia                                                                            hyponatremia, degrowth
                                                                                             bodies, increase in body weight
Disturbances of mentality
                            hallucinations, state  mania         suicide thinking,
                              the confused consciousness                            suicide behavior
Disturbances from a nervous system
the alarm increased excite -  extrapyramidal spasms  a serotoninovy syndrome, zlokachestven-
the bridge, disturb -                        a narusheniyaataksiya                    ny neyroleptiches-
stvo, sleeplessness, drowsiness,                                              cue syndrome, akathisia / psychomotor
tremor, headache,                                                          excitement, parasthesia, dysgeusia
dizziness

Disturbances from an organ of sight
                                                                                                  glaucoma, mydriasis
Disturbances from heart
feeling serdtsebiye-niya/tachycardia
      
Disturbances from vessels
                                  orthostatic hypotension
   
Disturbances from digestive tract
abdominal pain, lock,
diarrhea, dryness in a mouth,
dyspepsia, nausea, vomiting
      
Disturbances from a liver
                                                                                   disturbance
                                                                                functions of a liver
                                                                                (increase aktivnos-
                                                                                ти "hepatic"
                                                                                 enzymes)
Disturbances from skin and hypodermic fabrics
raised                   skin reactions                              of reaction of photosensitivity
sweating                giperchuvstvitel-
                                        to Nosta (including rash,
                                       itch, Quincke's disease)

Disturbances from skeletal and muscular and connecting fabric
                                                    arthralgia, mialgiya                  fractures of bones *
 
Disturbances from kidneys and urinary tract
                                                                                                      disturbances of an urination
                                                                                                  (including an ischuria, an incontience
                                                                                                 wet, a pollakiuria, a nokturiya and enuresis)
Disturbances from generative organs and a mammary gland
                             disturbance (delay) of an ejaculation     galactorrhoea  anorgazmiya, menstrual
                                                                                                             disturbances (such as amenorrhea,
                                                                                                            hypomenorrhea, metrorrhagia, menorrhagia)
General frustration
adynamy, indisposition                                                                    the Syndrome of "cancellation" of drug, including a syndrome
                                                                                                      "cancellations" at at newborns, whose mothers
                                                                                                   accepted флувоксамин on late terms
                                                                                                     pregnancies
 
* - The epidemiological researches executed, mainly, with participation of patients at the age of 50 years are also more senior, showed increase in risk of fractures of bones at the patients receiving SIOZS and tricyclic antidepressants. The mechanism of increase in risk is unknown.

Syndrome of "cancellation" after phase-out of a fluvoksamin

Phase-out of a fluvoksamin (especially sharp) often leads to development of a withdrawal. For this reason if treatment fluvoksaminy is not required, recommended to reduce gradually a dose to full drug withdrawal any more (see the section "Route of Administration and Doses" and "Special Instructions").

Interaction with other medicines:

MAO inhibitors

Fluvoksamin it is impossible to apply in combination with MAO inhibitors, including линезолид because of risk of development of a serotoninovy syndrome (see the section "Contraindications").

Influence of a fluvoksamin on oxidizing process of other drugs

Fluvoksamin can inhibit metabolism of drugs which are metabolized by certain isoenzymes of P450 cytochrome. In the researches in vitro and in vivo the powerful inhibiting effect of a fluvoksamin on isoenzymes of P450 1A2 cytochrome and P450 2C19 and to a lesser extent on isoenzymes of P450 2C9 cytochrome, P450 2D6 and P450 3A4 is shown.

Drugs which are considerably metabolized by these isoenzymes are removed and can have higher concentration in a blood plasma, in case of simultaneous use with fluvoksaminy more slowly. It is necessary to appoint such drugs in the minimum dose or to lower a dose to minimum at simultaneous use with fluvoksaminy. Careful observation of plasma concentration, effects or side effects, and also dose adjustment of these drugs is required, if necessary. It is especially significant for drugs which have narrow therapeutic range.

Ramelteon

At administration of drug of Fevarin® twice a day on 100 mg within 3 days before simultaneous use of drug рамелтеон in a dose of 16 mg, AUC value (the area under a curve "concentration time") for a ramelteon increased approximately by 190 times, and Cmax value (the maximum concentration) increased approximately by 70 times in comparison with these parameters at purpose of one ramelteon.

Drugs with a narrow therapeutic range

The patients who are at the same time accepting флувоксамин and the drugs with a narrow therapeutic range which are exposed to metabolism it is exclusive or a combination of isoenzymes of cytochrome, inhibiting флувоксамин (such as такрин, theophylline, methadone, мексилетин, Phenytoinum, carbamazepine and cyclosporine), have to be under careful observation. If necessary dose adjustment of these drugs is recommended.

Tricyclic antidepressants and neuroleptics

At simultaneous use of a fluvoksamin increase in concentration of tricyclic antidepressants (for example, кломипрамин, Imipraminum, amitriptyline) and neuroleptics (for example, clozapine, olanzapine, кветиапин) which are substantially metabolized by an isoenzyme of P450 1A2 cytochrome was observed. In this regard, if treatment fluvoksaminy is begun, the dose decline of these drugs has to be considered.

Benzodiazepines

At simultaneous use with fluvoksaminy the benzodiazepines which are exposed to oxidizing metabolism such as to triazoles, midazolam, to alprazola and diazepam, increase in their concentration in plasma is possible. The dose of these benzodiazepines should be reduced by time of reception of a fluvoksamin.

Cases of increase in plasma concentration

At simultaneous use of a fluvoksamin and ropinirol concentration of a ropinirol in plasma can increase, thus, increasing risk of development of overdose. In such cases control, or, in case of need, a dose decline or cancellation of a ropinirol for the period of treatment fluvoksaminy is recommended.

At interaction of a fluvoksamin with propranolol increase in concentration of propranolol in plasma was noted. In this regard it is possible to recommend a propranolol dose decline in case of simultaneous use with fluvoksaminy.

At use of a fluvoksamin in a combination with warfarin significant increase in concentration of warfarin in a blood plasma and lengthening of a prothrombin time was observed.

Cases of increase in frequency of side effects

It was reported about isolated cases of cardiotoxicity at simultaneous use of a fluvoksamin and thioridazine.

During reception of a fluvoksamin concentration of caffeine in plasma can increase. Thus, patients who consume a large number of the drinks containing caffeine have to reduce their consumption for reception of a fluvoksamin and when adverse effects of caffeine, such as a tremor, a heart consciousness, nausea, concern, sleeplessness are observed.

Isoenzyme of P450 3A4 cytochrome

Terfenadin, астемизол, цизаприд, sildenafit: at a combination therapy with fluvoksaminy concentration of a terfenadin, an astemizol or a tsizaprid in a blood plasma can increase, increasing risk of lengthening of an interval of QT/Bouveret's of ventricular disease like "pirouette". Therefore флувоксамин it should not be appointed together with these drugs.

Glyukuronirovaniye

Fluvoksamin does not exert impact on concentration of digoxin in plasma.

Renal excretion

Fluvoksamin does not exert impact on concentration of an atenolol in plasma.

Pharmakodinamichesky interactions

In case of simultaneous use of a fluvoksamin with serotonergic drugs (such as triptanes, трамадол, selective serotonin reuptake inhibitors and drugs of the St. John's Wort which is made a hole) serotonergic effects of a fluvoksamin can amplify (see. "Special instructions").

Fluvoksamin was applied in a combination with lithium drugs to treatment of the heavy patients who are badly answering pharmacotherapy. It should be noted that lithium (and, perhaps, also tryptophane) strengthens serotonergic effects of drug and therefore such combined pharmacotherapy has to be carried out with care.

At simultaneous use of indirect anticoagulants and the fluvoksamina can increase risk of development of hemorrhages. Such patients have to be under observation of the doctor.

Contraindications:

1. A concomitant use with tizanidiny and monoamine oxidase inhibitors (MAO inhibitors).

Treatment fluvoksaminy can be begun:

— in 2 weeks after the termination of reception of the MAO irreversible inhibitor;

— next day after the termination of reception of the MAO reversible inhibitor (for example, моклобемид, линезолид).

The period between the termination of reception of a fluvoksamin and the beginning of therapy by any MAO inhibitor has to make, at least, 1 week.

2. A concomitant use with drug рамелтеон (see the section "Interaction with Other Medicines").

3. Hypersensitivity to active agent or to any of drug components.

With care

Liver and renal failure, spasms in the anamnesis, epilepsy, advanced age, patients with tendency to bleedings (thrombocytopenia), pregnancy, a lactation.

Use during pregnancy and in the period of a lactation

Pregnancy

Epidemiological data give the grounds to assume that use of the selective serotonin reuptake inhibitors (SSRI) at pregnancy, in particular last months pregnancies, can increase risk of the persistent pulmonary hypertensia (PPH) of newborns. The available data show that PLG arises approximately in 5 cases on 1000 births (unlike 1-2 cases on 1000 births if mother did not apply SIOZS on deadlines for pregnancy).

Use of a fluvoksamin is not recommended during pregnancy, except for cases when the clinical condition of the woman indicates its uses the need.

Separate cases of a withdrawal at newborns after use of a fluvoksamin at the end of pregnancy were described.

Some newborns after influence of SIOZS in the third trimester of pregnancy had difficulties of feeding and/or breath, convulsive frustration, unstable body temperature, a hypoglycemia, a tremor, disturbances of a muscle tone, a syndrome of the increased neuroreflex irritability, cyanosis, irritability, a lethargy, drowsiness, nausea, difficulties with backfilling and continuous crying that can demand more long hospitalization.

Lactation period

Fluvoksamin gets into breast milk in small amounts. In this regard, drug should not be used in the period of a lactation.

Fertility

Researches of reproductive toxicity at animals showed what флувоксамин influences reproductive function of males and females, increases risk of pre-natal death of a fruit and reduces fruit body weight in the doses exceeding the maximum recommended doses for the person approximately by 4 times. Besides, increase in frequency of perinatal mortality of puppies in pre-and post-natal researches was observed. The importance of these data for the person is unknown.

Fluvoksamin patients who plan pregnancy, except for cases when the clinical condition of the patient demands purpose of a fluvoksamin should not appoint.

Overdose:

Symptoms

Gastrointestinal frustration (nausea, vomiting and diarrhea), drowsiness and dizziness belong to the most characteristic symptoms. Besides, there are messages on disturbances of cordial activity (tachycardia, bradycardia, arterial hypotension), abnormal liver functions, spasms and a coma.

Fluvoksamin has the big width of a therapeutic dose concerning safety of overdose. From the moment of release on the market of the message on death cases, attributed to overdose only fluvoksaminy, were noted extremely seldom. The highest registered dose of a fluvoksamin accepted by one patient made 12 g. This patient was completely cured. More serious complications were observed in cases of deliberate overdose of a fluvoksamin in combination with other drugs.

Treatment

The specific antidote of a fluvoksamin does not exist. At overdose the gastric lavage which has to be carried out as soon as possible after administration of drug, and also a symptomatic treatment is recommended. Besides, multiple dose of absorbent carbon, if necessary purpose of osmotic laxatives is recommended. The artificial diuresis or dialysis are not effective.

Storage conditions:

Period of validity 3 years. Drug cannot be used after a period of validity. At a temperature not above 25 °C. To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated 50, 100 mg: on 15 or on 20 tablets in PVC / PVDH / It is scarlet

blister. On 1, 2, 3 or 4 blisters in a cardboard pack together with the application instruction.