Fluoxetine - instructions for use, dose, side effects, contraindications

remembersubstances, lactose monohydrate (milk sugar) 80.8 mg or 161.6 mg: povidone (polyvinylpyrrolidone) 4 mg or 8 mg; potato starch 3 mg or 6 mg; calcium stearate 1 mg or 2 mg;

composition of hard gelatin capsules № 4 (for a dosage of 10 mg): gelatin, water, titanium dioxide;

agency hard gelatin capsules number 2 (for a dosage of 20 mg): (gelatin, water, gitanic dioxide, iron oxide yellow, indigocarmy).

Description:

hard gelatin capsules No. 4 in white with white caps (for 10 mg dosage) or No. 2 white with green caps (for a dosage of 20 mg); contents of capsules: granules and powder white or white with a slightly yellowish hue of color.

Pharmacotherapeutic group:antidepressant

ATX: & nbsp

N.06.A.B.03 Fluoxetine

Pharmacodynamics:

Antidepressant. It is a selective inhibitor of serotonin reuptake, which determines the mechanism of its action. Fluquistin has practically no affinity for other receptors, for example, alpha1, alpha2 and beta-adrenergic, serotonergic, dopaminergic, histamine, 1, muscarinic and GABA receptors, fluoxetine blocking the seizure of serotonin by human platelets.

Pharmacokinetics:

Absorption

Ingestion fluoxetine well absorbed.

Food intake nc has an effect on the systemic bioavailability of fluoxetine, but eating can lead to a delay in absorption for 1-2 hours, which is probably not of clinical significance. In this way, fluoxetine can be taken with food or without eating.

Binding to blood plasma proteins The maximum concentration in the blood plasma is achieved in 6-8 hours. At the concentrations or 200 to 1000 ng / ml approximately 94.5% fluoxetine in vitro is associated with human plasma proteins, including albumin and a 1-acid glycoprotein. Fluoxetine has a high volume of distribution (20-40 l / kg). The value of Stach is 15-55 ng / ml. The equilibrium concentrations after prolonged use of the drug are similar to the concentrations observed in the 4-5 pedel of the drug.

Metabolism

After 30 days of taking the drug at a dose of 40 mg / day, the fluoxetine concentration in the blood plasma was observed in the range from 91 to 302 ng / ml and the concentration of norfluoxetine from 72 to 258 ng / ml.

A part of the population (about 7%) had a decreased isoenzyme activity CY1P2D6), which metabolizes fluoxetine. These patients are called "slow metabolizers" of drugs such as debrisozoa, dextromethorphan and tricyclic antidepressants (TCAs). In a study using labeled and unlabeled enantiomers, which were administered as a racemic mixture, the metabolism S fluoxetine in these patients was slower, and the concentration S fluoxetine, therefore, they had higher. Hence the concentration S norfluoxetine in a state of equilibrium was lower. Metabolism R Fluoxetine in these patients was normal. When compared with "normal metabolizers," the total amount of equilibrium plasma concentrations of 4 active enantiomers in "slow metabolizers" was not significantly higher. Consequently, the overall pharmacological activity was almost the same. The metabolism of fluoxetine also goes through alternative unsaturated pathways (not through isoenzyme CYP2D6) This explains the achievement of fluoxetine equilibrium state instead of an unlimited increase in concentration.

Since in the metabolism of fluoxetine, as in the metabolism of some other compounds, including TCAs and other serotonin reuptake inhibitors (SSRIs), an isoenzyme system CYP2D6, combined use with drugs that are also metabolized by this enzyme system (such as TCAs) can lead to drug interactions.

Excretion

The half-life of fluoxetine is from 4 to 6 days, the half-life period of the holesfluoxetine - from 4 to 16 days. A long half-life leads to persistence of fluoxetine within 5-6 weeks after discontinuation of fluoxetine treatment.The primary route (about 60%) is through the kidneys.

Special patient groups Elderly patients

Kinetic indicators of healthy elderly papists are comparable with those of younger patients.

Liver failure:

In liver failure (alcoholic cirrhosis of the liver), the half-life of fluoxetine and norfluoxetine is increased to 7 and 12 days, respectively. In this case, it is necessary to consider the possibility of reducing the frequency of application or lower doses.

Renal insufficiency:

After a single dose of fluoxetine in patients with mild, moderate, or complete renal insufficiency, the kinetic parameters were not changed in comparison with healthy volunteers, but after repeated administration, an increase in the plateau of plasma concentration may be observed.

Indications:

depression of various etiologies;
bulimia nervosa: as an adjunct to psychotherapy to reduce uncontrolled eating;
obsessive-compulsive disorder.

Contraindications:

hypersensitivity to fluoxetine or other components of the drug;
simultaneous administration of monoamine oxidase inhibitors (MAO) and a period of at least 14 days after their cancellation. At least a 5-week interval should be between discontinuing fluoxetine and initiating the use of MAO inhibitors. If fluoxetine assigned for continuous use and / or at high doses, the interval between application of fluoxetine and MAO inhibitors should be increased;
simultaneous administration of thioridazine and a period of up to 5 weeks after its withdrawal;
simultaneous administration of pimozide;

-Children and adolescents under 18;

lactose intolerance, lactase deficiency and glucose-galactose malabsorption.

Carefully:

Diabetes mellitus, epilepsy (including in the anamnesis), suicidal mood (see section "Special instructions").

Pregnancy and lactation:

Epidemiological studies evaluating the risk of taking fluoxetine early in pregnancy have yielded mixed results without convincing evidence of an increased risk of congenital anomalies in the fetus. However, one of the meta-analyzes indicates a potential risk of developing cardiovascular malformations in a child, if the mother took fluoxetine during the first trimester pregnancy.Care should also be taken in late pregnancy, since in the case of a mother taking fluoxetine shortly before the birth, there are rare reports of the development of a "withdrawal" syndrome in a newborn (respiratory distress syndrome, cyanosis, apnea, convulsions, unstable temperature, vomiting, hypoglycemia, muscle hypotension or hypertension, tremor, incessant crying, reflex excitability, difficulty in feeding, frequent melon and irritability). Infants whose mothers took SSRIs in late pregnancy were at an increased risk of developing persistent pulmonary hypertension of newborns, whose incidence can not be estimated from the available data.

Fluoxetine penetrates into breast milk, therefore caution should be given to the administration of fluoxetine to nursing mothers. If fluoxetine is considered necessary, breastfeeding should be discontinued. In the event that breastfeeding is continued, it is necessary to reduce the dose of fluoxetine. The effect of fluoxetine on the process of childbirth in humans is unknown.

According to the results of pre-clinical and clinical studies, it was revealed that fluoxetine can damage the genetic structure of spermatozoa, thereby worsening the quality of sperm. This phenomenon is reversible, the quality of sperm is restored after the drug is discontinued.

Dosing and Administration:

Inside, regardless of food intake.

The initial dose is 20 mg I once a day in the morning. If necessary, can be increased to 40-60 mg / day, (20 mg / day daily), divided into 2 reception. The maximum daily dose is 80 mg.

The clinical effect develops 1-4 weeks after the start of treatment, in some patients it can be achieved later.

With depression the initial dose is 20 mg fluoxetine per day in the morning, regardless of the intake of the food. If necessary, the dose can be increased to 40-60 mg per day, divided into 2-3 doses. The maximum daily dose is 80 mg. The clinical effect develops 1-4 weeks after the start of the course of treatment. In some patients, it can be achieved later.

In obsessive-compulsive disorders the recommended dose is 20-60mg/ day,divided into 2-3 reception.

When bulimia nervosa the drug is used in a daily dose of 60 mg. separated by a 2-reception.

Dilitelnost reception is determined by the attending physician and can last for several years. Cancellation of fluoxetine therapy should be carried out gradually within one or two weeks, depending on the condition of the patient (see section "Special instructions").

Patients old age the recommended initial dose is 20 mg. If necessary, the dose can also be increased to 40-60 mg / day. divided into 2 to 3 reception. The maximum daily dose is 80 mg. The duration of treatment is determined by the attending physician. If necessary, it is possible to adjust the dose of the drug during the treatment, depending on the patient's condition. The elimination of fluoxetine should be done gradually within one or two weeks.

In patients with impaired liver and kidney function, low body weight, concomitant diseases or taking other medications, you should reduce doses and reduce the frequency of admission.

Side effects:

The frequency of side effects was estimated as follows: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000. <1/1000); very rarely (<1/10000).the frequency is unknown (the frequency of occurrence can not be estimated from the available data).

Violations from the blood and lymphatic system: very rarely - thrombocytopenia. frequency unknown - pancytopenia:

Immune system disorders', rarely - anaphylactic reactions, angioedema, hives, serum sickness.

Disorders from the endocrine system: frequency unknown - impaired secretion of antidiuretic hormone;

Disruption from the metabolism and nutrition: often - decreased appetite (including anorexia); rarely - hyponatremia;

Disorders of the psyche: very often insomnia (including early morning awakenings, sleep disturbances, sleep disturbance in the night, unusual dreams (including nightmares), often anxiety, nervousness, anxiety, stress, decreased libido (including loss of libido), infrequently - depersonalization, increased mood , euphoria, violation of thinking, bruxism; violation of orgasm (including amorgasmia). rarely - hypomania, hallucinations, agitation, panic attacks; frequency is unknown - suicidal thoughts or behavior (these symptoms can be due to existing diseases - confusion, memory impairment;

Disturbances from the nervous system: very often - headache; often - dizziness, attention disturbance, dysgeusia, lethargy, drowsiness (including excessive daytime drowsiness and sedation), tremor: infrequent - psychomotor hyperactivity, diskenezia, ataxia, imbalance, myoclonus, memory impairment: rarely convulsions, akathisia, cogossal syndrome; frequency unknown-serotanine syndrome, dysphemia;

Disturbance of vision: often - blurred vision; infrequently - mydriasis;

Hearing disorders and labyrinthine disorders: frequency unknown - tinnitus;

Heart Disease: often - a feeling of palpitations;

Vascular disorders: often - tides (including "hot flushes"); infrequently - lowering blood pressure; rarely - vasculitis, vasodilation;

Disturbances from the respiratory system, chest and mediastinal organs: often - yawning; infrequently - shortness of breath; rarely - pharyngitis; often that is unknown - inflammatory processes in the lungs (with different histopathology and fibrosis), epistaxis;

Disorders from the gastrointestinal tract: very often - diarrhea, nausea; often vomiting, dyspepsia,dry mouth; infrequently - dysphagia; rarely - pain in the esophagus; frequency unknown - gastrointestinal bleeding (including bleeding of varicose veins of the esophagus, gums and mucous membranes of the mouth, bloody vomiting, bloody stools, hematomas (intraperitoneal, peritoneal), bleeding (anal, esophageal, gastric, upper and lower intestinal, hemorrhoidal , peritoneal, rectal), bloody liquid stool and enterocolitis, diverticulitis, hemorrhagic gastritis, melena, hemorrhagic ulcers (esophageal, gastric, duodenal).

Disorders from the liver and bile ducts: frequency unknown - idiosyncratic hepatitis;

Disturbances from the skin and subcutaneous tissues: often - a rash (including erythema, peeling, rash, erythematous rash, follicular rash, rash, macular rash, maculopapulosis eruption, korepodoppuyu rash, papular rash, itching rash, vesiculosis rash, umbilical rash), itching, hyperhidrosis; infrequently - alopecia; rarely - ecchymosis, photosensitivity, purpura: frequency unknown - erythema multiforme (may pass into Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome);

Disturbances from musculoskeletal and connective tissue: often - arthralgia; infrequent - muscle twitching, frequency unknown - myalgia;

Disorders from the kidneys and urinary tract: frequent - frequent urge to urinate (including pollakiuria); infrequently - dysuria; rarely - urine retention; frequency unknown - impaired urination;

Violations of the genitals and breast: often - gynecological bleeding (including bleeding of the cervix, uterine dysfunction, uterine bleeding, genital bleeding, menometroragia, menorrhagic, postmenopausal hemorrhages, vaginal bleeding); erectile dysfunction, ejaculation disorder (including absence of ejaculation, ejaculatory dysfunction, premature ejaculation, ejaculation delay, retrograde ejaculation, rarely - galactorrhea, frequency unknown - priapism, hyperprolactinaemia;

General disorders and disorders at the site of administration: very often - lethargy (including asthenia): often - a feeling of anxiety, chills; infrequent - malaise, impaired well-being, a feeling of cold, a feeling of heat, a cold note, a tendency to form bruises is unknown frequency - bleeding from the mucous membranes;

Laboratory and instrumental data: often - weight loss; frequency unknown - impaired liver function.

Stopping fluoxetine usually leads to withdrawal symptoms. Most often reported on the following reactions: dizziness, sensory impairment (inclined paresthesia), sleep disturbance (including insomnia and intense dreams), asthenia. agitation or anxiety, nausea and vomiting, tremor and headache.

As a rule, these phenomena have a slight or medium degree of severity and severity and are spontaneous. However, in some patients, they can be more pronounced and prolonged. In this regard, patients who no longer need fluoxetine therapy, it is recommended to cancel the drug, gradually reducing the dose. Bone fractures: Data from epidemiological studies conducted in the main images among patients aged 50 years and older indicate an increased risk of bone fractures in patients receiving selective serotonin reuptake inhibitors (SSRIs). The reasons leading to an increase in this risk are not established.

Overdose:

Symptoms: usually an overdose of only fluoxetine is mild. Symptoms of overdose include nausea, vomiting, convulsions, cardiovascular system disorders from asymptomatic arrhythmia (atrioventricular rhythm and ventricular arrhythmia) or ECG changes. characteristic for lengthening the interval QT_C. to a stop

heart disease (including very rare cases of ventricular pirouette tachycardia), respiratory system disorders and signs of altered CNS state from excitation to co-administration. The fatal cases due to a fluoxetine overdose were extremely rare.

Treatment: it is recommended to monitor the general condition and cardiac activity, along with general symptomatic and supportive measures, gastric lavage with the appointment of activated charcoal, in case of seizures - diazepam, maintaining breathing, cardiac activity and body temperature. The specific antidote is unknown. The effectiveness of forced diuresis, dialysis, hemoperfusion and cross-transfusion is low. In the treatment of overdose, the effect of several drugs should be considered.In patients previously taking tripepticidal antidepressants (TCAs), additional use of cholinergic drugs and pressor amines is necessary. Continuous monitoring of cardiac activity, determination of TCA concentration in blood plasma, and, if necessary, carrying out resuscitation measures, are also necessary.

Interaction:

Fluoxetine and its main metabolite, norfluoxetine, have long half-lives, which must be considered when fluoxetine is combined with other drugs, and when it is replaced with another antidepressant.

Fluoxetine has a high affinity for plasma proteins, so the combination of fluoxetine with other drugs, which also largely bind to blood plasma proteins, can lead to a change in their concentrations.

Medications that affect the central nervous system:

Changes in the concentration of phenytoin, carbamazepine, haloperidol, clozapinea, imipramine and desipramine in the blood when combined with fluoxetine. In some cases, there were manifestations of intoxication. An increase in the dose of these drugs with their simultaneous use with fluoxetine should be carried out withcaution and under the control of the dynamics of the clinical condition.

Serotonergic drugs:

Simultaneous reception of serotonergic drugs (eg, SSRIs and serotonin and noradrenaline reuptake inhibitors (SSRIs), tramadol and triptans) also contributes to an increase in the likelihood of developing a delayed-onset syndrome. Simultaneous administration of triptans also contributes to an increase in the likelihood of development of constriction of coronary vessels and arterial hypertension.

Benzodiazepines:

Etcand the simultaneous use of fluoxetine and benzodiazepines may increase the half-life of the latter. When co-administered diazepam or alprazolam with

fluoxetine, an increase in the concentration of bispodiazepines in the blood and an increase in its concentration

sedative action.

MAO inhibitors

It is not recommended to use fluoxetine in combination with MAO inhibitors. When using fluoxetine with MAO inhibitors (selegiline, furazolidone, procarbazine, as well as tryptophan (a precursor of serotonin), special precautions must be followed: there is a risk of developing a serotypic syndrome manifested in confusion,hypomaniacal state, psychomotor agitation, convulsions, dysarthria, hypertensive crises, chills, tremor, nausea, vomiting and diarrhea. Clinical monitoring is recommended. After using MAO inhibitors, administration of fluoxetine is allowed no earlier than 14 days. Do not use MAO inhibitors earlier than 5 weeks after fluoxetine withdrawal.

Lithium and tryptophan:

It is known about the cases of the development of serotonin syndrome with the simultaneous use of SSRIs and lithium or tryptophan, and simultaneous administration of fluoxetine with these drugs should be carried out with caution. With the simultaneous use of fluoxetine and lithium, more frequent and careful monitoring of the clinical state is necessary.

Medications, metabolized with the participation of isoenzyme CYP2D6 systems of liver cytochromes:

Simultaneous reception of drugs, the main pathway of biotransformation of which is metabolism with the participation of isoenzyme CYP2D6, and having a small interval of therapeutic doses (such as propafenone, carbamazepine, tricyclic antidepressants),should be carried out using the minimum therapeutic doses. The above applies also if less than eight weeks have passed after fluoxetine was discontinued.

Indirect anticoagulants and other drugs that affect the blood coagulation system (var pharip, non-steroidal anti-inflammatory drugs, acetylsalicylic acid): fromof course, the change in anticoagulant effect (according to laboratory indicators and / or clinical manifestations) without any general characteristic tendency, but with the probability of increased bleeding with simultaneous administration of fluoxetine and oral anticoagulants. Functional state of the blood coagulation system in patients receiving warfarin, should be carefully monitored when fluoxetine is prescribed and withdrawn.

Metabolized preparations with the participation of isoenzyme CYP3A4:

In the study of interaction in vivo with the use of fluoxetine in combination with single doses of terferia (substrate isoenzyme CYP3A4) there was no increase in the plasma concentration of terfenadine. In addition, studies in vitro showed that the inhibitory activity of ketoconazole, a potent inhibitor of isoenzyme SURZA4, not less than 100 times the activity of fluoxetine or norfluoxetine when inhibiting the metabolism of several substrates of the enzyme, including astemizole, cisapride and milam. Such studies indicate that the degree of inhibition of the activity of the insulating tape CYP3A4 fluoxetine has little clinical significance.

Alcoholь:

In experimental studies fluoxetine did not contribute to increasing the concentration of alcohol in the blood, as well as enhancing the effects of alcohol. However, simultaneous intake of SSRIs and alcohol is not recommended.

Means containing St. John's wort:

As with other SSRIs, it is possible to develop a pharmacodynamic interaction between fluoxetine and products containing St. John's Wort, which can lead to an increase in undesirable effects.

Special instructions:

SweeIndividual risk:

With depression, there is a likelihood of suicidal attempts, which can persist until the onset of persistent remission. As with other drugs of similar pharmacological action (antidepressants), individual cases of suicidal thoughts of nutritional behavior were described against the background of therapyfluoxetype, or soon after its termination, careful monitoring of patients at risk should be necessary. Physicians should convince patients to immediately report any thoughts and feelings of concern.

Despite the fact that the effect of fluoxetine on the occurrence of such cases has not been established, data from pooled studies of the use of antidepressants in mental disorders have revealed an increased risk of suicidal ideation and / or suicidal behavior in young patients (younger than 25 years) compared with placebo.

Drug therapy of patients with high risk should be under close medical supervision. Doctors should encourage patients of different ages to report any unpleasant thoughts and feelings that arise at any time of therapy.

In studies on adult patients with major depressive disorder in both groups taking placebo and fluoxetine, the following risk factors for suicide were identified.

Before treatment:

more severe course of depression; the presence of thoughts of death.

InTreatment time:

weighting depression;

development of insomnia.

During the treatment with fluoxetine, the risk factor was the development of severe psychomotor agitation (eg, agitation, akathisia, panic).

The presence or occurrence of these conditions before or during therapy is the basis for strengthening clinical control or adjusting the treatment.

Cardiovascular effects:

In view of the possible risk associated with taking fluoxetine, lengthening the interval QT. Exetin should be used with caution in patients with congenital syndrome of interval lengthening QT. acquired lengthening interval syndrome QT (for example, with variable intake of fluoxetine with drugs that extend the interval QT), if there is an indication in the anamnesis of an increase in the duration of the interval QT at the patient's relatives. with other clinical conditions predisposing to the development of arrhythmia, for example, hypokalemia or hypomagnesemia) or with an increase in fluoxetine exposure (for example, with reduced liver function).

SkinI have a rash:

It is reported on the occurrence of skin rash, anaphylactic reactions and progressive systemic disorders, sometimes serious involving the pathological process of the skin, kidneys, liver and lungs in patients taking fluoxetine. If skin rashes or other possible allergic reactions occur, the etiology of which can not be determined, fluoxetine should be withdrawn.

Electroconvulsive therapy (ECT):

There are rare reports of an increase in the duration of seizures in patients taking fluoxetine and receiving ECT. in this regard, it is recommended to be careful.

Epileptic seizures:

As with other antidepressants fluoxetine should be administered with caution to patients who have previously had epileptic seizures.

Maniand: Antidepressants should be used with caution in patients with a history / megina / hypomania. The intake of fluoxetine, like any other antidepressant, must be discontinued if the patient is manic.

Akathisia / psychomotor disturbance:

The use of fluoxetine leads to the development of akathisia, which is manifested subjectively unpleasant sensations or restlessness, the need for constant movement, often without the possibility of sitting or standing still. Most often, such phenomena are observed during the first few weeks of treatment.Patients in whom these symptoms are observed, an increase in the dose of fluoxetine is undesirable.

Tamoxifen:

Fluoxetine, as a potent inhibitor of the CYP2D6 isoenzyme, can lead to a decrease in the concentration of endoxifene, one of the most important active metabolites of tamoxifsna. Therefore, when using tamoxifen, fluoxetine should be avoided.

Weight loss:

With fluoxetine, patients may have a loss of body weight, however, it is proportional to the initial mean body weight.

Hypotatremia:

There were cases of hyponatremia (in some cases, the level of sodium in the blood plasma was less than 110 mmol / l). In most cases, such cases were observed in elderly patients and in patients who received diuretics due to a decrease in the volume of circulating blood.

Glycemic control:

In patients with diabetes, during treatment with fluoxetine, hypoglycemia was noted, and after the drug was withdrawn, hyperglycemia developed. At the beginning or after the end of treatment with fluoxetine, you may need to adjust the doses of insulin and / or hypoglycemic drugs for ingestion.

Hepatic / Renal Failure:

Fluoxetine undergoes intensive metabolism in the liver and is excreted by the kidneys. Pannam with severe impairment of liver function is recommended to prescribe lower s fluoxetine, or prescribe the drug every other day. When fluoxetine was taken at a dose of 20 mg / day for two months, patients with severe renal dysfunction (creatinine clearance <10 ml / min) in need of hemodialysis, there was no difference in fluoxetine and norfluoxetine plasma concentrations from healthy volunteers with normal kidney function.

Mydriaz:

Mydriasis associated with fluoxetine was reported. Caution should be exercised in prescribing fluoxetine to patients with increased intraocular pressure or to patients at risk of developing acute angle-closure glaucoma.

Saint John's wort:

As with other SSRIs, it is possible to develop pharmacodynamic interactions between fluoxetine and products containing St. John's wort, which can lead to an increase in undesirable effects.

Symptoms of cancellation:

Often, with discontinuation of fluoxetine therapy, especially with a sharp withdrawal of the drug, withdrawal symptoms were noted.In clinical trials, approximately 60% of patients developed various side effects when treatment was withdrawn, both in the fluoxetine group and in the placebo group. In the fluoxetine group, 17% of these events were severe, in rpyi ps placebo - 12%.

The risk of developing withdrawal symptoms depends on several factors, including the duration of dose therapy and the rate of dose reduction. The most frequently reported dizziness, sensory disturbances (including paresthesia), sleep disorders (including insomnia and deep sleep), asthenia, anxiety or arousal, nausea and / or vomiting, tremor and headache. Usually, these episodes were mild or moderate, but some patients could have a more pronounced character. In most cases, these phenomena are resolved on their own within two weeks, but sometimes may be longer (2-3 months or more). In this regard, the abolition of therapy with fluoxetine should be carried out gradually within one or two weeks, depending on the patient's condition.

In rare cases, it has been reported associated with fluoxetine, the development of serotonin syndrome, or malignant neurolepticsyndrome (muscle rigidity, hyperthermia, extrapyramidal neurological disorders, and catatonic manifestations), especially when combined with other delayed-trigonal medications (including those containing L-tryptophan) and / or neuroleptics. Since these syndromes can lead to life-threatening conditions, fluoxetine therapy should be stopped in case of a combination of symptoms: hyperthermia, rigidity, myoclonus, autonomic nervous system disorder with the development of fluctuations in vital signs, changes in mental state, including confusion, irritability, extreme excitement possible development of delirium and coma, and appoint appropriate therapy.

Increased bleeding:

SSRIs and SSRIs, including fluoxetine, can increase the tendency to bleeding, including in the gastrointestinal tract. Therefore, caution should be exercised when administering fluoxetine to patients who are simultaneously receiving anticoagulants and / or medicines that can alter the properties of platelets (eg non-steroidal anti-inflammatory drugs, acetylsalicylic acid), or patients who already have increased bleeding.

All patients taking antidepressants for any indication should be monitored appropriately, and signs of clinical impairment, suicidal intentions, and unusual behavioral changes should be carefully monitored, especially during the first months of therapy or during dosage changes (increase or decrease).

The following symptoms were observed in adults and children taking antidepressants in the treatment of major depressive disorder, as well as with other mental and non-psychic disorders: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsiveness, akathisia (restlessness), hypomania , mania.

Despite the fact that the causal relationship between the appearance of such symptoms and the worsening of depression and / or the appearance of suicidal intentions is not established, there is a fear that such symptoms may be precursors of the appearance of suicidal intentions.

Effect on the ability to drive transp.cf. and fur:

Fluoxetine, like any drug with a psychotropic effect, can potentially influence behavior and the ability to reason. Patients are not advised to drive vehicles, work with moving mechanisms and perform work at altitudes until they are convinced that the drug has no effect on mental and motor activity.

Form release / dosage:Capsules of 10 mg and 20 mg.

Packaging:

For 7 or 10 capsules in a contour mesh package.

For 20, 30, 50 or 100 capsules in cans of polymeric.

Each bank or 2. 4 contour cellular packs of 7 capsules or 2. 3, 5, 10 contour cell packs of 10 capsules together with instructions for use are placed in a pack of cardboard box.

Storage conditions:

In dry, the dark place at a temperature of ns above 25 ° C.

In a place inaccessible to children.

Shelf life:3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-003118

Date of registration:29.07.2015

The owner of the registration certificate:MEDISORB, CJSC MEDISORB, CJSC Russia

Manufacturer: & nbsp

MEDISORB, CJSC Russia

Information update date: & nbsp20.10.2015

Illustrated instructions

Instructions

Fluoxetine (Fluoxetine)