Instructions for Fluxen capsules 20 mg No. 10
Composition
active ingredient: fluoxetine;
1 capsule contains fluoxetine hydrochloride equivalent to fluoxetine – 20 mg;
excipients: microcrystalline cellulose, colloidal anhydrous silicon dioxide, calcium stearate;
composition of the capsule shell:
titanium dioxide (E 171), patent blue V (E 131), quinoline yellow (E 104), sunset yellow FCF (E 110), gelatin.
Dosage form
Capsules.
Main physical and chemical properties: hard gelatin capsules number 0 or number 1, white body, green cap. Capsule contents: white powder.
Pharmacotherapeutic group
Antidepressants. Selective serotonin reuptake inhibitors.
ATX code N06A B03.
Pharmacological properties
Pharmacodynamics.
Antidepressant for oral administration, selectively and reversibly inhibits the neuronal reuptake of serotonin in the central nervous system. It is also a weak antagonist of muscarinic, histamine and α-adrenoceptors. Unlike other antidepressants, it does not reduce the functional activity of β-adrenoceptors, has little effect on the neuronal reuptake of norepinephrine and dopamine. It improves mood, eliminates feelings of fear and tension, dysphoria. It has stimulating and analgesic effects, does not have a sedative and cardiotoxic effect when taken in medium therapeutic doses.
Pharmacokinetics.
Absorbed from the digestive tract. Slightly metabolized during the first pass through the liver. Food intake does not affect the extent of absorption, although it may slow down its rate. When taken orally, the maximum concentration in the blood plasma is reached after 6–8 hours. Effective equilibrium concentration in the blood plasma is achieved only after continuous administration of the drug for several weeks. Binding to blood proteins is 94.5%. Easily penetrates the blood-brain barrier. Metabolized in the liver by dimethylation with the formation of the main active metabolite norfluoxetine.
T1/2 of fluoxetine in adults and elderly patients is 2–3 days, norfluoxetine – 7–9 days. In case of impaired liver function (cirrhosis) T1/2 increases to 7 and 12 days, respectively.
Fluoxetine is excreted mainly by the kidneys (about 60%) and through the intestines - about 15%.
Indication
Major depressive episodes/disorders.
Obsessive-compulsive disorders.
Bulimia nervosa: as part of comprehensive psychotherapy to reduce uncontrolled eating and to cleanse the intestines.
Contraindication
Hypersensitivity to fluoxetine or to any other components of the drug.
Severe hepatic and renal failure, epilepsy, history of convulsions, suicidal thoughts, glaucoma, bladder atony, benign prostatic hyperplasia.
Concomitant use with non-selective, irreversible monoamine oxidase (MAO) inhibitors, including iproniazid. The interval between the end of MAO inhibitor therapy and the start of fluoxetine treatment should be at least 14 days. The interval between the end of fluoxetine treatment and the start of MAO inhibitor therapy should be at least 5 weeks.
Concomitant use with metoprolol in heart failure.
Interaction with other medicinal products and other types of interactions
Contraindicated combinations
Non-selective irreversible MAO inhibitors. The period between discontinuation of non-selective irreversible MAO inhibitors (e.g. iproniazid) and initiation of treatment with the drug should be at least 14 days. After discontinuation of fluoxetine, at least 5 weeks should elapse before initiation of therapy with non-selective irreversible MAO inhibitors.
Severe, sometimes fatal reactions (hyperthermia, rigidity, myoclonus, autonomic instability, rapid changes in vital signs and disturbances of cerebral function, including severe agitation, delirium and coma) have been observed in patients taking fluoxetine in combination with non-selective irreversible MAO inhibitors, as well as in those who stopped taking it and then started therapy with non-selective irreversible MAO inhibitors.
Concomitant use of fluoxetine with non-selective, irreversible MAO inhibitors is contraindicated.
The long half-lives of both fluoxetine and norfluoxetine should be taken into account when considering pharmacodynamic and pharmacokinetic drug interactions (e.g., when switching from fluoxetine to other antidepressants).
Metoprolol (used in heart failure). The risk of developing adverse reactions associated with metoprolol, in particular bradycardia, may increase. This is due to the fact that fluoxetine inhibits the metabolism of metoprolol (see section Contraindications).
Not recommended combinations
Alcohol: Fluoxetine did not increase blood alcohol levels or enhance the effects of alcohol in studies. However, concomitant use of serotonin reuptake inhibitors and alcohol is not recommended.
MAO-A inhibitors (linezolid, methylene blue). Concomitant use of fluoxetine with MAO-A inhibitors may lead to the development of serotonin syndrome, the manifestations of which are diarrhea, tachycardia, increased sweating, tremor, confusion, or coma. If concomitant use of drugs cannot be avoided, treatment should be started with the lowest effective dose, and patients should be closely monitored by a physician.
Mequitazine: Since fluoxetine inhibits the metabolism of mequitazine, the risk of adverse reactions (QT prolongation) may increase when the latter is used.
Combinations requiring caution
Phenytoin. With the combined use of fluoxetine and phenytoin, changes in their blood levels are observed. In some cases, toxicity has occurred. The doses of the drugs should be titrated and the clinical condition of the patients should be monitored.
St. John's wort. As with other serotonin reuptake inhibitors, pharmacodynamic interactions between fluoxetine and St. John's wort may occur, and the risk of adverse reactions may be increased when the drug is used with St. John's wort.
Serotonergic drugs: Concomitant use with other serotonergic drugs (e.g. tramadol, triptans) increases the risk of serotonin syndrome. There is an additional increased risk of coronary vasoconstriction and hypertension with triptans.
Lithium and tryptophan: Fluoxetine should be used with caution with lithium or tryptophan, as cases of serotonin syndrome have been reported with the concomitant use of serotonin reuptake inhibitors with these drugs. When fluoxetine is used with lithium, the patient's clinical condition should be monitored more frequently.
QT prolongation. No pharmacokinetic or pharmacodynamic studies have been conducted with fluoxetine and other drugs that prolong the QT interval. The addictive effect of fluoxetine and these drugs cannot be excluded. Therefore, caution should be exercised when fluoxetine is co-administered with drugs that prolong the QT interval, such as class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarials, especially halofantrine, some antihistamines (astemizole, mizolastine).
Oral anticoagulants: Concomitant use of fluoxetine with warfarin has been associated with an increase in bleeding time. Changes in anticoagulant activity (laboratory parameters and/or clinical symptoms) were inconsistent.
As in the case of warfarin treatment with other drugs before the start of use or in the case of discontinuation of fluoxetine treatment during warfarin therapy, careful monitoring of blood coagulation parameters should be carried out. If it is necessary to prescribe other drugs after the withdrawal of fluoxetine, the long half-life of fluoxetine and its active metabolite norfluoxetine and, in this regard, the possibility of drug interactions should be taken into account.
Cyproheptadine: There have been reports of reduced efficacy of fluoxetine when used concomitantly with cyproheptadine.
Drugs causing hyponatremia. Hyponatremia is an undesirable effect of fluoxetine. Concomitant use of the drug with other drugs causing hyponatremia (e.g. diuretics, desmopressin, carbamazepine, oxcarbazepine) increases the risk of hyponatremia.
Drugs that lower the seizure threshold. Convulsions are an undesirable effect of fluoxetine. Concomitant use of the drug with other drugs that lower the seizure threshold (e.g., tricyclic antidepressants, other serotonin reuptake inhibitors, phenothiazines, butyrophenones, mefloquine, chloroquine, bupropion, tramadol) may increase the risk of seizures.
CYP2D6 isoenzyme. Since the metabolism of fluoxetine (both tricyclic antidepressants and other selective serotonin antidepressants) is included in the hepatic cytochrome CYP2D6 isoenzyme system, simultaneous use with drugs that are also metabolized by these enzymes may lead to interaction reactions. Therefore, treatment with drugs that are metabolized by this system, especially those with a narrow therapeutic index (such as flecainide, propafenone, nebivolol), as well as atomoxetine, carbamazepine, risperidone and tricyclic antidepressants, should be started at the lowest doses if the patient is simultaneously receiving fluoxetine or has taken it within the previous 5 weeks. In the case of including fluoxetine in the treatment regimen of a patient already taking a similar drug, a dose reduction of the first drug should be considered.
When used simultaneously with fluoxetine, changes in blood concentrations of clozapine, diazepam, alprazolam, imipramine and desipramine are noted, and in some cases, manifestations of toxic effects are observed. When taking fluoxetine with these drugs, conservative selection of the dose of the drug should be reviewed and the patient's condition monitored.
Fluoxetine is highly bound to plasma proteins, so when fluoxetine is prescribed with another drug that is highly bound to plasma proteins, changes in the plasma concentrations of both drugs are possible.
Electroconvulsive therapy: Rarely, an increase in seizure duration has been observed in patients receiving fluoxetine while undergoing electroconvulsive therapy. Therefore, caution should be exercised in such cases.
Fluoxetine enhances the effect of blood sugar-lowering drugs.
Application features
Skin rashes and allergic reactions. Cases of skin rashes, anaphylactic reactions and progressive systemic disorders involving the skin, lungs, liver and kidneys have been reported with fluoxetine. If skin rashes or other allergic reactions of undetermined etiology occur, fluoxetine should be discontinued.
Convulsions: There is a potential risk of seizures with antidepressants. Fluoxetine should be discontinued if a patient develops seizures or is at increased risk of seizures. Fluoxetine should be avoided in patients with unstable seizure disorders/epilepsy.
Mania: Antidepressants should be used with caution in patients with mania or hypomania. Fluoxetine should be discontinued if the patient is in a manic phase.
Liver/kidney function. Fluoxetine is extensively metabolized in the liver and excreted by the kidneys. A dose reduction is recommended for patients with significant hepatic impairment. When administered at 20 mg daily for 2 months in patients with severe renal impairment (creatinine clearance < 10 ml/min) and patients requiring hemodialysis, plasma levels of fluoxetine or norfluoxetine were similar to those in patients with normal renal function. Contraindicated in severe hepatic and renal impairment.
Tamoxifen: Fluoxetine, a potent CYP2D6 inhibitor, may decrease the concentration of endoxifen, one of the major active metabolites of tamoxifen. Therefore, concomitant use of tamoxifen and fluoxetine should be avoided whenever possible.
Cardiovascular disorders: Cases of QT prolongation and ventricular arrhythmias, including torsades de pointes, have been reported. Use with caution in patients with conditions such as congenital QT prolongation, a history of QT prolongation, or other clinical conditions that may predispose to arrhythmias (e.g., hypokalemia and hypomagnesemia, bradycardia, acute myocardial infarction, or decompensated heart failure), or in patients with increased fluoxetine concentrations (e.g., hepatic insufficiency), or in patients receiving concomitant medications known to prolong QT and/or torsades de pointes. An ECG should be performed before starting fluoxetine. If symptoms of cardiac arrhythmia occur during treatment with fluoxetine, fluoxetine should be discontinued and an ECG should be performed.
Weight loss: Weight loss may occur in patients taking fluoxetine.
Diabetes mellitus. Changes in blood glucose levels have been observed in diabetic patients during treatment with fluoxetine. Hypoglycemia has occurred during treatment with fluoxetine, and hyperglycemia has occurred after discontinuation of the drug. At the beginning and after the end of treatment with fluoxetine, dose adjustment of insulin and/or oral hypoglycemic agents may be necessary.
Suicide/suicidal thoughts or clinical worsening. Depression is associated with an increased risk of suicidal thoughts, suicide attempts. The risk persists until some remission has occurred. Improvement may not occur for several weeks or more of treatment, and patients should be closely observed until improvement occurs. General clinical experience suggests that the risk of suicide may be increased in the early stages of recovery.
Patients with major depressive disorder and other psychiatric illnesses should be monitored closely, as other psychiatric disorders may develop.
Patients should be closely monitored, especially those at high risk of developing suicidal ideation or attempts, especially at the beginning of treatment or when changing the dose. Use is contraindicated in patients with suicidal thoughts.
The use of antidepressants in adult patients with psychiatric disorders has shown an increased risk of suicidal behavior in patients under 25 years of age taking antidepressants. Appropriate measures should be taken if clinical worsening, suicidal attempts, or changes in behavior occur.
Withdrawal symptoms: Withdrawal symptoms are common if treatment is stopped abruptly. The risk of developing withdrawal symptoms depends on many factors, including duration of treatment, dose, and rate of dose reduction. Dose reduction should be titrated over 1 or 2 weeks according to patient need.
Withdrawal symptoms: dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), asthenia, agitation or agitation, nausea and/or vomiting, tremor and headache. In general, withdrawal symptoms are mild to moderate in severity, but may be severe. They usually occur within the first few days after discontinuation of fluoxetine, but there have been reports of such symptoms in patients who have missed a dose. Symptoms usually resolve spontaneously within the first 2 weeks, although in some cases they may persist for 2-3 months or longer. Therefore, it is recommended to gradually reduce the dose of fluoxetine over at least 1-2 weeks, according to the patient's needs.
Bleeding. Subcutaneous bleeding such as ecchymoses or purpura have been reported. Ecchymoses are rare with fluoxetine treatment. Other haemorrhagic manifestations (gynecological bleeding, gastrointestinal bleeding and other cutaneous or mucous membrane bleeding) have also been reported rarely. The drug should be used with caution in patients taking concomitant oral anticoagulants and drugs that affect platelet function (atypical antipsychotics such as clozapine, phenothiazines, most tricyclic antidepressants, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs), or other drugs that increase the risk of bleeding, in patients with a history of bleeding.
Mydriasis: Mydriasis has been reported in patients taking fluoxetine. Therefore, caution should be exercised if the patient has elevated intraocular pressure or is at risk of acute angle-closure glaucoma. Contraindicated in patients with glaucoma.
Electroconvulsive therapy: Rare cases of increased seizure duration have been reported in patients receiving fluoxetine during electroconvulsive therapy. Therefore, caution should be exercised in these cases.
St. John's wort: Concomitant use of fluoxetine and St. John's wort increases the risk of serotonergic effects, such as serotonin syndrome, which can occur with the use of serotonin reuptake inhibitors and herbal preparations containing St. John's wort.
Serotonin syndrome or neuroleptic malignant syndrome.
Rare cases of serotonin syndrome or neuroleptic malignant syndrome have been reported in patients receiving fluoxetine, especially in combination with other serotonergic (including L-tryptophan) and/or neuroleptic drugs. Since these symptoms can be life-threatening, treatment with fluoxetine should be discontinued and supportive and symptomatic therapy should be given if the following symptoms occur: hyperthermia, rigidity, myoclonus, autonomic instability with impairment of vital functions, mental status including altered consciousness, irritability, progressive agitation up to delirium and coma.
Nonselective irreversible MAO inhibitors. Serious, sometimes fatal, adverse reactions have been reported in patients receiving selective serotonin reuptake inhibitors in combination with nonselective irreversible MAO inhibitors. These cases presented with features suggestive of serotonin syndrome or neuroleptic malignant syndrome. Cyproheptadine or dantrolene may be useful in patients who develop such reactions.
Symptoms of interaction with MAO inhibitors include: hyperthermia, rigidity, myoclonus, instability of the autonomic nervous system with disturbances of vital functions, mental status, including impaired consciousness, irritability, progressive agitation up to delirium and coma.
Therefore, the concomitant use of fluoxetine and non-selective irreversible MAO inhibitors is contraindicated. The interval between the end of treatment with MAO inhibitors and the start of treatment with fluoxetine should be at least 14 days. The interval between the end of treatment with fluoxetine and the start of treatment with non-selective irreversible MAO inhibitors should be at least 5 weeks.
Hyponatremia may develop when using fluoxetine. This is mainly characteristic of elderly patients and patients receiving diuretics, due to a decrease in circulating blood volume.
The component sunset yellow FCF (E 110), which is part of the capsule shell, may cause allergic reactions.
Use during pregnancy or breastfeeding
Pregnancy.
Some epidemiological studies have shown an increased risk of cardiovascular malformations in mothers taking fluoxetine during the first trimester of pregnancy. The mechanism of the malformations is currently unknown. Overall, the risk of having a child with a cardiovascular malformation in a mother who took fluoxetine during pregnancy is about 2/100 (in the general population - about 1/100).
Epidemiological studies suggest that the use of SSRIs during pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn. This complication has been observed in approximately 5 out of 1000 newborns, compared with 1 to 2 out of 1000 newborns in the general population.
Breastfeeding period.
Fluoxetine and norfluoxetine are known to be excreted in human milk. There have been reports of adverse reactions in breast-fed infants whose mothers have taken fluoxetine.
Fertility.
Preclinical animal studies suggest that fluoxetine may have an effect on sperm quality. There are reports of reversible effects of serotonin reuptake inhibitors on sperm quality in humans. Data on the effects of fluoxetine on human fertility are currently lacking.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment with Fluxen®, one should refrain from potentially hazardous activities that require increased attention and rapid psychomotor reactions, as there is a risk of developing adverse reactions.
Method of administration and doses
The medicine should be taken orally, regardless of mealtime.
Major depressive episodes/disorders. The initial dose for depression in adults is 20 mg once daily in the morning. This dose is sufficient to achieve an antidepressant effect. If clinically necessary, the dose may be increased to 20 mg twice daily after 3–4 weeks of treatment; although an increase in dose may increase side effects, in some patients with an inadequate response to 20 mg, the dose may be gradually increased to 60 mg daily.
The dose should be increased individually and with caution, therapy should be initiated with the minimum effective dose.
Patients with depressive disorders should be treated for a sufficient period of time, at least 6 months, to ensure that symptoms of the disease are absent.
Obsessive-compulsive disorder. The usual recommended dose is 20 mg daily. Although increasing the dose may increase side effects, in some patients who do not respond adequately to treatment with 20 mg within 2 weeks, the dose may be gradually increased to 60 mg daily.
If there is no clinical effect within 10 weeks of treatment, fluoxetine therapy should be reviewed. If a positive therapeutic effect of treatment has been obtained, fluoxetine therapy should be continued at an individually selected dose. The dose should be increased individually and with caution, therapy should be carried out at the minimum maintenance dose. The patient's need for treatment with the drug should be periodically reviewed.
Prolonged pharmacotherapy (more than 24 weeks) in patients with obsessive-compulsive disorder has not been studied.
Bulimia nervosa: For adults and elderly patients, the dose is 20 mg per day. Prolonged pharmacotherapy (more than 3 months) in patients with bulimia has not been studied.
General recommendations. The usual recommended dose of the drug is 20 mg per day, which can be increased if necessary. The maximum daily dose is 80 mg. Doses above 80 mg per day have not been studied. If it is necessary to use a single dose of less than 20 mg, another form of the drug in the appropriate dosage should be used.
Fluoxetine can be prescribed 1–2 times a day, regardless of mealtimes.
After stopping the drug, the active substance circulates in the body for another 2 weeks, which should be taken into account when prescribing other drugs or discontinuing treatment.
Maintenance therapy: To achieve the full effect of fluoxetine, it may be necessary to
3–4 weeks.
The dose of the drug for patients with renal or hepatic insufficiency, for elderly patients with concomitant diseases, as well as for patients taking other medications, should be reduced.
Elderly patients: increase the dose with caution. Usually the daily dose does not exceed 40 mg. The maximum daily dose is 60 mg.
A reduced dose or intermittent dosing (e.g., every other day) may be recommended for patients with liver disorders or concomitant medications that may interact with fluoxetine.
Abrupt discontinuation of fluoxetine therapy should be avoided. When discontinuing the drug, the dose should be gradually reduced over 1–2 weeks to avoid withdrawal symptoms. If symptoms of worsening of the condition appear during dose reduction or discontinuation of treatment, treatment should be resumed at the previous effective therapeutic dose of the drug. After some time, the doctor may continue the gradual dose reduction.
Children
The medicine should not be used in children.
Overdose
Symptoms: nausea, vomiting, convulsions, cardiovascular disorders (including sinus rhythm disturbances and ventricular arrhythmias) or ECG changes indicating QT prolongation, heart attacks, including rare cases of torsades de pointes, respiratory disorders, central nervous system changes from agitation to coma, hypomania. Fatal outcomes due to fluoxetine overdose are extremely rare.
Treatment: induction of vomiting or gastric lavage, use of activated charcoal, sorbents, symptomatic and supportive therapy. There is no specific antidote. Forced diuresis, dialysis, hemoperfusion, blood exchange transfusion are ineffective in case of fluoxetine overdose.
It is recommended to monitor cardiac and respiratory activity.
It should be noted that overdose with multiple medications may occur.
Adverse reactions
General disorders: weakness, including asthenia, feeling of trembling, chills, fatigue, malaise, feeling cold, feeling hot, abnormal sensations, neuroleptic malignant syndrome, general malaise.
Blood and lymphatic system disorders: thrombocytopenia, neutropenia, leukopenia, hemorrhagic manifestations, subcutaneous or mucous hemorrhages, tendency to bruise.
Immune system disorders: hypersensitivity reactions, including angioedema, anaphylactic shock, anaphylactic reactions, anaphylactoid reactions, serum sickness.
On the part of the endocrine system: insufficient secretion of antidiuretic hormone.
Metabolic disorders: decreased appetite, including anorexia, hyponatremia.
Nervous system disorders: headache, disturbance in attention, dizziness, dysgeusia, lethargy, drowsiness including hypersomnia, sedation, tremor, psychomotor hyperactivity, dyskinesia, ataxia, impaired coordination of movements, myoclonus, convulsions, epileptic seizures, psychomotor agitation, aggression, disturbance in attention, anxiety, dysphemia, impaired concentration, akathisia, buccoglossal syndrome, serotonin syndrome, memory impairment including memory impairment after morning awakening, difficulty falling asleep, insomnia, agitation, nervousness, anxiety, tension, decreased libido including loss of libido, sleep disorders including abnormal dreams, nightmares, depersonalization, elevated mood, euphoric mood, thought disorders, orgasmic disorders including anorgasmia, bruxism, hypomania, mania, hallucinations, agitation, panic attacks attacks, suicidal thoughts and behavior, including suicide attempts and completed suicide, suicidal depression, deliberate self-harm, auto-aggressive ideas and behavior (may be due to an underlying disease), confusion, speech disorders, taste changes.
From the organs of vision: blurred vision, mydriasis.
From the side of the organs of hearing and vestibular apparatus: tinnitus.
Cardiovascular system: palpitations, ventricular arrhythmia, including torsades de pointes, QT prolongation, flushing, hot flushes, hypotension, vasculitis, vasodilation, palpitations.
Respiratory system: yawning, shortness of breath, pharyngitis, respiratory disorders (inflammatory processes or various histopathological changes and/or fibrosis, including atelectasis, interstitial lung diseases, pneumonia), epistaxis.
On the part of the digestive tract: diarrhea, nausea, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, including bleeding from the gums, vomiting blood, bloody stools, rectal bleeding, hemorrhagic diarrhea, melena and gastric bleeding from ulcers.
Hepatobiliary system: idiosyncratic hepatitis.
Skin and subcutaneous tissue disorders: rash, including erythema, exfoliative rash, hyperhidrosis, cold sweat, impetigo, erythematous, follicular, generalized, macular, maculo-papular, papular, crusty rash, pruritic rash, vesicular rash, periorbital rash, photosensitivity reactions, erythema multiforme, which may progress to Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell's syndrome), pruritus, urticaria, purpura, alopecia, ecchymoses.
Musculoskeletal system: arthralgia, muscle twitching, myalgia.
From the urinary system: frequent urination, dysuria, urinary retention, urination disorders, pollakiuria.
Reproductive system: gynecological bleeding, including cervical bleeding, uterine dysfunction, uterine bleeding, genital bleeding, menometrorrhagia, polymetrorrhagia, postmenopausal bleeding, vaginal bleeding; erectile dysfunction, ejaculation disorders, including ejaculation failure, ejaculation dysfunction, premature ejaculation, ejaculation delay, retrograde ejaculation, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism.
Investigations: weight loss, liver function abnormalities (increased transaminase levels), increased gamma-glutamyltransferase levels.
Cases of suicidal thoughts and behavior have been reported while taking fluoxetine or shortly after stopping fluoxetine.
Withdrawal symptoms. Discontinuation of fluoxetine is likely to result in withdrawal symptoms. The most common are: dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), asthenia, agitation or agitation, nausea and/or vomiting, tremor and headache. Withdrawal symptoms are generally mild to moderate in severity, but may be severe and prolonged. They usually occur within the first few days after discontinuation of fluoxetine. Therefore, it is recommended that the dose of fluoxetine be gradually reduced over a period of at least 1–2 weeks, according to the patient's needs.
Expiration date
5 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 capsules in a blister. 1 or 3 blisters in a pack.
Vacation category
According to the recipe.
Producer
PJSC "Kyivmedpreparat".
Location of the manufacturer and address of its place of business
Ukraine, 01032, Kyiv, Saksaganskoho St., 139.
