Index of drugs

Depressive disorders. Treatment of obsessive-compulsive disorder. Treatment of bulimia (bulimia nervosa).

1 capsule contains 20 mg of Fluoxetine in the form of a hydrochloride. The product contains lactose and quinoline yellow.

Antidepressant - a selective serotonin reuptake inhibitor (SSRI). It does not show affinity for other receptors: α₁-, α₂- and β-adrenergic, serotonergic, dopaminergic, histamine, muscarinic and GABA receptors. After oral administration is well absorbed from the gastrointestinal tract, the maximum plasma concentration usually occurs 6-8 hours after administration. It is highly bound to plasma proteins. The constant level of fluoxetine in plasma is determined only after a few weeks of use. Fluoxetine is extensively metabolised in the liver to norfluoxetine and numerous unidentified metabolites that are excreted in the urine. T_0,5 fluoxetine is 4-6 days, and its active metabolite (norfluoxetine) 4-16 days.

Hypersensitivity to fluoxetine or any component of the drug. Fluoxetine must not be given concurrently with MAO inhibitors, either selective (eg selegiline) or reversible (eg moclobemide), as it may cause symptoms similar to those of serotonin syndrome. If these symptoms occur, cyproheptadine or dantrolene may be helpful. As a result of the interaction of fluoxetine with MAO inhibitors, symptoms such as hyperthermia, stiffness, disorders of the autonomic nervous system, myoclonus, impaired motor coordination, emotional shakiness, including irritability, confusion and extreme agitation can sometimes lead to delirium or coma. Therefore, fluoxetine must not be used together with MAO inhibitors and at least 14 days after discontinuing MAO inhibitors. In contrast, the period after the end of fluoxetine and the initiation of MAO inhibitors should be at least 5 weeks (in the case of long-term use of fluoxetine or high doses of the drug should be maintained for more than 5 weeks a break before the use of MAO inhibitors).

In the case of rash or other allergic symptoms, the drug should be discontinued. Special care should be taken in patients with controlled epilepsy and in patients with a history of seizures. Avoid administering the preparation to patients with refractory epilepsy for treatment with antiepileptic drugs. Fluoxetine should be used with extreme caution in patients who have ever exhibited mania. The drug should be discontinued when a patient develops a manic phase. In patients with renal or hepatic impairment and in dialysis patients, lower doses should be considered or the dosage regimen should be changed. Due to the lack of sufficient data, caution should be exercised in patients with myocardial insufficiency. Hypoglycaemia during therapy and cases of hyperglycaemia have been reported after discontinuation of therapy. Patients with diabetes should have additional blood Glucose monitoring as well as a tailored or modified insulin dose regimen and / or oral antidiabetic agents. Special care should be taken in patients with bleeding in the form of subcutaneous haemorrhages, a history of genital or gut bleeding, and patients taking other medicines that may increase the risk of bleeding. Depression is associated with an increased risk of suicidal thoughts, self harm and suicide. This risk persists until full remission occurs. The patient should be closely monitored until the appearance of improvement and in the early stages of recovery (increased risk of suicide). In patients treated for other psychiatric disorders, the same precautions should be taken as in patients with severe depressive disorder. Patients with a history of suicide-related events or patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment are considered to be at increased risk of suicidal thoughts or suicide attempts and should be closely monitored during treatment, particularly in patients below 25 years of age. In patients with symptoms of akathisia, increasing the dose may be detrimental. Caution is advised in patients using fluoxetine and electroconvulsive therapy. With the simultaneous use of SSRIs and preparations containing St. John's wort, serotoninergic effects may increase.In rare cases, the development of serotonin syndrome or neuroleptic-like-like events has been reported in association with fluoxetine treatment, especially when the drug has been used concomitantly with other serotoninergic and / or neuroleptic preparations. The use of fluoxetine is not recommended in children, as the efficacy and safety of use in this age group have not been sufficiently investigated. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lakt deficiency or malabsorption of glucose-galactose.

Animal studies do not indicate direct or indirect harmful effects with respect to the development of the embryo or fetus and the development of pregnancy. Fluoxetine can be used in women during pregnancy only if, in the doctor's opinion, the benefits for the mother outweigh the potential risk to the fetus. Fluoxetine is excreted in human milk. The influence of fluoxetine on breastfed infants has not been established so far, therefore discontinuation of breastfeeding should be considered for women in whom fluoxetine treatment is necessary. There were reports of concentrations of fluoxetine and norfluoxetine 70.4 ng / ml in the blood of a mother-fed child who had the same substance concentration of 295.0 ng / ml, without adverse effects on the child. In another case, 340 ng / ml fluoxetine and 208 ng / ml norfluoxetine were found in a breast-fed child by a mother treated with fluoxetine; the child has symptoms such as crying, sleep disturbances, vomiting, abundant and watery stools.

Very common: insomnia (including early morning awakening, initial insomnia, insomnia central), headache, diarrhea, nausea, tiredness (including asthenia). Common: decreased appetite (including anorexia), anxiety, anxiety, nervousness, tension, decreased libido (including loss of libido), sleep disorders, unusual dreams (including nightmares), balance disorders, dizziness, taste disorders, lethargy, drowsiness ( increased drowsiness, sedation), tremors, convulsions, blurred vision, palpitations, paroxysmal redness of the face (including hot flushes), yawning, vomiting, dyspepsia, dry mouth, rash (including erythema, exfoliative erythema, red prickly, rash) , erythema erythema, erythema erythema, erythema multiforme, erythematous erythema, maculopathy, redulent rash, follicular erythema, umbilicus erythema), urticaria, pruritus, hyperhidrosis, joint pain, frequent urination (including pollakiuria), gynecological bleeding ( including cervical hemorrhage, uterine dysfunction, uterine bleeding, reproductive system haemorrhage, abnormal irregular menstrual period no, menorrhagia, uterine haemorrhage, excessive frequent menstruation, postmenopausal bleeding, uterine hemorrhage, vaginal haemorrhage), erectile dysfunction, ejaculation disorders (including no ejaculation, ejaculation disorders, premature ejaculation, delayed ejaculation, reverse ejaculation), nervousness, chills, weight loss. Uncommon: depersonalization, elevated mood, euphoria, thinking disorders, orgasm disorders (lack of orgasm), bruxism, psychomotor agitation, dyskinesia, ataxia, balance disorders, myoclonus, mydriasis, hypotension, dyspnoea, dysphagia, alopecia, increased tendency to form bruises, cold sweat, muscle tremors, difficulty urinating, sexual dysfunction, malaise, unusual well-being, feeling cold, feeling hot. Rare: anaphylactic reactions, serum sickness, hyponatremia, mild manic state (hypomania), mania, hallucinations, agitation, panic attacks, convulsions, akathisia, cheek-language syndrome, ventricular arrhythmia (including polymorphic ventricular tachycardia, extended QT interval in ECG) , vasculitis, vasodilation, pharyngitis, esophageal pain, angioneurotic edema, ecchymosis, photosensitivity, purpura, haemorrhagic diathesis, urinary retention, galactorrhoea, prolactin secretion. Very rare: thrombocytopenia. Frequency unknown: abnormal release of the antidiuretic hormone reducing the volume of urine, suicidal thoughts or the desire to self-harm, dizziness, stuttering, serotonin syndrome, memory problems, dizziness, confusion, sensitivity to light, tinnitus, orthostatic hypotension,pulmonary events (inflammatory processes of various histopathology and / or fibrosis), nosebleeds, gastrointestinal bleeding (including most frequently bleeding gums, bloody vomiting, rectal bleeding, hemorrhagic diarrhea, blood in the stools, gastric ulcer haemorrhage) , idiosyncratic hepatitis, erythema multiforme (Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome - Lyell syndrome), muscle pain, urination disorders, priapism, mucosal hemorrhage, abnormal liver function tests. After discontinuation of fluoxetine therapy, cases of withdrawal syndrome have been reported; The most common symptoms of withdrawal syndrome are dizziness, anxiety, sleep disturbances, asthenia, headache, paresthesia, vomiting and nausea.

Orally. Adults.Depressive disordersThe recommended dose is 20 mg fluoxetine per day. Dosage should be re-evaluated and adjusted if necessary, 3-4 weeks after the start of treatment, and later if it is considered appropriate for clinical reasons.Neurosis obsessionsThe recommended dose is 20-60 mg per day. The initial dose in this case should be 20 mg per day, and after a few weeks of use may be increased to 60 mg per day - however, the risk of side effects should be considered. If no improvement in the patient's condition occurs within 10 weeks, fluoxetine should be reconsidered. If a good response is obtained, treatment can be continued by adjusting the dose individually for each patient. Periodically, the need for further treatment should be assessed. However, long-term treatment efficacy has not been demonstrated (over 24 weeks).bulimiaThe recommended daily dose is 60 mg. Long-term efficacy of treatment (over 3 months) has not been demonstrated. Do not exceed the dose of 80 mg of fluoxetine per day. The effects of the drug usually occur after a few weeks of treatment. In elderly patients, the daily dose should generally not exceed 40 mg; the maximum recommended dose is 60 mg per day. Consideration should be given to using lower daily doses or larger intervals in taking doses in patients with hepatic impairment. In patients with renal insufficiency and dialysis patients, the possibility of reducing the dose or frequency of administration should also be considered (the concentration of fluoxetine and its metabolites in the blood is in dialysed patients at a similar level as in healthy people).
Fluoxetine can be given before, during and after meals.