Index of drugs

Adults. Episodes of major depression. Obsessive-compulsive disorder. Bulimia - the use of the preparation is indicated as a supplement to psychotherapy in order to reduce the desire to overeat and return the food consumed.Children aged 8 and over and young people. Episode of major depression with moderate to severe intensity, if after 4-6 sessions the patient does not respond to psychotherapy. Antidepressants should be recommended to children and adolescents with moderate or severe depression only together with psychotherapy.

1 capsule contains 20 mg of Fluoxetine in the form of a hydrochloride. The drug contains lactose.

Antidepressant - a selective serotonin reuptake inhibitor (SSRI). It does not show affinity for other receptors: α₁-, α₂- and β-adrenergic, serotonin, dopaminergic, histamine H₁, muscarinic and GABA-ergic. After oral administration is well absorbed from the gastrointestinal tract, the maximum plasma concentration usually occurs 6-8 hours after administration. Consumption of food does not affect the bioavailability. Fluoxetine is about 95% bound to plasma proteins. Steady-state plasma concentrations are achieved after several weeks of drug use. The drug is metabolised in the liver, mainly involving CYP2D6, in the process of demethylation to the main active metabolite - norfluoxetine. T_0,5 Fluoxetine in the elimination phase is 4-6 days, and norfluoxetine - 4-16 days. The drug is mainly excreted by the kidneys (in about 60%). Fluoxetine is excreted in human milk. In people with liver failure (alcoholic cirrhosis) T_0,5 fluoxetine and norfluoxetine extend to 7 and 12 days, respectively. In children, the average fluoxetine concentration is about 2 times higher than in adolescents, while the average concentration of norfluoxetine is 1.5 times higher. Plasma drug concentrations at steady state depend on body weight - higher concentrations are found in children with a lower body weight.

Hypersensitivity to fluoxetine or to any of the excipients. Concomitant use of fluoxetine and non-selective MAO inhibitors. Treatment with fluoxetine can be started 2 weeks after discontinuation of irreversible MAO inhibitors. You should keep at least 5 weeks. discontinuation after discontinuation of fluoxetine prior to treatment with MAO inhibitors. If fluoxetine has been used for a long time and / or in high doses, a longer break should be considered. Co-administration of fluoxetine with reversible MAO inhibitors (eg moclobemide) is not recommended. Treatment with fluoxetine can be started the Next day after discontinuing MAO inhibitors.

In clinical trials, suicidal behaviors (attempts and suicidal thoughts) and hostility (mainly aggression, rebel behavior and anger) were more frequently observed in children and adolescents receiving antidepressants compared to the placebo group. Fluoxetine can be used in children and adolescents aged 8 to 18 years only for the treatment of moderate to severe major depressive episodes; in this age group, fluoxetine should not be used for other indications. If, however, based on clinical need, a decision to treat is made, the patient should be closely monitored for signs of suicide. In addition, available data on the long-term effects on the safety of fluoxetine in children and adolescents, including on growth, maturation and cognitive, emotional and behavioral development are limited. In a 19-week clinical trial, a reduction in body weight gain and growth in fluoxetine-treated children and adolescents was observed; it has not been established whether the drug affects the achievement of normal growth in adulthood. You can not exclude the probability of delaying puberty. Therefore, the development of the child in terms of growth and puberty (height, body weight and stage of sexual development according to Tanner) should be monitored during and after fluoxetine treatment. If there is a delay in development, consideration should be given to referring the patient to the pediatrician.In clinical trials in children, manic and hypomanic conditions have been commonly reported - regular monitoring of patients for mania or hypomania is recommended. If the patient experiences a manic phase, fluoxetine should be discontinued. If rash or allergic symptoms occur during treatment that can not be associated with another cause, fluoxetine should be discontinued. Fluoxetine should be used with caution in patients with a history of seizures. Treatment should be discontinued if there is a seizure or an increase in their frequency. Fluoxetine should be avoided in patients with unstable epileptic seizures or epilepsy. Patients with controlled epilepsy should be closely monitored. Caution should be exercised in patients with a history of mania or hypomania. Fluoxetine should be discontinued when the patient develops a manic phase. In patients with significant hepatic impairment, lower doses are recommended. Caution is advised when using the drug in patients with acute heart disease. Fluoxetine should be avoided when taking tamoxifen. In diabetic patients, SSRIs can change blood Glucose levels. Hypoglycaemia may occur during treatment with fluoxetine and hyperglycaemia may occur upon discontinuation of fluoxetine. Adjustment of insulin dose and / or oral antidiabetic agents may be necessary. In depression, the risk of suicidal thoughts, self-mutilation and suicide attempts (suicide incidents) is increased. This risk persists until significant clinical improvement is achieved. Patients should be carefully monitored until improvement occurs and in the early stage of clinical improvement (increased risk of suicide). When treating patients with other psychiatric disorders, the same precautions should be taken as for patients with major depression. The risk of suicidal thoughts or suicide attempts in patients with a history of suicide incidents in which the suicidal ideation was worse before treatment is increased, therefore during treatment should be closely monitored, especially patients under 25 years of age. During therapy, especially in the initial period and during the change of dosage, patients should be closely monitored, in particular those at high risk. In patients who develop symptoms of akathisia, increasing the dose may be harmful. Due to the risk of abnormal bleeding, caution is recommended in patients taking SSRIs, especially when co-administered with oral anticoagulants, platelet-altering drugs (eg atypical neuroleptics, such as clozapine, phenothiazine derivatives, most tricyclic antidepressants, Acetylsalicylic acid, NSAIDs) or other drugs that may increase the risk of bleeding, as well as patients with a history of blood clotting disorders. Rare cases of prolonged seizures have been reported in patients treated with fluoxetine who have been treated with electroconvulsive shock - caution in this group of patients is recommended. Caution should be exercised when prescribing fluoxetine to patients with elevated intraocular pressure and in patients at risk of acute attack with narrow-angle glaucoma. When SSRI and herbal preparations containing St John's wort are used concomitantly, serotonergic effects such as serotonin syndrome may increase. In rare cases, the development of serotonin syndrome or neuroleptic-like-like events has been reported in relation to fluoxetine treatment, especially when the drug was used concomitantly with other drugs with serotoninergic effects (inter alia L-tryptophan) and / or neuroleptics. Due to the fact that these syndromes may cause potentially life-threatening symptoms, fluoxetine should be discontinued if symptoms such as hyperthermia, stiffness, muscular convulsions, autonomic instability with possible violent and fluctuating vital signs, changes in consciousness including confusion occur. , irritability, extreme agitation leading to delirium and coma, and supportive symptomatic treatment.The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

Caution should be exercised when using fluoxetine in pregnant women, especially in the third trimester or just before delivery due to the following symptoms in newborns: irritability, tremors, hypotonia, constant crying, problems with sucking or sleeping. These symptoms may indicate serotoninergic effects or withdrawal syndrome in the newborn. The time that elapses until these symptoms appear and their duration may be related to long T_0,5 fluoxetine (4-6 days) and its active metabolite - norfluoxetine (4-16 days). The results of some epidemiological studies indicate an increased risk of cardiovascular defects associated with the use of fluoxetine in the first trimester of pregnancy. In addition, the results of epidemiological studies indicate that the use of SSRI in pregnant women, especially in the third trimester of pregnancy, may increase the risk of persistent pulmonary hypertension syndrome (PPHN). Fluoxetine and its metabolite, nor Fluoxetine, are excreted in human milk. Adverse effects have been observed in breastfed infants. If fluoxetine therapy is necessary, discontinuation of breast-feeding should be considered. If you continue breastfeeding, the lowest effective dose of fluoxetine should be used. Animal studies have shown that fluoxetine may affect sperm quality. From the case reports of the use of certain SSRIs in humans, the effect on sperm quality is transient. No effects on human fertility have been observed so far.

Very often: insomnia (including early morning waking up, difficulty falling asleep, difficulty in continuing sleep after waking up), headache, diarrhea, nausea, tiredness (including asthenia). Common: decrease in appetite (including anorexia), anxiety, restlessness, nervousness, tension, libido disorders (including libido), unusual dreams (including nightmares), attention disorders, dizziness, taste disorders, lethargy, drowsiness ( including drowsiness, sedation), tremors, hyperactivity disorder, involuntary movements, impaired motor coordination, balance disorders, myoclonic muscle contraction, blurred vision, palpitations, flushing of the face or other parts of the body, yawning, vomiting, indigestion, dryness of the mucous membrane of the cavity oral, pruritus, urticaria, hyperhidrosis, rash (including erythema, exfoliative rash, prickly fever, rash, erythematous rash, follicular rash, generalized rash, macular rash, maculopapular rash, papular rash, morbid rash, itchy rash, rash follicular, erythema erythema of the navel, joint pain, frequent urination, bleeding from the road of the uterus (including cervical hemorrhage, uterine dysfunction, uterine bleeding, genital hemorrhage, irregular monthly bleeding, heavy monthly bleeding, off-cycle bleeding, too frequent monthly bleeding, menopausal haemorrhage, macrovascular bleeding, vaginal haemorrhage), erection, ejaculation disorders, shakiness, chills, weight loss. Uncommon: concentration and thinking disorders (eg depersonalization), elevated mood, euphoria, orgasmic disorders (including lack of orgasm), involuntary jaw clenching and grinding of teeth, mydriasis, hypotension, dyspnoea, dysphagia, alopecia, increased propensity to bruises, cold sweats, muscle cramps, dysuria, sexual dysfunction, feeling unwell, feeling cold, feeling hot. Rare: anaphylactic reactions, serum sickness, hyponatremia, hallucinations, manic reactions (hypomania, mania), agitation, panic attacks, convulsions, akathisia (agitation) - compulsion to be in constant motion), tardive dyskinesia (involuntary, abnormal muscle movements), inflammation vasodilation, vasodilatation, pharyngitis, esophageal pain, angioneurotic edema, petechiae, photosensitivity, purpura, urinary retention, amlectomy. Very rare: thrombocytopenia. Frequency unknown: abnormal secretion of antidiuretic hormone, suicidal thoughts and behaviors (these symptoms may be caused by the underlying disease), confusion, stuttering, serotonin syndrome, memory problems, tinnitus,lung disorders (including inflammation with different histopathological picture and / or pulmonary fibrosis), nosebleeds, gastrointestinal bleeding (most often bleeding from the gums, bloody vomiting, fresh blood in the stools, rectal hemorrhage, bloody diarrhea, tarry stools, gastric ulcer), cases of idiosyncratic hepatitis, erythema multiforme (may develop into Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell syndrome), muscle pain, urination disorders, priapism, membrane haemorrhage mucous, abnormal liver function tests. The results of epidemiological studies conducted mainly among patients aged 50 and more indicate an increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants (the mechanism of this action is not known). Discontinuation of fluoxetine often leads to withdrawal symptoms; the most frequently reported are dizziness, sensory disturbances (including paraesthesia), sleep disorders (including insomnia and intense dreams), weakness (asthenia), agitation or anxiety, nausea and / or vomiting, tremor and headache. In clinical trials in children and adolescents treated with antidepressants, suicide-related behaviors (suicide attempts and suicidal behavior) and hostility were observed more often compared to the placebo group. In clinical studies in children, manic and hypomanic conditions have been reported, which in most cases led to discontinuation of treatment (these patients had no previous episodes of mania or hypomania). There have been isolated cases of growth retardation when using the medicine. In clinical practice, single events of delay in sexual maturation or sexual dysfunction have been observed. In pediatric clinical trials, fluoxetine treatment was associated with decreased alkaline phosphatase.

Orally.Adults. Episodes of major depressionThe recommended dose is 20 mg daily. 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. For patients who have not responded sufficiently to treatment, the dose may be gradually increased to a maximum of 60 mg daily. The dose should be changed carefully, adjusting individually for each patient, so as to maintain the lowest effective dose of the preparation. Patients with depression should be treated for at least 6 months to ensure that the symptoms of the disease are completely resolved.Obsessive-compulsive disorderThe recommended dose is 20 mg daily. In the absence of a sufficient response after 2 weeks of treatment, the dose can be gradually increased, up to a maximum of 60 mg per day. If no improvement 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. Due to the chronic nature of obsessive-compulsive disorder, patients responding to treatment are justified to use the drug for more than 10 weeks. The dose should be changed carefully, adjusting individually for each patient, so as to maintain the lowest effective dose of the preparation. Periodically, the need for further treatment should be assessed. In obsessive-compulsive disorders, long-term efficacy of treatment (over 24 weeks) has not been demonstrated.bulimiaThe recommended dose is 60 mg daily. In bulimia, long-term efficacy of treatment (over 3 months) has not been demonstrated.Children aged 8 and over and young people. An episode of major depression with moderate to severe intensity. Treatment should be started and monitored under the supervision of a specialist. The starting dose is 10 mg a day. The dose should be changed carefully, individually for each patient, so as to maintain the lowest effective dose of the drug. After 1 or 2 weeks, the dose can be increased to 20 mg daily. Clinical experience with a dose greater than 20 mg is minimal. Data regarding treatment longer than 9 weeks are limited. In children with lower body weight, the plasma concentrations are higher, the therapeutic effect can be achieved with lower doses. For children who have responded to treatment, after 6 months the need for further treatment should be reconsidered.If clinical benefit has not been achieved within 9 weeks, treatment should be considered. In elderly patients, caution should be advised when increasing the dose, and the daily dose should generally not exceed 40 mg; the recommended maximum dose is 60 mg per day. In patients with hepatic impairment or those taking concomitant medications that may potentially interact with fluoxetine, a reduction in the dose or frequency of dosing should be considered (eg 20 mg every other day). It can be given as a single dose or in divided doses, with or without food.