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Fluoxetin Polpharma is an antidepressant drug belonging to the group of serotonin reuptake inhibitors. The active substance of the drug is fluoxetine. The preparation is used in the treatment of depression, obsessive-compulsive disorders and bulimia nervosa. The medicine is in the form of oral prescription capsules.
Fluoxetin Polpharma, Producer: Polpharma
form, dose, packaging | availability category | the active substance |
capsules; 10 mg, 20 mg; 30 pieces | prescription drug | fluoxetine |
Indications for taking Fluoxetin Polpharma
- Treatment of: episodes of major depression, obsessive-compulsive disorder and bulimia nervosa (as an adjunct to psychotherapy to reduce the urge to overeat and regurgitate) in adults.
- Treatment: episodes of major depression of moderate to severe semen, if the patient does not respond to psychotherapy after 4 to 6 sessions, in children and adolescents after 8 years of age.
Fluoxetin Polpharma and contraindications to use
Contraindications to the use of Fluoxetin Polpharma are:
- hypersensitivity to any component of the preparation,
- simultaneous use of monoamine oxidase inhibitors (MAOIs).
Treatment with fluoxetine can be started 2 weeks after stopping treatment with irreversible MAO inhibitors and the day after stopping treatment with reversible MAO inhibitors. MAO inhibitors can be started 5 weeks after stopping fluoxetine. Your doctor will consider taking a longer break if fluoxetine has been used for a long time and / or in high doses.
Dosage
Adults and the elderly:
Major Depressive Episodes:
- The usual dose is 20 mg daily. If necessary (after at least 3 to 4 weeks of using the preparation), the doctor may decide to increase the dose to a maximum of 60 mg per day.
- The preparation should be continued for at least 6 months to ensure the disappearance of depression symptoms. The doctor always decides when to use the preparation.
Obsessive Compulsive Disorder:
- The usual dose is 20 mg daily. If necessary, your doctor may decide to increase the dose to a maximum of 60 mg per day. If there is no improvement in the patient’s health after 10 weeks of using the drug, the doctor will consider continuing the treatment. Long-term treatment with fluoxetine (over 24 weeks) has not been shown to be effective.
Bulimia:
- The usual dose is 60 mg daily. The efficacy of long-term fluoxetine treatment (over 3 months) has not been demonstrated.
Children and adolescents after 8 years of age:
Moderate to severe major depressive episode:
- The usual dose is 10 mg daily (a lower dose may be sufficient for lighter children). If necessary (after at least 1 to 2 weeks of using the preparation), the doctor may decide to increase the dose to a maximum of 20 mg per day. In children who have responded to treatment, the doctor will evaluate the need for continued administration after 6 months. If there is no response to treatment within 9 weeks, your doctor will consider continuing the treatment. Any dosage modifications are possible only on the physician’s order, individually for each patient. There is no experience regarding the use of doses higher than 20 mg in this age group, as well as the use of the preparation for more than 9 weeks.
In people with hepatic impairment, it is recommended to use lower doses or longer intervals between subsequent doses (e.g. 20 mg daily every other day), the doctor always decides about the dose change.
Method of administration:
Fluoxetin Polpharma should be taken once a day (at a specified time) or twice a day, with or without a meal, with a sufficient amount of liquid.
Fluoxetin Polpharma – warnings
- In children from 8 to 18 years of age, treatment with the preparation is recommended only in cases of moderate and severe episodes of major depression.
- The effects of taking Fluoxetin Polpharma may not appear until several weeks of treatment, sometimes the duration is longer.
- People treated with fluoxetine for diseases other than depression, as well as people after suicide attempts, and those who show a significant degree of suicidal tendency before starting treatment, should be under constant medical supervision.
- There is limited information on the safety of long-term use in people under 18 years of age.
- Contact your doctor immediately if you develop a rash or other allergic symptoms.
- The patient should be under close medical supervision in the case of manic states, heart diseases, and the use of drugs that affect the work of platelets.
- Considerable weight loss may occur during treatment with Fluoxetin Polpharma.
- Diabetic patients should exercise caution. Your insulin dosage may need to be changed.
- People with galactose intolerance, lactase deficiency or malabsorption of glucose-galactose should not use it because it contains lactose.
- This medicine may impair your ability to drive or operate machinery. Be careful.
- Pregnant women may take the preparation if the doctor deems it necessary.
- If treatment with fluoxetine is unavoidable, consideration should be given to stopping breast-feeding.
Fluoxetin Polpharma with other drugs
Inform your doctor about taking:
- phenytoin (as there may be changes in blood levels of the drug and increased toxicity),
- serotonergic drugs (due to the increased risk of serotonin syndrome, simultaneous use with triptans is associated with an additional risk of hypertension and spasm of the coronary vessels of the heart),
- drugs metabolized by the cytochrome P-2 isoenzyme CYP6D450,
- acetylsalicylic acid, other non-steroidal anti-inflammatory drugs and oral anticoagulants, atypical antipsychotics, phenothiazines and most tricyclic antidepressants, as their effects can be altered (for example, increased bleeding).
- St. John’s wort, as the risk of side effects from fluoxetine increases.
Fluoxetin Polpharma – side effects, including: insomnia (including: waking up early in the morning, difficulty falling asleep, difficulty continuing to sleep after waking up), headache, diarrhea, nausea, fatigue (including asthenia).
Common may occur: decreased appetite (including anorexia), anxiety, restlessness, nervousness, nervousness, libido disturbances (including decreased libido), abnormal dreams (including nightmares), disturbance in attention, dizziness, dysgeusia, lethargy , drowsiness (including drowsiness, sedation), tremor, blurred vision, palpitations, reddening of the skin on the face or other parts of the body, vomiting, indigestion, abnormal erection, ejaculation disorder, jittery, chills, weight loss.
Uncommon the following may occur: disturbance in concentration and thinking (e.g. depersonalization), elevated mood, euphoria, abnormal orgasm (including anorgasmia), involuntary jaw clenching and grinding of the teeth, psychomotor hyperactivity, involuntary movements, impaired motor coordination, balance disorder, myoclonic muscle contractions, pupil dilation, shortness of breath.