As with the use of other psychotropic drugs, it is not recommended to consume alcohol during treatment with Fevarin®.
Suicide / suicidal thoughts or clinical impairment
Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide attempts (suicidal behavior). This risk persists until the state of significant improvement. Since the improvement may not occur during the first few weeks of treatment or longer, patients should be carefully monitored until such an improvement occurs.
In clinical practice, an increased risk of suicide in the early stages of recovery is widespread.
Other psychiatric disorders for which treatment is prescribed fluvoxamine, may also be associated with an increased risk of suicidal behavior. In addition, these conditions can accompany deep depression. Therefore, patients with other mental disorders should be carefully monitored.
It is known that patients with a history of suicidal behavior or who are largely suicidal in thinking, have a greater risk of suicidal thoughts or suicidal attempts before starting treatment and should be carefully observed during treatment.
Careful monitoring of patients, especially those at high risk, should accompany drug therapy, especially in its early stages and after dose changes.
It is necessary to warn patients (and caregivers) about the need to monitor any clinical deterioration, suicidal behavior or suicidal thoughts, unusual behavioral changes, and immediately seek professional advice if such symptoms appear.
Children's population
Fluvoxamine should not be used to treat children and adolescents under the age of 18 except for patients with obsessive-compulsive disorder. Due to a lack of clinical experience with the use of fluvoxamine in children for the treatment of depression can not be recommended. In clinical studies conducted among children and adolescents, suicidal behavior (suicidal attempts and thoughts) and hostility (mainly aggression, opposition behavior and anger) were observed more often in patients receiving an antidepressant compared with those receiving placebo. If, on the basis of the clinical need, the decision to treat is accepted, the patient should be carefully monitored for suicidal symptoms.
In addition, there is no long-term safety data for children and adolescents regarding the growth, development and development of cognitive behavior.
Adults (from 18 to 24 years)
A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with mental disorders revealed an increased risk of suicidal behavior when taking antidepressants compared with placebo in patients younger than 25 years of age.When prescribing fluvoxamine, the risk of suicide should be correlated with the benefit of its use.
Elderly patients
Data obtained in the treatment of elderly patients and younger patients indicate that there are no clinically significant differences between the usual daily doses used. However, increasing doses in elderly patients should always be slower and with greater caution.
Akathisia / psychomotor agitation
The development of akathisia associated with the administration of fluvoxamine is characterized by subjectively unpleasant and painful anxiety. The need to move was often accompanied by an inability to sit or stand still. The development of this condition is most likely during the first few weeks of treatment. An increase in the dose of the drug in patients with such symptoms may worsen their condition.
Treatment patients with hepatic or renal insufficiency, should start with low doses and such patients should be under strict medical supervision. In rare cases, fluvoxamine treatment may lead to an increase in hepatic enzyme activity,often accompanied by appropriate clinical symptoms and in such cases, Fevarin® should be withdrawn.
Nervous System Disorders
Care should be taken when prescribing a patient with a history of seizures. Avoid the administration of fluvoxamine in patients with unstable epilepsy, and patients with stable epilepsy should be closely monitored. Treatment with the drug Fevarin® should be discontinued if epileptic seizures occur or their frequency increases.
Rare cases of development of a serotonin syndrome or a condition similar to a malignant neuroleptic syndrome, which may be associated with the administration of fluvoxamine, are described, especially in combination with other serotonergic and / or antipsychotic medications. Since these syndromes can lead to potentially life-threatening conditions, manifested hyperthermia, muscle stiffness, myoclonus, lability of the autonomic nervous system with possible rapid changes in vital parameters (pulse, respiration, BP, etc.), changes in mental status, including confusion, irritability,extreme agitation, reaching the delirium or coma - in such cases treatment with fluvoxamine should be discontinued and appropriate symptomatic treatment should be started.
Metabolism and nutrition disorders
As with other selective serotonin reuptake inhibitors, in rare cases, hyponatremia may occur, which is reversed after the withdrawal of fluvoxamine. Some cases were caused by the syndrome of insufficient secretion of antidiuretic hormone. In most cases, these cases were observed in elderly patients.
Control over the level of glucose in the blood (eg, hyperglycemia, hypoglycemia, impaired glucose tolerance) may be impaired, especially in the early stages of treatment. In the case of prescribing fluvoxamine to patients with diabetes mellitus, a dose adjustment of antidiabetic drugs may be required.
The most commonly observed symptom associated with the use of the drug Fevarin® is nausea, sometimes accompanied by vomiting. This side effect, as a rule, disappears during the first two weeks of treatment.
Disturbance of vision
Cases of mydriasis have been reported in the use of SSRIs, such as fluvoxamine. Therefore, patients with increased intraocular pressure or patients at high risk of acute angle-closure glaucoma fluvoxamine should be administered with caution.
Hematologic disorders
There are reports of intradermal hemorrhages such as ecchymosis and purpura, as well as other hemorrhagic manifestations (eg, gastrointestinal bleeding or gynecological bleeding) observed with the use of selective serotonin reuptake inhibitors. Caution should be exercised when prescribing these medicines in elderly patients and patients concurrently receiving drugs acting on platelet function (eg, atypical antipsychotics and phenothiazines, many tricyclic antidepressants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs) or drugs that increase the risk of bleeding, as well as in patients with a history of bleeding or prone to bleeding (eg, with thrombocytopenia or a violation of coagulation).
Disorders of cardiac activity
Increased risk of lengthening the interval QT/ paroxysmal ventricular tachycardia of the "pirouette" type with combined therapy of fluvoxamine with terfenadine or astemizole or cisapride, due to an increase in the concentration of the latter in the blood plasma. therefore fluvoxamine should not be administered with these drugs.
Fluvoxamine may cause a slight decrease in heart rate (by 2-6 beats per minute).
Electroconvulsive therapy (ECT)
Experience in the clinical use of fluvoxamine on the background of ECT is limited, so this therapy should be conducted with caution.
Cancellation reactions
With the discontinuation of fluvoxamine, the development of the "withdrawal" syndrome is possible, although the available pre-clinical and clinical data have not revealed the dependence on fluvoxamine treatment. The most common symptoms noted in the case of cancellation of the product: dizziness, sensory disturbances (including paraesthesia, visual disturbances, and the feeling of electric shock), disorders of sleep (including insomnia and vivid dreams), agitation, irritability, confusion, emotional lability, headache, nausea and / or vomiting, diarrhea, sweating,palpitation, tremors and anxiety (see section "Side effects").
Most of these symptoms are mild or moderate and stop on their own, but in some patients they can be severe and / or prolonged. Similar symptoms usually occur within the first few days after discontinuation of treatment. For this reason, it is recommended to gradually reduce the dose of fluvoxamine before complete cancellation in accordance with the patient's condition (see section "Dosage and Administration"),
Mania / Hypomania
Fluvoxamine should be used with caution in patients with a history of mania / hypomania. When the patient develops a manic phase, fluvoxamine should be discontinued.