Fluoxetine Lannacher, 20mg capsules, 20pcs

Composition

1 capsule contains:

fluoxetine hydrochloride is 22.4 mg, which corresponds to a fluoxetine content of 20 mg.

Auxiliary substances:

Ingredients: lactose,

microcrystalline cellulose,

colloidal silicon dioxide (aerosil),

talc,

magnesium stearate.

Capsule composition:

titanium dioxide,

diamond black,

patent blue,

Ponceau 4R,

azorubin,

gelatin.

Pharmacological action

Fluoxetine has an antidepressant, anorexic effect.

Selectively inhibits the reuptake of serotonin, which leads to an increase in its concentration in the synaptic cleft, strengthening and prolonging its action on postsynaptic receptors. By increasing serotonergic transmission, it inhibits neurotransmitter exchange by a negative feedback mechanism.

With prolonged use, it reduces the activity of 5-HT1 receptors. It also blocks the reuptake of serotonin in platelets. Weakly affects the reuptake of norepinephrine and dopamine. It has no direct effect on serotonin, m-cholinergic, H1-histamine and alpha-adrenergic receptors. Unlike most antidepressants, it does not cause a decrease in the activity of postsynaptic beta-adrenergic receptors.

It is effective for endogenous depression and obsessive-compulsive disorders. Improves mood, reduces tension, anxiety and feelings of fear, eliminates dysphoria. It has an anorexic effect, may cause weight loss. In patients with diabetes mellitus, it can cause hypoglycemia, with the withdrawal of fluoxetine — hyperglycemia. A pronounced clinical effect in depression occurs after 1-4 weeks of treatment, in obsessive-compulsive disorders-after 5 weeks or more.

When using fluoxetine during pregnancy, there is an increased risk of premature birth, developmental abnormalities and low adaptation of newborns (including difficulty breathing, cyanosis, excitability).

There is evidence of the effectiveness of fluoxetine in the eating disorders (anorexia nervosa), alcohol abuse, and anxiety disorders, including social anxiety disorder; diabetic neuropathy, affective, including bipolar disorder; dysthymia, autism, panic attacks, premenstrual syndrome, narcolepsy, catalepsy, the syndrome of obstructive sleep apnea, kleptomania, schizophrenia, schizoaffective disorders, etc.

Indications

-Depressions of various origins. – Bulimia nervosa. – Obsessive-compulsive disorders (obsessive states).

Use during pregnancy and lactation

Contraindicated in pregnancy. Breast-feeding should be discontinued for the duration of treatment.

Contraindications

-Hypersensitivity. – Use of MAO inhibitors (in the previous 2 weeks). – Hepatic and renal insufficiency (creatinine clearance less than 10 ml / min). – Epilepsy and convulsive states (in the anamnesis). – Suicidal mood. – Diabetes mellitus. – Atony of the bladder. – Angle-closure glaucoma. – Prostatic hypertrophy. – Pregnancy. – Breast-feeding. With caution: – Children’s age (safety and efficacy have not been established). – Myocardial infarction, including in the anamnesis. – Cirrhosis of the liver. – Advanced age. – For cardiovascular diseases. – Insufficient liver and/or kidney function.

Side effects

From the central nervous system:  dizziness, headache, sleep disorders, increased fatigue, asthenia, tremor, agitation, motor agitation, increased suicidal tendencies, anxiety, mania or hypomania.

From the gastrointestinal tract:  decreased appetite, impaired taste, nausea, vomiting, dry mouth or hypersalivation, diarrhea.

Allergic reactions:  in the form of skin rash, pruritus, urticaria, myalgia, arthralgia, fever.

From the genitourinary system:  incontinence or urinary retention, dysmenorrhea, vaginitis, decreased libido, impaired sexual function in men (delayed ejaculation).

Other services:  increased sweating, tachycardia, impaired visual acuity, weight loss, systemic disorders of the lungs, kidneys or liver, vasculitis.

Interaction

It is incompatible with MAO inhibitors, other antidepressants, furazolidone, procarbazine, because it causes serotonergic syndrome (chills, hyperthermia, muscle rigidity, myoclonus, vegetative lability, hypertensive crisis, agitation, tremor, motor restlessness, convulsions, diarrhea, hypomanic state, delirium, coma. Possible death).

When taken concomitantly with drugs that have a high degree of binding to plasma proteins (oral anticoagulants, oral hypoglycemic agents, cardiac glycosides, etc. ), mutual displacement from protein binding is possible with a change in the concentration of the free fraction in the blood, the risk of side effects increases. The risk of bleeding increases when taking warfarin.

Inhibits the biotransformation of drugs metabolized with the participation of cytochrome P450 isoenzyme CYP2D6 (tricyclic antidepressants, dextromethorphan, vinblastine, carbamazepine). Prolongs the T 1/2 of diazepam, potentiates the effects of alprazolam.

When taken simultaneously, it changes (increases or decreases) the concentration of lithium in blood plasma, increases the content of phenytoin (before clinical manifestations of its overdose), the level of tricyclic antidepressants (imipramine, desipramine) increases 2-10 times.

Tryptophan enhances the serotonergic properties of fluoxetine (possible agitation, motor restlessness, impaired gastrointestinal function). Incompatible with ethanol.

How to take, course of use and dosage

Inside. A stable clinical effect is achieved after 2-3 weeks of treatment, and maintenance therapy can last up to 6 months.

Depressions: 20 mg once a day in the morning. If necessary, after 3-4 weeks, the dose can be increased to 20 mg 2 times a day (morning and evening). The maximum daily dose is 80 mg 1-2 times a day.

Bulimic neurosis: up to 60 mg / day.

Obsessive compulsive disorder: 20-60 mg / day.

Overdose

Symptoms: nausea, vomiting, restlessness, agitation, hypomania, convulsions, and other symptoms of CNS arousal.

Treatment: gastric lavage, use of activated charcoal, with seizures-diazepam.

Special instructions

Careful monitoring of patients with suicidal tendencies is required, especially at the beginning of treatment. The greatest risk of suicide is in patients who have previously taken other antidepressants, and patients who experience excessive fatigue, hypersomnia, or motor restlessness during treatment with fluoxetine.

When treating patients with low body weight, the anorexic properties of fluoxetine should be taken into account.

Prolonged epileptic seizures may occur during electroconvulsive therapy while taking fluoxetine.

The interval between the withdrawal of MAO inhibitors and the start of fluoxetine should be more than 2 weeks, and between the withdrawal of fluoxetine and the intake of MAO inhibitors-at least 5 weeks.

Influence on the ability to drive motor vehicles and manage mechanisms:

use with caution for drivers of vehicles and people whose activities require increased concentration of attention and speed of psychomotor reactions. Alcohol should be avoided during treatment.

Form of production

Capsules

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Fluoxetine

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Description

For adults as directed by your doctor

Indications

Depression, Obsessive-compulsive disorder