Instruction for use: Framex

Dosage form: capsules

Active substance: Fluoxetine*

ATX

N06AB03 Fluoxetin

Pharmacological groups:

Antidepressant

The nosological classification (ICD-10)

F32 Depressive episode: Adynamic subdepression; Astheno-adynamic subdepressive states; Asthenoadressive disorder; Astheno-depressive disorder; Asthenodepressive state; Astheno-depressive state; Major Depressive Disorder; Vyaloapatichesky depression with retardation; Double Depression; Depressive pseudodement; Depressive illness; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive disorders; Depressive syndrome; Depressive syndrome larviated; Depressive syndrome in psychoses; Depressed masks; Depression; Depression Depletion; Depression with the phenomena of inhibition within the framework of cyclothymia; Depression is smiling; Involutional depression; Involutionary melancholy; Involutional depression; Manic-depressive disorder; Masked Depression; Melancholic Attack; Neurotic depression; Neurotic depression; Shallow Depression; Organic depression; Organic depressive syndrome; Simple depression; Simple melancholic syndrome; Psychogenic depression; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Reactive depression; Recurrent depression; Seasonal depressive syndrome; Severostatic depression; Senile Depression; Symptomatic Depression; Somatogenic depression; Cyclotymic depression; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F42 Obsessive-compulsive disorder: Obsessive-compulsive syndrome; Obsessive compulsive states; Obsessive-compulsive syndrome; The Obsession Syndrome; The obsession neurosis; Obsessive-compulsive neurosis; Obsessions

Composition and release form

Capsules - 1 caps.

fluoxetine (as hydrochloride) 20 mg

auxiliary substances: titanium dioxide

in a blistere of 14 pcs .; in the box 1 or 2 blisters.

Description of dosage form

Contents of the capsule: powder white or almost white.

Capsule: self-closing, hard gelatin, size N3, upper and lower part of blue.

Pharmachologic effect

Pharmacological action - Selectively blocks the reverse neuronal seizure of serotonin in the central nervous system.

Pharmacokinetics

After oral administration, it is well absorbed from the digestive tract. It binds to plasma proteins by 95%. Cmax is achieved in 6-8 hours. It is metabolized in the liver with the participation of the isoenzyme P450 2D6 of the cytochrome P450 system, the main active metabolite is norfluoxetine. T1 / 2 fluoxetine - 4-6 days, norfluoxetine - 4-16 days. It is excreted by the kidneys in the form of metabolites.

Indication of the preparation Framex

Depression, obsessive-compulsive disorder.

Contraindications

Hypersensitivity, the use of MAO inhibitors (in the previous 2 weeks), pregnancy, breast-feeding, children's age.

Application in pregnancy and lactation

Contraindicated. For the duration of treatment, breastfeeding should be discontinued.

Side effects

From the cardiovascular system: tachycardia, vasodilation, vasculitis.

On the part of the intestine: dyspeptic phenomena, nausea, vomiting, anorexia, dry mouth, dysphagia.

From the side of the nervous system: dizziness, headache, anxiety, increased irritability, drowsiness, insomnia, nightmares, thinking disorders, depersonalization, manic affect, muscle twitching, myoclonia, tremor, akathisia, ataxia, cheek-language syndrome.

From the skin: skin rash, itching, sweating, urticaria, alopecia.

From the sense organs: a temporary decrease in visual acuity, mydriasis, a violation of the perception of taste sensations.

From the genitourinary system: disorders of urination.

Allergic reactions: reactions like serum sickness, anaphylactic reactions.

Other: dermal hemorrhages, ejaculation disorder, decreased libido and potency.

Interaction

Incompatible with MAO inhibitors; increases the plasma levels of tricyclic antidepressants and phenytoin, changes the concentration of lithium in the blood, increases T1 / 2 diazepam.

Dosing and Administration

Inside, the initial dose is 20 mg / day in the morning, with or without efficacy for several weeks the daily dose can be increased, the maximum daily dose is 80 mg in 2 divided doses (morning and noon).

Patients with impaired liver or kidney function reduce doses or increase the intervals between doses.

Overdose

Symptoms: nausea, vomiting. Excitation, hypomania, convulsions can be noted.

Treatment: gastric lavage, reception of activated charcoal, symptomatic and maintenance therapy. There is no specific antidote.

Storage conditions for Framex

In the dark place at a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life of Framex

3 years.

Do not use after the expiry date printed on the package.