Instruction for use: Helarium Hypericum

Dosage form: dragee

Active substance: Deerslayer perforated herb extract (Hyperici perforati herbae extract)

ATX

N06AX Antidepressants other

Pharmacological groups:

Antidepressant of plant origin [Antidepressants]

The nosological classification (ICD-10)

F32.0 Depressive episode of mild degree: Nervous depletion with depression

F32.1 Depressive episode of moderate degree

F48.9 Neurotic disorder, unspecified: Neurosis; Secondary neurotic symptom; Other neurotic conditions; Neurosis with increased irritability; Neuroses; Neuroses of all kinds; Neuroses with retardation; Neuroses of the heart; Neurotic disorders in alcoholism; Neurotic disorders with retardation; Neurotic disorders with anxiety syndrome; Neurotic reactions; Neurotic symptoms with alcoholism; Neurotic states; Neurotic syndrome; Neurotic disorder; Attack of neurological dysfunction; School neurosis; Emotional Stress

F60.3 Emotionally unstable personality disorder: Mood swings; Mental lability; Emotional fencing; Emotional detachment; Mood Change; Lability of mood; Instability of emotional background; Mixed emotional disorders; The state of emotional stress; Emotional lability; Emotional tension; Emotional instability; Emotional instability; Mood disturbance; Mood disorders; Decreased Mood; Deterioration of mood; Mood swings

R45.3 Demoralization and apathy: Apatiko-Abulian phenomenon; Apathy; Apatobulic conditions; Apathoabulic Disorder; Apatobulic state; Indifference; Bezynitsiativnost; Vyaloapaticheskoe condition; Sluggish-apathic state; Deficiency of motivations and motivations; Lack of initiative; Lack of emotionality and avoidance of communication; Feeling of inferiority; Decreased initiative; Decreased motivation; Reduced initiative

Composition

Dragee 1 dragee

active substance:

Hypericum perforated herb extract dry 285 mg

(4.5-6.7: 1, extractant - ethanol 60%)

auxiliary substances: silicon colloidal dioxide - 15 mg; potato starch - 40 mg; lactose - 56 mg; magnesium stearate - 4 mg

shell: shellac - 6.483 mg; talc - 69.941 mg; calcium carbonate - 23,136 mg; titanium dioxide (E171) - 9.417 mg; sucrose - 28.444 mg; kaolin - 3.02 mg; gum arabic - 9.076 mg; macrogol - 0.432 mg; quinoline yellow (E104) 0.015 mg; green lacquer (E104 / E132) 0.036 mg

Description of dosage form

Dragee biconvex round in shape, covered with a shell of a greenish-yellow color.

Pharmachologic effect

Mode of action - antidepressive, anxiolytic.

Pharmacodynamics

Means of plant origin. Has antidepressant and anxiolytic action (relieves anxiety, stress, improves mood).

Indications for Helarium Hypericum

psycho-vegetative disorders (depression of mood, apathy);

neurotic reactions;

depressive states of mild and moderate severity.

Contraindications

individual hypersensitivity to the components of the drug;

Children under 12 years of age (not enough clinical data);

lactase insufficiency, lactose intolerance, glucose-galactose malabsorption, sugarase / isomaltase deficiency, fructose intolerance;

the presence of photosensitization (increased sensitivity) of the skin to UV radiation;

simultaneous use with cyclosporine, tacrolimus (for systemic use), amprenavir, indinavir and other HIV protease inhibitors (in the treatment of HIV-positive patients), as well as with irinotecan and warfarin, MAO inhibitors (the interval between admission should be at least 14 days ).

Application in pregnancy and lactation

It should not be used during pregnancy and during breast-feeding; There is insufficient experience in the use of the drug during these periods.

Side effects

Allergic reactions: skin pruritus, rash, eczema, skin pigmentation, photosensitization (more often in HIV-infected patients), sensitization to animal wool is possible.

From the side of the central nervous system: anxiety, excessive fatigue, headache.

On the part of the digestive system: nausea, abdominal pain (including in the epigastric region), dryness of the oral mucosa, flatulence, diarrhea or constipation, anorexia.

On the part of the organs of hematopoiesis: iron deficiency anemia.

Interaction

Reduces the effectiveness of indirect anticoagulants (fenprokumone, warfarin), imatinib and other cytostatics, midazolam, digoxin, amitriptyline, fexofenadine, benzodiazepines, nortriptyline, theophylline, methadone, verapamil, simvastatin, finasteride.

With simultaneous admission with certain antidepressants, such as nefazodone, paroxetine, sertraline, buspirone, tryptans, their effects may increase, and the appearance of symptoms such as nausea, vomiting, fear, anxiety, confusion.

The drug is able to enhance the photosensitizing effect of several other drugs: tetracyclines, sulfonamides, thiazide diuretics, quinolones, piroxicam.

Lengthens sleep caused by drugs for general anesthesia and narcotic analgesics, but shortens sleep caused by barbiturates. Reduces the hypotensive effect of reserpine. Reduces the concentration of cyclosporine in the blood.

Hypericum perforated reduces the concentration in the blood and the effectiveness of indinavir therapy. When used concomitantly with ethinylestradiol and desogestrel, the risk of bleeding from the breakthrough increases. Increases the metabolic rate of theophylline. Reducing the concentration in the blood of digoxin, reduces its effectiveness.

For women taking oral contraceptives, additional contraceptive methods should be used during treatment with the drug.

Dosing and Administration

Inside.

Adults and children over 12 years of age take 1 pills 3 times a day with meals. Dragee should be swallowed without chewing, if necessary, washed down with water. The drug should be taken at least 4 weeks. If symptoms persist for more than 4 weeks, you should consult your doctor.

Overdose

Symptoms: may increase dose-related side effects.

Treatment: symptomatic; In addition, patients should avoid sunlight or UV radiation for 1-2 weeks.

Special instructions

The drug may be administered to patients with diabetes mellitus, one dragee contains less than 0.03 XE counted.

During the treatment it is necessary to refrain from using ethanol-containing beverages and during 1-2 weeks to avoid UV radiation (including visiting the solarium, using a UV lamp, prolonged exposure to sunlight).

Influence of the drug on the ability to drive vehicles, work with moving mechanisms. The drug has no effect on the ability to perform potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions (including vehicle management, work with moving mechanisms).

Release form

Dragee. In foil blisters aluminum (bottom) and PVC / PVDC film (top) for 15, 20 or 25 pieces; in a box of cardboard folding 2 (15 pcs.), 3 (20 pcs.) or 4 (25 pcs.) blisters.

Conditions of leave from pharmacies

Without recipe.

Storage conditions for Helarium Hypericum

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of Helarium Hypericum

3 years.

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