Helarium Hypericum

Registration code:
Trade nomination of the preparation: Helarium Hypericum
Drug formulation: pill

Composition:
1 pill of Helarium Hypericum contains:
285.0 mg. of the dry extract of common Saint-Johns' wort (Hypericum perforatum L.) in the ratio of the extract of the crude drug is 4.5-6.7:1, extracting agent ethanol 60% (м/м).
Auxiliary components: colloidal silicon dioxide, potato flour, lactose, magnesium stearate.
Pill cover: stick lac, talcum powder, calcium carbonate, titanium dioxide (Е 171), saccharose, parclay, acacia gum, macrogol, yellow quinoline Е 104, green lacker-form agent Е 104/Е 132.

Description: round double radius pills with cover of greenish-yellow color.

Pharmacotherapeutic group: antidepressant drug of the vegetative origin.
Code ATX: N07XX.

Pharmacological properties: remedy of the vegetative origin. It produces antidepressant and anxiolytic effect (reduces anxiety, tense, raises mood).

Indications for use:
psycho-vegetative disorders (decrease of mood, apathy and other), neurotic reactions. Depressive state of light and middle severity level.

Contra indications: children up to 12 years. Individual intolerance and sensibility to the components of the preparation. Patients shouldn't apply preparation having photo sensibilization (hyper sensibility) of skin to ultraviolet emission. Treatment of HIV-positive patients with cyclosporine, indinavir and other substances, which inhibit protease, contradicts the application of Helarium Hypericum.

Application during pregnancy and breast-feeding period: do not apply preparation during pregnancy and in the breast-feeding period, because there is no enough application experiment during these periods.

Posology and method of administration: adults and children elder than 12 apply 1 pill of Helarium Hypericum 3 times a day without chewing, washing down during meals. It is ought to apply Helarium Hypericum not less than 4 weeks. If the symptoms remain unchanged for more than 4 weeks, it is necessary to consult a physician.

Side effects: rarely allergic response is possible, and also complaints from the gastro-intestinal tract, exhaustion, anxiety. Photo sensibilization (hyper sensibility) of skin to ultraviolet emission is possible, especially of people with light skin.

Overdosage: the cases of acute intoxication of preparation are uncertain up to the present moment. Patients ought to avoid sun light and UV emission at the cases of serious overdosage.

Interaction with other medication:
The interaction with the following preparation will lead to decrease of their effectiveness: anticoagulants like coumarin (phenprocoumon, warfarin), cyclosporine, digoxin, indinavir, amitriptyline, nortryptiline, theophyllin, methadone, verapamil.
The simultaneous application of the preparation with inhibitors monoaminooxidase (MAO) is contraindicated.
Simultaneous application with this preparation of remedies for the treatment of depressions, for example nefazodone, paroxetine, sertraline, can strengthen their effect.
Application of the preparation together with the oral contraceptives can decrease their effect.
Preparation has the ability to strengthen photosensibilitive effect of some other remedies: tetracyclines, sulfalinamide, thiazide diuretic, quinolones, piroxicam.

Special remarks:
Preparation does not influence on the perception reaction time at operating the vehicle or the mechanism.
It is possible to apply preparation to the patients with pancreatic diabetes: the single dosage of the preparation consists less than 0,03 bread units.

Form of issue: by 15, 20 and 25 pills in blister of the aluminum foil (lower part) and polyvinylchloride /polyvinylidenchloride coating (upper part). It is packed by 2 (15 pills), 3 (by 20 pills), 4 (by 25 pills) blisters together with the application instruction into the cardboard pack.

Storage conditions: keep in dry and shadowed place, at temperature up to 25оС.

Expire date: 3 years. Do not use preparation if the expiry date (month and year) printed on the pack has passed.

Pharmacy purchasing terms: Without receipt.

Manufacturing enterprise:
BIONORIKA AG D-92318 Neumarkt/Germany
Kerschenstaistrasse 11-15
92318 Neumarkt
Germany

Representative office in Moscow
119 526, Moscow, Vernadski prospect, house 105, building 2
phone. 502-90-19.

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