Composition, form of production and packaging
? The dragees are greenish-yellow in color, round, biconvex.
1 dragee
dry extract of St. John's wort penetrated 285 mg,
that acc. the content of the sum of hypericins in terms of hypericin 900 Ојg
Auxiliary substances: silicon dioxide highly dispersed, potato starch, lactose, magnesium stearate.
Sheath composition: shellac, talc, calcium carbonate, titanium dioxide (E171), sucrose, kaolin, macrogol, acacia, quinoline yellow (E104), green lacquer (E104 / E132).
15 pcs. - packings cellular planimetric (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Phytomedication. Has antidepressant and anxiolytic action (relieves anxiety, stress, improves mood).
PHARMACOKINETICS
Data on the pharmacokinetics of the preparation Gelarium В® Hypericum are not available.
INDICATIONS
- psycho-vegetative disorders (depression of mood, apathy);
- Depressive states of mild and moderate severity;
- neurotic reactions.
DOSING MODE
Adults and children over 12 years of age are prescribed 1 tablet 3 times / day.
The course of treatment - at least 4 weeks. The patient should be informed that if the symptoms persist for more than 4 weeks, a doctor's consultation is necessary.
Dragee should be taken with food, not liquid, squeezed with water.
SIDE EFFECT
Dermatological reactions: photosensitization (especially in persons with fair skin).
Other: rarely - allergic skin reactions, dyspepsia, fatigue, anxiety.
CONTRAINDICATIONS
- simultaneous treatment with cyclosporin, indinavir and other protease inhibitors of HIV-positive patients;
- children's age till 12 years;
- established photosensitivity of the skin to ultraviolet radiation;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
Gelarium В® Hypericum can not be administered during pregnancy and lactation (breastfeeding) due to the lack of sufficient experience in using the drug during these periods.
APPLICATION FOR CHILDREN
Contraindicated in children under 12 years.
SPECIAL INSTRUCTIONS
Do not take the drug at the same time with antidepressants - MAO inhibitors. The interval between taking these drugs should be at least 14 days.
When prescribing the drug to patients with diabetes should take into account that 1 single dose of the drug contains less than 0.03 XE.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive and work with cars.
OVERDOSE
Cases of acute drug poisoning are not known to date. With a significant overdose, patients should avoid exposure to sunlight and UV irradiation for 1-2 weeks.
DRUG INTERACTION
With simultaneous application of Heliperium Hypericum with anticoagulants such as coumarin (fenprokumone, warfarin), cyclosporin, theophylline, indinavir, digoxin, amitriptyline, nortryptiline, methadone, verapamil, their effectiveness may be reduced.
With the simultaneous application of Heliperium Hypericum with nefazodone, paroxetine, sertraline, their effect is possible.
With the simultaneous application of Gelarium Hypericum with oral hormonal contraceptives, it is possible to weaken their action.
The drug enhances the photosensitizing effect of tetracyclines, sulfonamides, thiazide diuretics, quinolones, piroxicam.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, protected from light at a temperature of no higher than 25 В° C. Shelf life - 3 years.