Composition, form of production and packaging
? The tablets covered with a film cover of yellow color, oval, biconcave, with cross-sectional risk.
1 tab.
extract of St. John's wort 612 mg
ratio of medicinal raw materials / extract 5 - 8: 1
Excipients: maltodextrin 61.2 mg, silicon dioxide 14.8 mg, talc 32 mg, titanium dioxide (E171) 20 mg, lactose monohydrate 64 mg, sodium croscarmellose 80 mg, magnesium stearate 12 mg.
Eudragit E100 (butyl methacrylate, dimethylaminoethyl methacrylate and methyl methacrylate copolymer [1: 2: 1] - 13.37 mg, talc 7.97 mg, titanium dioxide (E171) 6.67 mg, croscarmellose sodium 0.12 mg, magnesium stearate 0.12 mg, macrogol 4000 1.77 mg, riboflavin (E101) 4.38 mg.
20 pcs. - blisters (1) - packs of cardboard.
20 pcs. - blisters (3) - packs of cardboard.
20 pcs. - blisters (5) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
The drug has antidepressant, anxiolytic and sedative effect. The therapeutic effect of St. John's wort is mainly associated with the presence in it of naphthodianthrenes hypericin and pseudo-hypericin, a derivative of floroglucin hyperphorin and flavonoids. Thanks to them, the drug positively affects the functional state of the central and autonomic nervous system, which improves mood and attention, increases mental and physical activity, normalizes sleep in patients with depression.
The leading mechanism that causes the antidepressant effect of St. John's wort is oppression of the reuptake of norepinephrine, serotonin and dopamine.
PHARMACOKINETICS
Hypericin and pseudo-hypericin
After a single ingestion of 1 tablet, LifВ® 600 C max hypericin in blood plasma (3.1 В± 1.6 ng / ml) is detected after 8.1 В± 1.8 hours. After 3 В± 1.4 hours C maxpseudohydricine is achieved (8.5 В± 4.4 ng / ml). T 1/2 is 23.8 В± 5.5 h for hypericin and 25.9 В± 10.2 h for pseudohypericin. Hypericins, due to their lipophilic nature, penetrate the hemato-encephalic barrier.
Hyperforin
After a single ingestion of 1 tablet, LayfВ® 600 C max in blood plasma (83.5 В± 27.8 ng / ml) is observed through 4.4 В± 1.5 h. T 1/2 is 19.6 В± 6.4 h.
With the daily use of Life В® 600 (1 tablet per day), the equilibrium C max in blood plasma is reached within 14 days. and is about 2.8 ng / ml for hypericin, pseudohypericin about 1.5 ng / ml, hyperforin about 14.8 ng / ml. Hypericin, pseudo-hypericin and hyperphorinum do not accumulate in the body.
INDICATIONS
Major depressive episodes of mild to moderate severity.
DOSING MODE
Tablets are taken orally, without chewing, with a small amount of liquid, after breakfast.
If not prescribed otherwise, it is recommended to use 1 tablet 1 time per day for 4-6 weeks.
The decision to increase the daily dose or duration of treatment should be made only by the attending physician.
Since the effect of the drug develops gradually, during the first 14 days it must be taken continuously.
SIDE EFFECT
The drug, as a rule, is well tolerated in recommended doses.
Side effect develops rarely, not more than 1-3% of patients, and is represented mainly by the following undesirable phenomena:
On the part of the skin: photosensitization (more often in HIV-infected patients and patients with fair skin), allergic skin reactions (skin itching, skin rash, urticaria).
From the central nervous system: anxiety, fatigue, headache.
From the digestive system: nausea, abdominal pain (including in the epigastric region), flatulence, diarrhea or constipation. In the literature it is reported that St. John's wort can cause dryness of the oral mucosa and anorexia, but so far they have not been observed with the use of the preparation LaifВ® 600.
CONTRAINDICATIONS
Allergies to St. John's wort or to any of the auxiliary substances of the drug, hypersensitivity of the skin to light (including in the anamnesis), depressive episodes of severe degree, lactase deficiency, lactose intolerance, glucose-galactose malabsorption. Simultaneous use of cyclosporine, sirolimus, tacrolimus or indinavir and other protease inhibitors used to treat HIV, irinotecan and other cytotoxic agents, as well as antidepressants.
It is not recommended to use in patients under the age of 18 years.
It is not recommended to use during pregnancy and during breastfeeding.
PREGNANCY AND LACTATION
Use during pregnancy and during breastfeeding is not recommended.
APPLICATION FOR CHILDREN
It is not recommended to use in patients under the age of 18 years.
SPECIAL INSTRUCTIONS
During the period of taking the drug, patients should avoid intense UV radiation (prolonged exposure to the sun, under a UV lamp, in a solarium) or to perform the necessary sun protection measures.
Due to the presence of lactose in the formulation, its use in the absence of lactase, lactose intolerance, glucose-galactose malabsorption is not recommended.
When used simultaneously with low-dose hormonal contraceptives for the period of treatment with the drug, the use of additional non-hormonal methods of contraception is recommended.
Impact on the ability to drive and machinery
During the period of treatment, it is not recommended to operate vehicles and mechanisms.
OVERDOSE
Until now, there are no data on overdose cases of LifeВ® 600.
In case of taking the drug in excessive doses, it is necessary to protect the skin from sunlight or UV irradiation for 2 weeks.
DRUG INTERACTION
Pharmacokinetic interaction
Preparations of St. John's wort stimulate the activity of enzymes of the cytochrome P450 system. This can lead to a weakening and / or shortening of the clinical effect of the coumarin anticoagulants (eg fenprocumone, warfarin), immunosuppressants (eg, cyclosporin, sirolimus, tacrolimus), digoxin, indinavir and other protease inhibitors used to treat HIV, irinotecan and other cytostatics, amitriptyline, midazolam, theophylline.
In women with simultaneous application of St. John's wort with low-dose hormonal contraceptives, intermenstrual bleeding is possible.
Pharmacodynamic interaction
The simultaneous use of St. John's wort with a number of antidepressants (nefazodone, paroxetine, sertraline), the pharmacological effect of the latter can intensify. In some cases, unwanted (serotonergic) effects such as nausea, vomiting, a sense of fear, anxiety, confusion may increase.
It is theoretically possible to enhance the phototoxic effect of St. John's wort, when combined with photosensitizing preparations.
The simultaneous application of St. John's wort with cyclosporine, sirolimus, tacrolimus or indinavir and other protease inhibitors used for HIV treatment, irinotecan and other cytostatics, as well as antidepressants is not recommended.
In all cases where other medicines are prescribed, it is necessary to consult a doctor.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The preparation should be stored in a dry, protected from light place, at a temperature not exceeding 25 В° РЎ. Keep out of the reach of children.
Shelf life - 3 years. Do not use after the expiration date printed on the package.
