Life 600 - instructions for use, dose, side effects, contraindications

active ingredient: St. John's wort penetrated grass extract in the ratio of medicinal raw materials - extract: 5-8:1, Extragent ethanol 50 % (ml / ml) - 612,00 mg;

Excipients:

core tablet: maltodextrin - 61,20 mg, silicon dioxide - 14,80, talc - 32,00 mg, titanium dioxide (E 171) - 20,00 mg, lactose monohydrate - 64,00 mg, croscarmellose sodium - 80,00 mg, magnesium stearate - 12.00 mg;

tablet shell: eudragit E 100 (butyl methacrylate, dimethylaminoethyl methacrylate and methyl methacrylate copolymer [1:2:1]) - 13,37 mg, talc - 7,97 mg, titanium dioxide (E 171) - 6,67 mg, croscarmellose sodium - 0,12 mg, magnesium stearate - 0,12 mg, macrogol 4 000 - 1,77 mg, riboflavin (E 101) - 4,38 mg.

Description:

Oval, biconvex tablets, covered with a film coating of yellow color with a transverse risk.

Pharmacotherapeutic group:An antidepressant of vegetable origin

ATX: & nbsp

A.13 Tetanus preparations

N.07.X.X Other drugs for the treatment of diseases of the nervous system

Pharmacodynamics:

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 oral intake 1 LIFE® tablets 600 the maximum concentration of hypericin in the blood plasma (3,1 ± 1,6 ng / ml) is detected through 8,1 ± 1,8 h. Via 3 ± 1,4 h the maximum concentration of pseudo-hypericin is achieved (8.5 ± 4.4 ng / ml).The half-life is 23.8 ± 5.5 h for hypericin and 25.9 ± 10.2 h for pseudohypericin. Hypericins, due to their lipophilic nature, penetrate the blood-brain barrier.

Hyperforin:

After a single ingestion of 1 tablet Layf® 600, the maximum concentration in the blood plasma (83.5 ± 27.8 ng / ml) is observed after 4.4 ± 1.5 hours. The half-life period is 19.6 ± 6.4 hours.

With the daily use of Life® 600 (1 tablet per day), the equilibrium concentration in the blood plasma is reached within 14 days and amounts to about 2.8 ng / ml for hypericin, about 1.5 ng / ml for pseudohypericin, about 14.8 giperforin ng / ml.

Hypericin, pseudo-hypericin and hyperphorinum do not accumulate in the body.

Indications:

Major depressive episodes of mild to moderate severity.

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.

Dosing and Administration:

Tablets are taken orally, not liquid, 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 effects:

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:

From 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 until now they have not been observed with the use of the preparation Lif® 600.

Overdose:

Until now, there is no evidence of overdose of Lif® 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.

Interaction:

Pharmacokinetic interaction

St John's wort preparations induce the activity of the enzymes of the cytochrome P 450 system. This may lead to a weakening and / or shortening of the duration of the clinical effect of the coumarinic anticoagulants (for example, fenprocumone, warfarin), immunosuppressants (eg, ciclosporin, sirolimus, tacrolimus), digoxin, indinavir and other protease inhibitors used to treat HIV, irinotecan and other cytotoxic agents, amitriptyline, midazolam, theophylline.

In women with simultaneous application of St. John's wort with low-dose hormonal contraceptives, intermenstrual bleeding is possible.

Pharmacodynamic interaction

Pi simultaneous application of St. John's wort with a number of antidepressants (nefazodone, paroxetine, sertraline) the pharmacological effect of the latter can be strengthened.

In some cases, unwanted (serotonergic) effects may increase, such as nausea, vomiting, a sense of fear, restlessness, confusion.

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 (see "Contraindications").

In all cases where other medicines are prescribed, it is necessary to consult a doctor.

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 is not recommended for lactase deficiency, lactose intolerance, glucose-galactose malabsorption (see the section "Contraindications").

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.

Effect on the ability to drive transp. cf. and fur:During the period of treatment, it is not recommended to operate vehicles and mechanisms.

Form release / dosage:

Tablets, film-coated, 612 mg.

Packaging:

For 20 tablets in a blister of aluminum foil.

1, 3 or 5 blisters are placed in a cardboard box together with instructions for use.

Packing for hospital

5 blisters are placed in a cardboard box together with instructions for use. 5 cardboard packs are grouped together using a paper marked tape.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-000407

Date of registration:28.02.2011

Expiration Date:28.02.2016

The owner of the registration certificate:Steigerwald Arzneimittelwerk GmbHSteigerwald Arzneimittelwerk GmbH Germany

Manufacturer: & nbsp

STEIGERWALD ARZNEIMITTELWERK, GmbH Germany

Representation: & nbspRegard, OOORegard, OOORussia

Information update date: & nbsp09.02.2018

Illustrated instructions

Instructions

Life® 600 (Life® 600)