Life 600 (Tablets) Instructions for Use

Marketing Authorization Holder

Steigerwald Arzneimittelwerk, GmbH (Germany)

Manufactured By

Klocke Pharma-Service, GmbH (Germany)

ATC Code

N07XX (Other drugs for the treatment of nervous system diseases)

Active Substance

Hyperici herba (DAB German Pharmacopoeia)

Dosage Form

Life 600

Film-coated tablets, 612 mg: 20, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, oval, biconvex, with a break line.

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.

Coating composition eudragit E100 (butylmethacrylate, dimethylaminoethyl methacrylate and methylmethacrylate 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) – carton packs.
20 pcs. – blisters (3) – carton packs.
20 pcs. – blisters (5) – carton packs.

Clinical-Pharmacological Group

Herbal preparation with antidepressant activity

Pharmacotherapeutic Group

Antidepressant of plant origin

Pharmacological Action

The drug has antidepressant, anxiolytic, and sedative effects. The therapeutic effect of St. John’s wort is mainly associated with the naphthodianthrones hypericin and pseudohypericin, the phloroglucinol derivative hyperforin, and flavonoids present in it. Thanks to them, the drug has a positive effect on the functional state of the central and autonomic nervous systems, which improves mood and attention, increases mental and physical activity, and normalizes sleep in patients with depression.

The leading mechanism that determines the antidepressant effect of St. John’s wort is the inhibition of the reuptake of norepinephrine, serotonin, and dopamine.

Pharmacokinetics

Hypericin and pseudohypericin

After a single oral administration of 1 Life^® 600 tablet, the C_max of hypericin in blood plasma (3.1±1.6 ng/ml) is detected after 8.1±1.8 hours. The C_max of pseudohypericin (8.5±4.4 ng/ml) is reached after 3±1.4 hours. T_1/2 is 23.8±5.5 hours for hypericin and 25.9±10.2 hours for pseudohypericin. Due to their lipophilic nature, hypericins penetrate the blood-brain barrier.

Hyperforin

After a single oral administration of 1 Life^® 600 tablet, the C_max in blood plasma (83.5±27.8 ng/ml) is observed after 4.4±1.5 hours. T_1/2 is 19.6±6.4 hours.

With daily use of Life^® 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, about 1.5 ng/ml for pseudohypericin, and about 14.8 ng/ml for hyperforin. Hypericin, pseudohypericin, and hyperforin do not accumulate in the body.

Indications

Mild to moderate major depressive episodes.

ICD codes

Dosage Regimen

The tablets are taken orally, without chewing, with a small amount of liquid, after breakfast.

Unless otherwise prescribed, it is recommended to take 1 tablet once a 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, it must be taken continuously during the first 14 days.

Adverse Reactions

The drug is generally well tolerated at recommended doses.

Adverse effects develop rarely, in no more than 1-3% of patients, and are mainly represented by the following undesirable phenomena.

Skin and subcutaneous tissue disorders photosensitization (more often in HIV-infected patients and patients with fair skin), allergic skin reactions (skin itching, skin rash, urticaria).

Nervous system disorders anxiety, increased fatigue, headache.

Gastrointestinal disorders nausea, abdominal pain (including in the epigastric region), flatulence, diarrhea or constipation. The literature reports that St. John’s wort may cause dry mouth mucosa and anorexia, but these have not been observed so far with the use of Life^® 600.

Contraindications

Allergy to St. John’s wort or to any of the excipients of the drug, skin hypersensitivity to light (including in the anamnesis), severe depressive episodes, lactase deficiency, lactose intolerance, glucose-galactose malabsorption. Concurrent use of cyclosporine, sirolimus, tacrolimus or indinavir and other protease inhibitors used for HIV treatment, irinotecan and other cytostatics, as well as antidepressants.

Use in patients under 18 years of age is not recommended.

Use during pregnancy and breastfeeding is not recommended.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is not recommended.

Pediatric Use

Use in patients under 18 years of age is not recommended.

Special Precautions

During the period of taking the drug, patients must avoid intense UV radiation (prolonged exposure to the sun, under a UV lamp, in a solarium) or take necessary sun protection measures.

Due to the presence of lactose in the composition of the drug, its use is not recommended in case of lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

When used concurrently with low-dose hormonal contraceptives, it is recommended to use additional non-hormonal methods of contraception during the treatment period with the drug.

Effect on ability to drive vehicles and machinery

During treatment, it is not recommended to drive vehicles or operate machinery.

Overdose

To date, there are no data on cases of overdose with Life^® 600.

In case of taking the drug in excessive doses, it is necessary to protect the skin from sunlight or UV radiation for 2 weeks.

Drug Interactions

Pharmacokinetic interaction

St. John’s wort preparations induce the activity of cytochrome P450 system enzymes. This may lead to a weakening and/or reduction in the duration of the clinical effect of coumarin anticoagulants (e.g., phenprocoumon, warfarin), immunosuppressants (e.g., cyclosporine, sirolimus, tacrolimus), digoxin, indinavir and other protease inhibitors used for HIV treatment, irinotecan and other cytostatics, amitriptyline, midazolam, theophylline.

In women, with concurrent use of St. John’s wort with low-dose hormonal contraceptives, intermenstrual bleeding is possible.

Pharmacodynamic interaction

When St. John’s wort is used concurrently with a number of antidepressants (nefazodone, paroxetine, sertraline), the pharmacological effect of the latter may be enhanced. In some cases, undesirable (serotonergic) effects such as nausea, vomiting, feeling of fear, anxiety, confusion may be enhanced.

Theoretically, an enhancement of the phototoxic effect of St. John’s wort is possible when used concurrently with photosensitizing drugs.

Concurrent use 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.

Storage Conditions

Store the drug in a dry place, protected from light, at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.