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Dosage form: & nbspfilm-coated tablets
Composition:

For 1 tablet:

Active substance: St. John's Wort perforated grass extract dry (3 - 7: 1) 300 mg, extractant - methanol 80%.

Excipients:

core pills: ascorbic acid 6.00 mg, microcrystalline cellulose 144.00 mg, corn starch 40.00 mg, croscarmellose sodium 30.00 mg, silicon dioxide precipitated 5.00 mg, magnesium stearate 5.00 mg4

tablet shell accessories: hypromellose (5mPz) 7.00 mg, hypromellose (15mPz) 7.00 mg, macrogol 4000 6.00 mg, lactose monohydrate 4.92 mg, vanillin 0.433 mg, sodium saccharinate 0.037 mg, iron oxide yellow E 172 1.80 mg , titanium dioxide E 171 3.60 mg, talc 1.20 mg, defoaming emulsion 0.01 mg (simethicone 9.2 μg, methyl cellulose (HeAr.F.) 0.77 μg, sorbic acid 0.03 μg).

Description:

Round, biconvex tablets, covered with a film coat, brownish-yellow color.

Pharmacotherapeutic group:antidepressant of plant origin
ATX: & nbsp
  • St. John's wort
  • Pharmacodynamics:

    The preparation of vegetable origin, contains as an active ingredient a dry extract of St. John's wort of perforated. Has antidepressant, anxiolytic and sedative effect. Favorably affects the functional state of the central and autonomic nervous system.It is assumed that the drug is able to inhibit the activity of mainly monoamine oxidase (MAO) Atype and to some extent - MAO B-type. Bioflavonoids bind to benzodiazepine receptors and have a sedative effect. The drug improves mood, improves mental and physical performance, normalizes sleep. The antidepressant effect is due to the ability to inhibit the reuptake of serotonin, adrenaline and dopamine.

    Pharmacokinetics:

    The herb extract of St. John's wort contains a large number of biologically active substances, which together determine its pharmacological activity. Therefore, the data on the pharmacokinetics of individual chemical components that make up the extract are not sufficient for extrapolation to the preparation as a whole.

    Indications:

    Depressive conditions of mild and moderate severity, accompanied by the following symptoms: depressed mood, apathy, decrease working capacity.

    Contraindications:

    Do not take the drug with increased sensitivity to active or other components of the drug; in the case of established photosensitivity of the skin; with a severe degree of depression.

    Neuroplant should not be used for patients under 18 years of age, as there is insufficient data on the use of this drug in children and adolescents.

    Also, do not take the drug to people who suffer from rare hereditary intolerance to galactose, lactase deficiency and glucose-galactose malabsorption.

    It is not recommended to take other medicines at the same time: ciclosporin, tacrolimus; indinavir and other protease inhibitors used in the treatment of HIV infection; irinotecan, imatinib and other cytostatic agents; digoxin, theophylline; warfarin and others anticoagulants;

    antiepileptics, antidepressants, including MAO inhibitors, triptans (serotonin 5-HT antagonists1- receptors), oral contraceptives.

    Pregnancy and lactation:

    Due to the lack of sufficient research data to date, the drug is not recommended for use during pregnancy and during breastfeeding.

    Dosing and Administration:

    In the absence of other prescriptions, the treating physician should follow the instructions for using the Neuroplant.

    Adults Apply 1 tablet 3 times a day, which corresponds to a daily dose of 900 mg of extract of St. John's wort perfumed.

    Tablets should be taken without chewing, while drinking a sufficient amount of liquid (preferably a glass of water), regardless of food intake.

    Do not take the pill while lying down.

    If the drug was missed, then it should be taken as described in this manual without any changes.

    To achieve a clear relief of the symptoms of the disease, the drug should be taken within 4-6 weeks.

    If, as a result of the use of the drug for 4 weeks, the symptoms do not go away or, despite adherence to the instructions, deterioration occurs, then you should consult a doctor.

    Side effects:

    Estimating the incidence of adverse reactions is based on the WHO classification: very frequent - 1/10 appointments (≥ 10%), frequent - 1/100 appointments (≥ 1%, but < 10%), Mr.Frequent - 1/1000 appointments (≥ 0.1%, but <1%), rare - 1/10000 prescriptions (≥ 0.01%, but <0.1%), very rare - less than 1 / 10,000 appointments (<0.01%).

    Infringements from immune system, skin and subcutaneous tissue

    It is rare to have allergic reactions: itching, skin rash, eczema.

    In very rare cases, photosensitization may occur in persons with fair skin (more often in HIV-infected patients) and the appearance of skin pigmentation.

    Disorders from the central nervous system

    Rarely, there may be anxiety, fatigue.

    Violations from the sides of the digestive system

    Rarely, there may be abnormalities in the digestive system: nausea, abdominal pain (including the epigastric region), flatulence, diarrhea or constipation, anorexia.

    Overdose:

    No cases of drug overdose have been reported.

    When using the drug in doses exceeding the recommended dose, it is possible to increase the severity of dose-dependent side effects.

    Treatment: symptomatic; Avoid exposure to sunlight and other sources of ultraviolet radiation for 1-2 weeks.

    After daily intake for 2 weeks of a daily dose of 4.5 grams, and then 15 g of dry extract of St. John's wort just before hospitalization, there was an occurrence of seizures and confusion of consciousness.

    Interaction:

    Interaction with the following drugs may cause a decrease in their effectiveness:

    - anticoagulants of the coumarin series (including fenprokumone, warfarin),

    - cyclosporine,

    - tacrolimus,

    - Ditoxin,

    - indinavir and other protease inhibitors used in the treatment of HIV infection,

    - prinetokan, imatinib and other cytotoxic agents,

    - amitriptyline, nortriptyline,

    - midazolam,

    - theophylline,

    - other antidepressants.

    Preparations containing extract of St. John's Wort, can accelerate the metabolism of drugs metabolized with the participation of cytochrome P450-3A4, CYP2C9, CYP2C19 and P-glycoprotein (including, fexofenadine, benzodiazepines and their derivatives, methadone, simvastatin, finasteride). This can weaken and / or shorten the duration of the drug. The enzyme activity returns to normal within 1 week after drug discontinuation.

    In the case of simultaneous reception of some antidepressants (nefazodone, paroxetine, sertraline, buspirone or tryptans), there may be an increase in the effect of these drugs.

    In some cases, side effects such as nausea, vomiting, anxiety, confusion may be more pronounced (serotonin syndrome).

    Simultaneous reception with photosensitizing agents can lead to increased photosensitization. In case of concomitant treatment with other medicinal drugs that cause photosensitivity (including tetracyclines, sulfonamides, thiazide diuretics, quinolines, piroxicam and others), it is possible to enhance the phototoxic effect.

    Simultaneous reception with oral contraceptives can lead to a decrease in their effectiveness and safety and the appearance of intermenstrual bleeding.

    Increases the antidepressant effect of MAO inhibitors, while increasing the risk of developing hypertensive crises (not taken simultaneously with antidepressants (MAO inhibitors), the interval between admission should be at least 14 days).

    When used together with fluoxetine, paroxetine, sertraline, fluvoxamine or citalopram, hemolytic reactions and the course of "serotonin syndrome" (increased sweating, tremor, dizziness, nausea, vomiting, headache, epigastric pain, anxiety, anxiety, confusion, confusion , a feeling of anxiety and irritability).

    Before the planned operation, it is necessary to determine the possible interaction with the drugs used during general and local anesthesia. If necessary, stop taking the herbal medicine.

    Reduces the concentration of cyclosporine in the blood.

    Reduces the concentration in the blood and the effectiveness of indinavir therapy.

    Before using the drug on the basis of St. John's wort extract to patients taking other medicines, it is necessary consult with your doctor.

    Special instructions:

    When taking Neuroplant should avoid prolonged exposure to the sun, in a solarium, under ultraviolet light.

    Effect on the ability to drive transp. cf. and fur:

    Care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions.

    Form release / dosage:Film-coated tablets, 300 mg.
    Packaging:

    20 tablets per blister of aluminum foil and PVC film; 1, 2 or 3 blisters together with instructions for use in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date of the drug.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001603
    Date of registration:23.03.2012 / 02.10.2015
    Date of cancellation:2017-03-23
    The owner of the registration certificate:Dr. Wilmar Schwabe GmbH & Co. KGDr. Wilmar Schwabe GmbH & Co. KG Germany
    Manufacturer: & nbsp
    Representation: & nbspDr. Wilmar Schwabe GmbH & Co. KG. KG Dr. Wilmar Schwabe GmbH & Co. KG. KG Germany
    Information update date: & nbsp10.02.2016
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