Universal reference book for medicines
Name of the preparation: NEUROPLANT ®

Active substance: St.
John's wort
Type: Phytopreparation with antidepressant activity

Manufacturer: Dr.
WILLMAR SCHWABE (Germany)
Composition, form of production and packaging
?
The tablets covered with a film membrane brownish-yellow color, round, biconcave.
1 tab.

dry extract of the herb St. John's wort (3-7: 1) * 300 mg

Excipients: ascorbic acid - 6 mg, microcrystalline cellulose - 144 mg, corn starch - 40 mg, croscarmellose sodium - 30 mg, silicon dioxide colloid - 5 mg, magnesium stearate - 5 mg.

The composition of the membrane: hypromellose (5mPz) - 7 mg, hypromellose (15mPz) - 7 mg, macrogol 4000 - 6 mg, lactose monohydrate - 4.92 mg, vanillin - 433 μg, sodium saccharinate - 37 μg, iron oxide yellow (E172) - 1.8 mg, titanium dioxide (E171) 3.6 mg, talc 1.2 mg, defoaming emulsion 10 μg.

* Extractant: methanol 80%.

20 pcs.
- blisters (1) - packs of cardboard.
20 pcs.
- blisters (2) - packs of cardboard.
20 pcs.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

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, mainly MAO type A and to some extent - MAO type B. 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 in efficiency.

DOSING MODE

The drug is taken orally, regardless of food intake.
Tablets should be swallowed without chewing and drinking with a sufficient amount of liquid (preferably a glass of water). Do not take the pill while lying down.
Adults appoint 1 tablet.
3 times / day (corresponds to a daily dose of 900 mg of herb extract of St. John's wort perforated).
If you missed the drug, follow-up should be done 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 the adherence to the instructions, the patient deteriorates, the patient should consult a doctor.

SIDE EFFECT

Estimates of the frequency of adverse reactions are based on the WHO classification: very often - 1/10 appointments (? 10%), often - 1/100 prescriptions (? 1%, but <10%), infrequently 1/1000 appointments (? 0.1% but <1%), rarely - 1/10 000 prescriptions (? 0.01%, but <0.1%), very rarely - less than 1/10 000 prescriptions (<0.01%).

From the skin and subcutaneous tissues: rarely - skin itching, skin rash, eczema;
very rarely - photosensitization in persons with fair skin (more often in HIV-infected patients) and skin pigmentation.
From the side of the central nervous system: rarely - anxiety, fatigue.

From the digestive system: rarely - nausea, abdominal pain (including in the epigastric region), flatulence, diarrhea or constipation, anorexia.

CONTRAINDICATIONS

- established photosensitivity of the skin;

- severe depression;

- age to 18 years (there is insufficient data on the use of the drug in children and adolescents);

- rare hereditary intolerance of galactose, lactase deficiency and glucose-galactose malabsorption syndrome;

- simultaneous administration of other medications (indinavir and other protease inhibitors used in the treatment of HIV infection, cyclosporine, tacrolimus, irinotecan, imatinib and other cytotoxic agents, digoxin, theophylline, warfarin and other anticoagulants, antiepileptics, antidepressants, including MAO inhibitors, triptans (serotonin 5-HT 1 -receptor antagonists), oral contraceptives);

- Hypersensitivity to active or other components of the drug.

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.

APPLICATION FOR CHILDREN

Contraindicated at the age of 18 years.

SPECIAL INSTRUCTIONS

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

Impact on the ability to drive vehicles and manage mechanisms

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

OVERDOSE

No cases of drug overdose have been reported.

Symptoms: when the drug is used in doses exceeding the recommended dose, it is possible to increase the severity of dose-dependent side effects.
After daily application for 2 weeks of the drug in a daily dose of 4.5 grams, and then 15 dry extract of St. John's wort immediately before admission, the onset of seizures and confusion of consciousness were recorded.
Treatment: symptomatic therapy;
Avoid exposure to sunlight and other sources of UV radiation for 1-2 weeks.
DRUG INTERACTION

Interaction with the following drugs may cause a decrease in their effectiveness: coumarin anticoagulants (eg fenprokumone, warfarin), cyclosporin, tacrolimus, digoxin, indinavir and other protease inhibitors used in the treatment of HIV infection, irinotecan, 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, 2C9, 2C19 and P-glycoprotein isoenzymes (including fexofenadine, benzodiazepines and their derivatives, methadone, simvastatin, finasteride).
This can reduce the effect 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 drugs that cause photosensitivity (including tetracyclines, sulfonamides, thiazide diuretics, quinolines, piroxicam and others), phototoxic effect may be enhanced.
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, feeling 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, patients taking other medicines should consult with the doctor in charge.

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 out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 3 years.
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