Instructions Neuroplant 300 mg film-coated tablets No. 20
Composition
active ingredient: dry extract of St. John's wort herb (Hypericum perforatum L.)
1 film-coated tablet contains 300 mg of dry extract of St. John's wort herb (Hypericum perforatum L.) (3-7:1) [extractant: methanol 80% (v/v)];
excipients: ascorbic acid, microcrystalline cellulose, croscarmellose sodium, hypromellose, lactose monohydrate, macrogol 4000, magnesium stearate, sodium saccharin, silicon dioxide, talc, vanillin, titanium dioxide (E 171), yellow iron oxide (E 172), pregelatinized starch, antifoam emulsion (contains methylcellulose, simethicone, sorbic acid).
Dosage form
Film-coated tablets.
Main physicochemical properties: round brownish-yellow (ocher color) film-coated tablets.
Pharmacotherapeutic group
Antidepressants. ATX code N06A X25.
Pharmacological properties
Pharmacodynamics.
Dry extract of St. John's wort inhibits synaptosomal uptake of the neurotransmitters serotonin, noradrenaline, and dopamine. Subchronic treatment causes downregulation of beta-adrenergic receptors; this alters animal behavior in some antidepressant models (e.g., forced swim test) in a manner similar to synthetic antidepressants. Naphthodianthrones (e.g., hypericin, pseudohypericin), phloroglucinol derivatives (e.g., hyperforin), and flavonoids are responsible for this effect.
Pharmacokinetics.
The pharmacokinetics of hypericin and pseudohypericin, characteristic markers of St. John's wort preparations, were studied in a study of hyperiplant 300 mg at steady-state concentrations: with 10 days of daily administration of 1200 mg of methanolic extract of St. John's wort, maximum plasma levels of 2.3-7.6 ng/ml hypericin and 1.1-7 ng/ml pseudohypericin were obtained.
Pharmacokinetic data of hyperforin were obtained after administration of the specified ethanolic extract (3-6% hyperforin): after oral administration of single doses of 600 mg and 1200 mg of extract, maximum plasma levels of 301.8 ng/ml were determined after 3.5 hours and 437.3 ng/ml after 2.8 hours, respectively. The half-life was 8.5 hours and 9.6 hours, respectively. With continuous treatment for 8 days with the use of 900 mg of extract once a day, the minimum plasma level of 35.5 ng/ml and the maximum plasma level of 246 ng/ml were detected on the 8th day of treatment. The half-life was 11.2 hours.
Indication
Treatment of mild depressive episodes.
Contraindication
Hypersensitivity to the components of the drug. Known hypersensitivity of the skin to light, photosensitization. Concomitant treatment with drugs metabolized by cytochrome P450 3A4, CYP2C9, CYP2C19 and P-glycoproteins:
protease inhibitors for the treatment of HIV infection (cyclosporine, tacrolimus, indinavir or others);
hepatitis C virus protease inhibitors;
immunosuppressants;
agents that inhibit cell growth and are used to treat cancer (irinotecan, imatinib, and others);
amitriptyline, nortriptyline;
midazolam;
theophylline;
hypocholesterolemic agents (statins);
cardiac glycosides;
coumarin anticoagulants (warfarin);
other antidepressants;
oral contraceptives, injectable contraceptives, and contraceptive implants.
Severe depressive states. Arterial hypertension.
Interaction with other medicinal products and other types of interactions
Concomitant use of Neuroplant may reduce the effectiveness of the following medications: coumarin anticoagulants (e.g., phenprocoumon, warfarin); amitriptyline, nortriptyline; midazolam; theophylline; antibiotics; sulfonamides; calcium channel blockers; female sex hormones, hypocholesterolemic agents (statins), cardiac glycosides, therefore their simultaneous use is contraindicated.
With simultaneous use of oral contraceptives, intermenstrual bleeding may occur; the reliability of contraceptives may be reduced.
In case of concomitant therapy with drugs that affect the increased sensitivity of the skin to photosensitivity, increased sensitivity to sunlight is possible.
Medicinal products containing St. John's wort extract may reduce the plasma concentration of drugs metabolized by cytochrome P450 3A4, CYP2C9, CYP2C19 and P-glycoproteins (e.g. amitriptyline, nortriptyline, fexofenadine, benzodiazepines and their derivatives, methadone, simvastatin, finasteride), antidepressants and other serotonergic substances (such as buspirone, citalopram, escitalopram, fluoxetine, sertraline, triptans, nefazolone, tramadol and others).
Application features
While taking Neuroplant, you should avoid intense exposure to sunlight for a long time if the skin is unprotected, and procedures using ultraviolet radiation (quartz, UV lamps, solarium).
With the concomitant use of certain antidepressants (nefazodone, paroxetine, sertraline), in some cases, adverse reactions (nausea, vomiting, feelings of fear, anxiety and confusion) may be more pronounced.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Neuroplant.
Information for diabetics: 1 film-coated tablet contains 0.048 g of carbohydrates.
Before surgery, it is recommended to determine the possibility of interaction with drugs used for general and local anesthesia. If necessary, the drug should be discontinued.
Preparations containing St. John's wort herb extract should be taken with caution together with serotonin inhibitors or other serotonergic drugs, as in very rare cases undesirable effects (serotonin syndrome) may occur in the form of autonomic dysfunctions (e.g. increased sweating, tachycardia, diarrhea, fever), mental (e.g. agitation, disorientation) and motor changes (e.g. tremor or myoclonus).
Due to lack of sufficient data, the use of the medicinal product in children and adolescents under 18 years of age is not recommended.
Use during pregnancy and breastfeeding
Since there are no sufficient studies, Neuroplant should not be used during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Unknown.
Method of administration and doses
Adults and elderly patients:
Single dose – 300 mg.
Frequency of administration – 3 times a day.
Daily dose – 900 mg.
Duration of treatment
Treatment for 4 weeks is necessary to achieve a clear improvement in symptoms. If symptoms persist for more than four weeks or if the condition worsens despite proper treatment, a doctor should be consulted.
The film-coated tablets should be taken without chewing, with sufficient liquid. Taking the tablets does not depend on meals.
Children.
The medicine should not be used in children.
Overdose
Phototoxic reactions may occur after taking excessive doses of the drug. In this case, the skin should be protected from sunlight and UV rays for a week (reduce the time spent outdoors, wear appropriate clothing and use sunscreen with a high protection factor). Treatment of phototoxic skin reactions is symptomatic.
Convulsions and confusion have been reported after taking 4.5 g of dry extract of St. John's wort herb per day for two weeks, as well as an additional 15 g of dry extract. In case of overdose, a bitter taste in the mouth and an unpleasant feeling in the liver area are also possible.
Side effects
Skin, subcutaneous tissue/immune system disorders: allergic reactions (redness, swelling, itching, rash). Hypersensitivity to photosensitivity: in rare cases, Neuroplant may cause, especially in people with delicate fair skin, reactions similar to sunburn on areas of the skin that have been exposed to intense sunlight or other types of UV radiation (photosensitization) and dysesthesia (e.g. tingling, sensitivity to cold or pain, burning sensation).
Nervous system: apathy or anxiety.
Gastrointestinal disorders may rarely occur.
If any adverse reactions occur, treatment should be discontinued and a doctor should be consulted.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
Blisters of 20 film-coated tablets; 1 or 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Dr. Wilmar Schwabe GmbH & Co. KG.
Address
Wilmar-Schwabe-Strasse, 4,
76227 Karlsruhe, Germany.
