NEUROPLANT 300 mg Novo film-coated tablets

Product details & mandatory informationFull of zest for life againActive ingredients300 mg St John's wort dry extract (3-7:1); extractant: Methanol 80% (V/V)ExcipientsMagnesium stearateCroscarmellose sodiumSimeticoneHypromelloseIron(III) oxide hydrate, blackCorn starch, pregelatinisedSaccharin sodiumCellulose, microcrystallineSilicon dioxide, precipitatedAscorbic acidVanillinLactose-1-waterMethylcelluloseMacrogol 4000Sorbic acidTitanium dioxideTalcumIndication:The preparation is a herbal medicinal product for depressive moods.It is used for mild temporary depressive disorders (mild depressive episodes).Dosage:Always take the medicine exactly as directed. Please ask your doctor or pharmacist if you are not sure.Unless otherwise prescribed by your doctor, the usual dose is:Adults (aged 18 years and over): You should take 1 film-coated tablet 3 times a day (equivalent to 900 mg St John's wort extract per day).Please talk to your doctor or pharmacist if you have the impression that the effect of this medicine is too strong or too weak.Duration of useExperience has shown that a period of 4 - 6 weeks is required until there is a clear improvement in symptoms; however, if the symptoms persist for longer than 4 weeks or increase despite the prescribed dosage, a doctor should be consulted again.If you have taken a larger amount than you should:Overdose symptoms from preparations containing St John's wort extract have not been reported to date. The side effects listed below may occur more frequently; in this case, please inform your doctor. After taking massive overdoses, the skin should be protected from sunlight and UV radiation for a week due to possible increased sensitivity to light (limit time spent outdoors, protect from the sun by covering clothing and use sunscreens with a high sun protection factor, so-called "sun blockers"). If you forget to take the medicine:Do not take twice the amount the next time, but continue taking the medicine as prescribed by your doctor or as described.Method of administration:Oral use:Take the film-coated tablets whole with plenty of liquid (preferably a glass of drinking water). Do not take the film-coated tablets lying down.should be taken in the morning, at lunchtime and in the evening, preferably with meals.side effects:Like all medicines, this preparation can have side effects.the list includes all known side effects during treatment with St John's wort dry extract, including those with higher doses or long-term therapy.Very rarely (may affect up to 1 in 10,000 people treated), the use of this medicinal product, especially in fair-skinned people, may lead to sunburn-like reactions in areas of the skin that have been exposed to strong sunlight due to hypersensitivity of the skin to light (photosensitisation).Rarely (may affect up to 1 in 1,000 people) gastrointestinal complaints, allergic reactions (e.g. reddening of the skin, swelling, itching), tiredness or restlessness may occur.If you notice any of the above side effects, please inform your doctor so that he or she can decide on the severity and any necessary measures.If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects that are not listed.Interactions:Interactions with other medicinal productsThe medicinal product must not be used together with active substances from the following classes of medicinal products in whose degradation and excretion certain liver enzymes (cytochrome P450-3A4, CYP2C9, CYP2C19) or a certain drug transport system (P-glycoprotein) are involved:Medicinal products in anti-HIV ("AIDS") treatment, e.g. indinavir and neutrophils.e.g. indinavir and nevirapine;protease inhibitors for the treatment of hepatitis C infections, e.g. telaprevire.g. telaprevir;immunosuppressants, e.g. ciclosporin and tacrolimus;cell growth inhibitors in cancer treatment, e.g. irinotecan; imatinib and related substances (protein kinase inhibitors); vinca alkaloids; taxanes; etoposide; cyclophosph-amide;anticoagulants of the coumarin type, e.g. warfarinThe effectiveness of other medicines may be reduced if the preparation is taken at the same time. If used at the same time, regular medical therapy checks should be carried out. These medicines include, for example:digoxin,fexofenadine,benzodiazepines and related substances,methadone,simvastatin,finasteride.Please inform your doctor or pharmacist if you are taking or have recently taken other medicines, even if they are non-prescription medicines.The increased activity of drug-degrading liver enzymes normalises within one week after discontinuation of the medicinal product.The pharmacological effect of certain active substances for the treatment of depression (nefazodone, paroxetine, sertraline), buspirone or certain active substances for the treatment of migraine (triptans) may be increased if they are taken at the same time. In individual cases, undesirable effects such as nausea, vomiting, anxiety, restlessness and confusion may occur more frequently (serotonergic syndrome) and in women who use hormonal contraceptives and take this medicine at the same time, intermenstrual bleeding may occur and the safety of contraception may be reduced.Concomitant treatment with other medicinal products that increase the skin's sensitivity to light may increase the undesirable effects on the skin and it should be clarified before planned operations whether interactions may occur between the anaesthetics and this medicinal product. If necessary, the preparation should be discontinued.Contraindications:The medicinal product must not be taken in the case of severe transient depressive disorders, as there is insufficient data available on this subjectduring pregnancy.The medicinal product must not be used together with active substances from the following classes of medicinal products in whose degradation and excretion certain liver enzymes (cytochrome P450-3A4, CYP2C9, CYP2C19) or a certain drug transport system (P-glycoprotein) are involved:Medicinal products in anti-HIV ("AIDS") treatment, e.g. indinavir and nephritol.e.g. indinavir and nevirapine;protease inhibitors for the treatment of hepatitis C infections, e.g. telaprevir;immunosuppressants, e.g. Ciclosporin and tacrolimus;cell growth inhibitors in cancer treatment, e.g. irinotecan; imatinib and related substances (protein kinase inhibitors); vinca alkaloids; taxanes; etoposide; cyclophosphamide;anticoagulants of the coumarin type, e.g. warfarin.Furthermore, the medicine must not be taken together with other medicines for the treatment of depression (antidepressants).Not to be used in cases of hypersensitivity to the active pharmaceutical ingredient or any of the other ingredients or in cases of known hypersensitivity of the skin to light.Pregnancy and breastfeeding:PregnancyThe preparation must not be taken during pregnancy due to insufficient studies. The potential risk to humans is unknown.Women of childbearing age must use a reliable method of contraception during and for at least two weeks after treatment (women using hormonal contraceptives should take additional measures).LactationThere is insufficient information on whether components of the active substance or their metabolites pass into breast milk. Breastfeeding mothers should not take the medicinal product as there are insufficient studies available.Patient information:Special care is required when taking the medicinal productWhen should you only use the preparation after consulting your doctor or pharmacist?Medicinal products containing St. John's wort can influence the metabolism of other medicinal products used at the same time. This may result in a reduced and / or shortened effect for the medicines concerned, which is why it may be necessary to adjust the dosage of these medicines.what should be taken into account in children and adolescents? the use of the medicine in children and adolescents up to the age of 18 is not recommended as there is insufficient data on this.what else do you need to watch out for?You should avoid intensive UV radiation (long sunbathing, high-altitude sun, solariums) while taking this medicine.If you are using hormonal contraceptives, e.g. the contraceptive pill or hormone implants, and are taking this medicine at the same time, intermenstrual bleeding may occur and the safety of contraception may be reduced. You should therefore take additional contraceptive measures.Ability to drive and operate machineryNo sufficient studies are available on the effects on the ability to drive and operate machinery.