Simidon Forte tablets 13mg №30×1

Product Description Simidona forte. Composition 1 tablet contains active substance: 13 mg of dry native extract of rhizomes of cimicifuga (Cimicifuga racemose) (4.5-8.5:1), extractant – ethanol 60% (v/v), excipients: povidone, croscarmellose sodium, microcrystalline cellulose , lactose monohydrate, magnesium stearate, anhydrous colloidal silicon dioxide. Description: Round, biconvex, yellow-beige tablets, debossed with “C” on one side and “13” on the other side and a characteristic odor. Pharmacotherapeutic group Other drugs used in gynecology. Cimicifuga rhizomes. Code ATX G02CX04. Pharmacological properties Pharmacodynamics Neither the mechanism of action nor the components responsible for the relief of complaints caused by menopause are known. Clinical pharmacological studies indicate that menopausal symptoms (such as hot flashes and profuse sweating) may improve with treatment with cimicifuga root medicinal products. Pharmacokinetics No data available. Preclinical data In a six-month rat trial, the maximum no observed effect (NOEL) dose for the isopropanol extract (granulate) was determined to be 21.06 mg native extract/kg body weight. The data obtained from in-vitro and in-vivo pharmacological studies suggest that cimicifuga extracts do not affect the delay or development of breast cancer. However, conflicting results have been obtained in other in-vitro experiments. When cimicifuga extract (an isopropanol extract of cimicifuga, equivalent to 40 mg of root and rhizome) was administered to transgenic female mice, the percentage of mice with detectable mild metastatic tumors on necropsy was increased compared to mice that were on a diet free of the test substance. However, in the same experimental model, no increase in the primary breast tumor was found. An effect on breast cancer or other hormone-dependent tumors cannot be completely ruled out. A genotoxicity study (metabolic activation test) of the ethanol extract (4.5-8.5:1, ethanol 60% (v/v)) was carried out up to a concentration of 1 mg/plate. The test does not meet recent criteria for such testing and therefore the significance of these results for safety assessment is questionable. There are no definitive studies of carcinogenicity and reproductive toxicity. Indications for use Herbal remedy for the relief of climacteric complaints such as hot flashes and profuse sweating. Simidone forte (dry native extract of rhizomes of cimicifuga (Cimicifuga racemosa) 13 mg) is recommended when the effect of using Simidon uno (dry native extract of rhizomes of cimicifuga (Cimicifuga racemosa) 6.5 mg) is insufficient. Dosage and administration Doses Adult women during menopause 1 tablet once a day (morning or evening) whole with a small amount of liquid, preferably at the same time. Reception of tablets does not depend on food intake. The effect is not immediate. It is recommended to take Simidon forte for at least 6 weeks. Duration of use If symptoms persist during the use of the drug, you should seek the advice of a doctor or pharmacist. Cimicifuga should not be taken for more than 6 months without the advice of a doctor. Method of application: Oral administration. Adverse effects Liver toxicity (including hepatitis, jaundice, abnormal liver function tests) associated with the use of preparations containing cimicifuga. The frequency is unknown. Skin reactions (urticaria, pruritus, exanthema), facial edema, peripheral edema, and gastrointestinal symptoms (eg, dyspepsia, diarrhea) have been observed. The frequency is unknown. If other adverse reactions not listed above are observed, it is necessary to seek the advice of a doctor or pharmacist. Contraindications Hypersensitivity to the active or auxiliary components of the drug. Interactions with other medicinal products have not been reported. Warnings and Precautions Patients with a history of liver disease should take Cimicifuga preparations with caution (see section “Side effect”). Patients should stop taking cimicifuga preparations and seek immediate medical attention if they develop signs and symptoms suggestive of liver damage (fatigue, loss of appetite, yellowing of the skin and eyes, or severe pain in the upper abdomen with nausea and vomiting, or dark urine). In case of vaginal bleeding or other symptoms, you should seek medical advice. Cimicifuga preparations should not be used together with estrogens unless prescribed by a doctor. Patients who have been or are being treated for breast cancer or other hormone-dependent tumors should not take Simidon forte without medical advice. Please see section “Preclinical data”. If during the use of the drug the symptoms worsen, you should seek the advice of a doctor or pharmacist. Use during pregnancy and lactation Safety during pregnancy and lactation has not been established. Due to lack of sufficient data, use during pregnancy and lactation is not recommended. Women of childbearing potential should consider using effective contraceptive methods during treatment. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms There are no studies on the effect on the ability to drive vehicles or work with other automated systems. Overdose No cases of overdose have been found. Release form and packaging 30 tablets in a blister pack made of PVC / PVDC and aluminum foil. 1 or 3 blister packs together with instructions for medical use are placed in a cardboard box. Storage conditions Store at a temperature not exceeding 25 ° C in the original packaging. Keep out of the reach of children. Shelf life 3 years Do not use after the expiration date! Terms of dispensing from pharmaciesWithout a prescription. 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