Simidona uno 6.5 mg (30 tablets)

The instruction for medical use of Simidona medicine uno the Trade name of Simidon uno the International unlicensed name Is not present the Dosage form of the Tablet of 6.5 mg Structure 1 tablet contains active agent: 6.5 mg of dry native extract of rhizomes of a tsimitsifuga (Cimicifuga racemosa) (4.5-8.5:1), extractant - ethanol of 60% (about/about), excipients: povidone, sodium of a kroskarmelloz, cellulose microcrystalline, lactoses monohydrate, magnesium stearate, silicon dioxide colloidal anhydrous. The description Round biconvex tablets of yellow-beige color with a characteristic smell. Pharmacotherapeutic group Other drugs for treatment of gynecologic diseases. Rhizome Tsimitsifug. The ATX G02CX04 code the Pharmacological Etanolnye's Pharmacodynamics properties extracts of a rhizome of a tsimitsifuga contain triterpenovy glycosides, derivatives of flavonoids and aromatic acids. Influence of extract of a tsimitsifuga on estrogen receptor (ER) positive and negative lines of cells of a breast cancer of the person was tested in various experiments of in vitro. The received results are contradictory. In the majority of the published researches, among others – a research of extract of a tsimitsifuga Ze 450, the inhibition of proliferation is revealed and/or the lack of proliferation of cells is confirmed. It was succeeded to show that components of extract of a tsimitsifuga have a certain affinity to linking with an estrogen receptor, but do not render estrogenic effect. Researches of undesirable pharmakodinamichesky properties endometrium thickness by transvaginal ultrasonography was measured In one clinical trial with participation of 400 women in a postmenopause. Within more than one year of increase in thickness of endometrium it was not observed. Change of hormonal parameters (LG, FSG, oestradiol and prolactin) is also not recorded. The obtained data demonstrate that observed effects of extract of a tsimitsifuga have probably no direct influence on these hormonal parameters. Clinical performance Simidon's Efficiency uno for treatment of symptoms of a climacteric was studied during prospective placebo - controlled randomized clinical trial. Data on Simidon's advantages uno in comparison with placebo are provided in the specified three-group research within 12 weeks. Primary final point (Kupperman's index) in sample of all randomized subjects which received the studied drug at least once (N = 153), showed the efficiency correlating depending on a dose. The dose in 13 mg can be applied to treatment at women with climacteric symptoms for which the dose of 6.5 mg is not sufficient. Pharmacokinetics concerning a galenichesky form in which are provided Simidona uno the pharmacokinetic researches were not conducted. Preclinical data during preclinical trial of toxicity against the background of repeated oral administration of dry extract of a tsimitsifuga (Ze 450) within 7 days the development of toxic reactions was not confirmed by either histologic, nor microscopic examinations. The analysis of a microsome of a salmonella according to Ames did not show any signs of mutagen effect of dry Ze 450 extract of a rhizome of a tsimitsifuga (Cimicifuga racemosa). In a six-month research at a preclinical stage the maximum dose of drug which is not leading ment of observed effects (NOEL) for izopropanolny extract (granulate) was defined from 21.06 mg of native extract/kg of body weight. At use of extract of a tsimitsifuga (izopropanolny extract of a tsimitsifuga, 40 mg of roots and rhizomes are equivalent) to opukholenesushchy transgenic models, the percent with the detected slight metastatic tumors at a nekropsiya was increased, in comparison with those which were on the diet excluding the studied substance. Nevertheless, in the same experimental model, no increase in primary tumor of a mammary gland was revealed. Influence on a breast cancer or other hormonedependent tumors cannot be completely excluded. Dry extract of a tsimitsifuga Ze 450 was deprived of any genotoksichesky potential in a standard set of tests for genotoxicity, including the analysis of a microsome of in vitro with use of salmonellas according to Ames, the test for an aberation chromosome of in vitro and in Vivo MNT a research at models to 2000 mg/kg. There are no final researches of carcinogenicity and reproductive toxicity. Indications Medicine of plant origin for relief of symptoms in climacteric disorders, such as inflows of heat, perspiration, sleep disorder, nervousness and differences of mood. Once a day on 1 tablet (in the morning or in the evening), entirely, washing down a route of administration and doses with a small amount of liquid, preferably at the same time. Reception of tablets does not depend on meal. The effect does not occur instantly. It is recommended to accept Simidon uno within at least 6 weeks. The recommended course Simidona duration uno, however, should not exceed several months 6 months without consultation of the doctor. Side effects are given Below side effects which were observed against the background of Simidon's use uno in the course of clinical trials and during supervision of the market. From the immune system: puffiness of the face and body (frequency of emergence is unknown). From digestive tract: in rare instances there can be discomfort in a stomach, nausea, dyspepsia and diarrhea. From a gepatobiliarny system: in some cases there are confirmations partly of serious damage of a liver (for example, abnormal indicators of function of a liver, jaundice, hepatitis). From integuments: rash, an itching, urticaria (frequency of emergence is unknown). From a reproductive system and mammary glands: it was in some cases reported about: - tension and puffiness of a breast smearing and breakthrough bleedings, - resuming of regular periods. Simidon's contraindications should not be accepted in a case uno: - hypersensitivity to any of components or plants of family of a crowfoot family (Ranunculaceae) or any of excipients, - lactose intolerances, deficiency of lactase, glyukozo-galaktozny malabsorption. Medicinal interactions it is not established. Special instructions the Patients having in the anamnesis of a disease of a liver should take Simidon uno with caution (see the section Side effects). Patients have to stop taking the drugs of a tsimitsifuga and to consult immediately with the doctor, at emergence of the signs and symptoms indicating injury of a liver (fatigue, loss of appetite, yellowing of skin and eyes or severe pains in an upper part of a stomach with nausea and vomiting or darkening of urine). Drugs of a tsimitsifuga should not be used together with estrogen if only their reception is not intended by the doctor. Patients who passed or undergo cancer therapy of a mammary gland or other hormonedependent tumors tsimitsifug without medical consultation should not take the drugs. Please, watch the section Preclinical Data. In case of the emergence of tension and puffiness of a breast smearing and breakthrough bleedings and also resuming of regular periods or an ukhudshayeniye of symptoms during use of periods the consultation of the doctor is necessary. Use for elderly people there Are no data on features of use for elderly people. Use during pregnancy or feeding by a breast Use of the drugs containing a tsimitsifuga (Cimicifuga racemosa) is shown to women during a climacteric. Use during pregnancy and in the period of a lactation is not provided. Safety at pregnancy and feeding by a breast is not established. In the absence of sufficient data use during pregnancy and a lactation is not recommended. Women with a breeding potential should consider the possibility of use of effective methods of contraception during treatment. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms the Corresponding researches were not conducted. Overdose About cases of overdose it was not reported. A form of release and packing On 30 tablets in blister strip packaging from aluminum foil from the inside with thermovarnish and a thermoforming film of PVH/PVDH. On 1 or 3 blister strip packagings together with the instruction for medical use in the Kazakh and Russian languages place in a cardboard pack. To Store storage conditions at a temperature not higher than 25 wasps in original packing. To store out of children's reach! 3 years not to apply a period of storage after an expiration date. Prescription status Without prescription of Proizvoditel Max Tseller Zyone AG, Zeeblikstrasse 4, 8590 Romanskhorn, Switzerland (Max Zeller Söhne AG, Seeblickstrasse 4, 8590 Romanshorn, Switzerland) the Holder of the registration certificate of Amaksa Pharm LTD, 72 Hammersmit Road, London, W14 8TH, Great Britain (Amaxa Pharma LTD, 72 Hammersmith Road, London, W14 8TH, United Kingdom) the Address of the organization, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine of AEM Services LLP, 050040, Republic of Kazakhstan, Almaty, Al-Farabi Ave., 75A, office 102-103 Ph.: +7 707 798 83 99, e-mail:
aemservices@mail.ru