Prefemin 20 mg (30 tablets)

The instruction for medical use of Prefemin Torgovoye medicine a name Prefemin Mezhdunarodnoye the unlicensed name Is not present the Dosage form of the Tablet film coated 20 mg Structure One tablet contains active agent: 20 mg of dry native extract of fruits of a summer cypress of ordinary (Agnus castus fruit) (6-12:1), extractant - ethanol of 60% (mom), excipients: microcrystalline cellulose, lactoses monohydrate, magnesium stearate, silicon dioxide colloidal anhydrous, cover: gipromelloza, titan dioxide (E171), macrogoal 400, macrogoal 20000, propylene glycol. The description of the Tablet of round shape, with a biconvex surface, film coated white color, with a fragrant smell. Pharmacotherapeutic group Other drugs for treatment of gynecologic diseases. The ATX G02CX code the Pharmacological Pharmacodynamics Basic Preclinical Pharmacological Data properties were obtained with use of etanolny or methanol extracts. The inhibiting influence on release of prolactin and dofaminergichesky (dopamine - agonistic) effects were noticed by different groups of researchers. There are opposite results concerning linking with estrogen receptors generally and selective binding with β- or α-receptors. Besides, there are data concerning β-endorfinny activity (possibly by linking with μ-opiate receptors). Researches of receptors binding with dry extract which contains in this product showed that extract has affinity to D2 - dopamine to a receptor. In the conditions of in vitro this extract inhibits linking of a 3H-spiroperidol with its website of linking in striatum of a calf with high degree of affinity. All extract showed dose-dependent inhibition of a 3H-spiroperidol _C50 in number of 52 mkg/ml. From 4 divided fractions (including water fraction of methanol extract), only the hexane fraction was active with _C50 in number of 32 mkg/ml. Directly hexane extract from fresh fruits showed even stronger influence (_C50 in number of 15 mkg/ml), assuming that the main components of a dopamine receptor of binding in fruits, the lipophilic nature. In additional experiments of in vitro the binding of dry extract of a summer cypress ordinary with dopamine D3 a receptor was investigated with use is specially radioactive a marked ligand 7-(dipropilamino)-5,6,7,8-tetrahydronaphthene-2-ol (R-(+) - 7-OH-3H-DPAT). Results for both series of dry extract showed from weak to moderate extent of binding (10 mkg/ml & lt, _C50 & lt, 100 mkg/ml) with dopamine D3 a receptor in comparison with positive control (+)-butaklamol. Clinical performance and safety of 170 women with the diagnosed premenstrual syndrome (PMS) underwent treatment both dry extract of a summer cypress ordinary, and placebo, in randomized, double blind study throughout three menstrual cycles. Women who underwent treatment by dry extract of a summer cypress ordinary had considerably reduced symptoms of PMS (irritability, differences of mood, anger, a headache, chest pains) in comparison with the group accepting placebo. ІІІ the phase of a research on selection of a dose of dry extract of a summer cypress ordinary at patients with a premenstrual syndrome included 3 doses of dry extract of a summer cypress ordinary (8, 20 or 30 mg), the effective dose was defined in comparison with placebo. Patients estimated intensity of each of 6 points: irritability, differences of mood, anger, a headache, an abdominal distension and chest pain, at the beginning and at the end of treatment. It was shown that 20 mg of dry extract of a summer cypress ordinary, accepted once a day, are effective at treatment of PMS. It is revealed that all tested doses are well tolerable and safe during the test period lasting three menstrual cycles. The conclusion was drawn that 20 mg are an optimum dose for treatment as further improvement was not reached when using a dose of 30 mg. Indications - medicine of plant origin for treatment of a premenstrual syndrome - disturbance of the menstrual cycle Route of administration and a dose the Recommended dose of the drug Prefemin makes 1 tablet a day. The tablet is intended for intake, it should not be chewed or rassasyvat, and it is necessary to swallow entirely, washing down with a glass of water. For achievement of optimum effect of treatment, it is recommended to accept without interruption not less than 3 months. The beginning of reception can occur at any moment. In case of lack of the expected therapeutic effect it is necessary to consult with the attending physician about expediency of further therapy by this means. Side effects - heavy allergic reactions with face edemas, short wind and problems of swallowing - headaches, dizzinesses - gastrointestinal disorders (for example, nausea, an abdominal pain) - skin (allergic) reactions (rash, urticaria), an acne - disturbances of periods of the Contraindication - at hypersensitivity to fruits of a summer cypress ordinary or to any of excipients - children's age up to 12 years Medicinal interactions because of ability of fruits of a summer cypress ordinary interaction between Prefemin and agonists (allergic skin reactions (rash, urticaria), an acne), antagonists of a dopamine, estrogen and anti-estrogen is possible to show dopaminergic and estrogenic effects. Special instructions At feeling of tension and swelling of mammary glands and also at disturbances of a menstrual cycle it is necessary to consult with the doctor. This medicine contains about 40 mg of the acquired carbohydrates on one dose. Pregnancy, the lactation period during pregnancy and in the period of a lactation not to take the drug. 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. The form of release and packing On 30 tablets place in blister strip packaging from PVH/PVDH and the printing aluminum foil varnished. On 1 or 3 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions at a temperature not over 25 s in original packing. To store out of children's reach! 3 years not to apply a period of storage after expiry 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 Owner 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, 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