Država: Armenija
Jezik: angleščina
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
agnus castus dry extract
Bionorica SE
G02CX
agnus castus dry extract
4mg
tablets film-coated
(30/2x15/) in blister
Prescription
Registered
2018-01-10
PATIENT LEAFLET INFORMATION CYCLODYNON ® Film-Coated Tablets ACTIVE SUBSTANCE: Dry extract from chaste tree fruits (agni casti fructus) COMPOSITION: 1 film-coated tablet contains 4.0 mg (7-11:1) of dry extract from chaste tree fruits as active substance. Extractant: 70% ethyl alcohol (v/v). OTHER INGREDIENTS: Povidone, colloidal anhydride of silicum dioxide, potato starch, microcrystalline cellulose, lactose monohydrate, macrogol, magnesium stearate, talc, E 171, E 172, E 132, poly (ethyl acrylate, methyl acrylate) trimethylamine-acetyl-methacrylate-chloride 1 : 2 : 0.2, molecular weight - 150 000. INDICATIONS: Cyclodynon ® film-coated tablets constitute the phytogenous therapeutic agent, which is used for complex therapy (see interactions with other medicinal products and other forms of interactions), in the cases as follows: - menstrual cycle disturbances - premenstrual syndrome - cyclic mastodynia (cyclic breast pain) In cases of tension and tumescence in the area of mammary glands as well as with menstrual disturbances, medical advice should be sought, to investigate whether there are other diseases that need additional medical research. CYCLODYNON ® SHOULD NOT BE USED: In case of hypersensitivity to the active substance or to any of the excipients of the medicinal product. PRECAUTIONS: A) PREGNANCY: There is no indication for the use during pregnancy. Cyclodynon ® film-coated tablets must not be taken during pregnancy. B) LACTATION: Data from reproductive studies suggest that extracts of chaste tree fruit may affect lactation. Cyclodynon ® film-coated tablets must not be taken during lactation. C) EFFECTS ON THE ABILITY TO DRIVE A VEHICLE AND OPERATE MACHINERY: No studies on the effect on the ability to drive and use machines have been performed. SPECIFIC INSTRUCTIONS: Patients who suffer or suffered from an oestrogen-sensitive cancer should consult their doctor before using this medicinal product. Patients who are using dopamine agonists, dopamine antagonists, oestrogens and antioestrogens should consu Preberite celoten dokument
Cyclodynon Film-Coated Tablets (096AGF) SPC Cycldoynon Film-coated tablets Page: 1 of 6 April 2016 SUMMARY OF PRODUCT CHARACTERISTICS CYCLODYNON FILM-COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Cyclodynon ® Film-Coated Tablets Active substance: Dry extract derived from chaste tree fruit ( agni casti fructus) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains: 4.0 mg dry extract derived from chaste tree fruit (7-11:1); extracting agent: ethanol 70 % (V/V) Excipients: Lactose monohydrate 25.0 mg For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet The film-coated tablets are greenish blue, round, biconvex with dull surface. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cyclodynon® film-coated tablets constitute the phytogenous therapeutic agent, which is used for complex therapy (see interactions with other medicinal products and other forms of interactions), in the cases as follows: Cyclodynon Film-Coated Tablets (096AGF) SPC Cycldoynon Film-coated tablets Page: 2 of 6 April 2016 menstrual cycle disturbances premenstrual syndrome cyclic mastodynia (cyclic breast pain) In cases of tension and tumescence in the area of mammary glands as well as with menstrual disturbances, medical advice should be sought, to investigate whether there are other diseases that need additional medical research. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Take 1 times daily 1 film-coated tablet. To achieve an optimal treatment effect, continued use – even during menstruation over three months is recommended. If the symptoms persist after a continued use over three months, a doctor or a qualified health care practitioner should be consulted. The use in children and adolescents under 18 years of age is not rcommended (see section 4.4 “Special warnings and precautions for use!). Swallow film-coated tablets with sufficient liquid (e.g. a glass of water). Do not chew tablets. 4.3 CONTRAINDICATIONS Cyclodynon Film-Coated Tablets must not be taken in case of hy Preberite celoten dokument