Држава: Израел
Језик: Енглески
Извор: Ministry of Health
DRY EXTRACT FROM CIMICIFUGA RACEMOSA (L.) NUTT, RHIZOMA (BLACK COHOSH) (5-10:1) EXTRACTION SOLVENT: ETHANOL 58% (V/V)
DR.SAMUELOV IMPORTING & MARKETING LTD
G02CX04
FILM COATED TABLETS
DRY EXTRACT FROM CIMICIFUGA RACEMOSA (L.) NUTT, RHIZOMA (BLACK COHOSH) (5-10:1) EXTRACTION SOLVENT: ETHANOL 58% (V/V) 2.8 MG
PER OS
Required
BIONORICA SE, GERMANY
CIMICIFUGAE RHIZOMA
Herbal medicinal product indicated in female adults for the relief of menopausal complaints such as hot flushes and profuse sweating
2020-07-20
Page 1 of 6 _ _ 1. NAME OF THE MEDICINAL PRODUCT Menopret ® Film-coated tablet_ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains 2.8 mg dry extract from Cimicifuga rhizoma (Black cohosh) (5-10:1) Extraction solvent: ethanol 58 % (V/V) Excipients with known effect: Lactose monohydrate 17.2 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets The film-coated tablets are terracotta-coloured, round, biconvex with smooth surface. The film-coated tablet has a diameter of 7.0-7.2 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Herbal medicinal product indicated in female adults for the relief of menopausal complaints such as hot flushes and profuse sweating. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: _Female adults in the menopause _ Daily dose: 2 times daily (morning and evening) 1 film-coated tablet. If the symptoms persist during the use of the medicinal product, a doctor or a pharmacist should be consulted. Menopret ® Film-coated tablets should not be taken for more than 6 months without medical advice. Paediatric population There is no relevant use of Menopret ® Film-coated tablets in the paediatric population. Special populations No data are available for a dosing instruction in case of impaired renal function. In the package leaflet patients with a history of liver disorder are informed not to take Menopret ® Film-coated tablets without medical advice (see section 4.4 ‘Special warnings and precautions for use’ and 4.8 ‘Undesirable effects’). Page 2 of 6 Method of administration: For oral use. Take film-coated tablets with some liquid. Do not chew or suck. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Menopret ® Film-coated tablets is contraindicated for patients with a current or previous liver disorder. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In prospective clinical trials involving more than 1200 patients, black cohosh was not associated wit Прочитајте комплетан документ