البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
DRY EXTRACT FROM CIMICIFUGAE RHIZOMA (BLACK COHOSH)
RAFA LABORATORIES LTD
G02CX04
TABLETS
DRY EXTRACT FROM CIMICIFUGAE RHIZOMA (BLACK COHOSH) 13 MG
PER OS
Required
MAX ZELLER SOHNE AG, SWITZERLAND
CIMICIFUGAE RHIZOMA
Alleviation of menopausal complaints (hot flashes, excessive perspiration, sleep disorders, nervousness and depressive moods).
2020-02-13
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold with a doctor's prescription only CIMIDONA FORTE 13 MG Tablets ACTIVE INGREDIENT: Each tablet of Cimidona Forte 13 mg contains: Dry extract from cimicifugae rhizoma (black cohosh) 13 mg For a list of other ingredients see section 6. See also 'Important information about some of the medicine's ingredients' in section 2. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed for treatment for you. Do not pass it on to others. It may harm them, even if you think their medical condition is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended to relieve menopausal symptoms (hot flashes, excessive perspiration, sleep disorders, nervousness and depressive moods). THERAPEUTIC GROUP: Gynecological drugs 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active substance, plants of the buttercup family (ranunculaceae) or any of the other ingredients that the medicine contains (for a list of the other ingredients, see section 6). • If you suffer or suffered in the past from liver disorder. SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: • Discontinue use of the medicine and seek medical attention immediately if you develop symptoms that may indicate liver injury (abnormal fatigue, lack of appetite, weight loss, yellow coloration of the skin and/or eyes, severe epigastric pain accompanied by nausea and vomiting, diarrhea or dark urine). • LIVER FUNCTIONS MONITORING WILL BE PERFORMED IN ACCORDANCE WITH THE INSTRUCTIONS OF THE ATTENDING DOCTOR. See also “Tests and monitoring” and “Side effects”. BEFORE STARTING TREATMENT WITH THE MEDICINE, TELL YOUR DOCTOR IF: • You have any other medical conditions or any allergy. • CONSULT YOUR DOCTOR IF you experien اقرأ الوثيقة كاملة
1 NAME OF THE PRODUCT Cimidona 6.5 mg Cimidona Forte 13 mg Tablet. COMPOSITION _Active substance_ : Cimidona 6.5 mg: Dry extract from cimicifugae rhizoma (black cohosh) 6.5 mg Cimidona Forte 13 mg: Dry extract from cimicifugae rhizoma (black cohosh) 13 mg THERAPEUTIC INDICATIONS: Alleviation of menopausal complaints (hot flashes, excessive perspiration, sleep disorders, nervousness and depressive moods). DOSAGE: 1 tablet to be taken once daily, unchewed, with some fluid, preferably always at the same time of the day (in the morning or in the evening). The intake of the tablets does not depend on meals. The effect does not set in immediately. Intake of Cimidona is recommended for a period of at least 6 weeks. It is recommended to take Cimidona over several months; however, it should not be used for more than 6 months without medical advice. CONTRAINDICATIONS: - Hypersensitivity to the active substance, to Ranunculaceae (buttercup plants) or to any of the excipients - Cimidona is contraindicated for patients with a current or previous liver disorder. SPECIAL WARNINGS AND PRECAUTIONS: - This preparation has an effect on physical and psychological complaints during the menopause. Since there is no clinical data so far with regard to a positive effect on bones, this preparation cannot be used for the prevention of osteoporosis. - In prospective clinical trials involving more than 1200 patients, black cohosh was not associated with serum enzyme elevations during treatment and no cases of 2 clinically apparent liver injury were reported. However, Products labeled as black cohosh have been linked to more than fifty instances of clinically apparent liver injury that have ranged in severity from symptomatic elevations in serum enzymes without jaundice, to acute self-limited hepatitis, prolonged hepatitis with cholestasis, autoimmune hepatitis, and acute liver failure requiring liver transplantation or with a fatal outcome. The latency to onset of liver injury ranged from 1 to 48 weeks, but was usually within 2 to 12 weeks. اقرأ الوثيقة كاملة