Država: Malta
Jezik: engleski
Izvor: Medicines Authority
DRY EXTRACT, OF AGNUS, CASTUS FRUIT
Florealis ehf. Síðumúla 25, 108 Reykjavík, Iceland
G02CX03
DRY EXTRACT OF AGNUS CASTUS FRUIT 4 mg
FILM-COATED TABLET
DRY EXTRACT OF AGNUS CASTUS FRUIT 4 mg
OTC
OTHER GYNECOLOGICALS
Withdrawn
2018-11-07
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FEMONIA FILM-COATED TABLETS Agnus castus fruit extract TRADITIONAL HERBAL MEDICINAL PRODUCT READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 3 months. WHAT IS IN THIS LEAFLET 1. What Femonia is and what it is used for 2. What you need to know before you take Femonia 3. How to take Femonia 4. Possible side effects 5. How to store Femonia 6. Contents of the pack and other information 1. WHAT FEMONIA IS AND WHAT IT IS USED FOR Femonia is a traditional herbal medicinal product for the relief of minor symptoms in the days before menstruation (premenstrual syndrome). The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMONIA DO NOT TAKE THIS MEDICINE: - If you are allergic to agnus castus or to any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before you take Femonia if: you have a history of oestrogen-sensitive cancer or pituitary disorder. you are using dopamine agonists (e.g. levodopa or bromocriptine used for Parkinson´s disease), dopamine antagonists (some medicines used for schizophrenia, bipolar disorders, nausea and vomiting), oestrogens (e.g. used for hormone replacement therapy) and antioestrogens (e.g. fulvestrant, tamoxifen and toremifene used for breast cancer). you have had prolactin secreting tumours of the pituitary gland. If t Pročitajte cijeli dokument
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Femonia, film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: 4 mg of extract (as dry extract) from _Vitex agnus-castus_ L., fructus (agnus castus), equivalent to 28-52 mg of dried agnus castus fruit. Extraction solvent: ethanol 68% (V/V) Excipients with known effect: One film-coated tablet contains lactose monohydrate, corresponding to 118 mg anhydrous lactose and 36 mg of liquid glucose, spray dried. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Salmon pink, round, convex curved 9.1 mm tablets and with a score mark on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Traditional herbal medicinal product for the relief of minor symptoms in the days before menstruation (premenstrual syndrome). The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ One tablet daily continuously for 3 months or longer. _Paediatric population _ The use of Femonia in children and adolescents under 18 years of age is not recommended (see section 4.4). Method of administration Oral use. Page 2 of 5 Duration of use If the symptoms persist after a continued use over three months, a doctor or a qualified health care practitioner should be consulted. 4.3 CONTRAINDICATIONS Hypersensitivity to agnus castus fruit or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients who suffer or suffered from an oestrogen-sensitive cancer should consult their doctor before using _Vitex agnus-castus_ . Patients who are using dopamine agonists, dopamine antagonists, oestrogens and antioestrogens should consult their doctor before using _Vitex agnus-castus_ (see section 4.5). If the symptoms Pročitajte cijeli dokument