Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
TINCTURE FROM AGNUS CASTUS FRUITS
Bioforce (UK) Ltd
TINCTURE FROM AGNUS CASTUS FRUITS
Oral Drops Solution
Product not subject to medical prescription
Authorised
2014-12-12
Read all of this leaflet carefully before you start taking this product because it contains important information for you. Always take this product exactly as described in this leaflet or as your doctor, pharmacist or nurse 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, pharmacist or nurse. 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 Agnus castus is and what it is used for 2. What you need to know before you take Agnus castus 3. How to take Agnus castus 4. Possible side effects 5. How to store Agnus castus 6. Contents of the pack and other information Information Package Leaflet: Information for the user _Please turn over..._ Do's and Don'ts for taking Agnus castus Agnus castus oral drops Agnus castus tincture 31454IN1 1. What Agnus castus is and what it is used for Agnus castus is a traditional herbal medicinal product containing the extract of Agnus castus fruit. It is used to relieve the minor symptoms of premenstrual syndrome. This is exclusively based on long-standing use. Agnus castus is for use in women over 18 years of age. Premenstrual syndrome (PMS) consists of the symptoms that can occur in the two weeks before a monthly period. It is also known as premenstrual tension (PMT). Symptoms can be both physical and emotional and can include irritability, mood swings, breast tenderness, bloating and menstrual cramps. 2. What you need to know before you take Agnus castus Do not take Agnus castus If you are allergic to any of the ingredients of this product (listed in section 6). If you have a pituitary disorder. If you are pregnant, trying to become pregnant or bre Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Agnus castus oral drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (15-20 drops) contains 407 – 542 mg of tincture from Agnus castus fruits (_Vitex agnus-castus _L.) (1:10). Extraction solvent: ethanol 69.5% v/v. 1 ml of oral drops contains 895 mg of tincture (equivalent to 33 drops). Excipients with known effect: Each dose (15 -20 drops) contains approximately 252 – 336 mg of ethanol (alcohol). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral drops, solution. Clear, yellow-brown liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product for the relief of minor symptoms of premenstrual syndrome, exclusively based upon long-standing use. This product is indicated for use in women over 18 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Women experiencing minor premenstrual symptoms: Take 15-20 drops in a little water twice daily. As treatment effects may not be apparent immediately, the product may need to be taken up to 3 months continuously. The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). DURATION OF USE If symptoms worsen during use or do not improve after a continued use over 3 months, a qualified healthcare professional e.g. a doctor or pharmacist should be consulted. METHOD OF ADMINISTRATION For oral use only. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to Agnus castus fruit or to any of the excipients listed in section 6.1. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 12/12/2014_ _CR Διαβάστε το πλήρες έγγραφο