देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
AGNUS CASTUS EXTRACT (AS DRY ROOT) FROM AGNUS CASTUS FRUIT (VITEX AGNUS-CASTUS L)
Holland & Barrett International Limited
AGNUS CASTUS EXTRACT (AS DRY ROOT) FROM AGNUS CASTUS FRUIT (VITEX AGNUS-CASTUS L)
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Tablet
Product not subject to medical prescription
Authorised
2014-05-30
P A C K A G E L E A F L E T : I N F O R M A T I O N F O R T H E P A T I E N T More information on back panel IMPORTANT NOTES PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS TRADITIONAL HERBAL MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU • Always take this traditional herbal 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 a healthcare professional eg a doctor or a pharmacist if you need more information or advice • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet • You must talk to a doctor if you feel worse or you do not feel better after 10 days of taking this traditional herbal medicine WHAT IS IN THIS LEAFLET 1 What this traditional herbal medicine is and what it is used for 2 What you need to know before you take this traditional herbal medicine 3 How to take this traditional herbal medicine 4 Possible side effects 5 How to store this traditional herbal medicine 6 Contents of the pack and other information 1 - WHAT THIS TRADITIONAL HERBAL MEDICINE IS AND WHAT IT IS USED FOR Nature’s Bounty Echinacea Cold and Flu Hard Capsules is a traditional herbal medicinal product used to relieve common cold and flu-like symptoms in adults and adolescents over 12 years. This is exclusively based upon long-standing use. 2 - WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS TRADITIONAL HERBAL MEDICINE DO NOT TAKE THIS TRADITIONAL HERBAL MEDICINE IF YOU: • Are allergic to Echinacea or traditional herbal medicines from the same plant family (Asteracaea/Compositae) such as daisies, marigolds or artichokes, or to any of the other ingredients in this traditional herbal medicine (listed in section 6 of this leaflet) • Suffer from Sarcoidosis (a connective tissue disorder which causes the formation of clumps of cells, mainly in the lymph nodes, lungs and liver) • Are having treatment that reduces your natural response to पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 05 March 2020 CRN009MP9 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nature’s Bounty Agnus Castus PMS Relief Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 3.9 mg of extract (as dry extract) from Agnus Castus fruit (_Vitex agnus castus _L.) equivalent to 23.4 – 31.2 mg of Agnus Castus fruit. Extraction solvent: Ethanol 75%v/v. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Clear film coated, speckled brown round-shaped tablet, plain on both sides. 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral short-term use only. ADULTS WOMEN EXPERIENCING MINOR PREMENSTRUAL SYMPTOMS: Take 1 tablet daily. Swallow the whole tablet with water. The tablet should be taken at the same time of the day (morning or evening). Do not exceed the stated dose DURATION OF USE: If symptoms worsen during the use of this product or do not improve after a continued use over three months, a qualified Healthcare Professional e.g. a doctor or pharmacist should be consulted. Not for use in children under 18 years (see section 4.4 Special warning and precautions for use). 4.3 CONTRAINDICATIONS Hypersensitivity to Agnus Castus or any of the excipients Pregnancy and lactation (see section 4.6) Current pituitary disorder 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients who suffer or who have suffered from an oestrogen-sensitive cancer should consult their doctor before using Vitex agnus-castus In cases of prolactin secreting tumours of the pituitary gland, the intake of agnus-castus, can mask symptoms of the tumor. Health Products Regulatory Authority 05 March 2020 CRN009MP9 Page 2 of 4 Agnus Castus is thought to act on the pituitary-hypothalamic axis and therefore patients with a history of a p पूरा दस्तावेज़ पढ़ें