Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
GINKGO BILOBA EXTRACT
Pharma Nord ApS
GINKGO BILOBA EXTRACT
.
Film-coated tablet
Product not subject to medical prescription
Authorised
2018-03-16
B. PACKAGE LEAFLET PACKAGE LEAFLET : INFORMATION FOR THE USER GINKGO-BILOBA PHARMA NORD® FILM-COATED TABLETS _GINKGO DRY EXTRACT_ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS TRADITIONAL HERBAL MEDICINE 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 2 weeks. WHAT IS IN THIS LEAFLET 1. What Ginkgo-Biloba Pharma Nord is and what it is used for 2. What you need to know before you take Ginkgo-Biloba Pharma Nord 3. How to take Ginkgo-Biloba Pharma Nord 4. Possible side effects 5. How to store Ginkgo-Biloba Pharma Nord 6. Contents of the pack and other information 1. WHAT GINKGO-BILOBA PHARMA NORD IS AND WHAT IT IS USED FOR Ginkgo-Biloba Pharma Nord is a traditional herbal medicine containing an extract obtained from leaves of the _Ginkgo biloba_ tree. It is used to relieve the symptoms of poor blood flow in conditions such as cold hands and feet. This is exclusively based on long-standing use. Prior to use, other serious conditions should have been ruled out by a medical doctor. Ginkgo-Biloba Pharma Nord is for use in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GINKGO-BILOBA PHARMA NORD DO NOT TAKE GINKGO-BILOBA PHARMA NORD • If you are allergic (hypersensitive) to Ginkgo biloba or any of the other ingredients in this product (listed in section 6). • If you are pregnant, may become pregnant or if you are breastfeeding WARNINGS AND PRECAUTIONS Before taking this product • Check with your doctor that your symptoms are not caused by any serious underlying condition. • Talk to your doctor or pharmacist if you have a cond Pročitajte cijeli dokument
Health Products Regulatory Authority 09 September 2022 CRN00CZQV Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ginkgo-Biloba Pharma Nord film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of extract (as dry extract, refined) from _Ginkgo biloba _L., folium (Ginkgo leaf) (35-67:1), corresponding to: 22.0-27.0 mg of flavonoids expressed as flavone glycosides 2.8-3.4 mg of ginkgolides A, B and C 2.6-3.2 mg of bilobalide. First extraction solvent: acetone 60 % w/w For full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet (tablet). White, round (12 mm diameter), biconvex film coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product used to alleviate the symptoms of poor blood flow in conditions such as cold hands and feet. This is exclusively based on long-standing use. Prior to use, other serious conditions should have been ruled out by a medical doctor. This product is indicated for use in adults and older people. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults: _One tablet to be taken twice daily, after food. Tablets should be swallowed whole with a glass of water_. _ _Elderly: _No adjustment of dose is required for the treatment of elderly patients. _Children and Adolescents:_ This product is not indicated or recommended for use in children or adolescents less than 18 years old (see section 4.4). Duration of use If symptoms worsen or persist for more than 2 weeks, a qualified healthcare professional (e.g. a doctor or a pharmacist) should be consulted. Health Products Regulatory Authority 09 September 2022 CRN00CZQV Page 2 of 5 Method of administration For oral use only. 4.3 CONTRAINDICATIONS Hypersensitivity to Ginkgo preparations or to any of the excipients listed in section 6.1 Pregnancy and Lactation (see section 4.6 ‘Fertility, pregnancy and lactation’). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The use in children and adolescents under 18 years Pročitajte cijeli dokument