Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
TINCTURE FROM FRESH ECHINACEA PURPUREA (L.) MOENCH HERB (1:12-13) EXTRACTION SOLVENT: ETHANOL 57.3%M/M, TINCTURE FROM FRESH ECHINACEA PURPUREA (L.) MOENCH ROOT (1:11-12). EXTRACTION SOLVENT: ETHANOL 57.3%M/M
Bioforce (UK) Ltd
L03A
TINCTURE FROM FRESH ECHINACEA PURPUREA (L.) MOENCH HERB (1:12-13) EXTRACTION SOLVENT: ETHANOL 57.3%M/M, TINCTURE FROM FRESH ECHI
Unknown
Oral Drops Solution
Product not subject to medical prescription
Immunostimulating agents
Authorised
2013-07-19
Bioforce UK Echinaforce drops GB – Irvine, Ayrshire CTD Module 1 April 2018 ___________________________________________________________________________________ PACKAGE LEAFLET Page 1 of 5 Echinaforce (4) Art. no. 01311600 PACKAGE LEAFLET: INFORMATION FOR THE USER ECHINAFORCE Cold & Flu oral drops Echinacea purpurea herb & root tinctures 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 10 days. WHAT IS IN THIS LEAFLET: 1. What Echinaforce is and what it is used for 2. What you need to know before you take Echinaforce 3. How to take Echinaforce 4. Possible side effects 5. How to store Echinaforce 6. Contents of the pack and other information 1. WHAT ECHINAFORCE IS AND WHAT IT IS USED FOR Echinaforce is a traditional herbal medicinal product containing the extracts of fresh _Echinacea purpurea_ herb and root. It is used to relieve: • Common cold symptoms • Flu-like symptoms This is exclusively based on long-standing use. Echinaforce is for use in adults and adolescents over 12 years of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ECHINAFORCE DO NOT TAKE ECHINAFORCE • If you are under 12 years of age. • If you are ALLERGIC to o Echinacea or plants of the daisy (Asteraceae/Compositae) family. Echinacea is a member of the daisy family. Bioforce UK Echinaforce drops GB – Irvine, Ayrshire CTD Module 1 April 2018 ___________________________________________________________________________________ PACKAGE LEAFLET Page 2 of 5 Echinaforce (4) Art. no. 01311600 o Any of the ot Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Echinaforce Cold and Flu Oral Drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 20 drops (one dose) is equivalent to 0.714 ml. 0.714 ml [ approx. 0.646 g] of oral drops contains: 614 mg of tincture from fresh_ Echinacea purpurea_ (L.) Moench herb (purple coneflower herb) (1:12-13) Extraction solvent: Ethanol 65% v/v and 32 mg of tincture from fresh_ Echinacea purpurea_ (L.) Moench root (purple coneflower root) (1:11-12) Extraction solvent: Ethanol 65% v/v Excipients with known effect: One dose (20 drops) contains approx 0.464 ml (366 mg) of ethanol (alcohol). For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oral drops Clear, olive-green coloured liquid 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product used to relieve common cold and flu-like symptoms, exclusively based on long- standing use. This product is indicated for use in adults and adolescents over 12 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults, older people and adolescents over 12 years: 20 drops in a little water two to five times daily. Start at first signs of common cold. If symptoms persist, worsen or do not improve after 10 days use of this product, a qualified healthcare professional e.g. a doctor or pharmacist should be consulted. The use in children below 12 years of age is not recommended (see 4.4 Special warnings and precautions for use). METHOD OF ADMINISTRATION For oral short-term use only. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active substance, to plants of the Asteraceae (Compositae) family or to any of the excipients listed in section 6.1. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Lestu allt skjalið