Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
EXTRACT (AS DRY EXTRACT) FROM FRESH ECHINACEA PURPUREA (L.) MOENCH HERB, EXTRACT (AS DRY EXTRACT) FROM FRESH ECHINACEA PURPUREA (L.) MOENCH ROOT
Bioforce (UK) Ltd
L03A
EXTRACT (AS DRY EXTRACT) FROM FRESH ECHINACEA PURPUREA (L.) MOENCH HERB, EXTRACT (AS DRY EXTRACT) FROM FRESH ECHINACEA PURPUREA
Tablets
Product not subject to medical prescription
Immunostimulating agents
Authorised
2012-11-05
666 Package Leaflet: Information for the user 31355IN3 09452501/20170111 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 Echinacea or plants of the daisy (Asteraceae/Compositae) family. Echinacea is a member of the daisy family. Any of the other ingredients of this product (listed in section 6). If you suffer from TB (the infection tuberculosis) Sarcoidosis (a connective tissue disease disorder which causes the formation of clumps of cells mainly in the lymph nodes, lungs and liver) An autoimmune disease such as collagenoses (inflammation of the connective tissue) or multiple sclerosis HIV, AIDS or any other condition which decreases your resistance to infection A disorder which affects your white blood cells such as agranulocytosis (low white blood cell count due to bone marrow disorders) or leukemia (blood cell cancer) If you are having treatment to reduce the response of your immune system (immunosuppression) e.g. chemotherapy, radiotherapy. If you have had an organ or bone marrow transplant. Warnings and precautions Stop taking this product and see your doctor if: You have a high temperature (fever) Your symptoms worsen or if you do not feel an improvement within 10 days If you have a tendency to allergies such as hives, allergic eczema or asthma consult your doctor before use. This product may not be suitable for you. Children Do not give this product to children under 12 years of age. Other medicines and Echinaforce Do not take this product if you are taking any medicine which affects your immune system. If you are speaking to your doctor, pharmacist or nurse always remember to Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Echinaforce Cold & Flu tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: 5.9 mg of dry extract from_ Echinacea purpurea_ (L.) Moench herb (equivalent to 100 mg – 200 mg of fresh_ Echinacea_ _purpurea_ (L.) Moench herb) (Purple coneflower herb) Extraction solvent: ethanol 65% v/v and 0.3 mg of dry extract from_ Echinacea purpurea_ (L.) Moench root (equivalent to 5.6 mg – 9.8 mg of fresh_ Echinacea_ _purpurea_ (L.) Moench root) (Purple coneflower root) Extraction solvent: ethanol 65% v/v Excipients with known effect: One tablet contains 232.55 mg of lactose monohydrate For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Tablets. Greenish, round-shaped, bi-convex, bevelled tablet 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 of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults, elderly and adolescents over 12 years: 2 tablets two to five times daily Start at first signs of common cold. The use in children below 12 years of age is not recommended (see 4.4 Special warnings and precautions for use). 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. METHOD OF ADMINISTRATION For oral short term use only. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Read the complete document