Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Echinacea root extract (as dry root) from echinacea root (echinacea purpurea l)
Holland & Barrett International Limited
Echinacea root extract (as dry root) from echinacea root (echinacea purpurea l)
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Capsule, hard
Product not subject to medical prescription
Authorised
2014-01-17
PACKAGE LEAFLET: Information for the Patient ECHINACEA COLD AND FLU HARD CAPSULES _ECHINACEA PURPUREA_ ROOT EXTRACT IMPORTANT NOTES WHAT IS IN THIS LEAFLET 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 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 Holland & Barrett 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. 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 infection (eg chemotherapy or radiotherapy) ◆ Suffer from autoimmune conditions such as inflammation of the connective tissue (collagenosis) or multiple sclerosis ◆ Suffer from conditions which decrease your resistance to infection (eg HIV or Read the complete document
Health Products Regulatory Authority 03 May 2019 CRN008LSX Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Holland & Barrett Echinacea Cold and Flu Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 140mg of extract (as dry extract) from _Echinacea purpurea_ root (equivalent to 838 mg –1117 mg of _Echinacea purpurea_ (L.) Moench (purple coneflower), root). Extraction solvent: Ethanol 75% v/v. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard Capsule (Capsules) Two piece clear hard capsules with grey/brown fill. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product used to relieve common cold and flu-like symptoms in adults and adolescents over 12 years, exclusively based upon long-standing use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral short-term use only. _ADULTS, OLDER PEOPLE AND ADOLESCENTS OVER 12 YEARS:_ Take one capsule 2 times daily. Swallow the whole capsule with water. Start at the first sign of a common cold. Do not exceed the stated dose. DURATION OF USE: Do not use this product for more than 10 days. The use in children below 12 years of age is not recommended (see 4.4 Special warnings and precautions for use). If symptoms worsen or persist for more than 10 days, or if new symptoms develop, or if high fever occurs whilst taking this product, a doctor or pharmacist should be consulted. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to _Echinacea purpurea_ root, to plants of the Asteraceae (Compositae) family or to any of the excipients listed in section 6.1. Because of their immune-modulatory activity, Echinacea extracts must not be used in cases of progressive systemic disorders (Tuberculosis sarcoidosis), autoimmune diseases (e.g. collagenosis, multiple sclerosis), immunodeficiencies (e.g. HIV infection, AIDS), immunosuppression (e.g. oncological cytostatic therapy, history of organ or bone marrow transplant) and diseases of the white blood cell sy Read the complete document