Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Echinacea
A.Vogel UK Ltd
n/a
Echinacea
Oral tablet
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: ; GTIN: 7610313304561 7610313303557
i Information Patient Information Leaflet _Please turn over..._ Important things you need to know This product is used to relieve the symptoms of cold and flu. Don't take this product if you are allergic to any of the ingredients: see section 6. Before you take this product: read section 2. Dosage instructions: see section 3. Talk to your doctor if your symptoms worsen or do not improve within 10 days. Side effects can rarely occur when using this product: see section 4. Now read the rest of this leaflet carefully. Keep this leaflet. You may need to read it again. 1. What this product is for Echinaforce Chewable is a traditional herbal medicinal product used to relieve the symptoms of: Cold Flu This is based on traditional use only. 3. How to take this product Adults, the elderly and children over 12 years: Chew 2 tablets two to three times daily. Not for use in children under 12. Start taking this product at the first signs of a cold. For oral use only. Do not take more than the recommended dose. Do not take this product for a cold or flu for more than 10 days. If you take too much If you take too much and feel ill, talk to your doctor. Taking too much is unlikely to be harmful. If you forget to take this product Don't worry about the missed dose. Take the next dose as usual. 2. Before you take this product Do not take this product If you are allergic to Echinacea_ _or plants of_ _ the daisy (Asteraceae/ Compositae) family. Echinacea is a member of the daisy family. 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. If you are pregnant or breast- feeding. If you are having treatment to reduce the response of your immune system (immunosuppression) e.g. chemotherapy, radiotherapy. If you are taking ciclosporin or methotrexate, or any other immunosuppressant medicine. If you have had an organ or bone marrow transplant. Do's & Don'ts If you suffer from TB (the infection tuberculosis) Sarcoidosis (a connective tissue d Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Echinaforce Forte Cold & Flu Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 1,140 mg of extract (as dry extract) from fresh _Echinacea _ _purpurea _(L.) Moench herb (1:12) and 60 mg of extract (as dry extract) from fresh _Echinacea purpurea_ (L.) Moench root (1:11). Extraction solvent: Ethanol 65% v/v Excipients: One tablet contains 683.4 mg lactose monohydrate and 7.5 mg of soya polysaccharide. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Greenish, round-shaped, bi-convex, bevelled tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product used to relieve the symptoms of the common cold and influenza type infections based on traditional use only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration Adults, elderly and children over 12 years: 1 tablet two to three times daily This tablet formulation is not intended for children below 12 years. Start at first signs of common cold. Do not use the product for more than 10 days. If symptoms worsen during the use of the product or persist for more than 10 days, a doctor or qualified healthcare practitioner should be consulted. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to plants of the Asteraceae (Compositae) family. Because of its immunostimulating activity, Echinacea must not be used in cases of progressive systemic disorders (tuberculosis, sarcoidosis), autoimmune diseases (e.g.: collagenoses, multiple sclerosis), immunodeficiences (e.g.:HIV infection; AIDS), immunosuppression (e.g.: oncological cytostatic therapy; history of organ or bone marrow transplant), diseases of the white blood cell system (e.g.: agranulocytosis, leukemias) and allergic diathesis (e.g.: urticaria, atopic dermatitis, asthma). This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not tak Read the complete document