Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Kwizda Pharma GmbH
R05X
Oral solution
OTHER COLD PREPARATIONS
Not marketed
2021-02-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BUTTERCUP BRONCHOSTOP DAY & NIGHT ORAL SOLUTION Marshmallow root dry extract Lime flower dry extract Ribwort plantain dry extract READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this 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 your 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. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 7 days. WHAT IS IN THIS LEAFLET 1. What Buttercup Bronchostop Day & Night oral solution is and what it is used for 2. What you need to know before you take Buttercup Bronchostop Day & Night oral solution 3. How to take Buttercup Bronchostop Day & Night oral solution 4. Possible side effects 5. How to store Buttercup Bronchostop Day & Night oral solution 6. Contents of the pack and other information 1. WHAT BUTTERCUP BRONCHOSTOP DAY & NIGHT ORAL SOLUTION IS AND WHAT IT IS USED FOR Buttercup Bronchostop Day & Night oral solution contains the active substances marshmallow root, lime flower and ribwort plantain extracts. Traditional herbal medicinal product used in adults and adolescents aged 12 years and older for the symptomatic treatment of throat irritation and dry cough, associated with common cold. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.. If the symptoms worsen, persist or do not improve after 7 days, a a doctor should be consulted. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUTTERCUP BRONCHOSTOP DAY & NIGHT ORAL SOLUTION _ _ DO NOT TAKE BUTTERCUP BRONCHOSTOP DAY & NIGHT ORAL SOLUTION - if you are allergic to marshmallow root, lime flower or ribwort plantain or any of the other ingredie Leggi il documento completo
Health Products Regulatory Authority 10 June 2022 CRN00CX74 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Buttercup Bronchostop Day & Night Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 15 ml (= 16.3 g) of oral solution contains: 187.5 mg of extract (as dry extract) from _Althaea officinalis _L._, _radix (Marshmallow root) (7- 9:1). Extraction solvent: water 136.4 mg of extract (as dry extract) from _Tilia cordata _Miller, _Tilia platyphyllos _Scop., _Tilia _x _europaea _L. or their mixtures, flos (Lime flower) (3-8:1). Extraction solvent: water 150.0 mg of extract (as dry extract) from _Plantago lanceolata _L., folium (Ribwort plantain leaf) (4-6:1). Extraction solvent: water Excipients with known effect: Each 15 ml of oral solution contains 2.76 g xylitol (E967), 11.3 mg methyl- parahydroxybenzoate (E 218), 6.6 mg propyl parahydroxybenzoate (E216) and strawberry flavour (containing 13.6 mg propylene-glycol and 0.0018 mg benzyl-alcohol) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. Brown opaque liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Traditional herbal medicinal product used in adults and adolescents aged 12 years and older for the symptomatic treatment of throat irritation and dry cough, associated with common cold. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Start at the first sign of the common cold (throat irritation and dry cough). Posology _Adults and adolescents aged 12 years and above:_ Using the measuring cup provided, 15 ml of oral solution should be taken as required up to four times daily (the maximum recommended dose is 60 ml in 24 hours). The last dose should be taken directly before bedtime. _Paediatric population_ Children under 12 years: The use in children under 12 years of age is not recommended. Method of administration For oral use (undiluted). Due to the p Leggi il documento completo