País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
IVY LEAF DRY EXTRACT (HEDERA HELIX L.) (4-6:1) EXTRACTION SOLVENT: ETHANOL 30% V/V
Laboratoires ARKOPHARMA
R05
IVY LEAF DRY EXTRACT (HEDERA HELIX L.) (4-6:1) EXTRACTION SOLVENT: ETHANOL 30% V/V
Syrup
Product not subject to medical prescription
Cough and cold preparations
Authorised
2014-01-10
1/5 PACKAGE LEAFLET 2/5 PACKAGE LEAFLET: INFORMATION FOR THE USER ARKOVOX SYRUP _Ivy leaf dry extract _ CARAMEL FLAVOUR 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. It 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 fell worse after 1 week. WHAT IS IN THIS LEAFLET 1. What ARKOVOX Syrup is and what it is used for 2. What you need to know before you take ARKOVOX Syrup 3. How to take ARKOVOX Syrup 4. Possible side effects 5. How to store ARKOVOX Syrup 6. Contents of the pack and other information 1. WHAT ARKOVOX SYRUP IS AND WHAT IT IS USED FOR ARKOVOX Syrup is an herbal medicinal product used as an expectorant in case of productive cough._ _ 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARKOVOX SYRUP DO NOT TAKE ARKOVOX SYRUP : - If you are allergic to ivy leaf, to plants of the Araliaceae family or to any of the other ingredients of ARKOVOX Syrup (listed in section 6). DO NOT GIVE ARKOVOX SYRUP: - To your children below 4 years of age because of the risk of aggravation of the respiratory symptoms. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using ARKOVOX Syrup if: you have gastritis (inflammation of lining of the stomach) or gastric ulcer (stomach ulce Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arkovox syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ivy leaf dry extract (DER 4-6:1), extraction solvent ethanol 30% (v/v) Each 5 ml of syrup contains 50 mg of an Ivy Leaf (_Hedera helix _L.) dry extract (DER 4-6:1), extraction solvent ethanol 30% (v/v) Excipients: Sucrose (1.7 mg/5 ml syrup) Sodium methyl parahydroxybenzoate (3 mg/ 5 ml syrup) Sodium propyl parahydroxybenzoate (1.5 mg/5 ml syrup) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Syrup Brown syrup 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Herbal medicinal product used as an expectorant in case of productive cough. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY In adolescents, adults and elderly, 1 measuring spoon (5 ml) 2 times daily, morning and evening (corresponding to a single dose of 50 mg dry extract and a daily dose of 100 mg dry extract); In children between 6-12 years of age, half a measuring spoon (2.5 ml) 2 times daily, morning and evening (corresponding to a single dose of 25 mg dry extract and a daily dose of 50 mg dry extract); In children between 4-5 years of age, a quarter of a measuring spoon (1.25 ml) 2 times daily, morning and evening (corresponding to a single dose of 12.5 mg dry extract and a daily dose of 25 mg dry extract). _Paediatric population_ The use in children under the age of 4 is contraindicated (see section 4.3 “Contraindications”). DURATION OF USE If the symptoms persist longer than 1 week during the use of ARKOVOX Syrup, a doctor or a pharmacist should be consulted. METHOD OF ADMINISTRATION Oral use. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/03/2014_ _CRN Leia o documento completo