Страна: Мальта
мова: англійська
Джерело: Malta Medicines Authority
HEDERA HELIX
Engelhard Arzneimittel GmbH & Co. KG Herzbergstrasse 3 61138 Niederdorfelden, Germany
R05CA
HEDERA HELIX 35 mg/5ml
ORAL LIQUID
HEDERA HELIX 35 mg/5ml
OTC
COUGH AND COLD PREPARATIONS
Authorised
2013-09-25
Cough Syrup PACKAGE LEAFLET: INFORMATION FOR THE USER PROSPAN ® COUGH SYRUP - STICK PACK _Active substance:_ Ivy leaves dry extract READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU STILL NEED TO USE PROSPAN ® COUGH SYRUP AS DIRECTED TO GET THE BEST RESULTS FROM IT. 1. WHAT PROSPAN ® COUGH SYRUP IS AND WHAT IT IS USED FOR PROSPAN ® COUGH SYRUP IS A HERBAL MEDICINE USED TO TREAT CATARRHAL DISEASES OF THE RESPIRATORY TRACT, BY ITS SECRETOLYTIC, BRONCHO-SPASMOLYTIC AND COUGH- RELIEVING EFFECTS. PROSPAN ® COUGH SYRUP IS USED to improve symptoms of chronic-inflammatory bron- chial diseases; acute inflammations of the respiratory tract accompanied by coughing. NOTE: In the event of persistent complaints or the appearance of shortness of breath, fever as well as purulent or bloody expectoration, a doctor should be consulted immediately. 2. BEFORE YOU TAKE PROSPAN ® COUGH SYRUP DO NOT TAKE PROSPAN ® COUGH SYRUP if you are hypersensitive (allergic) to the active substance or any of the other ingre- dients of Prospan ® Cough Syrup (see section 6). TAKE SPECIAL CARE WITH PROSPAN ® COUGH SYRUP: CHILDREN: Prospan ® Cough Syrup should be used in children under the age of one only after having consulted a doctor. Compared with older children, this age group should be monitored very carefully when being given Prospan ® Cough Syrup, as particular attention must be paid to possible diarrhoea and vomiting. Please also read the notes contained in the section “Side effects”. TAKING PROSPAN ® COUGH SYRUP TOGETHER WITH OTHER MEDICINES: Please tell your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without prescription. No interactions have become known so far. However, no studies have been carried out. PREGNANCY AND BREAST-FEEDING: Medicines should generally be taken during pregnancy and breast-feeding only after having previously consulted a d Прочитайте повний документ
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Prospan® Cough Syrup in stick packs Oral Liquid 2. QUALITATIVE AND QUANTITATIVE COMPOSITION (ACTIVE INGREDIENTS) 5ml liquid (1 stick pack) contain 35 mg of ivy leaves extract [5-7.5 : 1]. 100 ml solution contains 0.7g of ivy leaf dry extract [5-7.5 : 1]. [Extractive agent: ethanol 30% w/w] Excipients see under point 6.1. 3. PHARMACEUTICAL FORM Oral Liquid 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To improve complaints of chronic-inflammatory bronchial diseases; acute inflammations of the respiratory tract accompanied by coughing. Note: In the event of persistent complaints or the appearance of shortness of breath, fever as well as purulent or bloody expectoration, a doctor should be consulted immediately. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Children under the age of 6 years take 2.5 ml solution 2 times daily (corresponding to 35 mg of ivy leaves dry extract), children aged 6 to 12 years take 5 ml solution 2 times daily (corresponding to 70 mg of ivy leaves dry extract), children from the age of 12 years and adults take 5 ml solution 3 times daily (corresponding to 105 mg of ivy leaves dry extract). Take the syrup with the enclosed measuring cup. SHAKE THE BOTTLE WELL BEFORE EVERY USE ! The syrup should be taken in the morning, (at lunchtime) and in the evening. Cough Syrup in stick packs Adults and adolescents from 12 years onwards take the solution of 1 stick (5ml) 3 times daily corresponding to 105 mg of ivy leaves dry extract and children aged 6-11 years take the solution of 1 stick pack (5ml) 2 times daily corresponding to 70 mg of ivy leaves dry extract. Knead the stick pack lightly before using! Take the liquid undiluted in the morning, (at lunchtime) and in the evening. Pg. 1 Page 2 of 4 Duration of treatment depends on the type and severity of the symptoms, but it should last forat least one week, even in the case of minor inflammations of the respiratory tract. To ensure success of therapy, treatment should b Прочитайте повний документ