দেশ: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
HEDERA HELIX
Engelhard Arzneimittel GmbH & Co. KG Herzbergstrasse 3 61138 Niederdorfelden, Germany
R05CA
HEDERA HELIX 26 mg
LOZENGE
HEDERA HELIX 26 mg
OTC
COUGH AND COLD PREPARATIONS
Authorised
2013-09-25
Cough Lozenges PACKAGE LEAFLET: INFORMATION FOR THE USER PROSPAN ® COUGH LOZENGES _Active ingredient:_ Ivy leaves dry extract READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORT- ANT INFORMATION FOR YOU. THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU STILL NEED TO USE PROSPAN ® COUGH LOZENGES CAREFULLY TO GET THE BEST RESULTS FROM THEM. ➢• Keep this leaflet. You may need to read it again. ➢• Ask your pharmacist if you need more information or advice. ➢• You must contact a doctor if your symptoms worsen or do not improve after 7 days. ➢• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or phar- macist. IN THIS LEAFLET: 1. WHAT PROSPAN ® COUGH LOZENGES ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU TAKE PROSPAN ® COUGH LOZENGES 3. HOW TO TAKE PROSPAN ® COUGH LOZENGES 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PROSPAN ® COUGH LOZENGES 6. FURTHER INFORMATION 1. WHAT PROSPAN ® COUGH LOZENGES ARE AND WHAT THEY ARE USED FOR PROSPAN ® COUGH LOZENGES ARE A HERBAL MEDICINE USED TO TREAT CATARRHAL DISEASES OF THE RESPIRATORY TRACT. Prospan ® Cough Lozenges are used to improve complaints of chronic inflammatory bronchial diseases; common colds. 2. BEFORE YOU TAKE PROSPAN ® COUGH LOZENGES PROSPAN ® COUGH LOZENGES MUST NOT BE TAKEN IF you are hypersensitive (allergic) to the active substance or any of the other ingredients of Prospan ® Cough Lozenges. SPECIAL CARE MUST BE TAKEN WITH PROSPAN ® COUGH LOZEN- GES IN THE FOLLOWING INSTANCES: In the event of persistent complaints or the appearance of shortness of breath, fever as well as purulent or bloody expec- toration, a doctor should be consulted immediately. CHILDREN: Prospan ® Cough Lozenges are not intended for use in children below the age of 6. TAKING PROSPAN ® COUGH LOZENGES WITH OTHER MEDICINES: No research has been carried out. No interactions have become known so far. Please tell your doctor or pharmacist if you are taking / using or have re সম্পূর্ণ নথি পড়ুন
Page 1 of 4 1. NAME OF THE MEDICINAL PRODUCT Prospan ® Cough Lozenges 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 lozenge contains 26 mg of ivy leaves dry extract (5 – 7.5 : 1). Extractive agent: ethanol 30 % (m/m). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lozenges 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prospan ® Cough Lozenges are used to improve complaints of chronic inflammatory bronchial diseases; common colds. 4.2 POSOLOGY, METHOD AND DURATION OF USE Adults and children aged 12 and above suck 1 lozenge 4 times a day (equivalent to 104 mg of dried ivy leaf extract or 624 mg of drug a day). Children aged between 6 and 12 suck 1 lozenge twice a day (equivalent to 52 mg of dried ivy leaf extract or 312 mg of drug a day). Method of use For oral use, to be sucked. Allow the lozenges to dissolve in the mouth after meals (not while lying down). Duration of use The duration of the therapy is determined by the type and severity of the condition to be treated; in the case of minor inflammation of the respiratory tract, treatment should, however, last for at least 1 week. In the interests of ensuring that your recovery is permanent and complete, it is recommended that the preparation be taken for a further 2-3 days after symptoms hav subsided. 4.3 CONTRAINDICATIONS Prospan® Cough Lozenges should not be taken by patients with known allergy to the active ingredients or to any of the excipients contained in this product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Pg. 1 Page 2 of 4 The package leaflet contains the following note for patients: “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.”. Prospan® Cough Lozenges are not intended for use in children below the age of 6. Patients suffering from rare hereditary fructose intolerance should not take Prospan® Cough Lozenges. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERA সম্পূর্ণ নথি পড়ুন