TUSAVIT cough syrup x 125 g

TUSSAVIT
Description: Herbal medicinal product for relieving cough in: - catarrh of the respiratory system; - colds, infections and inflammations of the mucous membrane of the oral cavity and pharynx.
Usage: Always take Tusavit exactly as described in the dosage leaflet, user information or as your doctor has told you. If you are not sure about anything, ask your doctor or pharmacist. Adults and children over 12 years should take 2 x 10 ml Tusavit syrup with a measuring cup up to 6 times a day. Children between 4 and 12 years should take 10 ml Tusavit syrup 3-5 times a day. Children from 2 to 4 years should take 5 ml Tusavit syrup 3-5 times a day. Use in children under 2 years is not recommended. Method of administration: Tusavit syrup should be taken between meals. Tusavit syrup should be taken undiluted or diluted (e.g. with tea or water). With longer retention in the mouth, the effect of Tusavit syrup increases. Duration of use: If symptoms worsen or last more than 5 days, a doctor should be consulted. TUSSAVIT / TUSSAVIT composition: 100 g contains: 7.53 g Thyme, liquid extract of stems (1:1); Extractant: purified water: ethanol 96% (v/v): glycerol 85% (18:6:1)7.53 g Plantain lanceolate, liquid leaf extract (1:1) Extractant: ethanol 36% (v/v). Other ingredients are: sucrose, alcohol, caramel, glycerol, sodium benzoate (E211), purified water. PACKAGE LEAFLET INFORMATION FOR THE USER Tussavit 7.53 g / 7.53 g/ 100 g syrup Tussavit 7.53 g/7.53 g/100g syrup Active substances: -7.53 g thyme, liquid extract of stems (1:1); Extractant: purified water: ethanol 96% (v/v): glycerol (18:6:1) -7.53 g Plantain lanceolate, liquid leaf extract (1:1) Extractant: ethanol 36% (v/v) Read all of this leaflet carefully because it contains important information for you This medicine is available without a prescription. However, to get the best results from your treatment with Tusavit syrup, you should carefully follow the instructions for use of the medicinal product. Keep this leaflet. You may need to read it again If you have any further questions or need advice, ask your pharmacist. You should seek medical advice if your symptoms worsen or do not improve after 5 days. If any of the side effects become serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Tusavit syrup is and what it is used for 2. Before you take Tusavit syrup 3. How to take Tusavit syrup 4. Possible side effects 5. How to store Tusavit syrup 6. Additional information 1. WHAT TUSAVIT SYRUP IS AND WHAT IT IS USED FOR Herbal medicinal product to relieve cough in: – catarrh of the respiratory system, – colds, infections and inflammations of the mucous membrane of the oral cavity and pharynx 2. BEFORE YOU TAKE TUSAVIT SYRUP Do not take Tusavit syrup – if you are allergic (hypersensitive) to thyme, other plants of the La niaceae family, plantain leaves or any of the excipients of Tusavit syrup. Take special care when using Tusavit syrup Use in children under 2 years of age is not recommended due to alcohol content. In cases of shortness of breath, fever or purulent sputum, a doctor should be consulted. Taking Tusavit syrup with other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. No interactions with other medicines have been observed so far. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Because there is insufficient data on use during pregnancy and breast-feeding, use is not recommended. Driving and using machines No studies have been conducted on the ability to drive and use machines. Important information about some of the ingredients of Tusavit syrup This medicinal product contains 5.3 % (v/v) ethanol (alcohol), i.e. up to 420 mg in one dose equivalent to 20 ml of beer per dose for an adult, or up to 210 mg in one dose equivalent to 10 ml of beer per dose for children. It is harmful for people suffering from alcoholism. The alcohol content should be taken into account in pregnant or breastfeeding women, depots and risk groups such as patients with liver disease or epilepsy. This medicinal product contains up to 11.58 g of sucrose per dose (Adults and children over 12 years), up to 5.79 g of sucrose per dose (children 4 to 12 years) or 2.90 g of sucrose per dose (children 2 to 4 years). Please consult your doctor before taking Tusavit syrup if you know that you have an intolerance to some sugars. 3. HOW TO TAKE TUSAVIT SYRUP Always take Tusavit syrup exactly as described in the dosage instructions in the leaflet, information for the user or as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Adults and children over 12 years should take 2x10 ml of Tusavit syrup with a measuring cup up to 6 times a day. Children between 4 and 12 years old should take 10 ml of Tusavit syrup 3-5 times a day. Children from 2 to 4 years old should take 5 ml of Tusavit syrup 3-5 times a day. Use in children under 2 years old is not recommended. Method of administration: Tusavit syrup should be taken between meals. Tusavit syrup should be taken undiluted or diluted (e.g. with tea or water). With longer retention in the mouth, the effect of Tusavit syrup increases. Duration of use: If symptoms worsen or last more than 5 days, a doctor should be consulted. If you have taken more than the required dose of Tusavit syrup Overdose with Tusavit syrup is not known to date. Excessive use may cause local redness of the mucous membrane and gastrointestinal disorders. Note: Due to the alcohol content in Tusavit syrup, the possibility of alcohol intoxication should be considered, especially in children. If you have any doubts, please ask your doctor or pharmacist or the nearest hospital. If you forget to take Tusavit syrup Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, please ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Tusavit syrup can cause side effects, although not everybody gets them. If any of the side effects gets serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist. Hypersensitivity reactions (including one case of anaphylactic shock and one case of Quincke's oedema) and stomach upset have been observed. The frequency cannot be determined. 5. HOW TO STORE TUSAVIT SYRUP Keep out of the reach of children. Do not use the medicinal product after the expiry date stated on the label. The expiry date corresponds to the last day of the month stated. Store below 30°C. Keep the bottle tightly closed in the outer carton in order to protect from light. Shelf life after first opening the package: 6 months. 6. ADDITIONAL INFORMATION What Tusavit syrup contains 100 g of syrup contain: -7.53 g thyme, liquid extract of stem (1:1); Extractant: purified water: ethanol 96% (v/v): glycerol 58 % (18:6:1) -7.53 g Plantain lanceolate, liquid extract of leaves (1:1); Extractant: ethanol 36% (v/v) Other ingredients are: Sucrose, alcohol, caramel, glycerol, sodium benzoate (E211), purified water What Tusavit syrup looks like and what the package contains Syrup – Clear, dark brown liquid with a sweet, aromatic taste. Primary packaging: dark glass bottles type III (100 ml, 200 ml) or brown plastic bottles made of PET (100 ml, 200 ml) for 125 g or 250 g of syrup. Each bottle is labeled and placed in a cardboard box, accompanied by a leaflet (information for the user) and a suitable PP measuring cup (2.5-20 ml) for accurate dosing. MARKETING AUTHORISATION HOLDER AND MANUFACTURER Pharmaceutische Fabrik Montavit Ges.mbH, Salzbergstrasse 96, A-6060 Absam / Tirol, Austria Telephone: +43 5223 57926 0 Fax: + 43 5223 57926 11 e-mail: [email protected] Marketing authorisation number: 20060745