Tusavit Cough syrup x250 g Montavit

TUSAVIT syrup 250 g MONTAVIT
PACKAGE LEAFLET: INFORMATION FOR THE USER
Tussavit 7.53 g / 7.53 g / 100 g syrup Tussavit 7.53 g / 7.53 g / 100 g syrup
Active ingredients: -7.53 g Thyme, liquid extract of stems (1:1); Extractant: purified water: e 96% (v/v): glycerol 85% (18:6:1) -7.53 g Plantain, liquid extract of leaves (1:1) Extractant: ethanol 36% (v/v)
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.
If you need any further information or advice, ask your pharmacist. If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If you do not feel well after 5 days or your condition worsens, you should seek medical attention.

What this leaflet contains:
1. What Tusavit syrup is and what it is used for2. What you need to know before you take Tycat3. How to take Tusavit syrup4. Possible side effects5. How to store Tusavit syrup6. Contents of the pack and other information
1. What Tusavit syrup is and what it is used for
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.
If you do not feel better after 5 days or your condition worsens, you should seek medical attention.
2. What you need to know before you take Tusavit syrup
Do not take Tusavit syrup if you are allergic to thyme, other plants of the Lamiaceae family, plantain leaves or any of the other ingredients of this medicine (listed in section 6).
Warning and precautions Use in children under 2 years of age is not recommended due to the alcohol content. In cases of shortness of breath, fever or purulent sputum, a doctor should be consulted.
Other medicines and Tusavit syrup
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions with other drugs have been noted so far.
Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Due to insufficient data on use during pregnancy and breastfeeding, use is not recommended.
Driving and using machines No studies on the ability to drive and use machines have been conducted. Tusavit syrup contains ethanol and sucrose
This medicinal product contains 5.3 % (v/v) ethanol (alcohol), i.e. up to 420 mg per dose, equivalent to 20 ml beer per dose for adults, or up to 210 mg per dose, equivalent to 10 ml beer per dose for children. It is harmful for people suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and risk groups such as patients with liver disease or epilepsy.
This medicinal product contains up to 11.58 g sucrose per dose (Adults and children over 12 years of age), up to 5.79 g sucrose per dose (children 4 to 12 years of age) or 2.90 g sucrose per dose (children 2 to 4 years of age).
This should be taken into account in patients with diabetes mellitus.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
3. How to take Tusavit syrup
Always take Tusavit syrup exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Adults and children over 12 years of age should take 2 x 10 ml Tusavit syrup with a measuring cup up to 6 times daily.
Children between 4 and 12 years old should take 10 ml of Tusavit syrup 3-5 times daily.
Children from 2 to 4 years old should take 5 ml of Tusavit syrup 3-5 times a day.
How to use: Tusavit syrup should be taken between meals. Tusavit syrup should be taken undiluted or diluted (e.g. with tea or water). The longer you keep it in the mouth, the more effective Tusavit syrup will be. Use in children under 2 years of age is not recommended.
Duration of use:
If symptoms worsen or persist for more than 5 days, a doctor should be consulted.
If you take more Tusavit syrup than you should: Overdoses with Tusavit syrup are not known to date.
Excessive use may cause local redness of the mucous membrane and gastrointestinal disturbances.
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 the missed 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, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions (including one case of anaphylactic shock and one case of angioedema) and gastrointestinal disorders have been observed. The frequency cannot be estimated.
Reporting of side effects If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: Bulgarian Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, Tel.: 35 928903417, Website: www.bda.bg.
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store Tusavit syrup
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Store below 30°C.
Keep the bottle tightly closed in the carton in order to protect from light.
Shelf life after first opening the package: 6 months.
6. Contents of the pack and other information
What does Tusavit syrup contain? 100 g of syrup contain: - 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 extract of leaves (1:1); Extractant: ethanol 36% (v/v) - The other ingredients are: sucrose, ethanol 96%, caramel, glycerol, sodium benzoate (E 211), purified water.
What does Tusavit syrup look like and what the package contains? Syrup – a clear, dark brown liquid with a sweet, aromatic taste.
Primary packaging: dark glass bottles type Ш (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 ManufacturerPharmaceutische Fabrik Montavit, AustriaTelephone: + 43 5223 57926 0Fax: + 43 5223 57926 11e-mail: [email protected] Authorisation Number: 20060745
Date of last revision of this leaflet: November 2016