Fiordatussi Sirup 200 ml

Adolescents over 12 years of age, adults and the elderly:
10 ml of syrup 3 to 4. times a day.

Children aged 5 - 11 years:
10 ml of syrup 3 times a day.

Children aged 3 - 4 years:
5 ml of syrup 3 times a day.

Read the leaflet before using the drug. Oral administration. Shake the bottle before use.
Storage: Store at ambient temperature.
Dimensions: Height: 135 mm. Width: 70 mm. Depth: 70 mm.

Each ml of syrup (equivalent to 1.2 g) contains 30 mg of extract (as a dry extract) of Plantago lanceolata L., folium (lanceolate leaf) (3-5:1), extraction solvent: ethanol 20% (m/m), Contains: liquid maltitol (E 965), For further information, please refer to the leaflet.

Phytopharm Klęka S.A.

Phytopharm Klęka S.A.
Klęka 1
63-040 Nowe Miasto nad Warta,
Poland
Tel: +48 61 28 68 000
Fax: +48 61 28 68 529
info@europlant-group.pl

Keep the drug out of sight. and out of reach of children.

Recommended: 3 years/years/years

Read the leaflet carefully before taking this medication, as it contains important information for the patient.
Always take this medication exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
- If there is no improvement after 7 days or if the patient feels worse, contact your doctor.
- If symptoms persist while taking the medicinal product, or if you experience side effects not listed in the leaflet, consult your doctor or pharmacist.

Table of contents of the leaflet
1 What is Fiordatussi drug and what is it used for?
2. important information before taking Fiordatussi drug
3. how to take Fiordatussi drug
4 Possible side effects
5. how to store the drug Fiordatussi
6. package contents and other information

1 What is the drug Fiordatussi and for what purpose it is used.
Fiordatussi Syrup is a herbal medicinal product in the form of a syrup, which contains in its composition a dry extract of the leaves of plantain.
Syrup Fiordatussi is a traditional herbal medicinal product used to relieve the symptoms of irritation of the mouth or throat and the associated dry cough.
Traditional herbal medicinal product for use for specific indications, which are based solely on long-term use.
Fiordatussi Syrup is intended for use in adults, adolescents and children over 3 years of age.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.
2 Important information before taking Fiordatussi
When not to take Fiordatussi drug:
- if the patient is allergic to the active substance, plantain (Plantago lanceolata L.), or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
If symptoms worsen during the use of the drug, the patient develops shortness of breath, fever or purulent sputum (yellowish phlegm), consult a doctor.
Children
The use of Fiordatussi in children under 3 years of age is not recommended due to the occurrence of complaints requiring medical advice and due to the lack of adequate data.
Fiordatussi drug and other drugs
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as medications you plan to take.
No interactions with other drugs have been observed.
Fiordatussi with food, drink and alcohol
Food does not affect the intake of the drug.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a baby, you should consult your doctor or pharmacist before taking this drug.
The safety of use during pregnancy and breastfeeding has not been established. Due to insufficient data, use during pregnancy and lactation is not recommended.
Driving and operating machinery
No studies have been conducted on the effects on the ability to drive and operate machinery.
Fiordatussi drug contains liquid maltitol
The drug may have a mild laxative effect. Caloric value: 2.3 kcal/g of liquid maltitol.
If you have a history of intolerance to certain sugars, you should contact your doctor or pharmacist before taking the drug.
3 How to take Fiordatussi drug.
Always take this drug exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Recommended dose:
Adolescents over 12 years of age, adults and the elderly:
10 ml of syrup 3 to 4 times a day.
Children aged 5 to 11 years:
10 ml of syrup 3 times a day.
Children aged 3 to 4 years:
5 ml of syrup 3 times a day.
Method of administration
Oral administration.
For proper dosage of the drug, use the included measuring cup, using the appropriate graduations of 5 and 10 ml.
Shake the bottle before use.
Duration of use
If symptoms persist for more than 7 days while using the drug product, consult a doctor or pharmacist.
Children
Fiordatussi is not recommended for use in children under 3 years of age due to symptoms that may require medical advice and lack of adequate data.
Taking more than the recommended dose of Fiordatussi medicine
So far, no symptoms of drug overdose have been reported.
Omission of taking the drug Fiordatussi
Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this drug, ask your doctor or pharmacist.
4 Possible side effects
Like any drug, this medication may cause side effects, although they will not occur in everyone. So far, they are not known. If you experience adverse reactions, consult your doctor.
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: + 48 22 49 21 301,
fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the responsible party.
By reporting side effects, it will be possible to gather more information on the safety of the drug.
5 How to store the drug Fiordatussi
Store the drug out of sight and reach of children.
During storage, sediment may appear, it does not affect the quality of the product.
After first opening, store at a temperature below 25 ° C.
Do not use this drug after the expiration date on the box. Expiration date means the last day of the stated month.
Expiration date after the first opening of the bottle - 3 months.
Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Such treatment will help protect the environment.
6 Contents of the package and other information
What the drug Fiordatussi contains
- The active substance of the drug is dry extract of the leaves of plantain. Each ml of syrup contains 30 mg of dry extract of plantain leaf (Plantago lanceolata L., folium) (DER 3-5:1), extraction solvent: ethanol 20% (m/m).
- Other ingredients are: maltodextrin, liquid maltitol (E 965), xanthan gum (E 415), potassium sorbate (E 202), citric acid (E 330), purified water
What Fiordatussi drug looks like and what the package contains
The syrup is a brown liquid with a characteristic odor, packaged in 100 ml or 200 ml bottles. The bottles are packaged in cardboard boxes together with a patient information leaflet and a measuring cup.
Pack size 100 ml: the measuring cup shows three different scales, including a corresponding graduation of 1, 5, 10, 15 and 20 ml.
Package size 200 ml: the measuring cup shows a scale with graduations of 2.5, 5, 10, 15 and 20 ml.
Responsible entity and manufacturer
Phytopharm Klęka S.A.
Klęka 1
63-040 Nowe Miasto nad Warta
Poland
Tel: + 48 61 28 68 700
Fax: + 48 61 28 68 709
info@europlant-group.pl
This medicinal product is authorized in the member countries of the European Economic Area under the following names:
Austria: Fiordatussi Sirup
Romania: Fiordatussi 30 mg/ml sirop

3 How to take the drug Fiordatussi
Always take this drug exactly as described in this leaflet or as recommended by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Recommended dose:
Adolescents over 12 years of age, adults and the elderly:
10 ml of syrup 3 to 4 times a day.
Children aged 5 to 11 years:
10 ml of syrup 3 times a day.
Children aged 3 to 4 years:
5 ml of syrup 3 times a day.
Method of administration
Oral administration.
For proper dosage of the drug, use the included measuring cup, using the appropriate graduations of 5 and 10 ml.
Shake the bottle before use.
Duration of use
If symptoms persist for more than 7 days while using the drug product, consult a doctor or pharmacist.
Children
Fiordatussi is not recommended for use in children under 3 years of age due to symptoms that may require medical advice and lack of adequate data.
Taking more than the recommended dose of Fiordatussi medicine
So far, no symptoms of drug overdose have been reported.
Omission of taking the drug Fiordatussi
Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this drug, ask your doctor or pharmacist.

5 How to store the drug Fiordatussi
Store the drug out of sight and reach of children.
During storage, sediment may appear, it does not affect the quality of the product.
After first opening, store at a temperature below 25°C.
Do not use this drug after the expiration date on the box. Expiration date means the last day of the stated month.
Expiration date after the first opening of the bottle - 3 months.
Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Such treatment will help protect the environment.

4 Possible side effects
Like any drug, this medication may cause side effects, although they will not occur in everyone. So far, they are not known. If you experience adverse reactions, consult your doctor.
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: + 48 22 49 21 301,
fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the responsible party.
By reporting side effects, more information on the safety of the drug can be gathered.

6 Contents of the package and other information
What the drug Fiordatussi contains
- The active substance of the drug is a dry extract of the leaves of plantain. Each ml of syrup contains 30 mg of dry extract of plantain leaf (Plantago lanceolata L., folium) (DER 3-5:1), extraction solvent: ethanol 20% (m/m).
- Other ingredients are: maltodextrin, liquid maltitol (E 965), xanthan gum (E 415), potassium sorbate (E 202), citric acid (E 330), purified water
What Fiordatussi drug looks like and what the package contains
The syrup is a brown liquid with a characteristic odor, packaged in 100 ml or 200 ml bottles. The bottles are packaged in cardboard boxes together with a patient information leaflet and a measuring cup.
Pack size 100 ml: the measuring cup shows three different scales, including a corresponding graduation of 1, 5, 10, 15 and 20 ml.
Package size 200 ml: the measuring cup shows a scale with graduations of 2.5, 5, 10, 15 and 20 ml.
Responsible entity and manufacturer
Phytopharm Klęka S.A.
Klęka 1
63-040 Nowe Miasto nad Warta
Poland
Tel: + 48 61 28 68 700
Fax: + 48 61 28 68 709
info@europlant-group.pl
This medicinal product is authorized in the member countries of the European Economic Area under the following names:
Austria: Fiordatussi Sirup
Romania: Fiordatussi 30 mg/ml sirop

2 Important information before taking Fiordatussi
When not to take the drug Fiordatussi:
- if you are allergic to the active substance, plantain (Plantago lanceolata L.), or any of the other ingredients of this drug (listed in section 6).
Warnings and precautions
If symptoms worsen during the use of the drug, the patient develops shortness of breath, fever or purulent sputum (yellowish phlegm), consult a doctor.
Children
The use of Fiordatussi in children under 3 years of age is not recommended due to the occurrence of complaints requiring medical advice and due to the lack of adequate data.
Fiordatussi drug and other drugs
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as medications you plan to take.
No interactions with other drugs have been observed.
Fiordatussi with food, drink and alcohol
Food does not affect the intake of the drug.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a baby, you should consult your doctor or pharmacist before taking this drug.
The safety of use during pregnancy and breastfeeding has not been established. Due to insufficient data, use during pregnancy and lactation is not recommended.
Driving and operating machinery
No studies have been conducted on the effects on the ability to drive and operate machinery.
Fiordatussi drug contains liquid maltitol
The drug may have a mild laxative effect. Caloric value: 2.3 kcal/g of liquid maltitol.
If you have a history of intolerance to certain sugars, you should contact your doctor or pharmacist before taking the drug.