Hedussin Expectorant Syrup for children and adults 100 ml

Hedussin Expectorant Syrup for children and adults 100 ml

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Description

Hedussin Expectorant Syrup for children and adults 100 ml

Key features of the product
medicine does not contain ethanol and sugar, expectorant syrup for children and adults, contains dry extract of ivy leaves
Description
Hedussin, 33 mg/4 ml, syrup
Each ml of syrup contains 8.25 mg of dry extract of ivy leaves (Hedera helix L., folium)
(4-8:1). Extraction solvent: ethanol 30% (m/m).

Hedussin is a medicinal, herbal product used as an expectorant for productive (wet) cough.

OTC - Medicinal product dispensed without a prescription.
Storage and use.
Recommended dosage:
Adults and adolescents 12 years of age and older:
- 6 ml of syrup twice daily;
Children aged 6 to 11 years:
- 4 ml of syrup twice daily;
Children aged 2 to 5 years:
- 2 ml of syrup twice daily.

Shake the bottle vigorously before each use.

Oral administration.
Read the leaflet before using the drug.
Storage: Store at ambient temperature.
Dimensions: Height: 118 mm. Width: 65 mm. Depth: 57 mm.
Packaging: Box
Composition
Each ml of syrup contains 8.25 mg of dry extract of ivy leaves (Hedera helix L., folium) (4-8:1), Extraction solvent: ethanol 30% (m/m), Other ingredients: Contains sorbitol (E420)
Manufacturer
Phytopharm Klęka S.A.
Manufacturer's address
Responsible entity:
Phytopharm Klęka S.A.
Klęka 1,
63-040 Nowe Miasto nad Wartą
Poland
Tel: +48 61 28 68 700
Fax: +48 61 28 68 709
Safety warning
Keep out of sight and reach of children. Do not give to children under 2 years of age due to the risk of worsening respiratory symptoms. Do not use during pregnancy or lactation.
Lower age limit
Recommended: 2 years/years/years
General information
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.
Table of contents of the leaflet
Table of contents of the leaflet
1 What is Hedussin drug and for what purpose it is used.
2. important information before taking Hedussin drug
3. how to take Hedussin drug
4 Possible side effects
5. how to store drug Hedussin
6. package contents and other information
Description and use
1. what is the drug Hedussin and for what purpose it is used
Hedussin is a herbal medicinal product used as an expectorant for productive (wet) cough.
The active substance of the drug is dry extract of ivy leaves.
Hedussin is intended for adults, adolescents and children over 2 years of age.

If, after 7 days, there is no improvement or the patient feels worse, consult a doctor.

2 Important information before taking Hedussin
When not to take Hedussin drug:
if the patient is allergic to dry ivy leaf extract, to other plants of the Araliaceae family (the botanical family to which ivy belongs) or any of the other ingredients of this drug (listed in section 6), in children under 2 years of age due to the risk of worsening respiratory symptoms.

Warnings and precautions
Discuss with your doctor or pharmacist before taking Hedussin.

Consult your doctor or pharmacist if you experience shortness of breath, fever or purulent sputum.
Caution is advised in patients with stomach problems such as heartburn, burning, abdominal pain, nausea or stomach ulcers.
If the first signs of a severe allergic reaction occur, discontinue use of this drug immediately and contact your doctor (see section 4).

Children
Children aged 2 to 4 years with persistent or recurrent cough require a medical diagnosis before starting treatment.

Hedussin 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.

The effect of Hedussin on the effect of other drugs has not been reported. Interaction studies with other drugs have not been conducted.

Use of Hedussin with food, drink and alcohol.
No data available.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a child, you should consult your doctor or pharmacist before taking this drug.

Safety during pregnancy and lactation 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.

Hedussin drug contains sorbitol
Sorbitol is a source of fructose. If you (or your child) have been previously diagnosed with intolerance to certain sugars or have been previously diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should contact your doctor before taking the drug or giving it to your child.
Sorbitol can cause gastrointestinal discomfort and a mild laxative effect in children.

3 How to take Hedussin medicine
This drug should always be taken exactly as described in the leaflet for patients, or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Recommended dose:
Adults and adolescents aged 12 years and over: 6 ml of syrup twice daily;
Children aged 6 to 11 years: 4 ml of syrup twice daily;
Children aged 2 to 5 years: 2 ml of syrup twice daily.

Use in children
Children aged 2 to 4 years with persistent or recurrent cough require a medical diagnosis before treatment.
Do not use in children under 2 years of age (see section "When not to take Hedussin").

Route of administration
Oral administration.

Use the provided graduated measuring spoon of 2 ml and 4 ml.
It is recommended to administer a dose of 6 ml using a measuring spoon (4 ml) and half a spoon (2 ml).

Shake the bottle vigorously before each use.

Duration of use
If there is no improvement after 7 days or the patient feels worse, consult a doctor.

Taking more than the recommended dose of Hedussin drug.
Ingestion of a higher dose than recommended can cause nausea, vomiting, diarrhea and agitation. Treatment is symptomatic.

Omission of Hedussin drug intake
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.
Undesirable effects are divided into the following groups according to their frequency of occurrence:

Very common
may occur in more than 1 in 10 people

Frequently
may affect up to 1 in 10 people

Uncommon
may affect up to 1 in 100 people

Rarely
may affect up to 1 in 1,000 persons

Very rarely
May occur in up to 1 in 10,000 persons

Unknown frequency
cannot be determined based on available data

Side effects that may occur during treatment with Hedussin:

Common:
- Nausea, vomiting, diarrhea.

Uncommon:
- Allergic reactions (urticaria, skin rash, anaphylactic reaction , shortness of breath).

At the first signs of a severe allergic reaction, discontinue use of this drug immediately and contact your doctor.
If you experience other side effects not listed above, consult your doctor or pharmacist.

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,
Jerozolimskie Avenue 181 C, 02-222 Warsaw,
tel. (22) 49 21 301, fax (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions 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 Hedussin
Store out of sight and reach of children.
After the first opening of the syrup, do not store at a temperature above 25 ° C.
Do not use this drug after the expiration date on the package. The expiration date means the last day of the given month. Use the product within 3 months from the first opening of the bottle.
Medicines should not be disposed of in the sewage system or household waste containers. Ask your pharmacist what to do with medicines that are no longer needed. Doing so will help protect the environment.

6 Contents of the package and other information
What the drug Hedussin contains
- The active substance of the drug is a dry extract of ivy leaves. Each ml of the product contains 8.25 mg of dry extract of ivy leaves (Hedera helix L., folium) (4-8:1). Extractor: ethanol 30% m/m.
- Other ingredients: liquid sorbitol (non-crystallizing) (E420), potassium sorbate (E202), xanthan gum (E415), citric acid anhydrous (E330), purified water.

What the drug Hedussin looks like and what the package contains
Hedussin drug is a brown, opalescent liquid with a sweet taste, with a possible small precipitate.

The syrup is filled into brown glass bottles with white plastic (polyethylene) caps. The bottles are then packaged in cardboard boxes along with a measuring spoon (with 2 ml and 4 ml graduations).
Package size: 100 ml of syrup in one bottle.

Responsible entity and manufacturer
Phytopharm Klęka S.A.
Klęka 1, 63 - 040 Nowe Miasto nad Wartą
Poland
Tel: + 48 61 28 68 700
Fax: + 48 61 28 68 709

This medicinal product is authorized in the EEA member states under the following names:
Austria: Hedussin Sirup
Poland: Hedussin
Romania: Hedussin 8.25 mg/ml sirop
Norway: Hedexin
Sweden: Hedexin
How to use the drug
3 How to take Hedussin medicine
This drug should always be taken exactly as described in the leaflet for patients, or as prescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Recommended dose:
Adults and adolescents aged 12 years and over: 6 ml of syrup twice daily;
Children aged 6 to 11 years: 4 ml of syrup twice daily;
Children aged 2 to 5 years: 2 ml of syrup twice daily.

Use in children
Children aged 2 to 4 years with persistent or recurrent cough require a medical diagnosis before treatment.
Do not use in children under 2 years of age (see section "When not to take Hedussin").

Route of administration
Oral administration.

Use the provided graduated measuring spoon of 2 ml and 4 ml.
It is recommended to administer a dose of 6 ml using a measuring spoon (4 ml) and half a spoon (2 ml).

Shake the bottle vigorously before each use.

Duration of use
If there is no improvement after 7 days or the patient feels worse, consult a doctor.

Taking more than the recommended dose of Hedussin drug.
Ingestion of a higher dose than recommended can cause nausea, vomiting, diarrhea and agitation. Treatment is symptomatic.

Omission of Hedussin drug intake
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.
How to store the drug
5 How to store the drug Hedussin
Store out of sight and reach of children.
After the first opening of the syrup, do not store at a temperature above 25 ° C.
Do not use this drug after the expiration date on the package. The expiration date means the last day of the given month. Use the product within 3 months from the first opening of the bottle.
Medicines should not be disposed of in the sewage system or household waste containers. Ask your pharmacist what to do with medicines that are no longer needed. Doing so will help protect the environment.
Possible side effects
4 Possible side effects
Like any drug, this medicine may cause side effects, although they will not occur in everyone.
Undesirable effects are divided into the following groups according to their frequency of occurrence:

Very common
may occur in more than 1 in 10 people

Frequently
may affect up to 1 in 10 people

Uncommon
may affect up to 1 in 100 people

Rarely
may affect up to 1 in 1,000 persons

Very rarely
May occur in up to 1 in 10,000 persons

Unknown frequency
cannot be determined based on available data

Side effects that may occur during treatment with Hedussin:

Common:
- Nausea, vomiting, diarrhea.

Uncommon:
- Allergic reactions (urticaria, skin rash, anaphylactic reaction , shortness of breath).

At the first signs of a severe allergic reaction, discontinue use of this drug immediately and contact your doctor.
If you experience other side effects not listed above, consult your doctor or pharmacist.

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,
Jerozolimskie Avenue 181 C, 02-222 Warsaw,
tel. (22) 49 21 301, fax (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the responsible party.
By reporting side effects, more information on the safety of the drug can be gathered.
Package contents and other information
6 Package contents and other information
What the drug Hedussin contains
- The active substance of the drug is dry extract of ivy leaves. Each ml of the product contains 8.25 mg of dry extract of ivy leaves (Hedera helix L., folium) (4-8:1). Extractor: ethanol 30% m/m.
- Other ingredients: liquid sorbitol (non-crystallizing) (E420), potassium sorbate (E202), xanthan gum (E415), citric acid anhydrous (E330), purified water.

What the drug Hedussin looks like and what the package contains
Hedussin drug is a brown, opalescent liquid with a sweet taste, with a possible small precipitate.

The syrup is filled into brown glass bottles with white plastic (polyethylene) caps. The bottles are then packaged in cardboard boxes along with a measuring spoon (with 2 ml and 4 ml graduations).
Package size: 100 ml of syrup in one bottle.

Responsible entity and manufacturer
Phytopharm Klęka S.A.
Klęka 1, 63 - 040 Nowe Miasto nad Wartą
Poland
Tel: + 48 61 28 68 700
Fax: + 48 61 28 68 709

This medicinal product is authorized in the EEA member states under the following names:
Austria: Hedussin Sirup
Poland: Hedussin
Romania: Hedussin 8.25 mg/ml sirop
Norway: Hedexin
Sweden: Hedexin
Important before use
2 Important information before taking Hedussin
When not to take Hedussin drug:
if you are allergic to dry ivy leaf extract, to other plants of the Araliaceae family (the botanical family to which ivy belongs) or to any of the other ingredients of this drug (listed in section 6), in children under 2 years of age due to the risk of worsening respiratory symptoms.

Warnings and precautions
Discuss with your doctor or pharmacist before taking Hedussin.

Consult your doctor or pharmacist if you experience shortness of breath, fever or purulent sputum.
Caution is advised in patients with stomach problems such as heartburn, burning, abdominal pain, nausea or stomach ulcers.
If the first signs of a severe allergic reaction occur, discontinue use of this drug immediately and contact your doctor (see section 4).

Children
Children aged 2 to 4 years with persistent or recurrent cough require a medical diagnosis before starting treatment.

Hedussin drug and other medications
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as medications you plan to take.

The effect of Hedussin on the effect of other drugs has not been reported. Interaction studies with other drugs have not been conducted.

Use of Hedussin with food, drink and alcohol.
No data available.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a child, you should consult your doctor or pharmacist before taking this drug.

Safety during pregnancy and lactation 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.

Hedussin drug contains sorbitol
Sorbitol is a source of fructose. If you (or your child) have previously been diagnosed with intolerance to certain sugars, or you have previously been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should contact your doctor before taking the drug or giving it to your child

Product Details

15 Items

Specific References

EAN13
5909991235383

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