Hedussin o smaku ovocovim

Package Leaflet: Information for the User

Hedussin Fruit-Flavored

Hederae helicis folii extractum siccum,8.25 mg/mL, syrup

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet for the patient, or according to the doctor's or pharmacist's instructions.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 7 days or the patient feels worse, the doctor should be consulted.

Package Leaflet Contents

• 1. What is Hedussin Fruit-Flavored and what is it used for
• 2. Important information before taking Hedussin Fruit-Flavored
• 3. How to take Hedussin Fruit-Flavored
• 4. Possible side effects
• 5. How to store Hedussin Fruit-Flavored
• 6. Package contents and other information

1. What is Hedussin Fruit-Flavored and what is it used for

Hedussin Fruit-Flavored syrup contains dry extract of ivy leaves (Hedera helix L., folium) (4-8:1). Hedussin Fruit-Flavored is a herbal medicinal product used as an expectorant in productive cough (wet cough). If there is no improvement after 7 days or the patient feels worse, the doctor should be consulted.

2. Important information before taking Hedussin Fruit-Flavored

When not to take Hedussin Fruit-Flavored:

• if the patient is allergic to dry extract of ivy leaves, to other plants of the Araliaceae family (botanical family to which ivy belongs) or to any of the other ingredients of this medicine (listed in section 6),
• in children under 2 years of age due to the risk of worsening respiratory symptoms.

Package Leaflet: Information for the User

Warnings and Precautions

Before taking Hedussin Fruit-Flavored, the doctor or pharmacist should be consulted. If shortness of breath, fever, or purulent sputum occurs, the doctor or pharmacist should be consulted. Hedussin Fruit-Flavored should not be taken with cough suppressants, such as codeine or dextromethorphan, without consulting a doctor. Caution is recommended in patients with gastric mucosa inflammation (gastritis) or stomach ulcers.

Children

Children aged 2 to 4 years with persistent or recurrent cough require a medical diagnosis before starting treatment. This medicine should not be given to children under 2 years of age due to the risk of worsening respiratory symptoms (see "When not to take Hedussin Fruit-Flavored").

Hedussin Fruit-Flavored and other medicines

The doctor or pharmacist should be informed about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. No interactions of Hedussin Fruit-Flavored with other medicines have been reported. No studies on interactions with other medicines have been conducted.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult the doctor or pharmacist before taking this medicine. Due to the lack of sufficient data, the use of Hedussin Fruit-Flavored during pregnancy and breastfeeding is not recommended. Hedussin Fruit-Flavored is not recommended during pregnancy and breastfeeding due to the lack of sufficient data on the use of dry extract of ivy leaves.

Driving and Using Machines

No studies on the effect on the ability to drive and use machines have been conducted.

Hedussin Fruit-Flavored contains sorbitol

Package Leaflet: Information for the User

Hedussin Fruit-Flavored syrup contains 465 mg of sorbitol (E420) per 1 mL. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult the doctor before taking the medicine or giving it to their child.

3. How to take Hedussin Fruit-Flavored

This medicine should always be taken exactly as described in the package leaflet for the patient, or according to the doctor's or pharmacist's instructions. If there are any doubts, the doctor or pharmacist should be consulted.

Recommended dose:

Adults and adolescents over 12 years: 6 mL of syrup twice a day; Children aged 6 to 11 years: 4 mL of syrup twice a day; Children aged 2 to 5 years: 2 mL of syrup twice a day. This medicine should not be used in children under 2 years of age (see "When not to take Hedussin Fruit-Flavored").

Method of administration

Oral administration. The bottle should be shaken before use.

Duration of treatment

If there is no improvement after 7 days or the patient feels worse, the doctor should be consulted.

Overdose of Hedussin Fruit-Flavored

No more than the recommended dose should be taken. Taking more than the recommended dose (more than three times the single dose) may cause nausea, vomiting, diarrhea, and agitation. The doctor should be consulted, who will decide on the appropriate treatment. A case of overdose of Hedussin Fruit-Flavored has been observed in a 4-year-old child. After accidental ingestion of a large amount of ivy extract (corresponding to 1.8 g of the herbal substance, i.e., approximately 36 mL of Hedussin Fruit-Flavored syrup), agitation and diarrhea occurred.

Missed dose of Hedussin Fruit-Flavored

A double dose should not be taken to make up for a missed dose. If there are any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

Package Leaflet: Information for the User

4. Possible side effects

Like all medicines, Hedussin Fruit-Flavored can cause side effects, although not everybody gets them. Side effects are divided into the following groups based on their frequency:

Side effects that may occur during treatment with Hedussin Fruit-Flavored:

• Common: nausea, vomiting, diarrhea.

Uncommon:

• allergic reactions (hives, skin rash, anaphylactic reaction, shortness of breath).

If other side effects occur, not listed above, the doctor or pharmacist should be consulted.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel. (22) 49 21 301, fax (22) 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

Package Leaflet: Information for the User

5. How to store Hedussin Fruit-Flavored

Store in a place out of sight and reach of children. After opening the syrup, do not store above 25°C. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month. The product can be used for 6 months after opening the bottle. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Hedussin Fruit-Flavored contains

• The active substance is dry extract of ivy leaves. 1 mL of the product contains 8.25 mg of dry extract of ivy leaves (Hederae helicis folii extractum siccum) (4-8:1); extraction solvent: ethanol 30% m/m.
• Other ingredients: liquid sorbitol, non-crystallizing, (E420), potassium sorbate (E202), xanthan gum (E415), citric acid (E330), fruit flavor, purified water.

What Hedussin Fruit-Flavored looks like and package contents

Hedussin Fruit-Flavored is a brown, opalescent liquid with a sweet taste, with a possible slight sediment. The immediate packaging of Hedussin Fruit-Flavored syrup is a brown glass bottle with a capacity of 100 or 200 mL, with a measuring spoon attached. Not all pack sizes may be marketed.

Marketing authorization holder 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. For further information on this medicine, the local representative of the marketing authorization holder should be contacted.

Package Leaflet: Information for the User

This medicinal product has been authorized in the EEA member states under the following names:

Austria: Hedussin Sirup Fruchtgeschmack, Poland: Hedussin o smaku owocowym

Date of last revision of the package leaflet: