Hedussin

Package Leaflet: Information for the User

Hedussin

Hederae helicis folii extractum siccum
33 mg/4 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 or as directed by a doctor or pharmacist.

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

Table of Contents of the Leaflet

• 1. What is Hedussin and what is it used for
• 2. Important information before taking Hedussin
• 3. How to take Hedussin
• 4. Possible side effects
• 5. How to store Hedussin
• 6. Contents of the pack and other information

1. What is Hedussin and what is it used for

Hedussin is a herbal medicinal product used as an expectorant in the case of productive cough (wet cough).
The active substance of the medicine is dry extract of ivy leaves.
Hedussin is intended for adults, adolescents, and children over 2 years of age.
If there is no improvement after 7 days or the patient feels worse, they should consult their doctor.

2. Important information before taking Hedussin

When not to take Hedussin:

• if the patient is allergic to dry extract of ivy leaves, to other plants of the Araliaceae family (the 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, the patient should discuss it with their doctor or pharmacist.
In case of shortness of breath, fever, or purulent sputum, the patient should consult their doctor or pharmacist.
Cautions are recommended in patients with stomach problems such as heartburn, burning, stomach pain, nausea, or stomach ulcers.
In case of the first symptoms of a severe allergic reaction, the patient should stop taking the medicine immediately and contact their doctor (see section 4).
Children
Children between 2 and 4 years of age with persistent or recurrent cough require a medical diagnosis before starting treatment.

Hedussin and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions of Hedussin with other medicines have been reported. No studies on interactions with other medicines have been conducted.

Taking Hedussin with food, drink, and alcohol

No data available.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Safety during pregnancy and lactation has not been established.
Due to the lack of sufficient data, the use of Hedussin during pregnancy and breastfeeding is not recommended.

Driving and using machines

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

Hedussin contains sorbitol

Sorbitol is a source of fructose. If the patient (or their child) has 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, they should consult their doctor before taking the medicine or giving it to their child.
Sorbitol may cause gastrointestinal disorders and a mild laxative effect in children.

Package Leaflet: Information for the User

Hereditary fructose intolerance is a rare genetic disorder in which the patient's body does not break down fructose. If the patient has been diagnosed with this condition, they should consult their doctor before taking the medicine or giving it to their child.
Sorbitol may cause gastrointestinal disorders and a mild laxative effect in children.

3. How to take Hedussin

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose:

Adults and adolescents over 12 years of age: 6 ml of syrup twice a day;
Children between 6 and 11 years of age: 4 ml of syrup twice a day;
Children between 2 and 5 years of age: 2 ml of syrup twice a day.

Use in children

Children between 2 and 4 years of age with persistent or recurrent cough require a medical diagnosis before starting treatment.
The medicine should not be used in children under 2 years of age (see "When not to take Hedussin").

Method of administration

Oral administration.
The patient should use the enclosed measuring spoon with a 2 ml and 4 ml scale.
A dose of 6 ml is recommended to be taken using the measuring spoon (4 ml) and half a spoon (2 ml).
The bottle should be shaken well before each use.

Duration of treatment

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

Overdose of Hedussin

Taking a higher dose than recommended may cause nausea, vomiting, diarrhea, and excitement. Treatment is symptomatic.

Missed dose of Hedussin

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

Package Leaflet: Information for the User

4. Possible side effects

Like all medicines, Hedussin 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:
Common:

• nausea, vomiting, diarrhea.

Uncommon:

• allergic reactions (hives, skin rash, anaphylactic reaction, shortness of breath). At the first signs of a severe allergic reaction, the patient should stop taking the medicine immediately and contact their doctor. In case of other side effects not listed above, the patient should consult their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Hedussin

Store in a place out of sight and reach of children.

Package Leaflet: Information for the User

After the first opening of 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 should be used within 3 months of opening the bottle.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Hedussin contains

• The active substance of the medicine 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). Extractant: ethanol 30% m/m.
• Other ingredients: liquid sorbitol (non-crystallizing) (E420), potassium sorbate (E202), xanthan gum (E415), anhydrous citric acid (E330), purified water.

What Hedussin looks like and contents of the pack

Hedussin is a brown, opalescent liquid with a sweet taste and a possible slight sediment.
The syrup is filled into brown glass bottles with white plastic (polyethylene) caps. The bottles are then packed in cardboard boxes with a measuring spoon (with a 2 ml and 4 ml scale).
Pack size: 100 ml of syrup in one bottle.

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

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

Austria: Hedussin Sirup
Poland: Hedussin
Romania: Hedussin 8.25 mg/ml syrup
Norway: Hedexin
Sweden: Hedexin

Date of last revision of the leaflet: