Package leaflet: Information for the user

Hedussin
Hederae helicis folii extractum siccum
33 mg/4 ml, syrup
Please read all of this leaflet carefully before taking this medicine, because
it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Contents of the leaflet

What Hedussin is and what it is used for
Important information before taking Hedussin
How to take Hedussin
Possible side effects
How to store Hedussin
Contents of the pack and other information

1. What Hedussin is and what it is used for

Hedussin is a herbal medicinal product used as an expectorant in productive (wet) cough.
The active substance in Hedussin is dry extract of ivy leaves.
Hedussin is intended for use in adults, adolescents, and children above 2 years of age.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

2. Important information before taking Hedussin

When not to take Hedussin:

if the patient is allergic to dry ivy leaf extract, to other plants from 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 starting to take Hedussin, discuss this with your doctor or
pharmacist.
If shortness of breath, fever or purulent sputum occur, consult your
doctor or pharmacist.
Caution is advised in patients with stomach problems such as: heartburn,
burning sensation, abdominal pain, nausea or gastric ulcers.
If the first signs of a severe allergic reaction occur, discontinue use of this medicine immediately and contact your doctor (see section 4).

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

Hedussin and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
No influence of Hedussin on the action of other medicines has been reported. Studies on interactions with other medicines have not been conducted.

Taking Hedussin with food, drink and alcohol
No data available.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this
medicine.
Safety during pregnancy and lactation has not been established.
Due to insufficient data, use during pregnancy and breastfeeding is not recommended.

Driving and operating machinery
Studies on the influence on the ability to drive and operate machinery have not been conducted.

Hedussin contains sorbitol
Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in the patient (or their child), or if the patient has a rare hereditary
fructose intolerance, a genetic disorder in which the patient's body cannot break down fructose, the patient should contact a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect in children.

3. How to take Hedussin

This medicine should always be taken exactly as described in this patient information leaflet, or
as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 12 years and above: 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 medical diagnosis
before starting treatment.
Do not use in children under 2 years of age (see section "When not to take Hedussin").
Route of administration
Oral use.
Use the provided measuring spoon with 2 ml and 4 ml graduations.
It is recommended to administer the 6 ml dose using the 4 ml measuring spoon and half of the 2 ml spoon.
Shake the bottle vigorously before each use.
Duration of treatment
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.
Taking more Hedussin than recommended
Taking more than the recommended dose may cause nausea, vomiting, diarrhoea, and agitation.
Treatment is symptomatic.
If you forget to take Hedussin
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

Package leaflet: information for the user

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are categorized into the following groups according to their frequency of occurrence:

Very common	may affect more than 1 in 10 people
Common	may affect up to 1 in 10 people
Uncommon	may affect up to 1 in 100 people
Rare	may affect up to 1 in 1,000 people
Very rare	may affect up to 1 in 10,000 people
Not known	cannot be estimated from the available data

Adverse reactions that may occur during treatment with Hedussin:
Common:

nausea, vomiting, diarrhea.

Uncommon:

allergic reactions (urticaria, skin rash, anaphylactic reaction, shortness of breath). If any signs of a severe allergic reaction occur, administration of this medicinal product should be stopped immediately and medical advice should be sought. In case of occurrence of other adverse reactions not listed above, consult a physician or pharmacist.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the Marketing Authorization Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store Hedussin

Keep out of sight and reach of children.

Package leaflet: information for the user

After first opening, do not store the syrup above 25°C.
Do not use this medicinal product after the expiry date stated on the container.
The expiry date refers to the last day of the stated month. The product should be used within 3 months after first opening of the bottle.
Medicinal products should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Hedussin contains

The active substance 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). Extraction solvent: ethanol 30% m/m.
Other ingredients: sorbitol liquid (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, which may contain a slight sediment.
The syrup is filled into brown glass bottles with white plastic (polyethylene) screw caps. The bottles are then packed into cardboard boxes together with a measuring spoon (marked at 2 ml and 4 ml).
Pack size: 100 ml of syrup in one bottle.

Marketing Authorisation Holder and Manufacturer
Phytopharm Klęka S.A.
Klęka 1, 63-040 Nowe Miasto nad Wartą
Poland
Tel.: +48 61 28 68 000
Fax: +48 61 28 68 529

This medicinal product is authorised in EEA countries under the following names:
Austria: VOICLA Hustenlöser Efeu Sirup
Poland: Hedussin
Romania: Hedussin 8.25 mg/ml sirop
Norway: Hedexin
Sweden: Hedexin
Denmark: Hedexin