Hedussin with fruit flavor

Package leaflet: Information for the user

Hedussin o smaku owocowym
Hederae helicis folii extractum siccum, 8.25 mg/mL, syrup
Please read the entire leaflet carefully before using the medicine, because
it contains important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or
according to the instructions of a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If the patient experiences any adverse effects, including any possible adverse effects not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

Contents of the leaflet

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

1. What Hedussin o smaku owocowym is and what it is used for
Hedussin o smaku owocowym syrup contains dry extract of ivy leaves ( Hedera helix L.,
folium) (4-8:1).
Hedussin o smaku owocowym syrup is a herbal medicinal product used as an expectorant in productive (wet) cough.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

2. Important information before taking Hedussin o smaku owocowym

When not to take Hedussin o smaku owocowym:

• if the patient is allergic to dry extract of ivy leaves, to other plants from the family Araliaceae (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 starting to take Hedussin o smaku owocowym, discuss it with a
doctor or pharmacist.
If shortness of breath, fever, or purulent sputum occurs, consult a
doctor or pharmacist.
Do not take Hedussin o smaku owocowym together with antitussive medicines, such as codeine or dextromethorphan, without consulting a doctor.
Caution is advised in patients with gastric mucosal inflammation (gastritis) or gastric ulcers.
Children
Children aged 2 to 4 years with persistent or recurrent cough require 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 o smaku owocowym").
Hedussin o smaku owocowym and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No influence of Hedussin o smaku owocowym on the action of other medicines has been reported. Studies on interactions with other medicines have not been conducted.
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 a doctor or pharmacist before using this
medicine.
Due to insufficient data, use during pregnancy and breastfeeding is not recommended.
Hedussin o smaku owocowym 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 operating machinery
No studies have been conducted on the effect on the ability to drive vehicles and
operate machinery.
Hedussin o smaku owocowym contains sorbitol

Package leaflet: Information for the user

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

3. How to take Hedussin fruit-flavoured syrup

This medicine should always be taken exactly as described in this patient information leaflet or
as directed by a doctor or pharmacist. If in doubt, consult a 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.
Do not use in children under 2 years of age (see section "When not to take Hedussin fruit-flavoured syrup").
Route of administration
For oral use.
Shake the bottle well before use.
Duration of treatment
If there is no improvement after 7 days, or if symptoms worsen, consult a doctor.
Taking more Hedussin fruit-flavoured syrup than recommended
Do not exceed the recommended dose. Taking higher than recommended doses (more than
three times the single dose) may cause nausea, vomiting, diarrhoea and agitation. In such
cases, consult a doctor who will decide on appropriate management.
A case of overdose has been observed in a 4-year-old child. After accidental ingestion of a
large amount of ivy extract (equivalent to 1.8 g of herbal medicinal substance, i.e. about
36 ml of Hedussin fruit-flavoured syrup), agitation and diarrhoea occurred.
If you forget to take Hedussin fruit-flavoured syrup
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.

Patient Information Leaflet: Information for the User

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience
them.
Side effects are categorized below according to their frequency of occurrence:

Adverse reactions that may occur during treatment with Hedussin o smaku owocowym:
Frequent:

• nausea, vomiting, diarrhoea.

Uncommon:

• allergic reactions (urticaria, skin rash, anaphylactic reaction, dyspnoea).

If any other adverse reactions not listed above occur, consult a doctor 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 of 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 authorisation holder.
Reporting adverse reactions enables further information on the safety of the medicinal product to be collected.

Package leaflet: information for the user

5. How to store Hedussin o smaku owocowym

Store in a place inaccessible and out of sight of children.
After first opening, do not store the syrup at temperatures 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 specified month. The product may be used within 6
months after first opening the bottle.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Hedussin fruit-flavoured contains

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

What Hedussin fruit-flavoured looks like and contents of the pack
Hedussin fruit-flavoured is a brown, opalescent liquid with a sweet taste, possibly with a slight sediment.
The immediate packaging for the syrup Hedussin fruit-flavoured is a brown glass bottle with a capacity of 100 or 200 ml, supplied with a measuring spoon.
Not all pack sizes may be marketed.

Marketing Authorisation 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 information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Package leaflet: information for the user

This medicinal product has been authorised in EEA countries under the following names:
Austria: Hedussin Sirup Fruchtgeschmack
Poland: Hedussin o smaku owocowym