PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Hederoin
Hederae helicis folii extractum siccum
15 mg, tablets
Please read the entire leaflet carefully before taking this medicine, because it
contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or
as directed by your doctor or pharmacist.

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

Table of contents of the leaflet

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

1. What Hederoin is and what it is used for

Hederoin tablets contain dried extract of ivy leaves (Hederae helicis folii extractum siccum), which has expectorant and spasmolytic effects on the smooth muscles of the bronchi. It helps to liquefy thick mucus accumulated in the respiratory tract.
Indications
This herbal medicinal product is used as an expectorant in productive cough (wet cough with difficult expectoration of thick, sticky mucus).

2. Important information before using Hederoin

When not to use Hederoin:

If the patient is allergic to the active substance, including plants from the Araliaceae family, or to any of the excipients (listed in section 6).
The medicinal product Hederoin is contraindicated in children under 6 years of age due to the formulation being unsuitable for young children (tablets).

Warnings and precautions
If shortness of breath, fever, bloody or purulent sputum occur, consult a
physician or pharmacist.
Concurrent use of this medicine with opioid antitussives such as
codeine or dextromethorphan is not recommended without consulting a physician.
Caution is advised in patients with gastric irritation or peptic ulcer disease.

Children
Do not use the medicinal product Hederoin in children under 6 years of age due to the formulation being unsuitable for young children (tablets).

Hederoin with other medicines
Inform your physician or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
Interactions with other medicines are not known.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a physician or pharmacist before using this medicine.

Pregnancy
The safety of use during pregnancy has not been established. Due to insufficient data, the use of this medicinal product is not recommended during pregnancy.

Breastfeeding
The safety of use during breastfeeding has not been established. Due to insufficient data, the use of this medicinal product is not recommended during breastfeeding.

Fertility
Not known.

Driving and operating machinery
No studies have been conducted on the effect of the product on the ability to drive vehicles
and operate machinery.

Hederoin contains sucrose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a physician before taking this medicine.

3. How to use Hederoin

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 your doctor or pharmacist.
Dosage
Children aged 6 to 11 years: 1 tablet three times daily (corresponding to an average of approximately 270 mg
of ivy leaf).
Adults and adolescents aged 12 years and above: 2 tablets two to three times daily (corresponding to
an average of approximately 360 mg to 540 mg of ivy leaf).
Children and adolescents
Do not use Hederoin in children under 6 years of age.
Duration of treatment
If symptoms persist for longer than one week during treatment with this medicinal product,
consult your doctor or pharmacist.
Method of administration
Take orally, with water.
Taking more Hederoin than recommended
Do not exceed the recommended doses.
In sensitive patients, taking more than the recommended dose may cause nausea, vomiting,
diarrhea, and restlessness.
If any of these symptoms occur, discontinue use immediately and seek medical advice.
Missed dose of Hederoin
Do not take a double dose to make up for a missed dose.
Stopping Hederoin
The duration of treatment depends on the type and clinical presentation of the disease and should
last at least one week. If symptoms do not improve or if the condition worsens during treatment,
seek medical advice.

4. Possible adverse reactions

Like all medicines, Hederoin may cause adverse reactions, although not everyone will experience them.
If any adverse reaction occurs, administration of the medicine should be discontinued immediately and medical advice should be sought.
Adverse reactions are presented according to organ and system classification as per MedDRA and frequency of occurrence: unknown (cannot be estimated based on available data).
When using Hederoin, the following may occur:
Gastrointestinal disorders (nausea, vomiting, diarrhoea) – frequency unknown.
Immune system disorders (allergic reactions: rash, urticaria, dyspnoea) – frequency unknown.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hederoin
Store at a temperature not exceeding 25°C, in a place not visible and inaccessible to children.
Do not use Hederoin after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

6. Contents of the packaging and other information

What Hederoin contains
The active substance in Hederoin is Dry extract of ivy leaf (Hederae helicis folii extractum siccum).
One tablet contains 15 mg of dry extract from Hedera helix L. folium (ivy leaf)
(DER 4-8:1), extraction solvent: ethanol 30% (m/m).
Excipients: microcrystalline cellulose, sodium croscarmellose, anise essential oil, potato starch, sucrose, povidone, talc.

What Hederoin looks like and contents of the pack
Hederoin is in the form of tablets.
The packaging contains 30 tablets.

Marketing Authorisation Holder and Manufacturer
Wrocławskie Zakłady Zielarskie „Herbapol” S.A.
50-951 Wrocław, ul. Św. Mikołaja 65/68
tel.: +48 71 33 57 225
fax: +48 71 372 47 40
e-mail: [email protected]

For further information, please contact the Marketing Authorisation Holder: tel. 71 321 86 04 ext. 123