Hederoin

1. What is Hederoin and what is it used for

Hederoin tablets contain dry extract of ivy leaves (Hederae helicis folii
extractum siccum), which has an expectorant and spasmolytic effect on the smooth muscles of the bronchi.
It thins the thick secretion accumulated in the airways.

Indications for use

Phytopharmaceutical product used as an expectorant in the case of productive cough (wet cough with difficult expectoration of thick secretion).

2. Important information before using Hederoin

When not to use Hederoin:

• If the patient is allergic to the active substance, including plants of the Araliaceae family, or any excipient (listed in section 6).
• Hederoin is contraindicated in children under 6 years of age due to the inappropriate form of the medicine for young children (tablets).

Warnings and precautions

In case of shortness of breath, fever, bloody or purulent sputum, a doctor or pharmacist should be consulted.
Concomitant use of this medicine with opioid cough suppressants, such as codeine or dextromethorphan, is not recommended without consulting a doctor.
Care should be taken in patients with gastritis or stomach ulcers.

Children

Hederoin should not be used in children under 6 years of age due to the inappropriate form of the medicine for young children (tablets).

Hederoin and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as any planned to be used.
Interactions with other medicines are not known.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
The safety of use during pregnancy has not been established. Due to the lack of sufficient data, the use of the medicinal product is not recommended during this period.
Breastfeeding
The safety of use during breastfeeding has not been established. Due to the lack of sufficient data, the use of the medicinal product is not recommended during this period.
Fertility
It is not known.

Driving and using machines

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

Hederoin contains sucrose.

If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.

3. How to use Hederoin

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.
In case of doubts, the doctor or pharmacist should be consulted.
Dosage
Children from 6 to 11 years old: 1 tablet 3 times a day (which corresponds to approximately 270 mg of ivy leaf).
Adults and adolescents over 12 years old: 2 tablets 2 to 3 times a day (which corresponds to approximately 360 mg to 540 mg of ivy leaf).
Children and adolescents
Hederoin should not be used in children under 6 years of age.
Duration of use
If symptoms persist for more than a week during the use of the medicinal product, a doctor or pharmacist should be consulted.
Method of administration
The medicine should be taken orally, with water.

Using a higher dose of Hederoin than recommended

The recommended doses should not be exceeded.
In sensitive patients, after taking a higher dose of the medicine than recommended, nausea, vomiting, diarrhea, and excitement may occur.
If any of these symptoms occur, the use of the medicine should be stopped immediately and medical advice should be sought.

Missing a dose of Hederoin

A double dose should not be used to make up for a missed dose.

Stopping the use of Hederoin

The duration of treatment depends on the type and clinical picture of the disease and should be at least one week. If symptoms do not improve or worsen during treatment, medical advice should be sought.

4. Possible side effects

Like all medicines, Hederoin can cause side effects, although not everybody gets them.
In case of any side effect, the use of the medicine should be stopped immediately and medical advice should be sought.
Side effects are presented according to the MedDRA system organ classification and frequency of occurrence: unknown (cannot be determined based on available data).
During the use of Hederoin, the following may occur:
Gastrointestinal disorders (nausea, vomiting, diarrhea) - frequency unknown.
Immune system disorders (allergic reactions: rash, urticaria, shortness of breath) - frequency unknown.
Reporting side effects
If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Hederoin

Store at a temperature not exceeding 25°C, out of sight and reach of children.
Hederoin should not be used after the expiry date stated on the packaging.
The expiry date means the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines.

6. Contents of the packaging and other information

What Hederoin contains

The active substance of the medicine is Dry extract of ivy leaf (Hederae helicis folii
extractum siccum).
One tablet contains 15 mg of dry extract of Hedera helixL. 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 what the packaging contains

Hederoin is in the form of tablets.
The packaging contains 30 tablets.

Marketing authorization 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: herbapol@herbapol.pl
To obtain more detailed information, the marketing authorization holder should be contacted: tel. 71 321 86 04 w. 123
Date of the last update of the leaflet: