Hederasal

1. What is Hederasal and what is it used for

Hederasal syrup contains a 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 reduces the frequency and painfulness of coughing fits. It thins the thick mucus that accumulates in the throat, larynx, and bronchi. It facilitates expectoration, soothes the cough reflex, and does not block the cough reflex.

Indications for use

The herbal medicinal product is used as an expectorant in the case of productive cough (wet cough with difficult expectoration of thick mucus).

2. Important information before taking Hederasal

When not to take Hederasal:

• -If the patient is allergic to the active substance, including plants of the Araliaceae family, or to any of the excipients (listed in section 6).
• Due to the possibility of exacerbating respiratory symptoms during the use of secretolytic (expectorant) drugs, the medicine should not be used in children under 2 years of age.

Warnings and precautions

Before starting treatment with Hederasal, the patient should discuss it with their doctor or pharmacist.
Persistent or recurrent cough in children aged 2 to 4 years requires a diagnosis by a doctor before treatment.
If shortness of breath, fever, bloody or purulent sputum occurs, the patient should consult their doctor or pharmacist.
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 gastric ulcer disease.

Children

The medicine should not be used in children under 2 years of age.
The medicine contains sorbitol.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.
A single dose of the syrup (5 ml) contains 4.935 g of sorbitol.
Guidelines for diabetics: the medicine does not contain sucrose. It can be used by people with diabetes. 1 teaspoon (5 ml, equivalent to 6.2 g) of the syrup contains 3.36 g of D-sorbitol, which corresponds to 0.28 bread units (BE).

Hederasal 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.
Interactions with other medicines are not known.

Pregnancy, breastfeeding, and fertility

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.
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
The effect on fertility 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.
There is no evidence that herbal medicinal products containing ivy leaf extracts affect the ability to drive and use machines.

3. How to take Hederasal

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
Oral administration. A measuring cup is attached to the packaging.
The syrup should be taken undiluted, followed by water.
Dosage
Children aged 2 to 5 years - 2 to 3 times a day, 2.5 ml or ½ teaspoon.
Children aged 6 to 11 years - 2 times a day, 5 ml or 1 teaspoon.
Adults and adolescents over 12 years - 3 to 4 times a day, 5 ml or 1 teaspoon.
Duration of use
If symptoms persist for more than a week during treatment with the medicinal product, the patient should consult their doctor or pharmacist.

Taking a higher dose of Hederasal than recommended

The recommended doses should not be exceeded, as nausea, vomiting, diarrhea, and agitation may occur.
In case of taking a higher dose than recommended and experiencing side effects, the patient should seek medical advice.

Missing a dose of Hederasal

Treatment should be continued. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Hederasal

Stopping treatment with Hederasal syrup may cause worsening of difficulties in expectorating thick mucus in the throat, larynx, and bronchi.

4. Possible side effects

Like all medicines, Hederasal can cause side effects, although not everybody gets them.
Side effects are presented in accordance with the MedDRA system organ classification and frequency: unknown (cannot be determined from available data).
The following side effects may occur during treatment with Hederasal syrup:
Gastrointestinal disorders (nausea, vomiting, diarrhea) - frequency unknown.
Immune system disorders (allergic reactions: rash, urticaria, shortness of breath) - frequency unknown.
In case of any of the above symptoms, the patient should stop taking the medicine and seek medical advice.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
phone: +48 22 49-21-301
fax: +48 22 49-21-309
website: https://smz.ezdrowie.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. Storing Hederasal

The medicine should be stored out of sight and reach of children.
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 specified month.
Shelf life after first opening: 6 months.
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. Package contents and other information

What Hederasal contains

The active substance of the medicine is a dry extract of ivy leaves ( Hederae helicis folii extractum
siccum).
100 g (equivalent to 81 ml) of the syrup contains 430.55 mg of dry extract of Hedera helicisL.
folium(ivy leaves), (DER 4-8:1), extraction solvent: ethanol 30% ( m/m).
Excipients: potassium sorbate, anise essential oil, propylene glycol, non-crystallizing liquid sorbitol 70%, purified water.

What Hederasal looks like and what the package contains

Hederasal is a brown syrup with a permissible slight opalescence or turbidity.
Package
A brown glass bottle with an HDPE cap containing 125 g of syrup, placed in a cardboard box with a leaflet and a measuring cup.

Marketing authorization holder and manufacturer

Wrocławskie Zakłady Zielarskie „Herbapol” S.A.
50-951 Wrocław, ul. Św. Mikołaja 65/68
phone: +48 71 33 57 225
fax: +48 71 37 24 740
e-mail: [email protected]
To obtain more detailed information, the patient should contact the marketing authorization holder: phone 71 321 86 04, ext. 123
Date of last update of the leaflet: