Package leaflet: Information for the patient

Hederasal
Hederae helicis folii extractum siccum
26.6 mg/5 ml, syrup
Please read all of this 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 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 adverse reactions 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.

Table of contents of the leaflet

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

1. What Hederasal is and what it is used for

Hederasal syrup contains dry extract of ivy leaves (Hederae helicis folii extractum siccum), which has expectorant and spasmolytic effects on the smooth muscles of the bronchi. It reduces the frequency and severity of coughing episodes. It liquefies thick mucus accumulated in the throat, larynx, and bronchi. It facilitates expectoration, soothes the cough reflex, and does not suppress cough reflexes.

Indications for use
A herbal medicinal product used as an expectorant in productive cough (wet cough with difficult expectoration of thick, stagnant mucus).

2. Important information before using Hederasal

When not to use 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 potential for worsening respiratory symptoms when using secretolytic (expectorant) medicines, Hederasal should not be used in children under 2 years of age.

Warnings and precautions
Before starting treatment with Hederasal, consult a doctor or pharmacist.
Persistent or recurrent cough in children aged 2 to 4 years should be evaluated by a doctor before initiating treatment.
If shortness of breath, fever, or bloody or purulent sputum occurs, consult a doctor or pharmacist.
Concurrent use of this medicine with opioid antitussives, such as codeine or dextromethorphan, is not recommended without consulting a doctor.
Caution is advised in patients with gastric mucosal irritation or peptic ulcer disease.

Children
Do not use in children under 2 years of age.
The medicine contains sorbitol.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
A single dose of syrup (5 ml) contains 4.935 g of sorbitol.
Advice for diabetics: the medicine does not contain sucrose. It may be used by people with diabetes. One teaspoon (5 ml corresponds to 6.2 g) of syrup contains 3.36 g of D-sorbitol, equivalent to 0.28 carbohydrate exchange units (BE).

Hederasal and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Interactions with other medicines are not known.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor 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 using machines
No studies have been conducted on the effect of this medicinal product on the ability to drive or operate machinery.
There is no evidence that medicinal products containing extracts from ivy leaves affect the ability to drive or operate machinery.

3. How to use Hederasal

This medicine should always be used exactly as described in this patient information leaflet, or
as directed by a doctor or pharmacist. If in doubt, consult a doctor
or pharmacist.
Oral administration. A measuring device is provided with the packaging.
Take the syrup undiluted, followed by water.

Dosage
Children aged 2 to 5 years: 2.5 ml (½ teaspoon) 2 to 3 times daily.
Children aged 6 to 11 years: 5 ml (1 teaspoon) 2 times daily.
Adults and adolescents aged 12 years and older: 5 ml (1 teaspoon) 3 to 4 times daily.

Duration of treatment
If symptoms persist for more than one week during treatment with this medicinal product,
consult a doctor or pharmacist.

Overdose of Hederasal
Do not exceed the recommended doses, as nausea, vomiting, diarrhoea, and nervous excitation may occur.
In case of overdose and occurrence of adverse effects, seek medical advice immediately.

Missed dose of Hederasal
Continue treatment as before. Do not take a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions are presented according to organ system classification as per MedDRA and frequency of occurrence: unknown (cannot be estimated from available data).

The following may occur during use of Hederasal syrup:
Gastrointestinal disorders (nausea, vomiting, diarrhoea) – frequency unknown.
Immune system disorders (allergic reactions: rash, urticaria, dyspnoea) – frequency unknown.

If any of the symptoms listed above occur, treatment with the medicine should be stopped immediately and medical advice should be sought.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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
Phone: +48 22 49-21-301
Fax: +48 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 medicine.

5. Storage of Hederasal medicine
Keep the medicine 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 stated month.
Shelf-life after first opening: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

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

What Hederasal looks like and contents of the pack
Hederasal is a syrup with a tea-coloured appearance, with a slight opalescence or turbidity permitted.
Pack:
An amber glass bottle with an HDPE screw cap containing 125 g of syrup, placed in a cardboard box with a leaflet and a measuring cup.

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 37 24 740
e-mail: [email protected]

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