Package leaflet: information for the patient

PROSPAN, 35 mg / 5 ml, syrup
Dry extract of ivy leaves
Hederae helicis folii extractum siccum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician 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 of treatment, or if your condition worsens, consult your doctor.

Table of contents of the leaflet:

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

1. WHAT PROSPAN SYRUP IS AND WHAT IT IS USED FOR

Prospan contains dry extract of ivy leaves. The main active ingredients of the dry ivy leaf extract are triterpene saponins of glycosidic nature (α-hederin, hederagenin, and hederacoside C). Prospan syrup is used as an expectorant in productive cough (so-called wet cough). The preparation has secretolytic properties (it liquefies viscous bronchial secretions), spasmolytic effects (relaxes smooth muscles of the bronchi), and antitussive properties. Due to these properties, the mucus accumulated in the respiratory tract becomes thinner and easier to expel.
Indications for use
Prospan is a herbal medicinal product containing ivy leaf extract and is used as an expectorant in productive cough (so-called wet cough).

2. IMPORTANT INFORMATION BEFORE USING PROSPAN SYRUP

When not to take Prospan syrup:

in case of hypersensitivity to the active substance or to other plants from the Araliaceae family (araliaceae), or to any of the excipients,
not to be used in children under 2 years of age due to the risk of worsening respiratory symptoms.

Warnings and precautions
Before starting treatment with Prospan, consult your doctor or
pharmacist.
If symptoms persist or if symptoms such as shortness of breath, fever, or purulent or bloody sputum occur, consult a doctor immediately.
Concurrent use of antitussive medicines, such as codeine or dextromethorphan, is not recommended without prior consultation with a doctor.
Caution is advised when administering to patients with gastric mucosal inflammation or gastric ulcer.
In rare cases, the medicine may irritate mucous membranes.
Information for diabetics: the medicine does not contain sugar and can be used by patients with diabetes.
Children
Persistent or recurrent cough in children aged between 2 and 4 years requires medical diagnosis before starting treatment.
Prospan syrup and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient intends to take, including those available without a prescription.
The medicine may be administered in combination with other drugs used during therapy, for example antibiotics. The medicine may enhance the effect of agents irritating the gastric mucosa due to the presence of saponins.
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 any medicine.
Studies on the safety of using the medicine in pregnant women and its effect on fetal development have not been conducted. Therefore, the medicine should only be used during pregnancy and breastfeeding when, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
Driving and operating machinery
No adverse effect on the ability to drive motor vehicles, operate machinery or psychomotor performance has been observed. The medicine does not contain alcohol.
The medicine contains sorbitol
A single dose (5 ml) contains 1.9 g of sorbitol. 2.5 ml of syrup contains 0.963 g sorbitol = 0.08 bread units. Do not use in patients with rare hereditary fructose intolerance. In such cases, treatment should be conducted only after consultation with a doctor.

3. HOW TO USE PROSPAN SYRUP

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 your doctor or pharmacist.
Shake the syrup well before use!
Adults and adolescents over 12 years of age: take 5 ml of syrup three times daily (corresponding to 105 mg of dry ivy leaf extract per day).
Children aged 6 to 11 years: 5 ml of syrup twice daily (corresponding to 70 mg of dry ivy leaf extract per day).
Children aged 2 to 5 years: administer on average 2.5 ml of syrup twice daily (corresponding to 35 mg of dry ivy leaf extract per day).
Do not use in children under 2 years of age.
Administration of the syrup to children under 5 years of age should be discussed with a doctor.
An appropriate measuring device should be used to measure the dose.
The medicine should be taken in the morning, (at noon), and in the evening.
The duration of treatment depends on the type and severity of symptoms.
Treatment with this medicine should last at least 7 days, even in mild respiratory tract inflammations.
If symptoms persist for longer than one week despite using the medicinal product, consult your doctor or pharmacist.
If you feel that the effect of Prospan syrup is too strong or too weak, consult your doctor or pharmacist.
Taking more than the recommended dose of Prospan syrup (more than three times the daily dose)
Nausea, vomiting, and diarrhoea due to the presence of sorbitol in the medicine may occur.
In such a case, consult a doctor.
Missing a dose of Prospan syrup
Do not take a double dose to make up for a missed dose.
Stopping treatment with Prospan syrup
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very common: in more than 1 in 10 patients.
Common: in 1 to 10 in 100 patients.
Uncommon: in 1 to 10 in 1,000 patients.
Rare: in 1 to 10 in 10,000 patients.
Very rare: in less than 1 in 10,000 patients.
Not known: frequency cannot be estimated based on available data.

Possible adverse reaction
Very rarely, allergic reactions such as shortness of breath, swelling, redness and itching of the skin may occur after taking medicines containing ivy extract.
In sensitive individuals, gastrointestinal disturbances such as nausea, vomiting, diarrhoea and a laxative effect related to the sorbitol content may uncommonly occur.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor, pharmacist or nurse. 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 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected].
Adverse reactions can also be reported to the Marketing Authorisation Holder or the representative of the Marketing Authorisation Holder.
Reporting adverse reactions enables better assessment of the safety of the medicine.

5. HOW TO STORE PROSPAN SYRUP

Keep this medicine out of sight and reach of children.
Store at a temperature not exceeding 25°C.
Slight cloudiness of the syrup may occur due to the presence of herbal ingredients.
This does not affect the efficacy of the medicine.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Prospan syrup contains
The active substance in Prospan syrup is dry extract of ivy leaves (Hederae helicis folii extractum siccum).

100 ml of syrup contains 0.7 g of dry extract from Hedera helix L., folium (ivy leaf) (5-7.5:1), extraction solvent: ethanol 30% (m/m).
Other ingredients (excipients) are: crystallizing liquid sorbitol (E420), potassium sorbate (E 202), anhydrous citric acid, xanthan gum, cherry flavor, purified water.

The syrup does not contain alcohol.
The syrup is sugar-free and may be used by diabetics.

What Prospan syrup looks like and contents of the pack
The immediate packaging of Prospan syrup consists of amber glass bottles with a polyethylene flow restrictor, with a capacity of 100 ml or 200 ml of syrup, closed with a polyethylene (HDPE) cap with a tamper-evident ring, and a polypropylene measuring cup, all contained in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Engelhard Arzneimittel GmbH & Co. KG
Herzbergstraße 3, 61138 Niederdorfelden, Germany