Package leaflet: Information for the patient

Please read the entire leaflet carefully, as it contains important information for the
patient.
The medicine is available without a prescription so that certain conditions can be treated without medical assistance. However, to achieve effective treatment, Prospan should be used carefully and in accordance with the information provided in this leaflet. Keep this leaflet for future reference. Consult your doctor or pharmacist if you need advice or further information. If symptoms worsen or do not improve within 7 days, consult a doctor.
PROSPAN
Hederae helicis folii extractum siccum (5-7.5:1)
oral drops, solution
20 mg/ml
Active substance: 1 ml of drops contains Hederae helicis folii extractum siccum (5-7.5:1) –
20 mg.
Extraction solvent – ethanol 30% (m/m).
Ethanol content: 47% (m/v).
Available pack sizes: 20 ml glass bottles.
Contents of the leaflet:

What Prospan is and what it is used for
What you need to know before taking Prospan
How to take Prospan
Possible side effects
How to store Prospan
Further information about Prospan

1. What Prospan is and what it is used for

Prospan contains a dry extract of ivy leaves: Hederae helicis folii extractum siccum (5-7.5:1). The main active components of the dry extract of ivy leaves (Hedera helix) are triterpene saponins of glycosidic nature (α-hederin, hederagenin and hederacoside C).
Prospan has secretolytic (liquefies bronchial mucus) and bronchospasmolytic (relaxes bronchial smooth muscles) effects, thereby helping to relieve cough.
Indications for Prospan
Adjunctive treatment of acute and chronic inflammatory conditions of the respiratory tract associated with cough.
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2. Before using Prospan

Do not use Prospan in individuals for whom even the smallest amount of alcohol is not recommended, or in those who are hypersensitive to any of the ingredients of the product.
Do not administer to children under 6 years of age, pregnant women, or breastfeeding women.
Exercise particular caution when using Prospan
Prospan oral drops contain 47% (m/v) alcohol. The product must not be used by individuals with alcohol dependence, patients with liver impairment, or those suffering from epilepsy.
Interactions with other medicinal products and other forms of interaction
No interactions with other medicinal products have been reported to date. The product may be administered in combination with other preparations used during therapy, for example, antibiotics.
Use in children
Do not use in children under 6 years of age.
Pregnancy and breastfeeding
Do not use.
Driving and operating machinery
Alcohol may be detected by breath alcohol measuring devices immediately after taking the product. For this reason, do not drive or operate mechanical vehicles immediately after taking the product. A minimum interval of half an hour should be observed.

3. How to use Prospan

Unless otherwise advised by a doctor, the following dosage regimen should be followed:
Adults and children over 6 years of age: 20 drops three times daily. The drops should be taken before meals.
Children may be given the drops mixed with sugar or honey.
Treatment with Prospan should last at least 7 days, even in mild respiratory tract infections.
After symptoms have subsided, treatment is recommended to be continued for another 2–3 days.
If you feel that the effect of Prospan is too strong or too weak, consult your doctor or pharmacist.
In chronic respiratory tract infections, use of the product requires medical consultation.
If you take more Prospan than recommended
Nausea, vomiting, and diarrhoea may occur. Overdosed preparation, due to its alcohol content,
may impair the ability to drive or operate machinery, as well as psychomotor performance.
Overdose may cause harmful effects in individuals with liver damage, alcoholism, epilepsy,
brain damage, or mental disorders.
If you forget to take a dose of Prospan
Do not take a double dose to make up for the missed dose.
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4. Possible adverse reactions

Like any medicinal product, Prospan may cause adverse reactions.
Allergic reactions may very rarely occur.
If any adverse symptoms occur, including those not listed in this leaflet, they should be reported to a doctor.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 or its representative.
Reporting adverse reactions contributes to the collection of additional information on the safety of the medicinal product.

5. Storage of the medicinal product

Keep out of the reach and sight of children.
Store in dry places, at a temperature not exceeding 25°C.
Do not use the Prospan medicinal product after the expiry date stated on the
packaging.

6. Further information
What Prospan® contains
The active substance in Prospan is dry ivy leaf extract (Hederae helicis folii extractum siccum (5-7.5:1)). Each 1 ml of drops contains 20 mg of dry ivy leaf extract (5-7.5:1).

The excipients are: sodium saccharin, caraway flavour, peppermint oil, ethanol 96°, purified water.

What Prospan looks like and contents of the pack
The immediate packaging of Prospan consists of 20 ml amber glass bottles with a polyethylene dropper and a polypropylene screw cap, packed in a cardboard box.

Marketing Authorisation Holder
Engelhard Arzneimittel GmbH & Co. KG
Herzbergstraße 3, 61138 Niederdorfelden, Germany
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For further information, please contact the representative of the Marketing Authorisation Holder:
Salveo Poland Sp. z o.o.
Wojskowa 6/B2
60-792 Poznań, Poland

Date of the most recent revision of the leaflet: ………………..
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