Prospan

PATIENT INFORMATION LEAFLET

Patient Information Leaflet

Read the entire leaflet carefully, as it contains important information for

the patient.
The medicine is available without a prescription, so that some conditions can be treated without the help of a doctor. However, to achieve a good treatment effect, the medicine Prospan should be used carefully and in accordance with the information contained in the leaflet. This leaflet should be kept, so that it can be read again if necessary. A doctor or pharmacist should be consulted if advice or additional information is needed. If symptoms worsen or do not improve within 7 days, a doctor should be consulted.

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.
Extractant – ethanol 30 % (m/m).
Alcohol content: 34.92 – 42.68 % (m/v).
Available medicinal packaging:glass bottles with a capacity of 20 ml.
Table of contents of the leaflet:

• 1. What is Prospan and what is it used for
• 2. Before taking Prospan
• 3. How to take Prospan
• 4. Possible side effects
• 5. Storage of Prospan
• 6. Other necessary information about Prospan

1. What is Prospan and what is it used for

Prospan contains dry extract of ivy leaves: Hederae helicis folii
extractum siccum(5-7.5:1). The main active ingredients of the dry extract of ivy leaves (Hedera helix)are triterpene saponins with a glycosidic character (α-hederin, hederagenin, and hederacoside C).
Prospan has secretolytic (thinning of the bronchial secretion) and bronchospasmolytic (relaxing the smooth muscles of the bronchi) effects, which helps to alleviate cough.

Indications for use of Prospan

As an auxiliary agent in acute and chronic inflammatory conditions of the respiratory tract with cough.

2. Before taking Prospan

Do not take Prospanin people who are not recommended to consume even the smallest amount of alcohol and if there is hypersensitivity to the components of the preparation.
Do not give to children under 6 years of age, pregnant women, and breastfeeding women.

Special caution when taking Prospan

Prospan oral drops contain 34.92 – 42.68 % (m/v) of alcohol. The preparation cannot be used by people addicted to alcohol, patients with liver damage, and those suffering from epilepsy.

Interactions with other medicines and other types of interactions

No interactions with other medicines have been reported so far. The preparation can be administered in combination with other preparations used during therapy, for example, with antibiotics.

Use in children

Do not use in children under 6 years of age.

Pregnancy and breastfeeding

Do not use.

Driving and operating machinery

Immediately after taking the preparation, alcohol may be detected by devices measuring alcohol in exhaled air, so vehicles should not be driven immediately after taking the preparation. At least a half-hour break should be maintained.

3. How to take Prospan

If the doctor does not recommend otherwise, the following dosage regimen should be used:
Adults and children over 6 years of age: 3 times a day, 20 drops each time. Drops should be taken before meals. It is recommended to give drops to children with sugar or honey.
Treatment with the preparation should last for at least 7 days, even in mild inflammatory conditions of the respiratory tract. After the symptoms of the disease have subsided, it is recommended to continue treatment for another 2-3 days.
If you feel that the effect of Prospanis too strong or too weak, you should consult a doctor or pharmacist.
In the case of chronic inflammatory conditions of the respiratory tract, the use of the preparation requires medical consultation.

In case of taking a larger dose of Prospan than recommended

nausea, vomiting, diarrhea may occur. The overdosed preparation, due to the alcohol content, may impair the ability to drive vehicles, operate moving machinery, and affect psychomotor performance. Overdose may cause harmful effects in people with liver damage, alcoholism, epilepsy, brain damage, and mental illness.

In case of missing a dose of Prospan

A double dose should not be taken to make up for the missed dose.

4. Possible side effects

Like any medicine, Prospan can cause side effects.
Very rare allergic reactions may occur.
If these or other side effects occur, the doctor should be informed.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. 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:
Aleje 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 or its representative.
Reporting side effects can help gather more information on the safety of the medicine.

5. Storage of Prospan

Store in a place inaccessible and invisible to children.
Store in dry rooms, at a temperature not exceeding 25°C.
Do not use Prospanafter the expiry date stated on the
packaging.

6. Other information

What Prospan contains

The active substance of Prospan is dry extract of ivy leaves (Hederae helicis folii
extractum siccum(5-7.5:1)). 1 ml of drops contains 20 mg of dry extract of ivy leaves (5-7.5:1).
The excipients of Prospan are: sodium saccharin, anise oil, caraway oil, peppermint oil, ethanol 96°, purified water.

What Prospan looks like and what the packaging contains

The immediate packaging of Prospan is 20 ml bottles of the medicine, made of colored glass with a dropper made of polyethylene, with a screw cap made of polypropylene in a cardboard box.

Marketing authorization holder

Engelhard Arzneimittel GmbH & Co. KG
Herzbergstraße 3, 61138 Niederdorfelden, Germany
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To obtain more detailed information, please contact the representative of the marketing authorization holder:
Salveo Poland Sp. z o.o.
Wojskowa 6/B2 street
60-792 Poznań
Date of last revision of the leaflet: 2016-04-29