Prospan

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Package leaflet: Information for the patient

Prospan, 35 mg / 5 ml, oral liquid
Hederae helicis folii extractum siccum
Dry extract of ivy leaves
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken 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, or if symptoms worsen, consult your doctor.

Table of contents of the leaflet:

1. What Prospan is and what it is used for
2. Important information before taking Prospan
3. How to take Prospan
4. Possible side effects
5. How to store Prospan
6. Contents of the package and other information

1. What Prospan is and what it is used for

Prospan is a herbal medicinal product containing dry extract of ivy leaves used as an
expectorant in productive cough (so-called wet cough).
This medicine belongs to a group of expectorants used to help remove mucus and phlegm
from the respiratory tract in productive cough (so-called wet cough).
If there is no improvement after 7 days, or if the patient feels worse, or if symptoms such as
dyspnoea, fever, purulent or bloody sputum occur, medical advice should be sought immediately.

2. Important information before using Prospan

When not to take Prospan:

• if the patient is allergic to the active substance or to other plants from the botanical family Araliaceae (araliads), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Prospan, consult a 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.
Concomitant use of antitussive medicines such as codeine or dextromethorphan is not recommended without consulting a doctor.
Caution is advised when administering to patients with gastric mucosal inflammation or gastric ulcer.

Children
Prospan is not intended for use in children under 6 years of age.

Prospan with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.
Studies have not been conducted. No known interactions have been reported to date.

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 this medicine.
This medicine should not be used during pregnancy and breastfeeding, as sufficient studies in pregnant and breastfeeding women have not been conducted.

Driving and operating machinery
No special precautions required.

Prospan contains sorbitol and glucose (component of maltodextrin in the flavour).
One sachet contains 2.7 g of crystallizing liquid sorbitol, equivalent to 1.9 g of sorbitol (E420).
If the patient has intolerance to certain sugars, consult a doctor.
Patients with hereditary fructose intolerance must not take this medicinal product.
Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if the patient has previously been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should consult a doctor before taking the medicine or giving it to a child.

3. How to use Prospan

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
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Unless otherwise prescribed by a doctor, the usual dose is:
Adults and adolescents aged 12 years and older: take the contents of 1 sachet (5 ml) 3 times
daily.
The maximum daily dose must not exceed 3 sachets per day (corresponding to 105 mg of dry extract
from ivy leaves).
Children aged 6 to 12 years: take the contents of 1 sachet (5 ml) 2 times daily (corresponding to
70 mg of dry extract from ivy leaves).
The maximum daily dose must not exceed 2 sachets per day (corresponding to 70 mg of dry extract from
ivy leaves).
Method of administration
For oral use.
The undiluted liquid should be taken in the morning, (at lunchtime), and in the evening.
Do not take while lying down.
Prospan oral solution is packed in a sachet, which is easy to open. The contents are also easy to take. For
more information on how to use the sachets, please refer to the instructions below:

Gently squeeze the sachet To open, tear off the end Squeeze the sachet to empty
before use, as shown. of the sachet, holding it the contents completely.
firmly.
Duration of treatment
If symptoms persist for longer than one week during treatment, consult a doctor.
If, despite using the medicine for more than 1 week, symptoms continue, there is no improvement, the
patient feels worse, or symptoms such as shortness of breath, fever, or purulent or bloody sputum occur,
consult a doctor immediately.
If you feel that the effect of Prospan is too strong or too weak, consult your doctor or pharmacist.
Taking more Prospan than recommended
Do not exceed the recommended daily dose. If a significantly higher dose than recommended (more than
three times the daily dose) is taken, nausea, vomiting, or diarrhoea may occur. In such a case, consult a doctor.
Missing a dose of Prospan
Do not take a double dose to make up for a missed dose. Continue taking the medicine as directed by your
doctor or as described in this leaflet.
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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.
The following classification is used to assess the frequency of adverse reactions:
Unknown frequency: (frequency cannot be estimated from the available data).
Unknown frequency:
Allergic reactions such as urticaria, rash, dyspnoea, oedema, erythema and itching of the skin may occur after taking medicines containing ivy leaf extract.
Unknown frequency:
Gastrointestinal disturbances such as nausea, vomiting and diarrhoea.
Treatment with Prospan should be discontinued if the first signs of hypersensitivity occur.
If any of these or other adverse reactions not listed in this leaflet occur, inform your doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse.
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 181C, 02-222 Warsaw, tel.: +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 authorisation holder or its representative.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Prospan medicine

Keep this medicine out of sight and reach of children.
No special storage instructions apply to this medicinal product.
Do not use the medicine after the expiry date stated on the carton and sachet after EXP.
The expiry date refers to the last day of the stated month.
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6. Contents of the pack and other information

What Prospan contains

• The active substance in Prospan is dry extract of ivy leaves Hederae helicis folii extractum siccum.
• Each sachet contains 35 mg of extract (in the form of dry extract) from Hedera helix L., folium (ivy leaf) (5-7.5:1), extraction solvent: ethanol 30% (m/m).
• Other ingredients are: Purified water, Potassium sorbate, Anhydrous citric acid, Crystallizing liquid sorbitol (E420), Xanthan gum, Natural mint flavor Frescofort Permaseal (composition: natural flavouring substance, corn maltodextrin, modified corn starch), Natural orange flavour (composition: orange essential oil, ethanol), Levomenthol. 5 ml of the oral solution (one sachet) contains 1.9 g of sorbitol (Ph.Eur.) (sweetener) = 0.16 bread units.

What Prospan looks like and contents of the pack
Prospan oral solution is available in original packs containing 21 and 30 sachets of 5 ml oral solution.
Not all pack sizes may be marketed.

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

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Salveo Poland Sp. z o.o.
Okrężna 83, 83a lok.5
02-933 Warsaw
e-mail: [email protected]

Note:
Prospan contains an active substance of plant origin. The herbal extract may occasionally cause slight cloudiness or a minor change in taste of Prospan. However, this does not affect the efficacy and quality of the product.
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