PROSPAN

PROSPAN cough syrup

Important notes (mandatory information)

Prospan Cough Syrup. Active ingredient: Ivy leaf dry extract. Areas of application: for improving symptoms of chronic inflammatory bronchial diseases and acute inflammations of the respiratory tract with the accompanying symptom of coughing.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Prospan Cough Syrup, liquid for oral use
Active ingredient: Ivy leaf dry extract

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Prospan Cough Syrup must be used as directed in order to be as effective as possible.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 7 days, you must consult a doctor.
• If any of the side effects listed here affect you severely or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

The package leaflet contains

1. WHAT IS PROSPAN COUGH SYRUP AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING PROSPAN COUGH SYRUP?
3. HOW TO TAKE PROSPAN COUGH SYRUP?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE PROSPAN COUGH SYRUP?
6. FURTHER INFORMATION

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

Prospan Cough Syrup is a herbal medicine for catarrhal diseases of the respiratory tract. Prospan Cough Syrup is used to improve symptoms of chronic inflammatory bronchial diseases and acute inflammations of the respiratory tract with the accompanying symptom of coughing. Note: If symptoms persist or if shortness of breath, fever, or purulent or bloody sputum occur, a doctor should be consulted immediately.

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING PROSPAN COUGH SYRUP?

Prospan Cough Syrup must not be taken if you are hypersensitive (allergic) to the active ingredient or any of the other ingredients of this medicine.

Special care must be taken when taking Prospan Cough Syrup

Children

Prospan Cough Syrup should only be used in children under one year of age after consulting a doctor. It should only be taken by this age group under careful supervision, because diarrhoea and vomiting are particularly likely to occur in children under one year of age compared to older children. Please also note the information under Side Effects.

When taking Prospan Cough Syrup with other medicines

No studies have been conducted. No interactions have been reported to date. Please tell your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, even if they are non-prescription medicines.

Pregnancy and breast-feeding

This medicine should not be used during pregnancy and breast-feeding, as there is insufficient research available.

Driving and using machines

No special precautions are necessary.

Important information about certain other ingredients of Prospan Cough Syrup

This medicine contains sorbitol. Up to 1.9 g of sorbitol is administered with each use. Please only take Prospan Cough Syrup after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE PROSPAN COUGH SYRUP?

Always take Prospan Cough Syrup exactly as described in this package leaflet. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is

Age	Single dose	Total daily dose
Children under 6 years	2.5 ml equivalent to 17.5 mg of ivy leaf dry extract	5 ml (2 times 2.5 ml) equivalent to 35 mg of ivy leaf dry extract
Children aged 6 – 12 years	5 ml equivalent to 35 mg of ivy leaf dry extract	10 ml (2 times 5 ml) equivalent to 70 mg of ivy leaf dry extract
Children aged 12 years and over and adults	5 ml equivalent to 35 mg of ivy leaf dry extract	15 ml (3 times 5 ml) equivalent to 105 mg of ivy leaf dry extract

Method of administration

To be taken orally with the enclosed measuring cup. The liquid is taken in the morning, (at noon) and in the evening. Shake the bottle well before each use!

Duration of use

The duration of treatment depends on the type and severity of the symptoms; it should generally be 1 week. However, if the symptoms persist for longer than 1 week, medical advice should be sought.

Please talk to your doctor or pharmacist if you have the impression that the effect of Prospan Cough Syrup is too strong or too weak.

If you have taken more Prospan Cough Syrup than you should

No more than the amount stated in the dosage instructions or prescribed by your doctor should be taken of Prospan Cough Syrup per day. Taking significantly higher amounts (more than three times the daily dose) can cause nausea, vomiting and diarrhoea. In this case, you should consult your doctor.

If you forget to take Prospan Cough Syrup

Do not take double the dose the next time, but continue taking it as prescribed by your doctor or as described in the package leaflet.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Prospan Cough Syrup can have side effects, although not everybody gets them.

The following frequency information is used to assess side effects:
Very common:	more than 1 in 10 people treated
Common:	1 to 10 in 100 people treated
Uncommon:	1 to 10 in 1,000 people treated
Rare:	1 to 10 in 10,000 people treated
Very rare:	fewer than 1 in 10,000 people treated
Not known:	frequency cannot be estimated from the available data.

Possible side effects

After taking ivy-containing medicines, allergic reactions such as shortness of breath, swelling, skin redness and itching can occur. The frequency is not known. Gastrointestinal symptoms such as nausea, vomiting and diarrhoea can occur in sensitive individuals, as well as a laxative effect due to the sorbitol content. The frequency is not known.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE PROSPAN COUGH SYRUP?

Keep out of the reach of children! Do not use the medicine after the expiry date which is stated on the carton and the container (label)! The expiry date refers to the last day of the month. Note on shelf life after opening or preparation: Shelf life after opening: 3 months.

6. FURTHER INFORMATION

What Prospan Cough Syrup contains?
The active ingredient is: Ivy leaf dry extract. 100 ml of liquid contains 0.7 g of dry extract from ivy leaves (5 - 7.5 : 1). Extraction solvent: Ethanol 30% (m/m). The other ingredients are: Potassium sorbate (Ph.Eur.) (preservative), anhydrous citric acid (Ph.Eur.), xanthan gum, flavouring, sorbitol solution 70% (crystallising) (Ph.Eur.), purified water. 2.5 ml of liquid contains 0.963 g of sugar substitute sorbitol (Ph.Eur.) = 0.08 BE.

What Prospan Cough Syrup looks like and contents of the pack

Prospan Cough Syrup is available in original packs of 100 ml (N 1) and 200 ml (N 2) of liquid. Hospital pack with 1000 ml of liquid (5 x 200 ml).

Pharmaceutical entrepreneur and manufacturer

Engelhard Arzneimittel GmbH & Co. KG
Herzbergstr. 3
61138 Niederdorfelden
Tel.: 06101 / 539 - 300
Fax: 06101 / 539 - 315
Internet:http://www.engelhard-am.de
E-mail: info@engelhard-am.de

This package leaflet was last revised in January 2015.

Source: Information from the package leaflet
Version: 11/2017
Active ingredient: Ivy leaf dry extract. Areas of application: for improving symptoms of chronic inflammatory bronchial diseases and acute inflammations of the respiratory tract with the accompanying symptom of coughing.