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PROSPAN COUGH SYRUP SACHETS

Active substance: GROUND IVY DRY EXTRACT 5-7.5:1 ETHANOLIC 30% W/W

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Module 1

Common Technical Document
Prospan Cough Syrup Sachets THR 33518/0022
Drug Substance: Ivy leaves dry extract
1.3.1 Package Leaflet

Page 5 of 10

Module 1.3.1 Package Leaflet
Prospan®
Cough Syrup Sachets
Ivy leaf extract
Patient Information Leaflet
Read all of this leaflet carefully because it contains important information for
you. This medicine is available without prescription. However, you still need to
use Prospan® Cough Syrup Sachets as directed to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor or qualified healthcare practitioner if your symptoms
worsen or do not improve after 7 days.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

What is in this leaflet:
1. What Prospan® Cough Syrup Sachets is and what it is used for
2. Before you take Prospan® Cough Syrup Sachets
3. How to take Prospan® Cough Syrup Sachets
4. Possible side effects
5. How to store Prospan® Cough Syrup Sachets
6. Further information

1. WHAT PROSPAN® COUGH SYRUP SACHETS IS AND WHAT IT IS USED FOR
This product is a traditional herbal medicinal product containing ivy leaf extract.
It is a traditional herbal medicinal product used to relieve chesty coughs associated with the common
cold based on traditional use only.

2. BEFORE YOU TAKE PROSPAN® COUGH SYRUP SACHETS
Do not take Prospan® Cough Syrup Sachets
• if you are allergic (hypersensitive) to the active ingredient, ivy leaf or to any of the excipients of
Prospan® Cough Syrup Sachets (see section 6).
• if you are under 12 years old

ENGELHARD Arzneimittel GmbH & Co. KG
Herzbergstraße 3, 61138 Niederdorfelden, Germany

Module 1

Common Technical Document
Prospan Cough Syrup Sachets THR 33518/0022
Drug Substance: Ivy leaves dry extract
1.3.1 Package Leaflet

Page 6 of 10

Consult your doctor or qualified healthcare practitioner before taking this medicine if
• you have gastritis (inflammation of lining of stomach) or have a gastric ulcer (stomach ulcer)
• you are already taking a medicine to help stop you coughing, such as codeine or dextromethorphan.
If you have difficulty breathing, have a fever or bloody phlegm, consult your doctor or qualified
healthcare practitioner.
Taking other medicines
Studies investigating the effects of Prospan® Cough Syrup in Sachets on other medicines have not
been performed. Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without prescription.
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before taking any medicine.
The safety of this product during pregnancy and breast-feeding has not been established, therefore the
use of this product during pregnancy and breast-feeding is not recommended.
Important information about some of the ingredients
of Prospan® Cough Syrup Sachets:
This medicine contains sorbitol. See section 6.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3. HOW TO TAKE PROSPAN® COUGH SYRUP SACHETS
For oral use only.
Always take Prospan® Cough Syrup Sachets exactly as described in this leaflet.
Do not exceed the stated dose.
You should check with your doctor or pharmacist if you are not sure. The usual dose is:
Adults, the elderly, children aged 12 years and over: take one sachet (5ml) three times daily.
Take one dose in the morning, at midday and in the evening.

For more details on using the sachet, please refer to the diagrams below:
Gently massage the sachet before
use, as shown in order to mix the contents.

Hold the sachet firmly and tear it

ENGELHARD Arzneimittel GmbH & Co. KG
Herzbergstraße 3, 61138 Niederdorfelden, Germany

Module 1

Common Technical Document
Prospan Cough Syrup Sachets THR 33518/0022
Drug Substance: Ivy leaves dry extract
1.3.1 Package Leaflet

Page 7 of 10

open.

Swallow the medicine, squeezing the
sachet until empty.

The contents of the sachet should be taken immediately after opening.
Consult your doctor or qualified healthcare practitioner if your symptoms worsen or if symptoms
persist after using the product for 7 days, if shortness of breath, fever or bloody phlegm occur, if side
effects listed in section 4 become serious or if side effects not listed in section 4 occur.
If you take more Prospan® Cough Syrup Sachets than you should
If you take more than the recommended dose (more than three times the daily dose), you may experience nausea, diarrhoea, vomiting or feel excitable. In this case speak to your doctor, pharmacist or
qualified healthcare practitioner and take this leaflet with you.
If you forget to take this product
Do not take twice the dose but continue to take the usual dose at the usual time.
If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or
qualified healthcare practitioner.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this product may have side effects, although not everybody gets them.
They are listed below.
Allergic reactions, such as skin rash, red itchy skin and shortness of breath; gastrointestinal disorders
such as nausea, vomiting and diarrhoea have been reported.
The frequency is not known.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or qualified healthcare professional. This
includes any possible side effects not listed in this leaflet. You can also report any side effects directly
to the national reporting system via the internet at www.mhra.gov.uk/yellowcard. Alternatively you
can get a paper Yellow Card form from your GP’s surgery or pharmacy, or call free phone 0808 100
3352 (available 10am – 2pm Monday – Friday).

ENGELHARD Arzneimittel GmbH & Co. KG
Herzbergstraße 3, 61138 Niederdorfelden, Germany

Module 1

Common Technical Document
Prospan Cough Syrup Sachets THR 33518/0022
Drug Substance: Ivy leaves dry extract
1.3.1 Package Leaflet

Page 8 of 10

5. HOW TO STORE PROSPAN® COUGH SYRUP IN SACHETS
Keep all medicines out of the reach and sight of children.
Do not use Prospan® Cough Syrup Sachets after the expiry date which is stated on the carton and
sachet after EXP. The expiry date refers to the last day of that month.

6. FURTHER INFORMATION
This product is a traditional herbal medicinal product containing ivy leaf extract.
Active ingredient: Each sachet (5 ml) contains 35 mg of extract (as dry extract) from ivy leaf (Hedera
helix L.) (5 - 7.5 : 1).
Extraction solvent: ethanol 30 % w/w.
This product also contains the following ingredients:
Potassium sorbate
Anhydrous citric acid
Xanthan gum
Cherry flavour
Sorbitol liquid 70% (crystallising)
Purified water.
Each 5 ml of syrup contains 1926 mg sorbitol.
Prospan® Cough Syrup Sachets contains a light brown, slightly cloudy syrup. It contains a plant extract as the active ingredient and its colour and taste can therefore occasionally vary. This, however,
does not affect the quality of the preparation.
Prospan® Cough Syrup Sachets is available in original packs of 21 sachets each containing 5 ml of
syrup.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicine no longer required. These measures will help to protect the environment.

Registration holder and manufacturer of the product:

ENGELHARD Arzneimittel GmbH & Co. KG
Herzbergstrasse 3
D-61138 Niederdorfelden
Germany
Telephone: +49 (0) 6101 539300
Email: info@engelhard.de
Traditional herbal registration number: THR 35693/0002

ENGELHARD Arzneimittel GmbH & Co. KG
Herzbergstraße 3, 61138 Niederdorfelden, Germany

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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