Common Technical Document

Prospan Cough Syrup Sachets THR 33518/0022

Drug Substance: Ivy leaves dry extract

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Module 1.3.1 Package Leaflet Prospan®

Cough Syrup Sachets

Ivy leaf extract

Patient Information Leaflet

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

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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.

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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).

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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

HerzbergstraBe 3, 61138 Niederdorfelden, Germany