PROSPANTUS GUMMY PASTILLES

Introduction

Package Leaflet: Information for the User

Prospantus®Gum Lozenges

Dry extract of Hedera helix L. (ivy)

Read the entire package leaflet carefullybefore starting to take thismedication,as it contains important informationfor you

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

• You should consult a doctor if your condition worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What Prospantus Gum Lozenges are and what they are used for
2. What you need to know before taking Prospantus Gum Lozenges
3. How to take Prospantus Gum Lozenges
4. Possible side effects
5. Storage of Prospantus Gum Lozenges
6. Package Contents and Additional Information

1. What Prospantus Gum Lozenges are and what they are used for

Prospantus Gum Lozenges are a herbal medicine used as an expectorant for productive cough.

They are indicated for adults, adolescents, and children over 6 years of age.

2. What you need to know before taking Prospantus Gum Lozenges

Do nottake Prospantus Gum Lozenges:

If you are allergic to ivy (Hedera helix L.), to plants of the Araliaceae family, or to any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before taking Prospantus Gum Lozenges. In case of persistent discomfort or difficulty breathing, fever, as well as purulent or bloody sputum, you should consult a doctor immediately.

If you have stomach problems such as gastritis or gastric ulcer, you should consult your doctor before taking this medication.

Children and Adolescents

Prospantus Gum Lozenges should not be administered to children under 6 years of age.

Other Medications and Prospantus Gum Lozenges

No interactions are known to date.

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

This medication should not be used in pregnant women and breastfeeding mothers, as there is not enough information available on its safety in these cases.

Driving and Using Machines

No special precautions are required.

Prospantus Gum Lozenges contain sorbitol and maltitol

If your doctor has told you that you have an intolerance to certain sugars or if you know you have one, consult with them before taking this medication.

3. How to take Prospantus Gum Lozenges

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years of age should suck 1 gum lozenge 4 times a day (equivalent to 104 mg of dry extract of ivy leaves per day).

Children between 6 and 12 years of age should suck 1 gum lozenge 2 times a day (equivalent to 52 mg of dry extract of ivy leaves per day).

Children under 6 years

Do not administer this medication to children under 6 years of age.

Method of Administration

For oral use.

The gum lozenges are for sucking. Allow the gum lozenges to dissolve in the mouth after meals (do not do this while lying down).

Duration of Treatment

The duration of treatment is determined by the type and severity of the condition being treated; in general, it should last approximately one week. However, if symptoms persist for more than 1 week, you should consult a doctor.

Consult your doctor or pharmacist if you think the action of Prospantus Gum Lozenges is too strong or too weak.

If you take more Prospantus Gum Lozenges than you should

Do not exceed the recommended daily dose. Ingestion of significantly higher amounts (more than three times the daily dose) may cause nausea, vomiting, diarrhea, and restlessness. In this case, consult your doctor.

If you forget to take Prospantus Gum Lozenges

Do not take a double dose to make up for the forgotten dose, but continue taking the medication as your doctor or pharmacist has indicated, or as described in this package leaflet.

If you stop taking Prospantus Gum Lozenges

If you have any other questions about the use of this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Allergic reactions, such as dyspnea, exanthema, and urticaria, have been observed after ingestion of preparations containing ivy. Gastrointestinal discomfort, such as nausea, vomiting, or diarrhea, may occur in sensitive patients. The frequency of these side effects is unknown.

If any of the side effects are severe, or if you notice side effects not included in this package leaflet, consult your doctor or pharmacist.

If you notice symptoms of an allergy (hypersensitivity), stop taking the medication and consult your doctor.

Reporting Side Effects

If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the national reporting system, Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Prospantus Gum Lozenges

Keep this medication out of the sight and reach of children.

Do not store above 25°C.

Keep in the original package to protect the contents from moisture.

Do not use this medication after the expiration date shown on the package and on the blister after CAD. The expiration date is the last day of the indicated month.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofProspantus Gum Lozenges

• The active ingredient is dry extract of ivy leaves. 1 gum lozenge contains 26 mg of Dry Extract of Ivy Leaves (Hedera helix L.) (5-7.5:1). Extraction solvent: ethanol 30% (m/m).
• The other components are: liquid maltitol solution 75%, non-crystallizable sorbitol solution 70% (Ph. Eur.), acacia, citric acid, acesulfame potassium, medium-chain triglycerides, orange flavor, menthol flavor, and purified water.

Appearance of the Product and Package Contents

Prospantus^®Gum Lozenges are honey-colored and hexagonal in shape.

They are supplied in blister strips of aluminum/PVS. Each blister strip contains 10 gum lozenges. Each package contains 20 gum lozenges.

Marketing Authorization Holder and Manufacturer

Engelhard Arzneimittel GmbH & Co.KG

Herzbergstr. 3.

61138 Niederdorfelden

Germany

Tel.: +49 6101 539 300

Fax: +49 6101 539 315

Email: [email protected]

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

FERRER INTERNACIONAL, SA

Gran Vía Carlos III, 94

08028 Barcelona (SPAIN)

Date of the Last Revision of thisPackage Leaflet:January 2020

Other Sources of Information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)