Leaflet: information for the user

Prospantus®Gum Tablets

Dried extract of Hedera helix L. (ivy)

Read this leaflet carefully before you start taking thismedicine, because it contains important informationfor you

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

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

• Ifyou experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

• You should consult a doctor if you get worse or do not improveafter 7 days.

1. What isProspantus Gum Tabletsand what it is used for

2. What you need to know before starting to takeProspantus Gum Tablets

3. How to takeProspantus Gum Tablets

4. Possible adverse effects

5. Storage ofProspantus Gum Tablets

6. Contents of the pack and additional information

Prospantus Chewable Tablets is a plant-based medicationused as an expectorant for productive cough.

It is indicated for adults, adolescents, and children over 6 years old.

Do not take Prospantus Chewable Tablets:

If you are allergic toivy (Hedera helix L.),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 Chewable Tablets. If you experience persistent discomfort or difficulty breathing, fever, or expectoration of purulent or bloody sputum, seek immediate medical attention.

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

Children and adolescents

Prospantus Chewable Tablets should not be administered to children under 6 years of age.

Other medications and Prospantus Chewable Tablets

No interactions are known to date.

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

Pregnancy and breastfeeding

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

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

Driving and operating machinery

No special precautions are required.

Prospantus Chewable Tablets contain sorbitol and maltitol

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 old should chew 1 tablet 4 times a day (equivalent to 104 mg of dry extract of ivy leaves per day).

Children between 6 years and 12 years old should chew 1 tablet 2 times a day (equivalent to 52 mg of dry extract of ivy leaves per day).

Children under 6 years old

Do not administer this medication to children under 6 years old.

Administration Form

For oral use.

The chewable tablets are for chewing. Let the chewable tablets dissolve in the mouth after meals (do not do it while lying down).

Treatment Duration

The treatment duration 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, consult your doctor.

Consult with your doctor or pharmacist if you estimate that the action of Prospantus Chewable Tablets is too strong or too weak.

If you take more Prospantus Chewable Tablets than you should

Do not exceed the recommended daily dose. The 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 Chewable Tablets

Do not take a double dose to compensate for the missed dose, but continue taking the medication as directed by your doctor or pharmacist, or as described in this leaflet.

If you stop taking Prospantus Chewable Tablets

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

Like all medications, this medication may produce adverse effects, although not all people 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 adverse effects is unknown.

If any of the adverse reactions are severe, or if you notice adverse reactions not included in this prospectus, consult your doctor or pharmacist.

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

Reporting Adverse Reactions

If you experience adverse reactions, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this prospectus. You can also report them directly through the national notification system,Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 25°C.

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

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofProspantus Chewable Tablets

• The active ingredient is dried extract of ivy leaves. 1 chewable tablet contains 26 mg ofDried extract of Hedera helix L. (ivy) (5 – 7.5: 1). Solvent for extraction: ethanol 30% (m/m).
• The other components are: liquid maltitol solution 75%, non-crystallizable sorbitol solution 70% (Ph. Eur.), acacia, citric acid, potassium acesulfame, medium-chain triglycerides, orange flavoring, menthol flavoring, and purified water.

Appearance of the product and content of the container

Prospantus®Chewable Tablets are yellow in color and hexagonal in shape.

They are supplied in aluminum/PVC blister strips. Each blister strip contains 10 chewable tablets. Each container contains 20 chewable tablets.

Marketing authorization holder and responsible manufacturer

Engelhard Arzneimittel GmbH & Co.KG

Herzbergstr.3.

61138 Niederdorfelden

Germany

Phone:+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)

Last review date of thisleaflet:January 2020

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)