Prosphantus chewing gum

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Prospantus® Chewable Tablets

Dry extract of Hedera helix L. (ivy)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given 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.

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

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

Contents of the leaflet

1. What Prospantus Chewable Tablets are and what they are used for
2. What you need to know before taking Prospantus Chewable Tablets
3. How to take Prospantus Chewable Tablets
4. Possible adverse effects
5. How to store Prospantus Chewable Tablets
6. Contents of the pack and other information

1. What Prospantus Chewable Tablets are and what they are used for

Prospantus Chewable Tablets is a herbal medicinal product used as an expectorant for productive cough.

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

2. What you need to know before taking Prospantus Chewable Tablets

Contraindication Prospantus Chewable Tablets:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Prospantus Chewable Tablets. If you experience persistent discomfort, breathing difficulties, fever, or if you cough up purulent or blood-tinged sputum, you must consult a doctor immediately.

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

Children and adolescents

Prospantus Chewable Tablets must not be given to children under 6 years of age.

Other medicines and Prospantus Chewable Tablets

No interactions are currently known.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

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

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

Driving and using machines

No special precautions are required.

Prospantus Chewable Tablets contain sorbitol and maltitol

If your doctor has informed you that you have an intolerance to certain sugars or if you know you have such an intolerance, consult your doctor before taking this medicine.

3. How to take Prospantus Chewable Tablets

Follow exactly the dosage instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years of age should suck 1 chewable tablet 4 times a day (equivalent to 104 mg of dried ivy leaf extract per day).

Children between 6 and 12 years of age should suck 1 chewable tablet 2 times a day (equivalent to 52 mg of dried ivy leaf extract per day).

Children under 6 years of age

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

Method of administration

For oral use.

The chewable tablets are meant to be sucked. Allow the tablets to dissolve in the mouth after meals (do not take while lying down).

Duration of treatment

The duration of treatment depends on the type and severity of the condition being treated; generally, it should last about one week. However, if symptoms persist for more than 1 week, consult your doctor.

If you feel that the effect of Prospantus Chewable Tablets is too strong or too weak, consult your doctor or pharmacist.

If you take more Prospantus Chewable Tablets 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, diarrhoea, and restlessness. In such a case, consult your doctor.

If you forget to take Prospantus Chewable Tablets

Do not take a double dose to make up for the missed dose. Continue taking the medicine as directed by your doctor or pharmacist, or as described in this leaflet.

If you stop taking Prospantus Chewable Tablets

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Allergic reactions such as, for example, dyspnea, rash, and urticaria have been observed after ingestion of preparations containing ivy. Gastrointestinal disturbances such as nausea, vomiting, or diarrhea may occur in sensitive patients. The frequency of occurrence of these adverse effects is unknown.

If any of these adverse reactions are severe, or if you notice any adverse reactions not listed in this leaflet, consult your doctor or pharmacist.

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

Reporting of adverse reactions

If you experience any adverse reactions, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Prospantus Chewable Tablets

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

Do not store above 25°C.

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prospantus Chewable Tablets

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

Appearance of the product and contents of the pack

Prospantus® Chewable Tablets are honey-colored and hexagonal in shape.

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

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]

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

FERRER INTERNACIONAL, S.A.
Gran Vía Carlos III, 94
08028 Barcelona (SPAIN)

Date of the most recent review of this leaflet: January 2020

Other sources of information

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