Prosphantus syrup in sachets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Prospantus Syrup in sachets

Dry extract of Hedera helix L. (ivy)

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or as 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.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

Contents of the leaflet

1. What Prospantus Syrup in sachets is and what it is used for
2. What you need to know before taking Prospantus Syrup in sachets
3. How to take Prospantus Syrup in sachets
4. Possible adverse effects
5. How to store Prospantus Syrup in sachets
6. Contents of the pack and other information

1. What Prospantus Syrup in sachets is and what it is used for

Prospantus Syrup in sachets is an expectorant.

Prospantus Syrup in sachets is a herbal medicinal product used as an expectorant for productive cough associated with benign bronchial conditions. It facilitates the elimination of mucus.

Prospantus Syrup in sachets is indicated for use in adults, adolescents, and children over 6 years of age.

2. What you need to know before taking Prospantus Syrup in sachets

Do not take Prospantus Syrup in sachets:

• 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).

• Do not administer to children under 2 years of age, as there is a risk that respiratory symptoms may worsen.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Prospantus Syrup in sachets.

You should consult your doctor or pharmacist if you have dyspnea (difficulty breathing), fever, or purulent sputum.

Concomitant use with other antitussives such as codeine or dextromethorphan is not recommended without prior medical advice.

Caution is recommended in patients with gastritis or gastric ulcer.

This medicine should not be administered to children aged 2 to 5 years, as it cannot be adequately dosed.

If symptoms worsen or no improvement occurs after 7 days of starting treatment, treatment should be discontinued and you should consult your doctor.

Taking Prospantus Syrup in sachets with other medicines:

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

Pregnancy, breastfeeding, and fertility:

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

Pregnancy:

There are no adequate and well-controlled studies in pregnant women; therefore, administration is not recommended.

Breastfeeding:

There is no information on whether the components of this medicine pass into breast milk; therefore, administration is not recommended to women during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

No studies have been conducted on the effects of this medicine on the ability to drive or operate machinery.

Prospantus Syrup in sachets contains sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Prospantus Syrup in sachets

Follow exactly the administration instructions for this medicine provided in this
leaflet or as indicated 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: 5 ml of syrup (1 sachet), 3 times daily (equivalent to 105 mg daily of dry ivy leaf extract).

• Children between 6 and 12 years of age: 5 ml of syrup (1 sachet), 2 times daily (equivalent to 70 mg daily of dry ivy leaf extract).

If you feel that the effect of Prospantus Syrup in sachets is too strong or too weak, inform your doctor or pharmacist.

Prospantus Syrup in sachets is taken orally.

For further details on how to use the sachets, follow the diagrams below:

Gently press the sachet before use, as shown.

Hold the sachet firmly and tear along the dotted lines.

Swallow the medicine by squeezing the sachet until it is empty.

You should consult a doctor if your condition worsens or does not improve after one week of treatment.

If you take more Prospantus Syrup in sachets than you should:

If you have taken more Prospantus Syrup in sachets than recommended, or in case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested.

Do not exceed the recommended daily dose. Ingestion of significantly higher amounts (more than three times the daily dose) may cause nausea, vomiting, and diarrhea.

In such cases, you should consult your doctor.

If you forget to take Prospantus Syrup in sachets:

Do not take a double dose to make up for the missed dose.

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

4. Possible adverse effects

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

Common (may affect between 1 and 10 out of 100 patients): gastrointestinal system reactions such as nausea, vomiting, or diarrhea have been reported.

Uncommon (may affect between 1 and 10 out of 1000 patients): allergic reactions such as urticaria, skin rashes, difficulty breathing (dyspnea) have been reported.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

If you notice symptoms of allergy (hypersensitivity), stop taking Prospantus Syrup in sachets.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Prospantus Syrup in sachets

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging, following "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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prospantus Syrup in sachets:

• The active substance is: dried extract of Hedera helix leaf. 5 ml of Prospantus Syrup in sachets contains 35 mg of dried extract of Hedera helix L., leaf (ivy leaves) (5-7.5:1), extraction solvent: ethanol 30% m/m.

• The other components are: purified water, potassium sorbate, anhydrous citric acid, crystallizable liquid sorbitol, xanthan gum, frescofort flavor permaseal, natural orange flavor, and levomenthol.

Appearance of the product and pack contents:

Prospantus Syrup in sachets is supplied in sachets containing 5 ml of syrup. The pack contains 21 sachets made of a polyethylene terephthalate / adhesive / aluminum / polyethylene laminate.

Marketing Authorization Holder and Manufacturer:

Engelhard Arzneimittel GmbH & Co. KG

Herzbergstrasse 3

D-61138 Niederdorfelden

Germany

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

Date of the most recent review of this leaflet: November 2025.

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