PROSPANTUS SYRUP

Introduction

Package Leaflet: Information for the User

PROSPANTUS Syrup

Dry Extract of Hedera helix L. (Ivy)

Read the entire package leaflet carefully before starting to take this medication because it contains important information for 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 symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

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

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

Prospantus Syrup is an expectorant.

Prospantus Syrup is a herbal medicine used as an expectorant for productive cough accompanying benign bronchial conditions. It facilitates the elimination of mucus.

Prospantus Syrup is indicated for adults, adolescents, and children over 2 years of age.

2. What you need to know before taking Prospantus Syrup

Do not take Prospantus Syrup:

• 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).

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

Warnings and Precautions:

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

You should consult your doctor or pharmacist in cases of dyspnea (difficulty breathing), fever, or purulent sputum.

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

Cautions are recommended in patients with gastritis or gastric ulcers.

In the event of worsening symptoms or if no improvement occurs after 7 days of starting treatment, treatment should be discontinued and a doctor consulted.

Children

In children between 2 and 4 years of age with persistent or recurrent cough, a medical diagnosis is required before starting treatment.

Taking Prospantus Syrup with other medications

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication.

Pregnancy, Breastfeeding, and Fertility:

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

Pregnancy:

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

Breastfeeding:

There is no information on the passage of the components of this medication into breast milk, so its administration is not recommended in breastfeeding women.

Driving and Using Machines

No studies have been conducted on the effects on the ability to drive and use machines.

Prospantus Syrup contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Prospantus Syrup

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

The recommended dose is:

Adults and adolescents over 12 years of age: 5 ml of syrup, 3 times a day, (equivalent to 105 mg daily of dry extract of ivy leaves).

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

• Children from 2 to 5 years: 2.5 ml of syrup, 2 times a day, (equivalent to 35 mg daily of dry extract of ivy leaves).

In children from 2 to 4 years with persistent or recurrent cough, a medical diagnosis is required before starting treatment.

Children under 2 years: Prospantus Syrup should not be administered to children under 2 years of age due to the risk of worsening respiratory symptoms.

If you think the action of Prospantus Syrup is too strong or too weak, tell your doctor or pharmacist.

Prospantus Syrup is taken orally. Shake the bottle well before use.

To ensure that you always take the recommended dose, you should use the measuring cup included, which is graduated in 2.5, 5, 7.5, and 10 ml.

You should consult a doctor if your symptoms worsen or do not improve after a week of treatment.

If you take more Prospantus Syrup than you should

In the event that you have taken more Prospantus Syrup than you should, or in case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medication 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 this case, you should consult your doctor.

If you forget to take Prospantus Syrup

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

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

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

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

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

If you notice symptoms of allergy (hypersensitivity), discontinue the use of Prospantus Syrup.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Prospantus Syrup

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging, after "EXP". The expiration date is the last day of the month indicated.

Once the packaging is opened, it expires after 6 months. Remember to record the opening date on the medication packaging.

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

6. Package Contents and Additional Information

Composition of Prospantus Syrup:

The active ingredient is: dry extract of ivy leaf. 2.5 ml of Prospantus Syrup contains 17.5 mg of dry extract of Hedera helix L., leaf (5-7.5:1), extraction solvent: ethanol 30% m/m.

The other components are: crystallizable liquid sorbitol, xanthan gum, potassium sorbate, anhydrous citric acid, purified water, and cherry flavor.

Appearance of the product and package contents:

Prospantus Syrup is presented in type III amber glass bottles of 100 or 200 ml and a white polyethylene screw cap. High-density polyethylene pouring device, transparent. Opaque and colorless polypropylene measuring cup graduated in 2.5, 5, 7.5, and 10 ml.

Marketing Authorization Holder and Manufacturer:

Engelhard Arzneimittel GmbH & Co. KG

Herzbergstrasse 3

D-61138 Niederdorfelden

GERMANY

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

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (SPAIN)

Date of the last revision of this package leaflet: April 2017.

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/