Prospect: information for the user

PROSPANTUS Syrup

Dried extract of Hedera helix L. (ivy)

Read this prospect carefully before starting to take this medicine because it contains important information for you.

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

- Keep this prospect, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

- You should consult a doctor if you worsen or do not improve after 7 days.

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

2. What you need to know before starting to take Prospantus Syrup

3. How to take Prospantus Syrup

4. Possible adverse effects

5. Storage of Prospantus Syrup

6. Contents of the package and additional information

Prospantus Syrup is an expectorant.

Prospantus Syrup is a plant-based medication used as an expectorant for productive coughs that accompany benign bronchial conditions.It facilitates the elimination of mucus.

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

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 (included in section 6).

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

Warnings and precautions:

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

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

Do not recommend concomitant use with other antitussives such as codeine or dextromethorphan without prior medical consultation.

Recommended caution in patients with gastritis or gastric ulcer.

In case of worsening of symptoms or if no improvement occurs after 7 days of starting treatment, treatment should be interrupted and your doctor should be consulted.

Children

In children between 2 and 4 years old 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 taken recently 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

No adequate and well-controlled studies have been conducted in pregnant women, so administration is not recommended.

Breastfeeding:

No information is available on the passage of components of this medication to breast milk, so administration is not recommended to women during the breastfeeding period.

Driving and operating 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 indicated that you have an intolerance to certain sugars, 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. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years old: 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 old: 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 old: 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 old 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 old due to the risk of worsening respiratory symptoms.

If you estimate that the action of Prospantus Syrup is too strong or too weak, inform 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 dosing cup included, which is graduated in 2.5; 5; 7.5 and 10 ml.

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

If you take moreProspantusSyrupthan 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 Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

Do not exceed the recommended daily dose. The 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 forgot to take Prospantus Syrup

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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

Ifyou experience adverse effects, consult your doctor or pharmacist,even if they are adverse effects not listed in this prospectus.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://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.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging, after “CAD”. The expiration date is the last day of the month indicated.

Once the packaging is opened, it expires after 6 months. Please note the date of opening on the medication packaging.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition ofProspantusSyrup:

The active ingredient is:dry extract of Hedera helix leaf.2.5 ml of Prospantus Syrup contains17.5 mg of dry extract of Hedera helix L., leaf (ivy leaves) (5-7.5:1), extraction solvent: ethanol 30% m/m

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

Appearance of the product and contents of the packaging:

Prospantus Syrup is presented in amber-colored type III glass bottles of 100 or 200 ml with a white polyethylene screw cap. High-density transparent polyethylene dropper.Graduated polypropylene dosing vialin opaque and colorlessgraduated in 2.5, 5, 7.5, and 10 ml.

Holder of the marketing authorization and responsible for manufacturing:

EngelhardArzneimittelGmbH & Co. KG

Herzbergstrasse3

D-61138Niederdorfelden

GERMANY

For more information about this medication, please contact the local representative of the marketing authorization holder:

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (SPAIN)

Last review date of this leaflet: April 2017.

Further 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/