Leaflet: information for the user

Prospantus Sachet

Dried extract of Hedera helix L. (ivy)

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

Follow exactly the administration instructions 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.

- If you experience any side 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 improve after 7 days.

1. What isProspantus Sachetand what it is used for

2. What you need to know before starting to takeProspantus Sachet

3. How to takeProspantus Sachet

4. Possible side effects

5. Storage ofProspantus Sachet

6. Contents of the pack and additional information

Prospantus Jarabe in sachets is an expectorant.

Prospantus Jarabe in sachets is a plant-based medication used as an expectorant for productive cough accompanying benign bronchial conditions. It facilitates the elimination of mucus.

Prospantus Jarabe in sachets is indicated for adults, adolescents, and children over 6 years old.

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 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 in sachets.

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.

Caution is recommended in patients with gastritis or gastric ulcer.

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

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.

Taking Prospantus Syrup in sachets with other medications:

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

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding, 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.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery.

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

Follow exactly the administration instructions of this medication contained in this

leaflet or those 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 old : 5 ml of syrup (1 blister pack), 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 (1 blister pack), 2 times a day, (equivalent to 70 mg daily of dry extract of ivy leaves).

If you estimate that the action of Prospantus Syrup in Blister Packs is too strong or weak, inform your doctor or pharmacist.

Prospantus Syrup in Blister Packs is taken orally.

For more details on the use of blister packs, follow the diagrams below:

Press the blister pack gently before using it, as shown.

Hold the blister pack firmly and tear the blister pack along the indicated lines.

Swallow the medication, pressing the blister pack until it is empty.

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

If you take more Prospantus Syrup in Blister Packs than you should

In the event that you have taken more Prospantus Syrup in Blister Packs 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 in Blister Packs:

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

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

Like all medications, this medication, rospantus, 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 that do not appear in this prospectus.

If you note allergy symptoms (hypersensitivity), discontinue taking Prospantus Syrup in sachets.

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear 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 usethis medicationafter the expiration date that appears onthe packaging,after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and

medicines that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Prospantus Syrup in sachets:

• The active principle is:dry extract of Hedera helix leaf.5 ml of Prospantus Syrup in sachets contain 35 mg of dry extract ofHedera helixL., 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, and cherry essence.

Appearance of the product and contents of the packaging:

Prospantus Syrup in sachets is presented in sachets containing 5 ml of syrup. The box is a 21-sachet complex of polyethylene terephthalate / adhesive / aluminum / polyethylene.

Holder of the marketing authorization and responsible for manufacturing:

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 holder of the marketing authorization:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Last review date of this leaflet: April 2017.

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/