Prosphantus syrup
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
PROSPANTUS Syrup
Dry extract of Hedera helix L. (ivy)
Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.
Follow exactly the instructions for administration of the medicine 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 adverse effects, consult your doctor or pharmacist, even if they are adverse 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
- What Prospantus Syrup is and what it is used for
- What you need to know before taking Prospantus Syrup
- How to take Prospantus Syrup
- Possible adverse effects
- Storage of Prospantus Syrup
- Contents of the pack and other 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 associated with benign bronchial conditions. It helps facilitate the elimination of mucus.
Prospantus Syrup is indicated for use in adults, adolescents, and children over 2 years of age.
2. What you need to know before taking Prospantus Syrup
Do not take Prospantus Syrup:
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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).
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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.
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 advised in patients with gastritis or gastric ulcer.
If symptoms worsen or if there is no improvement after 7 days of starting treatment, treatment should be discontinued and medical advice sought.
Children
In children aged 2 to 4 years with persistent or recurrent cough, a medical diagnosis is required before starting treatment.
Taking Prospantus Syrup 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 during breastfeeding.
Driving and use of machinery
No studies have been conducted on the effects on the ability to drive or operate machinery.
Prospantus Syrup contains sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Prospantus Syrup
Follow exactly the instructions for use 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: 5 ml of syrup, three times a day (equivalent to 105 mg daily of dried ivy leaf extract).
Children aged 6 to 12 years: 5 ml of syrup, twice a day (equivalent to 70 mg daily of dried ivy leaf extract).
Children aged 2 to 5 years: 2.5 ml of syrup, twice a day (equivalent to 35 mg daily of dried ivy leaf extract).
In children aged 2 to 4 years with persistent or recurrent cough, a medical diagnosis is required before starting treatment.
Children under 2 years of age: Prospantus Syrup must not be administered to children under 2 years of age due to the risk of worsening respiratory symptoms.
If you think that the effect 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 you always take the recommended dose, use the dosing cup provided, which is graduated at 2.5; 5; 7.5 and 10 ml.
Consult a doctor if your condition worsens or does not improve after one week of treatment.
If you take more Prospantus Syrup than you should
If you have taken more Prospantus Syrup 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 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 such a case, 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 further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Frequent (may affect between 1 and 10 out of 100 patients): gastrointestinal system reactions such as nausea, vomiting, or diarrhoea have been reported.
Uncommon (may affect between 1 and 10 out of 1000 patients): allergic reactions such as urticaria, skin rashes, difficulty breathing (dyspnoea) 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.
Reporting of adverse effects
If you experience any type of adverse effect, 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 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
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 container, following “EXP”. The expiry date refers to the last day of the month indicated.
After opening the container, it expires within 6 months. Remember to record the date of opening on the medicine container.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point located in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Prospantus Syrup:
The active substance is: dried extract of leaf of Hedera helix. 2.5 ml of Prospantus Syrup contains 17.5 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: crystallizable liquid sorbitol, xanthan gum, potassium sorbate, anhydrous citric acid, purified water, and cherry flavour.
Appearance of the medicinal product and contents of the container:
Prospantus Syrup is presented in amber glass bottles (type III) of 100 or 200 ml with white polyethylene screw caps. Transparent high-density polyethylene pouring device. Opaque, colourless polypropylene dosing cup graduated at 2.5, 5, 7.5 and 10 ml.
Marketing Authorisation Holder and Manufacturer:
Engelhard Arzneimittel GmbH & Co. KG
Herzbergstrasse 3
D-61138 Niederdorfelden
GERMANY
Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder:
FERRER INTERNACIONAL, S.A.
Gran Vía Carlos III, 94
08028 Barcelona (SPAIN)
Date of the most recent review of this leaflet: April 2017.
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/