Syrup based on dry ivy leaf extract indicated in adults and children over 2 years for the relief of productive cough, softening mucus and improving expectoration
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1. What it is PROSPANTUS Syrup and what it is used
PROSPANTUS Syrup is mucolytic and expectorant.
PROSPANTUS Syrup is indicated in adults, adolescents and children over 2 years old for the temporary treatment of cough that accompanies benign bronchial disorders. It facilitates the removal of mucus and modifies dry cough productive and less frequent coughing.
2. What you need to know before you start taking PROSPANTUS Syrup
Do not take PROSPANTUS Syrup if you are allergic (hypersensitive) to ivy (Hedera helix L.) plants of the Araliaceae family, or any of the other ingredients of PROSPANTUS Syrup (listed in section 6).
Do not administer to children under 2 years old as there is a risk of respiratory symptoms become serious.
Warnings and Precautions:
Consult your doctor, pharmacist or nurse before taking PROSPANTUS Syrup.
In children between 2 to 4 years with persistent or recurrent cough medical diagnosis is required before starting treatment.
Call your doctor or pharmacist in cases of dyspnea (difficulty breathing), fever or purulent sputum.
Concomitant use with other antitussives such as codeine or dextromethorphan without prior medical consultation is not recommended.
Caution is advised in patients with gastritis or gastric ulcer.
In case of worsening of symptoms or no improvement occurred after 7 days of starting treatment, it should be discontinued and the doctor should be consulted.
Syrup PROSPANTUS interaction with other medicines:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy, lactation and fertility:
If you are pregnant or breast feeding, or think you might be pregnant or planning to become pregnant, ask your doctor or pharmacist before using this medicine.
There are no adequate and well-controlled studies in pregnant women so their administration is not recommended.
There is no information over the components of this medicine into breast milk, so women no administration is recommended during breastfeeding.
Consult your doctor or pharmacist before taking any medicine.
PROSPANTUS syrup contains sorbitol. If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take PROSPANTUS Syrup
Follow exactly the instructions of medicine administration in this leaflet or as your doctor, pharmacist or nurse. If in doubt, ask your doctor, pharmacist or nurse.
The recommended dose is:
- Adults and adolescents over 12 years old: 5 ml of syrup, 3 times a day.
- Children between 6 and 12 years old: 5 ml of syrup, 2 times a day.
- Children from 2 to 5 years old: 2.5 ml of syrup, 2 times a day.
If it considers that the action of PROSPANTUS syrup is too strong or too weak, talk to your doctor or pharmacist.
PROSPANTUS Syrup should be taken orally. Shake the bottle well before use.
If you take more than you should PROSPANTUS Syrup
In the event that has taken more PROSPANTUS Syrup than you should or in case of overdose or accidental ingestion immediately consult your doctor or pharmacist or call poison control center, phone +34 915 620 420, indicating the medicine and the amount taken.
If you forget to take PROSPANTUS Syrup:
Do not take a double dose to make up for missed doses.
4. POSSIBLE SIDE EFFECTS
Like all medicines, PROSPANTUS Syrup can cause side effects, although not everybody gets them.
Common (may affect between 1 and 10 out of 100 patients) have been reported gastrointestinal reactions such as nausea, vomiting or diarrhea.
Uncommon (may affect between 1 and 10 in every 1,000 patients) have been reported allergic reactions such as hives, rashes, red cheeks (couperose), difficulty breathing (dyspnea).
If any side effects, contact your doctor, pharmacist or nurse, even if it comes to possible side effects not listed in this leaflet.
5. Conservation of PROSPANTUS Syrup
Keep this medicine out of the sight and reach of children. It does not require any special storage conditions.
Do not use PROSPANTUS Syrup after the expiry date on the carton after EXP. The expiry date is the last day of that month. Once broached, expires after 3 months.
6. Contents of the pack and other information
Composition of PROSPANTUS Syrup:
Composition per 2.5 ml syrup:
17.5 mg dry extract of Hedera helix L. leaf (Ivy) (5-7.5: 1), extraction solvent ethanol
30% w / w, equivalent to 88-131 mg of dried leaves of Hedera helix L. hederacoside C content >= 0.875 mg
The other ingredients are: purified water, potassium sorbate, citric acid anhydrous, liquid crystallizable sorbitol, xanthan gum and essence of cherries.
Looks like and contents of the pack:
PROSPANTUS syrup comes in glass jars with screw cap and pourer device, containing 100 ml or 200 ml syrup, together with a measuring cup graduated in 2.5, 5, 7.5 and 10 ml.
You may be marketed pack sizes.
Authorization holder responsible for marketing and manufacturing:
ENGELHARD ARZNEIMITTEL GmbH & Co. KG HERZBERGSTRA?E 3, D-61138 Niederdorfelden GERMANY
For any information about this medicine, please contact the local representative of the holder of the marketing authorization:
INTERNATIONAL FERRER, S.A. Gran Via Carlos III, 94
08028 Barcelona (SPAIN)
Source: Spanish Agency for Medicines and Health Products
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