PROSPAN lozenges x 20
Prospan / Prospan lozenges are recommended for acute and chronic respiratory diseases, as well as for bronchial inflammation accompanied by cough.
It is effective against cough and bronchitis, as it liquefies bronchial secretions and facilitates their discharge, affects inflammation of the respiratory tract, relaxes the bronchi, facilitates breathing and relieves cough. Available in a pack of 20 lozenges.
Method of administration and dosage:
Children from 6 to 12 years: 1 lozenge, 2 times daily.
Children over 12 years of age and adults: 1 lozenge, 4 times daily.
Allow the tablets to dissolve slowly in the mouth after a meal (do not take while lying down).
Patient information
Prospan® 26 mg lozenges
Dry ivy leaf extract
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What Prospan® lozenges are and what they are used for
2. What you need to know before using Prospan® syrup
3. How to use Prospan® lozenges
4. Possible side effects
5. How to store Prospan® lozenges
6. Contents of the pack and other information
1. What Prospan® lozenges are and what they are used for
Prospan® lozenges are a herbal medicinal product that is used for the symptomatic treatment of chronic bronchial diseases and acute inflammation of the respiratory tract accompanied by cough.
2. What you need to know before using Prospan® lozenges
Do not use Prospan® lozenges
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Prospan® lozenges.
If the complaints persist or shortness of breath, fever, or purulent or bloody sputum occurs, immediate consultation with a doctor is necessary.
Children
Prospan® lozenges are not intended for children under 6 years of age.
Other medicines and Prospan® lozenges
No interaction studies have been conducted to date. There are no known interactions between Prospan® lozenges and other medicinal products.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breastfeeding and fertility
This medicine should not be used during pregnancy and breastfeeding, as there is insufficient data from studies conducted with pregnant and breastfeeding women.
Driving and using machines
No special precautions are necessary.
Prospan® lozenges contain sorbitol and maltitol.
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this product.
3. How to use Prospan® lozenges
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Adults and children over 12 years of age: suck 1 tablet 4 times daily (equivalent to 104 mg of dry ivy leaf extract or 624 mg of the starting substance daily).
Children between 6 and 12 years of age: suck 1 tablet twice daily (equivalent to 52 mg of dry ivy leaf extract or 312 mg of the starting substance daily).
Method of administration
Lozenges
Allow the tablets to dissolve slowly in the mouth after a meal (do not take while lying down).
Duration of treatment
The duration of treatment depends on the type and severity of symptoms.
As a rule, treatment should last about 1 week. However, if your symptoms persist for more than 1 week, please seek medical advice.
Please inform your doctor or pharmacist if you feel that the effect of Prospan® lozenges is too strong or too weak.
If you take more Prospan® lozenges than you should
Do not exceed the recommended daily dose. Taking significantly larger 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 Prospan® lozenges
Do not take a double dose to make up for a forgotten dose. Continue taking the medicine as prescribed by your doctor or as directed in this leaflet.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following classification was used to assess adverse drug reactions.
Very common: more than 1 in 10 patients
Common: 1 to 10 in 100 patients
Uncommon: 1 to 10 in 1,000 patients
Rare: 1 to 10 in 10,000 patients
Very rare less than 1 in 10,000
Not known (frequency cannot be estimated from the available data)
Very rare
Allergic reactions such as shortness of breath, swelling, skin redness, and itching may occur after taking medications containing ivy.
Uncommon
In patients with increased sensitivity, gastrointestinal complaints such as nausea, vomiting and diarrhea may occur.
At the first symptoms of allergy, treatment should be discontinued.
Reporting side effects
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help to provide more information on the safety of this medicine.
Executive Agency for Medicines
Sofia 1303, 8 Damyan Gruev Str.
Tel.: +359 28903417
website: www.bda.bg
5. How to store Prospan® lozenges
Keep out of the reach of children.
Store below 25°C!
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
6. Contents of the pack and other information
What Prospan® lozenges contain
The active substance is: dry ivy leaf extract. 1 lozenge contains 26 mg of dry ivy leaf extract (Hedera helix L., folium) DER (5-7.5:1).
Extractant: ethanol 30 % vol./vol.
The other ingredients are: liquid maltitol, liquid sorbitol 70% (non-crystallizing), acacia, citric acid, acesulfame potassium, medium chain triglycerides, orange flavor, mint flavor, purified water.
1 lozenge contains: 0.53 g maltitol and 0.53 g sorbitol, equivalent to approximately 0.09 bread units.
1 lozenge contains 2.6 kcal=10.6 kJ.
What Prospan® lozenges look like and what the package contains
Prospan® tablets are brown hexagonal lozenges, packaged in a transparent PVC/Al foil blister with 20 tablets.
Marketing Authorisation Holder and Manufacturer:
Engelhard Arzneimittel GmbH & Co. KG
Herzbergstrasse 3, 61138 Niederdorfelden, Germany
Distributor:
Salveo Bulgaria EOOD
Sofia, 1505, 48 Sitnyakovo Blvd., 8th floor
www.salveopharma.bg
Date of last revision of the leaflet:
March 2020
Keep out of reach of children!