PROSPAN / Prospan cough syrup 100ml
Prospan / Prospan syrup is a herbal medicinal product from the German pharmaceutical company Engelhard Arzneimittel.
It is intended for the symptomatic treatment of chronic inflammatory bronchial diseases and acute inflammations of the respiratory tract 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.
Contains the special ivy extract EA 575®. Contains no sugar or artificial colors.
Available in 100 ml and 200 ml packaging.
Method of administration and dosage:
Unless your doctor has prescribed otherwise, the recommended dose is:
Children from 2 to 5 years: 2.5 ml 3 times daily.
Children aged 6 to 9 years: 5 ml 3 times daily.
Adults and children over 10 years: 5 ml 3 times a day. If necessary, the adult dose can be increased to 7.5 ml 3 times a day.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Patient information
Prospan 7 mg/ml syrup
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 syrup is and what it is used for
2. What you need to know before you use Prospan syrup
3. How to use Prospan syrup
4. Possible side effects
5. How to store Prospan syrup
6. Contents of the pack and other information
1. What Prospan syrup is and what it is used for
Prospan syrup is a syrup for oral administration.
Prospan syrup is used for the symptomatic treatment of chronic inflammatory bronchial diseases and acute inflammation of the respiratory tract accompanied by cough.
2. What you need to know before you use Prospan syrup
Do not use Prospan syrup
- 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 syrup.
If the complaints persist or shortness of breath, fever, or purulent or bloody sputum occurs, immediate consultation with a doctor is necessary.
Since there are no sufficient studies on the use of this medicinal product in children under 10 years of age regarding the nature and frequency of adverse reactions, it should only be taken in this age group under close medical supervision. It is not indicated in children under 2 years of age due to the risk of worsening respiratory symptoms!
Other medicines and Prospan syrup
Adverse drug reactions during the simultaneous use of dried ivy extract and other medications have not been observed.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Due to the lack of safety data during pregnancy and breastfeeding, the product should not be used during this period.
Driving and using machines
There is none.
Prospan syrup contains sorbitol and potassium sorbate.
If you take Prospan syrup according to the dosage instructions, you will receive 2.9 g of sorbitol with each dose (7.5 ml for adults). 2.5 ml of syrup contains 0.963 g of sorbitol (=0.08 bread units).
There is a risk for patients with congenital fructose intolerance.
In such cases, treatment should only be carried out after consulting a doctor.
Contains potassium sorbate – has an irritating effect and can cause dermatitis.
3. How to use Prospan syrup
The recommended dose is:
Children from 2 to 5 years: take 2.5 ml 3 times a day*,
Children from 6 to 9 years: take 5 ml 3 times a day,
Adults and children over 10 years: take 5 ml of syrup 3 times a day. If necessary, the adult dose can be increased to 7.5 ml three times a day.
*Prospan syrup is contraindicated for use in children under 2 years of age!
Method of administration
The syrup is taken in the morning, (at noon) and in the evening.
Use the measuring cup provided.
Duration of treatment
The duration of treatment depends on the type and severity of symptoms, but should last at least one week, even for mild respiratory tract inflammation.
For treatment to be successful, it must continue for 2-3 days after symptoms resolve.
If you take more Prospan syrup than you should
Do not exceed the recommended daily dose. Taking significantly high amounts (3 times the daily dose) may cause nausea, vomiting, diarrhea and agitation.
In case of overdose, treatment is symptomatic.
Consult your doctor immediately if you have taken a larger dose of Prospan syrup.
If you forget to take Prospan syrup
Do not take a double dose to make up for a forgotten dose. Instead, continue taking it at the usual time.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Gastrointestinal disorders
Very rare (<1/10,000)
A laxative effect may occur due to the sorbitol content.
Gastrointestinal complaints may occur in patients with increased sensitivity.
Skin and subcutaneous tissue disorders
Very rare (<1/10,000)
Allergic reactions
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 syrup
Store in the original packaging in a dry place at a temperature below 25°C!
Keep out of the reach of children.
Due to the plant extract content in Prospan syrup, it is possible to observe slight clouding of the solution or minimal changes in taste. However, this does not affect the therapeutic efficacy of the product.
6. Contents of the pack and other information
What Prospan syrup contains
The active substance is: dry ivy leaf extract (Hedera helix folium extractum siccum)
1 ml of syrup contains: 7 mg dry ivy leaf extract (5-7.5:1)
The other ingredients are: potassium sorbate, citric acid, xanthan gum, cherry flavor, liquid sorbitol 70% (crystallizing), purified water.
What Prospan syrup looks like and what the pack contains
Prospan syrup is available in the following types of packaging:
100 ml syrup in a brown glass bottle.
200 ml syrup in a brown glass bottle.
21 sachets of 5 ml, packed in a cardboard box.
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:
07/2019
Keep out of reach of children!
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