PROSPAN liquid 7mg/ml 5ml x 21
Prospan / Prospan liquid sachets are an oral liquid used in the treatment of acute and chronic inflammatory diseases 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. Herbal medicinal product with ivy leaf extract. Available in a pack of 21 sachets.
Method of administration and dosage:
Children aged 6 to 12 years: 1 sachet 2 times daily.
Adults and children over 12 years of age: 1 sachet 3 times daily.
For best effect, the oral solution should be taken undiluted – morning, noon, and evening.
Patient information
Prospan Liquid 7 mg/ml oral liquid
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 Liquid is and what it is used for
2. What you need to know before you use Prospan Liquid
3. How to use Prospan Liquid
4. Possible side effects
5. How to store Prospan Liquid
6. Contents of the pack and other information
1. What is Prospan® liquid and what is it used for?
Prospan® liquid is an oral liquid.
Prospan Liquid is used for the symptomatic treatment of: chronic inflammatory bronchial diseases and acute inflammation of the respiratory tract accompanied by cough.
If you do not feel better or your condition worsens, you should seek medical attention.
2. What you need to know before you use Prospan® liquid
Do not use Prospan® liquid
- 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® liquid.
If the complaints persist or shortness of breath, fever, or purulent or bloody sputum occurs, immediate consultation with a doctor is necessary.
Prospan Liquid is not suitable for children under 6 years of age.
Other medicines and Prospan® liquid
To date, there are no known interactions between Prospan® liquid 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
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 liquid contains sorbitol.
If used according to the dosage instructions, each dose of Prospan Liquid contains up to 1.9 g of sorbitol.
There is a risk for patients with congenital fructose intolerance.
In such cases, treatment should only be carried out after consulting a doctor.
3. How to use Prospan® liquid
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.
Adults and children over 12 years of age take 1 sachet (5 ml) three times a day. The daily dose (15 ml) corresponds to 105 mg of dry ivy leaf extract.
Children from 6 to 11 years of age take 1 sachet (5 ml) twice a day. The daily dose (10 ml) corresponds to 70 mg of dry ivy leaf extract.
Method of administration
Prospan liquid is taken in the morning, (at noon) and in the evening.
Shake the sachet lightly before opening it.
After opening, pour the entire amount of liquid directly into your mouth.
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 have any doubts that the effect of Prospan® liquid is too strong or too weak, please consult your doctor or pharmacist.
If you take more Prospan® liquid than you should
Do not exceed the recommended daily dose. Taking significantly high amounts (3 times the daily dose) may cause nausea, vomiting and diarrhea.
Consult your doctor immediately if you have taken a larger dose of Prospan Liquid.
If you forget to take Prospan® liquid
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.
The frequency of adverse drug reactions is determined according to the following classification:
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 patients
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.
Infrequent
In patients with increased sensitivity, gastrointestinal complaints such as nausea, vomiting and diarrhea may occur.
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® liquid
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the packaging.
The expiry date refers to the last day of that month.
Due to the plant extract content in Prospan® liquid, it is possible to observe slight clouding of the solution or minor changes in taste. However, this does not affect the therapeutic efficacy of the product.
6. Contents of the pack and other information
What does Prospan® liquid contain?
The active substance is: dry ivy leaf extract (Hedera helix folium extractum siccum)
1 ml syrup contains: 7 mg dry ivy leaf extract (5-7.5:1)
Extraction medium: ethanol 30% (v/v)
The other ingredients are: potassium sorbate (preservative), anhydrous citric acid, xanthan gum, liquid sorbitol 70% (crystallizing), flavor, menthol, purified water.
5 ml of the liquid contains 1.926 g of sorbitol = 0.16 bread units.
What Prospan® liquid looks like and what the package contains
Prospan® liquid is available in 5 ml sachets.
21 sachets per pack.
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
Last revision of the leaflet:
December 2014
Keep out of reach of children!