PROSPAN for cough relief X 10 effective tablets.

PROSPAN effervescent tablets 65 mg * 10
Leaflet: patient information Prospan 65 mg effervescent tablets Dry ivy leaf extract Prospan 65 mg effervescent tablets Hedera helix folium extractum siccum 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, 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 gets worse, you should seek medical advice.
What this leaflet contains 1. What Prospan effervescent tablets are and what they are used for 2. What you need to know before you use Prospan effervescent tablets 3. How to use Prospan effervescent tablets 4. Possible side effects 5. How to store Prospan effervescent tablets 6. Contents of the pack and other information
1. What are Prospan effervescent tablets and what are they used for?
Prospan effervescent tablets is a herbal medicinal product for the treatment of respiratory tract inflammations.
Prospan effervescent tablets are used for the symptomatic treatment of chronic inflammatory bronchial diseases and acute inflammation of the respiratory tract accompanied by cough.
Note: If symptoms persist or shortness of breath, fever, or purulent or bloody sputum occurs, a doctor should be consulted immediately.
2. What you need to know before you use Prospan effervescent tablets
Do not use Prospan effervescent tablets:

if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
In case of fructose intolerance, treatment should only be carried out after consulting a doctor.

Warnings and precautions Talk to your doctor or pharmacist before using Prospan effervescent tablets
Children: Prospan effervescent tablets should not be used in children under 6 years of age.
Other medicines and Prospan effervescent tablets No studies have been performed. No interactions are known to date. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding 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 insufficient research, the product should not be taken during pregnancy and breast-feeding.
Driving and using machines: No special warnings.
Prospan effervescent tablets contain sodium and lactose. Each effervescent tablet contains 6.58 mmol (or 151.33 mg) sodium. This should be taken into account by patients on a controlled sodium diet. The flavourings contain lactose. Each tablet contains 29.7 mg lactose. Patients with sugar intolerance should take Prospan effervescent tablets only after consulting a doctor.
3. How to use Prospan effervescent tablets
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.
Unless your doctor has prescribed otherwise, the usual dose is:

Age
Single dose
Daily dose

Adults and adolescents over 12 years of age
Morning: 1 effervescent tablet (equivalent to 65 mg dry ivy leaf extract) Evening: 1/2 effervescent tablet (equivalent to 32.5 mg dry ivy leaf extract) 
1 x 1 and 1 x 1/2 effervescent tablets corresponding to 97.5 mg dry ivy leaf extract

Children aged 6 to 12 years
1/2 effervescent tablet (corresponding to 32.5 mg dry ivy leaf extract   
2 x 1/2 effervescent tablet, corresponding to 65 mg of dry ivy leaf extract

Method of administration The effervescent tablets are taken after dissolving. The tablets can be divided in half. The tablets are dissolved in a glass of water (about 100 - 200 ml) and taken in the morning and evening. Warm or cold water can be used to dissolve them.
Duration of treatmentThe duration of treatment depends on the nature and severity of your condition. Even with mild inflammation of the respiratory tract, treatment should last at least one week. To ensure that your recovery is permanent and complete, it is recommended to continue taking Prospal for 2-3 days after the symptoms have passed. If you feel that the effect of Prospal is too strong or too weak, inform your doctor or pharmacist.
If you take more Prospan effervescent tablets than you should Do not exceed the recommended daily dose. Taking significantly higher amounts (more than 3 times the daily dose) may cause nausea, vomiting or diarrhea. In this case, you should consult your doctor.
If you forget to take Prospan effervescent tablets Do not take a double dose to make up for a forgotten dose. Continue taking Prospan effervescent tablets as prescribed by your doctor or as described in this leaflet.
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.

Possible side effects: In very rare cases, after taking a medicinal product containing ivy, allergic reactions such as shortness of breath, swelling, redness of the skin, itching may occur. In rare cases, in more sensitive patients, gastrointestinal complaints such as nausea, vomiting and diarrhea may occur.
Reporting of 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.
Bulgarian Medicines Agency, Sofia 1303, 8 Damyan Gruev Str., Tel.: +359-28903417, website: www.bda.bg.
5. How to store Prospan effervescent tablets Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
6. Contents of the pack and other information
What Prospan effervescent tablets contain

The active substance is: dry ivy leaf extract. Each effervescent tablet contains: 65 mg dry ivy leaf extract (5-7.5:1). Extracting agent: ethanol 30 % v/v;
The other ingredients are: Citric acid, anhydrous; sodium bicarbonate; sodium carbonate, anhydrous; mannitol; simethicone, saccharin sodium-2-hydrate; sodium cyclamate; sodium citrate-2-hydrate; sorbitol; medium chain triglycerides; macrogolglycerol hydroxystearate, flavour. Each effervescent tablet contains 328 mg of carbohydrates (corresponding to 0.03 bread units).

What Prospan effervescent tablets look like and what the package contains. The effervescent tablets are individually packaged in sachets. Prospan effervescent tablets are available in original packs of 10 and 20 effervescent tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer: Engelhard Arzneimittel GmbH & Co. KG, Herzbergstrasse 3, 61138 Niedeidofelden, Germany.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Vedra International AD, Sofia 1407.