PROSPAN Akut 65mg x 10 tabl eff
Prospan / Prospan effervescent tablets is a herbal medicinal product used to relieve cough in bronchitis, in acute inflammation of the respiratory tract accompanied by cough, for symptomatic treatment of chronic inflammatory bronchial diseases. 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 10 effervescent tablets.
Method of administration and dosage:
Children 6–11 years: ½ tablet 2 times daily.
Children over 12 years of age and adults: 1 tablet in the morning and ½ tablet in the evening.
The tablet is dissolved in a glass of warm or cold water and taken immediately after dissolution.
Patient information
Prospan 65 mg effervescent tablets
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, talk to your doctor or pharmacist.
This also 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
What Prospan effervescent tablets are and what they are used for
What you need to know before using Prospan effervescent tablets
How to use Prospan effervescent tablets
Possible side effects
How to store Prospan effervescent tablets
Package contents and additional 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 inflammation of the respiratory tract. 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, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Due to insufficient research, the product should not be taken during pregnancy and breast-feeding.
Driving and using machines
There are 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:
Daily dose
Adults and adolescents over 12 years of age
Morning: 1 effervescent tablet (equivalent to 65 mg of dry ivy leaf extract)
Evening: ½ effervescent tablet (equivalent to 32.5 mg dry ivy leaf extract)
Daily dose: 1 x 1 and 1 x 1/2 effervescent tablets, corresponding to 97.5 mg of dry ivy leaf extract
Children aged 6 to 12 years
½ effervescent tablet (equivalent to 32.5 mg dry ivy leaf extract
Daily dose: 2 x ½ 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 treatment
The duration of treatment depends on the nature and severity of your condition. Even in mild respiratory tract infections, treatment should last at least one week. To ensure that your recovery is permanent and complete, it is recommended to continue taking Prospan for 2-3 days after the symptoms have passed. If you feel that the effect of Prospan is too strong or too weak, tell your doctor or pharmacist.
If you take more Prospan effervescent tablets than you should
Do not exceed the recommended daily dose. Taking significantly high amounts (more than 3 times the daily dose) may cause nausea, vomiting or diarrhea. In such cases, 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 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 effervescent tablets
Keep out of the reach and sight 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, flavor.
Each effervescent tablet contains 328 mg of carbohydrates (equivalent to 0.03 bread units).
What Prospan effervescent tablets look like and what the pack 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 types of packaging can be released for sale.
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!
