PROSPAN Akut 65mg x 10 tabl eff
SLEEPING eff. table 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 also includes any possible side effects not described in this leaflet. See point 4.
If you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What Prospan effervescent tablets are and what they are used for
2. What you need to know before using 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 package and additional information
1. What is Prospan effervescent tablets and what is it 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 complaints persist or shortness of breath, fever, as well as purulent or bloody sputum appear, a doctor should be consulted immediately.
2. What you need to know before using Prospan effervescent tablets
Do not use Prospan effervescent tablets:
if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
in case of intolerance to fructose, treatment should be carried out only 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 conducted. No interactions are known to date.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy, lactation 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 breastfeeding.
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 considered in patients who need a sodium controlled diet.
Flavors contain lactose. Each tablet contains 29.7 mg of lactose. Patients suffering from 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 of dry ivy leaf extract)
Evening: 1/2 effervescent tablet (corresponding 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 dry ivy leaf extract
Application method
Effervescent tablets are taken after dissolution.
Tablets can be split 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 with mild inflammations of the respiratory tract, the 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 have the feeling that the effect of Prospal is too strong or too weak, tell your doctor or pharmacist.
If you have taken more than the required dose of Prospan effervescent tablets
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 a 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 missed 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;
Frequency not known: cannot be determined from the available data.
Possible side effects
In very rare cases, allergic reactions such as shortness of breath, swelling, redness of the skin, itching may occur after taking a medicinal product containing ivy.
In rare cases, in more sensitive patients, the appearance of gastrointestinal complaints, such as nausea, vomiting and diarrhea, is possible.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can contribute to getting more information about the safety of this medicine.
Executive Medicines Agency,
Sofia 1303, Damyan Gruev St. 8,
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 pack. The expiration date corresponds to the last day of the specified month.
6. Contents of the package and additional information
What Prospan effervescent tablets contain
The active substance is: dry ivy leaf extract. Each effervescent tablet contains: 65 mg of 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, aroma. 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
Effervescent tablets are individually packed in sachets.
Prospan effervescent tablets are available in original packs of 10 and 20 effervescent tablets.
Not all types of packaging can be put on sale.
