NOTICE
ANSM - Last updated: 13/02/2008
Name of the medicinal product
PROSPAN WITHOUT SUGAR, syrup
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Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist after 5 days, consult your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS PROSPAN WITHOUT SUGAR, syrup AND IN WHAT CASES IS IT USED?
2. BEFORE YOU TAKE PROSPAN WITHOUT SUGAR, syrup?
3. HOW TO TAKE PROSPAN WITHOUT SUGAR, syrup?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE PROSPAN WITHOUT SUGAR, syrup?
6. ADDITIONAL INFORMATION
1. WHAT IS PROSPAN WITHOUT SUGAR, syrup AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
Phytotherapy medication
Therapeutic indications
Traditionally used in occasional benign coughs
Traditionally used in acute benign bronchitis
Caution: If symptoms persist, consult a doctor.
2. BEFORE YOU TAKE PROSPAN WITHOUT SUGAR, syrup?
List of information needed before taking the medication
Not applicable.
Cons-indications
Not applicable.
Precautions for use; special warnings
Take special care with PROSPAN WITHOUT SUGAR, syrup:
Special warnings
Due to the presence of sorbitol, this medication SHOULD NOT BE USED in cases of fructose intolerance (rare hereditary disease).
This medicine contains 0.04 meq of potassium per 5 ml of syrup. Take this into account in people on a low potassium diet
Tell your doctor if you have kidney failure.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Pregnancy
It is best not to use this medication during pregnancy. If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue this treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect:
Sorbitol, potassium.
3. HOW TO TAKE PROSPAN WITHOUT SUGAR, syrup?
Instructions for proper use
Shake well before use.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Please measure the Prospan syrup with the graduated measuring cup.
In adults: 7.5 ml 3 times a day for one week
In children 5 to 15 years: 5 ml 3 times a day for one week
In children under 5 years: 2.5 ml 3 times a day for one week.
Oral use.
One week.
Symptoms and Instructions for Overdose
If you take more PROSPAN WITHOUT SUGAR, you should not have:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take PROSPAN WITHOUT SUGAR, syrup:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, Take special care with PROSPAN WITHOUT SUGAR, syrup: is likely to have undesirable effects, although not everyone is subject to it.
Due to the presence of sorbitol, possibility of digestive disorders and diarrhea.
Skin reactions can be observed.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE PROSPAN WITHOUT SUGAR, syrup?
Keep out of the reach and sight of children.
Expiration date
Do not use PROSPAN WITHOUT SUGAR, syrup after the expiry date stated on the label.
Storage conditions
Store at a temperature not exceeding 25ºC and protect from moisture.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does PROSPAN WITHOUT SUGAR contain, syrup?
The active substance is:
Climbing ivy (dry hydroalcoholic leaf extract) ......................................... ................................ 0.700 g
For 100 ml of syrup.
The other components are:
Purified water, 70% sorbitol (crystallizable), cherry flavor, xanthan gum, potassium sorbate, anhydrous citric acid.
Pharmaceutical form and content
What is PROSPAN WITHOUT SUGAR, syrup and contents of the outer packaging?
This medication is in the form of a syrup.
Bottle of 100, 150 or 200 ml.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
Laboratories MEDIFLOR
37, rue St Romain
69008 Lyon
exploiting
MERCK MEDICATION FAMILIALE
18C, bd Winston Churchill
21070 DIJON
Maker
Engelhard Arzneimittel GmbH & Co.KG
Herzbergstrasse 3
D-61138 NIEDERDORFELDEN
GERMANY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.