NOTICE
ANSM - Updated on: 24/02/2016
Name of the medicinal product
MAXILASE THROAT ALPHA-AMYLASE 200 U. CEIP / ml, syrup
Alpha-amylase
framed
Read this leaflet carefully before you start using 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, consult a physician.
· 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 MAXILASE ALPHA-AMYLASE 200 UGGS THICKNESS 200 U. CEIP / ml, syrup AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE MAXILASE ALPHA-AMYLASE 200 U. CEIP / ml, syrup?
3. HOW TO TAKE MAXILASE THROAT ALPHA-AMYLASE 200 U. CEIP / ml, syrup?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE MAXILASE ALPHA-AMYLASE 200 U. CEIP / ml, syrup?
6. ADDITIONAL INFORMATION
1. WHAT MAXILASE ALPHA-AMYLASE 200 UGGS THICKNESS 200 U. CEIP / ml, syrup AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
ANTI-INFLAMMATORY ENZYMES
Therapeutic indications
This medication is indicated in low sore throat and without fever.
2. BEFORE YOU TAKE MAXILASE ALPHA-AMYLASE 200 U. CEIP / ml, syrup?
List of information needed before taking the medication
If your doctor has informed you of an intolerance to some sugars, contact him or her before taking this medication.
Cons-indications
Never take MAXILASE ALPHA-AMYLASE 200 UPS THREATS. CEIP / ml, syrup
· in the case of a history of allergic reaction to alpha-amylase or to any of the components of the syrup, especially parabens.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with MAXILASE ALPHA-AMYLASE THROAT 200 U. CEIP / ml, syrup:
Special warnings
This medicine contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare hereditary diseases).
This medicinal product contains sodium parahydroxybenzoate (E219) and sodium propyl paraben (E217) and may cause allergic reactions.
This medication contains an azo dye (E110) and may cause allergic reactions.
Precautions for use
In case of fever and / or in case of new disorders (sore throat or head, purulent sputum (sputum), discomfort with the swallowing of food ...) CONSULT YOUR DOCTOR .
Do not use this medication without medical advice.
This medicine contains 3.2 g of sucrose per teaspoon (5 ml) and 9.6 g of sucrose per tablespoon (15 ml): take it into account in the daily diet in the case of a low-sugar diet or diabetes .
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR 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
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.
The use of this medication should be avoided during breastfeeding.
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 a well-known effect: S (E 110), S (E 110), Sucrose, Sodium methyl paraben (E219) and Sodium propyl parahydroxybenzoate (E217).
3. HOW TO TAKE MAXILASE THROAT ALPHA-AMYLASE 200 U. CEIP / ml, syrup?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Adult : 1 tablespoon (15 ml), 3 times a day.
Children over 3 years (more than 15 kg) : 2 teaspoons (10 ml), 3 times a day.
Infant and child 6 months to 3 years (7 kg to 15 kg) : 1 teaspoon (5 ml), 3 times a day.
THIS MEDICINE HAS BEEN PERSONALLY ISSUED OR PRESCRIBED IN A SPECIFIC SITUATION:
· IT CAN NOT BE ADAPTED TO ANOTHER CASE ,
· DO NOT ADVISE IT TO ANOTHER PERSON .
Method and route of administration
Oral use.
Duration of treatment
Do not use this medication without medical advice.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, MAXILASE ALPHA-AMYLASE 200 U. CEIP / ml, throat syrup is likely to have side effects, although not everyone is subject to it.
· Due to the presence of alpha-amylase, rare allergic reactions, usually cutaneous, particularly urticaria and angioedema, in this case, stop treatment;
· Possibility of respiratory discomfort (bronchospasm).
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 MAXILASE ALPHA-AMYLASE 200 U. CEIP / ml, syrup?
Keep out of the reach and sight of children.
Expiration date
Do not use MAXILASE ALPHA-AMYLASE 200 U. CEIP / ml, throat syrup after the expiry date stated on the outer packaging.
Storage conditions
This medication should be stored at a temperature below 25 ° C.
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 MAXILASE ALPHA-AMYLASE 200 U. CEIP / ml, syrup?
The active substance is:
Alpha-amylase ............................................... .................................................. ................... 20 000 U. CEIP *
For 100 ml of syrup.
* Or 14 286 U. Ph. Eur.
The other components are:
Excipients : sucrose solution, sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), citric acid monohydrate, orange yellow S (E 110), glycerol, soluble essential oil of mandarin S 164, drinking water.
Pharmaceutical form and content
What is MAXILASE THROAT ALPHA-AMYLASE 200 U. CEIP / ml, syrup and contents of the outer packaging?
This medication is in the form of a syrup. Box of 1 bottle of 125 ml 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
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
exploiting
SANOFI AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
UNITHER LIQUID MANUFACTURING
1-3, allee of the Nest
31770 COLOMIERS
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.