NOTICE
ANSM - Updated: 30/11/2015
Name of the drug
MAXILASE GROWTH ALPHA-AMYLASE 3000 U. CEIP, coated tablet
Alpha-Amylase
framed
Read this leaflet carefully before taking this medicine. It contains important information for your treatment.
· This medicine can be used for self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist beyond 5 days, if they worsen or if new symptoms appear, seek the advice of your pharmacist or doctor.
· This leaflet is meant to help you use this medicine. Keep there, you may need to read it again.
DO NOT LEAVE THIS MEDICINE WITHIN THE REACH OF CHILDREN
Summary record
In this notice :
1. WHAT IS MAXILASE ALPHA-AMYLASE THROAT WELL 3000 U. CEIP, coated tablet AND WHAT IT IS USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING MAXILASE ALPHA-AMYLASE 3000 UG THROAT WALLS CEIP, coated tablet?
3. HOW TO TAKE MAXILASE ALPHA-AMYLASE THROUGH WASH 3000 U. CEIP, coated tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE MAXILASE ALPHA-AMYLASE GROWTH 3000 U. CEIP, coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS MAXILASE ALPHA-AMYLASE THROAT WELL 3000 U. CEIP, coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
ENZYMES WITH ANTI-INFLAMMATORY VIEW.
Therapeutic indications
This medicine is indicated in adults for mild sore throat and without fever.
2. WHAT YOU SHOULD KNOW BEFORE TAKING MAXILASE ALPHA-AMYLASE 3000 UG THROAT WALLS CEIP, coated tablet?
List of information needed before taking the medication
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Never take MAXILASE ALPHA-AMYLASE 3000 U. CEIP THERAPY, coated tablet in the following case:
· History of allergy to alpha-amylase or any of the components of the tablet.
Precautions for use; special warnings
Take special care with MAXILASE ALPHA-AMYLASE THROAT 3000 U. CEIP, coated tablet:
Special warnings
The use of this drug is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
This medicine contains an azo coloring agent (E110, orange-yellow) and may cause allergic reactions.
Precautions for use
There is a syrup form more suitable for the child.
In case of occurrence of general signs of infection such as :
· high fever (> 38.5 ° C) and persistent (more than 3 days),
· other symptoms such as: sore throat or headache, nausea, vomiting, pain or discharge of the ear, pain in the face,
· persistence of symptoms without improvement, beyond 5 days.
CONSULT YOUR DOCTOR.
IF IN DOUBT, DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Interactions with other drugs
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
Interactions with food and drinks
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Pregnancy
It is best not to use this medicine during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor because only he can judge the need to continue.
feeding
The use of this medicine should be avoided during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
In general, during pregnancy and breastfeeding, always 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: S orange yellow (E110), sucrose, lactose.
3. HOW TO TAKE MAXILASE ALPHA-AMYLASE THROUGH WASH 3000 U. CEIP, coated tablet?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
RESERVED FOR THE ADULT.
1 tablet 3 times a day during meals.
Administration mode
Oral way.
Swallow the tablet without chewing it with a glass of water.
Duration of the treatment
Do not prolong treatment beyond 5 days without medical advice.
In the absence of improvement as in case of persistent symptoms, take medical advice.
Symptoms and instructions in case of overdose
Not applicable.
Instructions for omitting one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, MAXILASE GROWTH ALPHA-AMYLASE 3000 U. CEIP, coated tablet can cause side effects, although not everybody gets them.
· Due to the presence of alpha-amylase, rare reactions of allergic, usually cutaneous, especially urticaria and angioedema, in this case, stop the treatment;
· Possibility of occurrence of respiratory discomfort (bronchospasm).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE MAXILASE ALPHA-AMYLASE GROWTH 3000 U. CEIP, coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use MAXILASE ALPHA-AMYLASE 3000 U. ECIP THERAPY, coated tablet after the expiry date which is stated on the carton.
Storage conditions
Store at a temperature below 25 ° C.
If necessary, warn against some visible signs of deterioration
Medicines should not be thrown away with sewage or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does MAXILASE ALPHA-AMYLASE 3000 U. GOLD MUD contain? CEIP, coated tablet?
The active substance is:
Alpha-Amylase ............................................... .................................................. ..................... 3000 U. CEIP *
For a coated tablet.
* That is 2143 European Pharmacopoeia Units per tablet. A CEIP unit corresponds to the amount of enzyme in mg that catalyzes the hydrolysis of 1 mg of starch in 10 seconds under the conditions of the assay.
The other components are:
Carmellose calcium, povidone, stearic acid, colloidal anhydrous silica, lactose lactose, bleached decaffeinated shellac, gum arabic, sucrose, talc, titanium dioxide (E171), orange-yellow S (E110), white beeswax.
Pharmaceutical form and content
What is MAXILASE ALPHA-AMYLASE THROAT 3000 U. CEIP, coated tablet and contents of the pack?
This medicine comes in the form of coated tablets (pack of 15, 24 or 30 tablets in blister packs).
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
exploiting
SANOFI AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
SANOFI WINTHROP INDUSTRY
1 STREET OF THE VIRGIN
AMBARES & LAGRAVE
33565 CARBON WHITE CEDEX
or
Sofarimex
2735 CACEM
PORTUGAL
Names of the medicine in the member states of the European Economic Area
Not applicable.
Date of approval of the notice
The last date this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps (France) website.
Information reserved for health professionals
Not applicable.
Other
HEALTH EDUCATION ADVICE:
Due to the mainly viral origin of pathologies that can cause sore throat and without fever, simple actions must be taken to avoid contaminating your surroundings, including:
· wash your hands frequently
· stay away from the elderly and young children (wearing a mask is recommended)
· avoid smoking
· drink enough
· blow your nose often with disposable tissues
· moisten the nasal mucosa with suitable washing solutions
· live in rooms with a humid atmosphere (use of a humidifier if necessary),
· air the room regularly
YOUR PHARMACIST, YOUR DOCTOR, KNOW THE MEDICINES.
DO NOT HESITATE TO REQUEST PRECISIONS.
NEVER LEAVE A MEDICINAL DRINK FOR CHILDREN