In this manual :
1. WHAT IS MAXILASE SORE THROAT ALPHA-AMYLASE 3000 U. CEIP, coated tablet AND WHAT IS IT USED FOR?
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING MAXILASE SORE THROAT ALPHA-AMYLASE 3000 U. CEIP, coated tablet?
3. HOW TO TAKE MAXILASE SORE THROAT ALPHA-AMYLASE 3000 U. CEIP, coated tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO KEEP MAXILASE SORE THROAT ALPHA-AMYLASE 3000 U. CEIP, coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS MAXILASE SORE THROAT ALPHA-AMYLASE 3000 U. CEIP, coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
ENZYMES FOR ANTI-INFLAMMATORY PURPOSES.
This medicine is indicated in adults for mild sore throats without fever.
2. WHAT INFORMATION YOU SHOULD KNOW BEFORE TAKING MAXILASE SORE THROAT ALPHA-AMYLASE 3000 U. CEIP, coated tablet?
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him or her before taking this medicine.
Do not take MAXILASE HEALTH AILMENT ALPHA-AMYLASE 3000 U. CEIP, coated tablet in the following cases:
- History of allergy to alpha-amylase or any of the components of the tablet.
Precautions for use; special warnings
Take care with MAXILASE HEALTH AILMENT ALPHA-AMYLASE 3000 U. CEIP, coated tablet:
Special warnings
This medicine should not be used in patients with galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption syndrome (rare hereditary diseases).
The use of this medicine is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
This medicine contains an azoic colouring agent (E110, orange yellow) and may cause allergic reactions.
Precautions for use
There is a syrup form more suitable for children.
In case of occurrence of general signs of infection such as:
- high fever (> 38.5°C) and persistent (more than 3 days),
- appearance of other symptoms such as: severe sore throat or headache, nausea, vomiting, ear pain or discharge, facial pain,
- persistence of symptoms without improvement, beyond 5 days.
CONSULT YOUR DOCTOR.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and lactation
Pregnancy
This medicine should not be used during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether to continue the treatment.
Breastfeeding
The use of this medicine should be avoided during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medication.
In general, during pregnancy and breastfeeding, always ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a notorious effect
List of excipients with a notorious effect: Orange yellow S (E110), sucrose, lactose.
3. HOW TO TAKE MAXILASE SORE THROAT ALPHA-AMYLASE 3000 U. CEIP, coated tablet?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS.
1 tablet 3 times daily with meals.
Method of administration
Take by mouth.
Swallow the tablet, without chewing, with a glass of water.
Duration of treatment
Do not prolong the treatment beyond 5 days without medical advice.
If the symptoms do not improve or persist, seek medical advice.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, MAXILASE HEALTH AILMENT ALPHA-AMYLASE 3000 U. CEIP, coated tablet is likely to have side effects, although not everyone is susceptible.
- Due to the presence of alpha-amylase, rare allergic reactions, generally cutaneous, in particular urticaria and angioedema, in which case, stop the treatment;
- Possible occurrence of respiratory discomfort (bronchospasm).
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE MAXILASE SORE THROAT ALPHA-AMYLASE 3000 U. CEIP, coated tablet?
Keep out of the reach and sight of children.
Do not use MAXILASE SORE THROAT ALPHA-AMYLASE 3000 U. CEIP, coated tablet after the expiry date stated on the box.
Store at a temperature below 25°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines in the sewage system or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does MAXILASE HEALTH AID ALPHA-AMYLASE 3000 U. CEIP, coated tablet?
The active substance is:
Alpha-Amylase ...................................................................................................................... 3000 U. CEIP*
For one coated tablet.
* That is 2143 European Pharmacopoeia Units per tablet. One CEIP unit corresponds to the amount of enzyme in mg that catalyses the hydrolysis of 1 mg of starch in 10 seconds under the conditions of the dosage.
The other components are:
Calcium carmellose, povidone, stearic acid, colloidal anhydrous silica, lactoglobulin lactose, bleached shellac, gum arabic, sucrose, talc, titanium dioxide (E171), orange yellow S (E110), white beeswax.
Pharmaceutical form and content
What is MAXILASE HEALTH AILMENT ALPHA-AMYLASE 3000 U. CEIP, coated tablet and contents of the pack
This medicine is presented as coated tablets (box of 15, 24 or 30 tablets in blister packs).
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
SANOFI-AVENTIS FRANCE
1-13 BOULEVARD ROMAIN ROLLAND
75014 PARIS
Operator
SANOFI-AVENTIS FRANCE
1-13 BOULEVARD ROMAIN ROLLAND
75014 PARIS
Manufacturer
SANOFI WINTHROP INDUSTRIE
1 RUE DE LA VIERGE
AMBARES & LAGRAVE
33565 CARBON BLANC CEDEX
or
SOFARIMEX
2735 CACEM
PORTUGAL
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
HEALTH EDUCATION ADVICE:
Due to the mainly viral origin of the pathologies that can cause a sore throat without fever, simple gestures should be respected to avoid contaminating those around you:
- wash your hands frequently
- stay away from the elderly and young children (wearing a mask is recommended)
- avoid smoking
- drink enough fluids
- Blow your nose often with disposable tissues
- moisten the nasal mucosa with suitable washing solutions
- live in rooms with a humid atmosphere (use a humidifier if necessary),
- air the room regularly
YOUR PHARMACIST AND DOCTOR ARE FAMILIAR WITH THE MEDICINES.
DO NOT HESITATE TO ASK THEM FOR DETAILS.
NEVER LEAVE A MEDICINE WITHIN THE REACH OF CHILDREN
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