NOTICE
ANSM - Updated on : 23/11/2023
Product name
ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet
Alfa-amylase
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any of the side effects listed above, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 5 days.
What does this leaflet contain?
1. What is ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet and what is it used for?
2. What information should I know before taking ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet?
3. How should I take ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet ?
4. What are the possible side effects?
5. How to store ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet?
6. Package contents and other information.
1. WHAT IS ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Anti-inflammatory enzymes - ATC code: R02A.
This medicine is indicated for mild sore throats without fever.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet?
Never take ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet:
- if you are allergic to alfa-amylase or to any of the other ingredients listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before taking ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet.
Hypersensitivity: sometimes severe allergic reactions (anaphylactic reactions) such as drop in blood pressure, itchy rash, breathing difficulties alone or associated with swelling of the face, may occur after the1st dose. Some of these reactions may be serious or life-threatening. In such cases, discontinue treatment immediately and seek medical advice as soon as possible.
If general signs of infection occur, such as :
- high fever (> 38.5°C), persistent fever (more than 3 days).
- onset of other symptoms such as: severe headache or sore throat, nausea, vomiting, ear pain or discharge, facial pain.
- Symptoms persist without improvement for more than 5 days,
Consult your doctor.
Children and teenagers
Not applicable.
Other medicinal products and ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
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 taking this medicine.
Pregnancy
This medicine should not be used during pregnancy.
Breast-feeding
Avoid using this product while breast-feeding.
Driving and use of machinery
Not applicable.
ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet contains sucrose, orange yellow S (E110) and sorbitol.
If your doctor has informed you that you are intolerant to certain sugars, contact your doctor before taking this medicine.
This medicine contains approximately 353 mg sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has informed you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder characterized by the inability to break down fructose, talk to your doctor before taking or receiving this medication.
This medicine contains an azoic coloring agent (orange yellow S (E110)) and may cause allergic reactions.
3. HOW DO I TAKE ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet?
Dosage
FOR ADULTS ONLY.
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 treatment beyond 5 days without medical advice.
If symptoms persist or do not improve, seek medical advice.
If you have taken more ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet than you should have
Consult your doctor or pharmacist immediately.
If you forget to take ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet
Do not take a double dose to make up for the single dose you forgot to take.
If you stop taking ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Undesirable effects such as nausea and vomiting may occur after taking ALFA-AMYLASE BGR CONSEIL.
Contact your doctor immediately if any of the following symptoms occur:
- Rash, itching, swelling of the face, lips or tongue, difficulty breathing, drop in blood pressure. These effects may be signs of a severe allergic reaction (see section 2).
In this case, discontinue treatment immediately and seek prompt medical advice.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet contains
- The active substance is :
Alfa-amylase......................................................................................................... 3000 U.CEIP*
For one coated tablet
*2142.9 European Pharmacopoeia units.
- The other components are :
Magnesium stearate, sorbitol, shellac, butyl methacrylate copolymer of (2-dymetilaminoethyl) methacrylate and methyl methacrylate 1:2:1 (eudragit E100), talc, gelatin, sucrose, gum arabic, titanium dioxide, orange yellow S (E110), carnauba wax.
What is ALFA-AMYLASE BGR CONSEIL 3000 U.CEIP, coated tablet and what does it contain?
This medicine is a coated tablet. Box of 18 or 24 tablets.
Not all presentations may be marketed.
Marketing authorization holder
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing authorization holder
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Manufacturer
PHYTEO LABORATOIRE
11 RUE MONTBAZON
37260 MONTS
FRANCE
or
INPHARMASCI
ZI N°2 DE PROUVY ROUVIGNIES
1 RUE NUNGESSER
59121 PROUVY
FRANCE
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
Health education advice:
Given the predominantly viral origin of pathologies that can cause sore throats that are not very intense and without fever, simple gestures should be followed to avoid contaminating those around you, in particular:
- 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 frequently with disposable tissues
- moisten nasal mucous membranes with suitable cleansing solutions
- live in rooms with a humid atmosphere (use a humidifier if necessary)
- air the room regularly
YOUR PHARMACIST AND DOCTOR KNOW ALL ABOUT MEDICATIONS.
DON'T HESITATE TO ASK THEM FOR DETAILS.
NEVER LEAVE MEDICATION WITHIN THE REACH OF CHILDREN.