1. WHAT IS ALFA-AMYLASE BIOGARAN CONSEIL 3000 U.CEIP, coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Enzymes for anti-inflammatory purposes, ATC code: R02A.
This medicine is indicated for mild sore throats without fever.
2. WHAT YOU SHOULD KNOW BEFORE TAKING ALFA-AMYLASE BIOGARAN CONSEIL 3000 U.CEIP, coated tablet
Never take ALFA-AMYLASE BIOGARAN CONSEIL 3000 U.CEIP, coated tablet
- ·if you are allergic to alfa-amylase or to any of the other ingredients of this medicine, mentioned in section 6.
- ·if your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking ALFA-AMYLASE BIOGARAN CONSEIL 3000 U.CEIP, coated tablet
Warnings
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 S) and may cause allergic reactions.
Precautions
If general signs of infection occur, such as :
- ·high fever (> 38.5°C) and persistent (more than 3 days),
- ·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.
Children and adolescents
Not applicable.
Other medicines and ALFA-AMYLASE BIOGARAN 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 BIOGARAN CONSEIL 3000 U.CEIP, coated tablet with food, drink and alcohol
Not applicable.
Pregnancy and lactation
Pregnancy
It is preferable not to use this medicine during pregnancy.
Breastfeeding
The use of this medicine should be avoided during breastfeeding.
If you are pregnant or breastfeeding, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicineor pharmacist before taking this medicine.
Driving and using machines
Not applicable.
ALFA-AMYLASE BIOGARAN CONSEIL 3000 U.CEIP, coated tablet contains
Magnesium stearate, sorbitol, shellac, butyl methacrylate copolymer of (2-dimethylaminoethyl) methacrylate and methyl methacrylate 1:2:1 (eudragit E100), talc, gelatine, sucrose, gum arabic, titanium dioxide, orange yellow S (E110), carnauba wax.
Excipients of note: sucrose, orange yellow S (E110), sorbitol.
3. HOW TO TAKE ALFA-AMYLASE BIOGARAN CONSEIL 3000 U.CEIP, coated tablet
Dosage
RESERVED FOR ADULTS.
1 tablet, 3 times a day 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.
In the absence of improvement or if the symptoms persist, seek medical advice.
If you have taken more ALFA-AMYLASE BIOGARAN CONSEIL 3000 U.CEIP, coated tablet than you should have
Consult your doctor or pharmacist immediately.
If you forget to take ALFA-AMYLASE BIOGARAN CONSEIL 3000 U.CEIP, coated tablet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking ALFA-AMYLASE BIOGARAN CONSEIL 3000 U.CEIP, coated tablet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause undesirable effects, but they do not always occur in everyone.
- ·Rare allergic reactions, usually skin reactions, in particular urticaria and swelling of the face and neck with breathing difficulties (angioedema), in this case, stop the treatment.
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 Regional Pharmacovigilance Centres
By reporting adverse reactions, you contribute to providing more information about the safety of the medicine.
5. HOW TO USE ALFA-AMYLASE BIOGARAN CONSEIL 3000 U.CEIP, coated tablet
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the package. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine in the sewage system or in your household waste. Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What ALFA-AMYLASE BIOGARAN CONSEIL 3000 U.CEIP, coated tablet contains
The active substance is :
Alfa-amylase......................................................................................................... 3000 U.CEIP*
For one coated tablet
*Or 2142.9 European Pharmacopoeia units.
The other components are :
Magnesium stearate, sorbitol, shellac, butyl methacrylate copolymer of (2-dimethylaminoethyl) methacrylate and methyl methacrylate 1:2:1 (eudragit E100), talc, gelatin, sucrose, gum arabic, titanium dioxide, orange yellow S (E110), carnauba wax.
What ALFA-AMYLASE BIOGARAN CONSEIL 3000 U.CEIP is, coated tablet and what it contains
This medicine is presented as a coated tablet. Box of 18 or 24 tablets.
Not all presentations may be marketed.
Marketing authorisation holder
LABORATOIRE TOP PHARM
DOMAINE DE MONTCAUSSON
BP 50
31250 REVEL
FRANCE
Marketing authorisation holder
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
FRANCE
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