NOTICE
ANSM - Last updated: 22/06/2017
Name of the medicinal product
ALFA-AMYLASE BIOGARAN COUNCIL 200 U.CEIP / ml, syrup
Alfa-amylase
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine by following the instructions in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to 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 experience no improvement or feel less well after 5 days.
What is in this leaflet?
1. What is ALFA-AMYLASE BIOGARAN TIP 200 U.CEIP / ml, syrup and in which cases is it used?
2. What should be known before taking ALFA-AMYLASE BIOGARAN COUNCIL 200 U.CEIP / ml, syrup?
3. How to take ALFA-AMYLASE BIOGARAN TIP 200 U.CEIP / ml, syrup?
4. What are the possible side effects?
5. How to store ALFA-AMYLASE BIOGARAN TIP 200 U.CEIP / ml, syrup?
6. Package contents and other information.
1. WHAT IS ALFA-AMYLASE BIOGARAN COUNCIL 200 U.CEIP / ml, syrup AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: Anti-inflammatory Enzymes, ATC code: R02A.
This medication is indicated in low sore throat and without fever.
2. BEFORE YOU TAKE ALFA-AMYLASE BIOGARAN COUNCIL 200 U.CEIP / ml, syrup?
Do not take ALFA-AMYLASE BIOGARAN TIP 200 U.CEIP / ml, syrup:
· if you are allergic to alfa-amylase or to any of the other ingredients of this medication mentioned in section 6.
· if your doctor has informed you of an intolerance to some sugars, contact him or her before taking this medication.
Warnings and Precautions
Talk to your doctor or pharmacist before taking ALFA-AMYLASE BIOGARAN CONSEIL 200 U.CEIP / ml, syrup.
warnings
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
This medicinal product contains 2.8 g of sucrose per teaspoon (5 ml) and 8.4 g of sucrose per tablespoon (15 ml), which should be taken into account in the daily diet in the case of a low-sugar diet or of diabetes.
This medicinal product contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217) and may cause allergic reactions.
Precautions
In case of general signs of infection such as:
· high fever (> 38.5 ° C) and persistent (> 3 days)
· onset of other symptoms such as: severe sore throat or headache, nausea, vomiting, ear pain or discharge, face pain,
· persistence of symptoms without improvement, beyond 5 days,
consult your doctor.
Children and Youth
Not applicable.
Other medicines and ALFA-AMYLASE BIOGARAN TIP 200 U.CEIP / ml, syrup.
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
ALFA-AMYLASE BIOGARAN TIP 200 U.CEIP / ml, syrup with food, beverages and alcohol
Not applicable.
Pregnancy and breast feeding
Pregnancy
It is best not to use this medication during pregnancy.
feeding
The use of this medication should be avoided during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
ALFA-AMYLASE BIOGARAN CONSEIL 200 U.CEIP / ml, syrup contains
Sucrose, glycerol, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), mandarin essential oil, citric acid monohydrate and purified water.
Excipients with notable effects: Sucrose, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217).
3. HOW TO TAKE ALFA-AMYLASE BIOGARAN TIP 200 U.CEIP / ml, syrup?
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.
Administration mode
Oral use.
Duration of treatment
Do not prolong treatment beyond 5 days without medical advice.
If there is no improvement as in the case of persistent symptoms, take a medical opinion.
If you take more ALFA-AMYLASE BIOGARAN TIP 200 U.CEIP / ml, you should not have syrup
Immediately consult your doctor or pharmacist.
If you forget to take ALFA-AMYLASE BIOGARAN TIP 200 U.CEIP / ml, syrup
Do not take a double dose to make up for a missed dose.
If you stop taking ALFA-AMYLASE BIOGARAN TIP 200 U.CEIP / ml, syrup
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Rare allergic reactions, generally cutaneous, particularly urticaria and swelling of the face and neck with respiratory discomfort (angioedema), in this case, stop the treatment.
Declaration of side effects
If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ALFA-AMYLASE BIOGARAN COUNCIL 200 U.CEIP / ml, syrup?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ° C.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What ALFA-AMYLASE BIOGARAN CONSEIL contains 200 U.CEIP / ml, syrup
· The active substance is:
Alfa-amylase ............................................... .................................................. ......... 200 U.CEIP *
For 1 ml.
* Or 142.86 European Pharmacopoeia units per ml of syrup.
· The other components are:
Sucrose, glycerol, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), mandarin essential oil, citric acid monohydrate and purified water.
What is ALFA-AMYLASE BIOGARAN COUNCIL 200 U.CEIP / ml, syrup and contents of the pack
This medication is in the form of a syrup. Bottle of 125 ml, 200 ml, 250 ml or 300 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder
LABORATORY TOP PHARM
DOMAINE DE MONTCAUSSON
BP 50
31250 REVEL
LA FRANCE
Marketing Authorization Operator
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
LA FRANCE
Maker
LABORATORIES PASQUIER
ZI OF SIGNARGUES
RN 100
30390 DOMAZAN
LA FRANCE
OR
LABORATOIRES DELPHARM TOURS
RUE PAUL LANGEVIN
BP 90241
37172 CHAMBRAY LES TOURS
LA FRANCE
OR
FARMACLAIR
440 AVENUE OF THE GENERAL DE GAULLE
14200 HEROUVILLE SAINT CLAIR
LA FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
Due to the mainly viral origin of pathologies that can cause sore throats and fever-free, simple gestures must be respected, to avoid contaminating your surroundings, in particular:
· wash your hands frequently
· keep away from elderly and young children (wearing mask is recommended)
· avoid smoking
· drink enough
· blowing often with disposable handkerchiefs
· moisten the nasal mucosa with suitable washing solutions
· live in rooms with a humid atmosphere (using a humidifier as required)
· regularly ventilate the room
YOUR PHARMACIST, YOUR DOCTOR, KNOWS THE MEDICINES WELL.
DO NOT HESITATE TO ASK FOR THEM.
NEVER LEAVE A MEDICINE TO THE REACH OF CHILDREN.