NOTICE
ANSM - Updated on: 15/09/2015
Name of the medicinal product
HEXALYSE, sucked tablet
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist, worsen or new symptoms appear, seek advice from your pharmacist or doctor.
· This leaflet is designed to help you use this medicine. Keep it, you may need to reread it.
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
Review summary
In this notice :
1. WHAT HEXALYSIS , sucked tablet AND WHAT IT IS USED FOR?
2. WHAT TO DO ABOUT BEFORE TAKING HEXALYSE, tablet to suck?
3. HOW TO TAKE HEXALYSE, suck pill?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HEXALYSE, sucked tablet?
6. ADDITIONAL INFORMATION
1. WHAT HEXALYSIS, sucked tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Anti-inflammatory aim
Antibacterial target against gram-positive bacteria under conditions of use
(R: respiratory system).
Therapeutic indications
This medication is recommended as a supplemental local treatment in sore throats and fever-free.
2. WHAT TO DO ABOUT BEFORE TAKING HEXALYSE, tablet to suck?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
This medication MUST NOT BE USED in the following cases:
· in children under 6 years of age,
· history of allergy to biclotymol or to any of the components of the tablet.
Precautions for use; special warnings
Precautions for use
In the event of a fever and / or in the event of new disorders (major sore throat or head, purulent sputum (sputum), discomfort with the swallowing of food ...): CONSULT YOUR DOCTOR.
Do not use this medication for longer than 5 days without medical advice.
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 medicine contains 1.054 gg of sucrose per tablet, which must be taken into account in the daily diet in the case of diet low in sugar or diabetes.
This medication contains an azo coloring agent (E110, orange-yellow) and may cause allergic reactions.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
The simultaneous or successive use of local antiseptics should be avoided in view of possible interference (antagonism, inactivation).
This medicinal product contains biclotymol, lysosyme hydrochloride and enoxolone. Other medicines contain it. Do not combine them in order not to exceed the maximum recommended doses ( see dosage and method of administration ). |
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - Breastfeeding
Generally speaking, during pregnancy and breast-feeding, always ask your doctor or pharmacist for advice before taking any medicine.
As a precaution, it is preferable not to use this medication during pregnancy and lactation.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
HEXALYSE, sucking tablet contains orange yellow S (E110) and sucrose (see section 2).
3. HOW TO TAKE HEXALYSE, suck pill?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Administration mode
Slowly suck the tablets without chewing them.
Oral use.
Frequency of Administration
6 to 8 tablets to suck by 24 hours, distributing the catches.
Duration of treatment
Do not use this medication for longer than 5 days without medical advice.
Symptoms and Instructions for Overdose
If you take more HEXALYSE, tablet to suck than you should:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take HEXALYSE, tablet to suck:
Do not take a double dose to make up for the missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, HEXALYSE, tablet to suck is likely to have unwanted effects, although not everyone is subject to it.
Possible allergic skin reactions: in this case, stop 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 HEXALYSE, sucked tablet?
Keep out of the reach and sight of children.
Expiration date
Do not exceed the expiry date stated on the outer packaging
Storage conditions
Store at a temperature below 25 ° C.
If necessary, warnings against visible signs of deterioration
Not applicable.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What contains HEXALYSE, tablet to suck?
The active substances are :
Biclotymol ................................................. .................................................. .................................... 5.0 mg
Lysozyme hydrochloride ............................................... .................................................. 5.0 mg
Enoxolone ................................................. .................................................. .................................... 5.0 mg
For a 1200.0 mg sucking tablet.
The other components are :
Lemon essential oil, citric acid monohydrate, orange yellow S (E110), magnesium stearate, gum arabic, icing sugar.
Pharmaceutical form and content
What is HEXALYSE, sucked tablet and contents of the pack?
Suckable tablet, box of 20, 24 and 30.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
BOUCHARA-RECORDATI
68, rue Marjolin
BP 67
92302 Levallois-Perret Cedex
exploiting
BOUCHARA-RECORDATI LABORATORIES
68, rue Marjolin
92300 LEVALLOIS-PERRET
Maker
BOUCHARA RECORDATI LABORATORIES
Mecatronic Park
03410 SAINT VICTOR
or
EUROPEAN PHARMACOTECHNIE EUROPHARTEC
1, rue Henri Matisse
63370 LEMPDES
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.