In this manual :
1. WHAT IS HEXALYSE, chewable tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING HEXALYSE, sucking tablet
3. HOW DO I TAKE HEXALYSE, Sucking Tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE HEXALYSE, chewable tablet?
6. ADDITIONAL INFORMATION
1. WHAT HEXALYSE is, and WHAT IT IS USED FOR
Pharmacotherapeutic class
ANTI-INFLAMMATORY AND ANTISEPTIC
(R: respiratory system)
This medicine is recommended for mild sore throats without fever.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING HEXALYSE, chewable 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.
This medicine should NOT BE USED in the following cases:
- in children under 6 years of age,
- history of allergy to biclotymol or 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 the appearance of new problems (severe sore throat or headache, purulent sputum (sputum), difficulty swallowing food, etc.): CONSULT YOUR DOCTOR.
Do not use this medicine for longer than 5 days without medical advice.
The use of this medicine is not recommended in patients with fructose intolerance, glucose and galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
This medicine contains 1.054 g g of sucrose per tablet, which should be taken into account in the daily diet in case of a low sugar diet or in case of diabetes.
This medicine contains an azoic colouring agent (E110, orange yellow) and may cause allergic reactions.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medication, even if it is obtained without a prescription.
The simultaneous or successive use of local antiseptics should be avoided because of possible interference (antagonism, inactivation).
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This medication contains biclotymol, lysosyme hydrochloride and enoxolone.
Other drugs contain them. Do not combine them so as not to exceed the maximum recommended doses(see Dosage and Administration).
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Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - Lactation
In general, during pregnancy and breastfeeding, always ask your doctor or pharmacist for advice before taking any medicine.
As a precautionary measure, it is preferable not to use this medicine during pregnancy and breastfeeding.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Orange yellow S (E 110), sucrose.
3. HOW TO TAKE HEXALYSE, sucking tablet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Method of administration
Suck the tablets slowly without chewing them.
Oral use.
Frequency of administration
6 to 8 tablets to be sucked every 24 hours, dividing the doses.
Duration of treatment
Do not use this medicine for longer than 5 days without medical advice.
Symptoms and instructions in case of overdose
If you have taken more HEXALYSE chewable tablets than you should have:
Consult your doctor or pharmacist immediately.
Instructions in case of missed doses
If you forget to take HEXALYSE chewable tablet :
Do not take a double dose to make up for the one you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
As with all medicines, HEXALYSE is likely to have undesirable effects, although not everyone is subject to them.
Possible allergic skin reactions: in this case, stop the treatment.
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 CONSERVE HEXALYSE, chewable tablet?
Keep out of the reach and sight of children.
Do not exceed the expiry date stated on the outer packaging
Store at a temperature below 25°C.
If necessary, warnings against certain visible signs of deterioration
Not applicable.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What is in HEXALYSE chewable tablet?
The active ingredients are :
Biclotymol ........................................................................................................................................ 5.0 mg
Lysozyme hydrochloride ................................................................................................................. 5.0 mg
Enoxolone ........................................................................................................................................ 5.0 mg
For one 1200.0 mg sucking tablet.
Other components are:
Lemon essential oil, citric acid monohydrate, orange yellow S (E110), magnesium stearate, gum arabic, icing sugar.
Pharmaceutical form and content
What HEXALYSE is and what it contains
Sucking tablet, box of 20, 24 and 30.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BOUCHARA-RECORDATI
68, rue Marjolin
BP 67
92302 Levallois-Perret Cedex
Operator
LABORATOIRES BOUCHARA-RECORDATI
68, rue Marjolin
92300 LEVALLOIS-PERRET
Manufacturer
LABORATOIRES BOUCHARA RECORDATI
Parc Mécatronic
03410 SAINT VICTOR
or
EUROPEENNE DE 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 package leaflet
The last date of approval of this leaflet 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.
Not applicable.
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