NOTICE
ANSM - Last updated: 11/05/2017
Name of the medicinal product
HUMEX MAL DE GORGE BICLOTYMOL 20 mg SUGAR-FREE MINT, sweetened isomalt tablet
biclotymol
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed 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 of the 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.
Do not use this medication for children.
Review summary
What is in this leaflet?
1. WHAT HUMEX MAL DE GORGE BICLOTYMOL 20 mg SUGAR-FREE MINT, sweetened tablet with isomalt AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE HUMEX MAL DE GORGE BICLOTYMOL 20 mg SUGAR-FREE MINT, sweetened with isomalt?
3. HOW TO USE HUMEX BODY LIGHT BICLOTYMOL 20 mg SUGAR-FREE MINT, sweetened with isomalt?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HUMEX MAL DE GORGE BICLOTYMOL 20 mg SUGAR-FREE MINT, sweetened with isomalt?
6. Package contents and other information.
1. WHAT HUMEX MAL DE GORGE BICLOTYMOL 20 mg SUGAR-FREE MINT, sweetened tablet with isomalt AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
Antiseptic-based sucking tablet.
Therapeutic indications
This medication is indicated in adults and children over 6 years of age in the case of sore throat with low intensity and without fever, canker sores and small sores of the mouth.
2. BEFORE YOU USE HUMEX MAL DE GORGE BICLOTYMOL 20 mg SUGAR-FREE MINT, sweetened with isomalt?
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
Do not take HUMEX BODY LIP BICLOTYMOL 20 mg SUGAR-FREE MINT, sweetened isomalt tablet:
· If you are allergic (hypersensitive) to biclotymol or any of the other ingredients of this medication mentioned in section 6.
· Do not give this medicine to children under 6 years of age.
Precautions for use; special warnings
Warnings and Precautions
Warnings
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
Prolonged use (more than 5 days) of this medication is not desirable, as it is likely to alter the microbial balance of the mouth and throat.
Precautions for use
In case of fever, sputum (sputum) purulent, discomfort with the swallowing of the food as in case of aggravations or lack of improvement after 5 days: CONSULT YOUR DOCTOR.
The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).
This medication may cause mild digestive problems (diarrhea). Calorie value 2.3 Kcal / g maltitol (in isomaltitol).
Interaction with other medicines
Other medicines and HUMEX BICLOTYMOL GORGE MAL 20 mg SUGAR-FREE MINT, isomalt sweetened tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
The simultaneous or successive use of antiseptics should be avoided in view of possible interference (antagonism, inactivation).
This medicinal product contains biclotymol. Other medicines contain it; Do not combine them, in order not to exceed the maximum recommended doses ( see Dosage ) |
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Do not take this medicine without consulting your doctor or pharmacist. |
As a precaution, it is preferable not to use biclotymol during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
HUMEX MIC DE GORGE BICLOTYMOL 20 mg MENTHE WITHOUT SUGAR, islalt sweetened tablet contains isomalt (E 953).
3. HOW TO USE HUMEX BODY LIGHT BICLOTYMOL 20 mg SUGAR-FREE MINT, sweetened with isomalt?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS.
Adults: 1 tablet 4 to 6 times per day, distributing the catch
Children over 6 years: 1 tablet to be renewed if necessary, without exceeding 3 tablets per day.
Administration mode
Allow to melt slowly in the mouth (mouth).
Duration of the treatment
The duration of treatment is limited to 5 days. |
Symptoms and Instructions for Overdose
If you have used more HUMEX BODY HUME BICLOTYMOL 20 mg SUGAR-FREE MINT, sweetened to isomalt tablet you should:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take HUMEX MAL DE GORGE BICLOTYMOL 20 mg SUGAR-FREE MINT, sweetened with isomalt:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Undesirable effects of unknown frequency (can not be estimated from the available data):
· Possible allergic manifestations: lip edema, urticaria, rash, erythema (redness), angioedema (or angioedema): severe reaction manifested by abrupt swelling of the face, lips, tongue and / or larynx difficulty breathing or swallowing)
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 through the National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance 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 HUMEX MAL DE GORGE BICLOTYMOL 20 mg SUGAR-FREE MINT, sweetened with isomalt?
Keep this medicine out of the reach and sight of children.
Expiration date
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.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What HUMEX contains MAL DE GORGE BICLOTYMOL 20 MENT MENTHE WITHOUT SUGAR, tablet sweetened with isomalt?
The active substance is:
Biclotymol ................................................. .................................................. ..... 20.00 mg
For a pellet.
The other components are:
Isomalt, levomenthol
Pharmaceutical form and content
Aspect of HUMEX MAL DE GORGE BICLOTYMOL 20 mg MENTHE WITHOUT SUGAR, tablet sweetened with isomalt and contents of the pack
This medication is in the form of a tablet. Box of 6, 12 or 24 tablets.
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
URGO HEALTHCARE LABORATORIES
42 RUE DE LONGVIC
21300 CHENOVE
exploiting
URGO HEALTHCARE LABORATORIES
42 RUE DE LONGVIC
21300 CHENOVE
Maker
URGO LABORATORIES
Avenue of Strasbourg
Zone Excellence 2000
21800 CHEVIGNY SAINT SAUVEUR
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 notice was revised is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.