Sore throat little intense and without fever, mouth ulcers and small mouth sores
HUMEX MAL DE GORGE collutoire combines benzalkonium chloride (a local antiseptic) with lidocaine (a local anesthetic for pain relief). In particular, it acts against bacteria, targets and reduces pain.
Therapeutic indications :
This medicine contains a local antiseptic to fight infection and a local anesthetic to relieve pain.
It is indicated in adults and children over 6 years of age for mildsore throats without fever, mouth ulcers and small mouth sores.
For adults and children over 6 years of age only.
Method of administration: By mouth.
Frequency of administration: Do not use before meals or drinks. Intakes should be spaced at least 4 hours apart.
Duration of treatment: Treatment should not exceed 5 days without medical advice.
Composition in active ingredients:
Lidocaine hydrochloride . 0.30 g
Benzalkonium chloride . 0.03 g
Per 100 ml solution.
Notable excipients: glycerol, liquid maltitol.
For full list of excipients, see section 6.1.
Never use Humex Sore Throat, Mouth Spray, pressurized bottle:
Humex comes in a bottle.
Sore throat is a frequent symptom, most often due to a viral or, more rarely, a bacterial infection. Other causes of sore throat irritation include allergies, pollution, smoking and acid reflux from gastric fluids.
Sore throat symptoms
Sore throat relief: HUMEX SORE THROAT COLLUTOIRE is specially designed to soothe mild, fever-free sore throats. Its fast-acting formula provides relief and allows you to return to comfort.
Mouth ulcers and small mouth sores: As well as fighting sore throats, this mouthwash is also effective in relieving mouth ulcers and small mouth sores. It lets you eat, drink and talk without pain.
Suitable for the whole family: This mouthwash is suitable for all family members, from adults to children, for gentle relief.
Soothing sensation: HUMEX SORE MOUTH STICK offers a soothing sensation from the very first use. It soothes irritation and pain, so you can feel better quickly.
Easy to apply: Applying this mouthwash is simple and convenient. Simply gargle or rinse your mouth with the product to feel the benefits.
Versatility: As well as treating sore throats, mouth ulcers and small mouth sores, this mouthwash can also be used to prevent throat infections.
Make HUMEX Sore Throat Mouth Spray your ally for fast relief of sore throats, mouth ulcers and small mouth sores. Rediscover the pleasure of eating, speaking and living pain-free.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 11/05/2017
HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized flask
You should always use this medication exactly as prescribed 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, pharmacist or nurse. 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.
1. What is HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized vial and in which case is it used?
2. What information should be known before using HUMEX LIDOCAINE / BENZALKONIUM GALGE 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized vial?
3. How to use HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized bottle?
4. What are the possible side effects?
5. How to store HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized bottle?
6. Additional Information
LOCAL ANTISEPTIC / LOCAL ANESTHETICS
(R: respiratory system)
It is indicated in adults and children over 6 years of age in the case of sore throat with low intensity and without fever, mouth ulcers and small wounds of the mouth.
You should contact your doctor if you experience no improvement or feel less well after 5 days.
List of information needed before taking the medication
· in children under 6 years of age,
· in case of a history of allergy to local anesthetics and antiseptics of the quaternary ammonium class.
Precautions for use; special warnings
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
Anesthesia caused by this drug in the throat can promote false roads (coughing during a meal with "swallowing") when swallowing food. It is therefore imperative
· not to use this medication before meals or before drinking,
· use this medication only with caution in children under 12 years of age.
Prolonged use (more than 5 days) of this medication is undesirable as it can alter the natural microbial balance of the mouth, throat.
Take this medication exactly as it was prescribed by your doctor. If you are pregnant or are breast-feeding, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
This specialty should not be put in contact with the eyes, introduced into the nose or into the ears.
Sore throat :
If fever, sputum, purulent sputum, swallowing of food, as in case of aggravation or lack of improvement after 5 days, CONSULT YOUR DOCTOR.
Canker sores, small mouth sores:
In case of extensive lesions, extensions of the lesions, of fever: CONSULT YOUR DOCTOR IMMEDIATELY.
This medicine contains glycerol and can cause headaches and digestive disorders (diarrhea).
This medicine contains liquid maltitol. Its use is discouraged in patients with fructose intolerance (rare hereditary disease).
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Do not use several medicines containing an antiseptic at the same time.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Interactions with Herbal Medicines or Alternative Therapies
Use during pregnancy and lactation
Pregnancy, breast-feeding and fertility
Pregnancy
It is best not to use this medication during pregnancy.
feeding
The use of this medication should be avoided in case of breast-feeding.
Do not take any medicine during pregnancy or breast-feeding without asking your doctor or pharmacist for advice. |
Generally speaking, during pregnancy and breast-feeding, always ask your doctor or pharmacist for advice before taking any medicine.
The attention of athletes will be drawn to the fact that this specialty contains an active principle that can induce a positive reaction of the tests performed during the doping controls.
Effects on ability to drive or use machines
No effects on the ability to drive and use machines have been observed.
List of excipients with known effect
Reserved for adults and children over 6 years of age.
Adult: 1 spray 4 to 6 times a day.
Children 6 to 18 years: 1 spray 2 to 3 times a day.
Administration mode
Mouth.
Frequency of Administration
Do not use this medication before eating or drinking.
The catch must be spaced at least 4 hours apart.
Duration of treatment
Treatment should not exceed 5 days without medical advice.
Symptoms and Instructions for Overdose
If you have used more HUMEX THROAT LIDOCAINE / BENZALKONIUM 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized flask you should:
Not applicable.
Instructions for omission of one or more doses
Do not take a double dose to make up for a missed dose.
If you stop using HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized vial:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· occurrence of small lesions having the shape of bubbles at the level of the mouth,
· rash: in this case, stop treatment,
· possibility of temporary numbness of the tongue,
· in the event of a false path (cough during a meal with "swallowing" impression) it is advisable to discontinue the treatment and seek advice from a doctor.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist or nurse. 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.
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.
Pressurized container :
· do not expose to heat above 50 ° C, or to the sun,
· do not drill,
· do not throw into the even empty fire.
If necessary, warnings against visible signs of deterioration
Full list of active substances and excipients
The active substances are :
Lidocaine Hydrochloride ............................................... .................................................. 0.30 g
Benzalkonium chloride ............................................... .................................................. .................. 0.03 g
For 100 ml of solution.
The other ingredients are : liquid maltitol *, glycerol, lemon flavor **, purified water.
* Composition of liquid maltitol : D-maltitol, D-sorbitol.
** Composition of the lemon flavoring : lemon alcohol and alcohol, orange alcoholate, terpenated lemon essential oil, citral.
Propellant gas: nitrogen (pressure: 6.5 bar).
Pharmaceutical form and content
This medicine is in the form of a mouthwash in a 35 ml pressurized flask.
Box of 1 bottle.
Marketing Authorization Holder and Manufacturer
42 RUE DE LONGVIC
21300 CHENOVE
42 RUE DE LONGVIC
21300 CHENOVE
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
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Antiseptic and analgesic mouthwash
benzalkonium, lidocaine
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
HUMEX MAL DE GORGE: mouthwash (lemon flavoring); flask of 35 ml.
-
Laboratory
| p 100 ml | |
| Benzalkonium chloride | 30 mg |
| Lidocaine hydrochloride | 300 mg |
Usual dosage:
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