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HUMEX SORE THROAT MOUTHWASH
Over-the-counter medication

HUMEX SORE THROAT MOUTHWASH

Brand : Urgo Urgo
€3.81 EXCL. VAT €4.19 INCL. VAT
In stock
Reference : 3400938535594
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SORE THROAT HUMEX MOUTHWASH

Sore throat little intense and without fever, mouth ulcers and small mouth sores

HUMEX SICK THROAT COLLUTORY

HUMEX SICK THROAT associates benzalkonium chloride (a local antiseptic), with lidocaine (a local anesthetic that relieves pain). It acts in particular against bacteria, targets and reduces pain.

Description

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 in cases of mild throat pain without fever, mouth ulcers and small mouth sores .

using advice

Reserved for adults and children over 6 years old.

  • Adult : 1 spray 4 to 6 times a day. Children from 6 to 18 years old: 1 spray 2 to 3 times a day.
  • Children from 6 to 18 years old : 1 spray 2 to 3 times a day.

Method of administration : Oral route.
Frequency of administration : Do not use this medication before meals or before drinking. Sockets should be spaced at least 4 hours apart.
Duration of treatment : Treatment should not exceed 5 days without medical advice.

Composition

Composition of active substances :
Lidocaine hydrochloride. 0.30 g
Benzalkonium chloride. 0.03 g
Per 100 ml of solution.

Excipients with known effect : glycerol, liquid maltitol.
For the full list of excipients, see section 6.1.

Precautions for use

Never use Humex sore throat, mouthwash, pressurized bottle:

  • in children under 6,
  • if you have a history of allergy to local anesthetics and antiseptics of the quaternary ammonium class.

Presentation

Humex comes in the form of a bottle.

Sore throat is a frequent symptom, most often due to a viral infection and more rarely bacterial. Other causes can explain the irritation which is a source of pain: allergy, pollution, smoking, acidic rise in gastric fluid, etc.
Symptoms of sore throat

  • This very frequent pain is felt at the back of the throat. More precisely, it is located at the level of the pharynx and the tonsils.
  • It results in tingling, a burning sensation and sometimes, difficulty swallowing (dysphagia).
  • It can be accompanied by other symptoms: fever, enlargement of the glands in the neck, runny nose, difficulty swallowing, redness of the throat, cough, hoarse voice…

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Last updated: 11/05/2017

Name of the medicinal product

HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized flask

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 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.

Review summary

What this leaflet contains:

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

1. WHAT IS HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized vial AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

LOCAL ANTISEPTIC / LOCAL ANESTHETICS

(R: respiratory system)

Therapeutic indications

This medication 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 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.

2. BEFORE YOU USE HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized vial?

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

Never use HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized vial:

· 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

Warnings and Precautions

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

Other medicines and HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized vial:

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

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

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.

Sport

Sport

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

Driving and using machines

No effects on the ability to drive and use machines have been observed.

List of excipients with known effect

HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized flask contains g lycerol and liquid maltitol .

3. HOW TO USE HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized vial?

Instructions for proper use

Always use this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

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

If you forget to use HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized flask:

Do not take a double dose to make up for a missed dose.

Risk of withdrawal syndrome

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.

5. HOW TO STORE HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized vial?

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

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

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 MAL DE GORGE LIDOCAINE / BENZALKONIUM contains 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized vial

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

Appearance of HUMEX LIDOCAINE / BENZALKONIUM THROAT 0.30 g / 0.03 g per 100 mL, mouthwash, pressurized flask and contents of the pack

This medicine is in the form of a mouthwash in a 35 ml pressurized flask.

Box of 1 bottle.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Marketing Authorization Holder and Manufacturer

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 leaflet was approved 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.

VIDAL OF THE FAMILY

HUMEX MAL DE GORGE mouthwash

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

PRESENTATIONS (summary)

HUMEX MAL DE GORGE: mouthwash (lemon flavoring); flask of 35 ml.
-

Laboratory

COMPOSITION (summary)
p 100 ml
Benzalkonium chloride 30 mg
Lidocaine hydrochloride 300 mg

INDICATIONS (summary)
This mouthwash contains an antiseptic (benzalkonium) which has an antibacterial effect and a local anesthetic (lidocaine) which has an analgesic action.
It is used in the adjuvant treatment of affections of the mouth and throat (sore throats not intense and without fever, canker sores ...).
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
In case of fever, swallowing gene or persisting symptoms after 5 days, consult your doctor. It can tell the difference between a pharyngitis and an angina. In case of bacterial angina, antibiotic treatment is necessary to avoid further complications, cardiac or renal.
Prolonged use of local antiseptic treatments ( gargle , mouthwash , lozenge) is undesirable; it can alter the natural microbial balance of the throat.
Overconsumption may favor the passage of local anesthetic in the blood and cause nervous and cardiac disorders: follow the dosage .
DRUG INTERACTIONS (summary)
It is generally unnecessary to combine different antiseptics . These can be contained in many products available in self-medication: tablet, mouthwash and nasal solution; Consult your pharmacist.
PREGNANCY AND BREAST-FEEDING (summary)
The effect of this medication during pregnancy or lactation is not well known. The assessment of the possible risk associated with its use is individual: ask your pharmacist or doctor for advice.
DIRECTIONS FOR USE AND DOSAGE (summary)
Sprays should be spaced at least 4 hours apart.

Usual dosage:

  • Adult: 1 spray, 4 to 6 times a day.
  • Child 6-18 years: 1 spray, 2 or 3 per day.
The duration of treatment should not exceed 5 days.
TIPS (summary)
In children, spraying can cause spasm of the larynx: do not put the mouthpiece too deeply into the mouth.
Avoid using this medication before eating or taking drinks: the local anesthetic may cause swallowing problems; they could cause food to enter the respiratory tract.
POSSIBLE ADVERSE EFFECTS (summary)
Allergic reaction
Transient numbness of the tongue.


GLOSSARY (summary)


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


quaternary ammoniums
Family of antiseptics present in many medicines of local use. Generally well supported, they can however give rise to rare allergies.


anesthetic
Medication that results in anesthesia. In addition to the general anesthetics that allow the patients to fall asleep before surgery, there are local anesthetics that can be injected in contact with a nerve to insensitize a region of the body. Local anesthetics are also called contact anesthetics.


analgesic
Medication that works against pain. Analgesics act either directly on the centers of pain in the brain or by blocking the transmission of pain to the brain.
Synonym: analgesic.


antibiotic
A substance capable of blocking the multiplication of certain bacteria or killing them. The spectrum of an antibiotic is the set of bacteria on which this product is usually active. Unlike bacteria, viruses are not susceptible to antibiotics. The first antibiotics were extracted from mushroom cultures: penicillium (penicillin), streptomyces (streptomycin). They are currently manufactured by chemical synthesis. Antibiotics are divided into families: penicillins, cephalosporins, macrolides, tetracyclines (cyclines), sulphonamides, aminoglycosides, lincosanides, phenicolates, polymyxins, quinolones, imidazoles, etc.
Inappropriate use of antibiotics may lead to the development of resistance: use antibiotics only on medical prescription, adhere to its dosage and duration, do not give or advise another person an antibiotic prescribed for you .


antiseptic
A substance that locally destroys bacteria, reducing their numbers and preventing their proliferation. Some antiseptics are also active on microscopic fungi and viruses.


mouth ulcers
Very painful lesion of the mouth, having the appearance of a yellowish or gray spot, slightly hollowed out. Healing is usually spontaneous after a few days.
Stress, fatigue and certain foods (walnuts, hazelnuts, gruyere, citrus fruits ...) can cause a surge of canker sores. In very rare cases, canker sores may be due to disease or drug therapy.


mouthwash
Medication that acts by contact on the throat and internal walls of the mouth. It is administered by spraying or brushing.


gargle
A method of local treatment which aims to leave in contact with the throat a drug pure or diluted in cold or lukewarm water. The head is tilted backwards, a continuous exhalation preventing the liquid from descending into the lungs. The solution used must not be swallowed.


pharyngitis
Inflammation or infection of the pharynx.


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


Allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


treatment
Treatment that complements the action of a specific treatment, but generally does not achieve healing on its own.


way
  • Pathway (route of administration) used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
  • Set of hollow organs allowing the passage of air (airways), food (digestive tract), urine (urinary tract), bile (bile ducts), etc.

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