Humex Sore Throat Spray - Lemon Flavor

Antiseptic & Anesthetic Relief - Suitable from 6 Years Old

Who Can Use It: Adolescents, Adults, Children (6+ years)
Not Recommended For: Pregnant or breastfeeding women
Form: Throat Spray (Collutoire)
Packaging: 35 ml Bottle

Product Overview:

Humex Sore Throat Spray is designed to relieve mild sore throats without fever, as well as to soothe mouth ulcers and small oral wounds. Its dual-action formula contains:

• Benzalkonium Chloride (Antiseptic): Helps fight infections.

• Lidocaine Hydrochloride (Local Anesthetic): Provides fast-acting pain relief.

Other ingredients include liquid maltitol (D-maltitol, D-sorbitol), glycerol, lemon flavoring (lemon and orange extracts, de-terpenated lemon essential oil, citral), and purified water.

Recommended Usage:

• Adults: 1 spray, 4 to 6 times a day.

• Children (6-18 years): 1 spray, 2 to 3 times a day.

For children under 12, use with caution to prevent accidental inhalation. Ensure doses are spaced at least 4 hours apart. Do not administer right before meals or drinks to reduce the risk of choking.

Important: Treatment should not exceed 5 consecutive days without medical advice. Prolonged use may disrupt the natural microbial balance of the mouth and throat. Seek medical attention if symptoms persist or worsen, especially with signs like fever, thick mucus, swallowing difficulties, or spreading oral lesions.

Precautions:

• Do NOT Use If:

  • You have a known allergy to local anesthetics or quaternary ammonium antiseptics.

  • The patient is under 6 years old.

• Caution:

  • Contains liquid maltitol—consult your doctor if you have sugar intolerances or fructose intolerance.

  • Overdose can affect the heart and nervous system, potentially causing seizures.

  • Glycerol may cause headaches and digestive issues like diarrhea.

• Drug Interactions: Inform your doctor or pharmacist about any other medications you're taking to avoid potential interactions or overdoses.

• Pregnancy & Breastfeeding: Not recommended.

• Athletes: May cause a positive result in anti-doping tests.

Warnings:

• Read the package leaflet carefully before use.

• Consult your doctor or pharmacist if unsure.

• Keep out of reach of children.

Storage: Store in a cool, dry place away from direct sunlight.

Please read the following full disclosure before purchasing or using this product.

PRODUCT CHARACTERISTICS SUMMARY

ANSM - Last Updated: 10/17/2019

1. MEDICINAL PRODUCT NAME

HUMEX SORE THROAT LIDOCAINE/BENZALKONIUM 0.30 g/0.03 g per 100 mL, throat spray, pressurized bottle

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

• Lidocaine hydrochloride monohydrate: 0.30 g

• Benzalkonium chloride: 0.03 g

Per 100 mL of solution.

Notable excipients: Glycerol, liquid maltitol, ethanol.
(For the full list of excipients, see section 6.1.)

3. PHARMACEUTICAL FORM

Throat spray (collutoire).

4. CLINICAL DATA

4.1. Therapeutic Indications

Local adjunct treatment with antibacterial and analgesic properties for conditions affecting the oral mucosa and oropharynx.

Note: In cases of general signs of bacterial infection, systemic antibiotic therapy should be considered.

4.2. Dosage and Administration

• Route: Oral

• Age Restrictions: For adults and children over 6 years old

Dosage:

• Adults: 1 spray, 4 to 6 times per day

• Children (6-18 years): 1 spray, 2 to 3 times per day

Ensure doses are spaced at least 4 hours apart. If no improvement after 5 days, consult a doctor.

4.3. Contraindications

• Children under 6 years old

• Known allergy to local anesthetics or quaternary ammonium compounds

4.4. Special Warnings and Precautions for Use

• Risk of Aspiration: Avoid using before meals or drinks. Use cautiously in children under 12 years.

• Treatment Duration: Do not exceed 5 days without medical advice to prevent microbial imbalance or secondary infections.

• Systemic Toxicity Risk: Repeated or prolonged use may cause central nervous system effects (seizures, cardiovascular depression).

• Athletes: Contains an active substance that may cause a positive doping test.

• Additional Cautions:

  • Contains glycerol (may cause headaches, digestive issues)

  • Contains liquid maltitol (not recommended for patients with fructose intolerance)

  • Contains less than 100 mg of ethanol per spray

4.5. Interactions with Other Medications

Avoid simultaneous or successive use with other antiseptics due to potential interactions (antagonism, inactivation).

4.6. Fertility, Pregnancy, and Lactation

• Pregnancy: Not recommended due to insufficient data.

• Breastfeeding: Use should be avoided.

4.7. Effects on Driving and Machine Use

No reported effects on the ability to drive or operate machinery.

4.8. Undesirable Effects

• Oral mucosal blistering (quaternary ammonium compounds)

• Sensitization reactions (potential anaphylaxis)

• Temporary tongue numbness, risk of aspiration

Reporting Adverse Reactions:
Adverse reactions should be reported to ANSM via www.signalement-sante.gouv.fr.

4.9. Overdose

No reported cases of overdose.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

• Class: Local antiseptic/anesthetic

• ATC Code: R (Respiratory System)

Combination of benzalkonium chloride (antiseptic) and lidocaine hydrochloride monohydrate (local anesthetic).

5.2. Pharmacokinetic Properties

Not applicable.

5.3. Preclinical Safety Data

Not specified.

6. PHARMACEUTICAL DATA

6.1. List of Excipients

• Liquid maltitol

• Glycerol

• Lemon flavor (natural flavorings, ethanol, water)

• Purified water

• 30% sodium hydroxide solution

• Propellant gas: Nitrogen (pressure: 6.5 bars)

6.2. Incompatibilities

Not applicable.

6.3. Shelf Life

3 years.

6.4. Special Storage Precautions

• Do not expose to temperatures above 50°C or direct sunlight.

• Do not pierce or burn, even when empty.

6.5. Packaging

35 mL pressurized aluminum bottle with continuous valve and plastic diffuser.

6.6. Special Disposal Precautions

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

LABORATOIRES URGO HEALTHCARE
42 RUE DE LONGVIC
21300 CHENOVE

8. MARKETING AUTHORIZATION NUMBERS

• 34009 385 355 9 4: 35 mL pressurized bottle (aluminum)

9. DATE OF FIRST AUTHORIZATION/RENEWAL

• Initial Authorization: January 5, 1996

• Last Renewal: January 5, 2011 (valid indefinitely)

10. TEXT REVISION DATE

To be completed later by the authorization holder.

11. DOSIMETRY

Not applicable.

12. RADIOPHARMACEUTICAL PREPARATION INSTRUCTIONS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

Over-the-counter medication (no prescription required).