Humex Sore Throat Honey Lemon Sugar Free Lozenges 24

Description
Humex Mal de Gorge Honey Lemon Sugar-Free Lozenges are an effective solution for soothing mild sore throats without fever, treating mouth ulcers, and small oral wounds. These lozenges contain a powerful blend of active ingredients:

• Lidocaine hydrochloride (2 mg per lozenge) to provide local pain relief
• Two antiseptics: Amylmetacresol (1.20 mg) and 2,4-Dichlorobenzyl alcohol (0.60 mg) to combat infection

Additional Ingredients
Each lozenge also includes peppermint essential oil, lemon essential oil, honey flavor, and sweeteners such as isomalt (E953) and maltitol (E965). Other ingredients include quinoline yellow (E104), sodium saccharin, tartaric acid, and orange yellow S (E110).

Who Can Use It
Suitable for adults and adolescents aged 12 and over, Humex lozenges provide relief for sore throats and oral irritations.

Dosage Instructions

• Adults: Allow 1 lozenge to dissolve slowly in the mouth every 2 hours as needed, up to a maximum of 8 lozenges per day.
• Children (ages 12-15): Take 1 lozenge every 2 hours as needed, without exceeding 4 lozenges per day.

Take lozenges away from meals. Treatment should not exceed 5 days. If symptoms persist or worsen, seek medical advice.

Warnings and Precautions

• Do not exceed the recommended dose. Excessive intake may lead to side effects such as nervous system issues (convulsions) and heart complications.
• Avoid use if allergic to any ingredients, especially the azo dye (E110).
• Not suitable for individuals with sugar or fructose intolerance.
• Consult a doctor if you develop extensive lesions, a fever, or if you are pregnant or breastfeeding.
• This product may cause mild digestive issues (such as diarrhea).
• Athletes should be aware that this medication could affect anti-doping test results.
• If taking other medications, consult your pharmacist or doctor to prevent interactions.

Caloric Information
Each lozenge contains 2.3 kcal from maltitol or isomaltitol.

Additional Information
For more details, including the complete patient leaflet, please refer to our website. For a combined treatment, consider using Humex Dry Cough Syrup with oxomemazine.

Packaging: 24 sugar-free lozenges

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

SUMMARY OF PRODUCT CHARACTERISTICS
ANSM - Updated: 14/09/2020

1. NAME OF THE MEDICINAL PRODUCT
HUMEX MAL DE GORGE LIDOCAINE/ DICHLOROBENZYL ALCOHOL/ AMYLMETACRESOL 2 mg/1.2 mg/0.6 mg HONEY LEMON SUGAR-FREE, lozenge sweetened with sodium saccharin, maltitol, and isomalt.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine hydrochloride............................................. 2.00 mg
2,4-Dichlorobenzyl alcohol........................................ 1.20 mg
Amylmetacresol......................................................... 0.60 mg

Per lozenge.

Notable excipients: maltitol (E965), isomalt (E953), and orange yellow S (E110).
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Lozenge.

4. CLINICAL DATA

4.1. Therapeutic indications
This medicine is indicated for adults and children over 12 years of age for mild sore throats without fever, mouth ulcers, and small oral wounds.

4.2. Posology and method of administration

Posology
The minimum effective dose should be used for the shortest duration necessary to relieve symptoms.
Reserved for adults and children over 12 years old.
Lozenges should be taken away from meals.

• Adults and children over 15 years:
  Dissolve 1 lozenge slowly in the mouth without chewing, repeat if necessary after 2 hours, not exceeding 8 lozenges per day.

• Children aged 12 to 15 years:
  Dissolve 1 lozenge slowly in the mouth without chewing, repeat if necessary after 2 hours, not exceeding 4 lozenges per day.

• Children aged 6 to 12 years:
  Use in children under 12 years is not recommended.

• Children under 6 years:
  This product is contraindicated in children under 6 years (see section 4.3).

Method of administration
Oral use.

4.3. Contraindications

• Known hypersensitivity to local anesthetics, active substances, or any of the excipients listed in section 6.1.
• Children under 6 years of age.
• Patients with a history or suspicion of methemoglobinemia.

4.4. Special warnings and precautions for use

Special warnings

• Risk of choking due to anesthesia of the oropharyngeal area.
• Not recommended for patients with a history or current asthma or bronchospasm.
• Do not use this medication before meals or drinks.
• Treatment should not exceed 5 days to avoid disrupting the normal microbial flora of the mouth, which may lead to bacterial or fungal spread.
• Prolonged or repeated use on mucous membranes may lead to systemic toxic effects (central nervous system involvement with convulsions, cardiovascular depression) (see section 4.9).

Precautions for use

• If symptoms persist beyond 3 days and/or are associated with fever, consult a healthcare professional.
• Athletes should note that this product contains an active ingredient that may cause a positive reaction in anti-doping tests.
• This product contains maltitol (E965) and isomalt (E953). Patients with rare hereditary fructose intolerance should not take this medication.
• May have a mild laxative effect.
• Contains orange yellow S (E110), which may cause allergic reactions.

4.5. Interaction with other medicinal products and other forms of interaction
No clinically significant interactions are known to date.

4.6. Fertility, pregnancy, and lactation

Pregnancy
Animal studies are insufficient to conclude on the effects on reproduction (see section 5.3).
There is little or no available data on the use of HUMEX MAL DE GORGE LIDOCAINE/ DICHLOROBENZYL ALCOHOL/ AMYLMETACRESOL 2 mg/1.2 mg/0.6 mg HONEY LEMON SUGAR-FREE during pregnancy.
Due to the lack of data, it is not recommended to use this product during pregnancy or in women of childbearing potential not using contraception.

Lactation
Lidocaine and its metabolites are excreted in breast milk.
There is insufficient data on the excretion of 2,4-dichlorobenzyl alcohol, amylmetacresol, or their metabolites in breast milk.
Therefore, HUMEX MAL DE GORGE should not be used during breastfeeding.

Fertility
No data is available on the effects on fertility.

4.7. Effects on the ability to drive and use machines
Not applicable.

4.8. Undesirable effects
Adverse effects are classified by organ system and frequency:

• Immune system disorders: Hypersensitivity (frequency unknown)
• Gastrointestinal disorders: Nausea, transient tongue numbness, risk of choking (frequency unknown)

4.9. Overdose

Symptoms
In the unlikely event of an overdose, no severe adverse effects are expected. Gastrointestinal discomfort may occur.

Treatment
Treatment should be symptomatic.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties
Pharmacotherapeutic class: THROAT PREPARATIONS, ATC code: R02AA20

• Lidocaine hydrochloride: Local anesthetic
• Amylmetacresol and 2,4-dichlorobenzyl alcohol: Local antiseptics

5.2. Pharmacokinetic properties

• 2,4-Dichlorobenzyl alcohol is metabolized in the liver to form hippuric acid, which is excreted in urine.
• No available data on the metabolism and elimination of amylmetacresol.
• Lidocaine is easily absorbed through mucous membranes, with a plasma half-life of approximately 2 hours.

5.3. Preclinical safety data
No harmful effects of 2,4-dichlorobenzyl alcohol, amylmetacresol, or lidocaine on pregnancy or fetal development have been reported in rabbit studies.

6. PHARMACEUTICAL DATA

6.1. List of excipients
Peppermint essential oil, quinoline yellow (E104), sodium saccharin, tartaric acid, isomalt (E953), maltitol (E965), orange yellow S (E110), lemon essential oil, honey flavor.

6.2. Incompatibilities
Not applicable.

6.3. Shelf life
3 years.

6.4. Special precautions for storage
No special storage conditions required.

6.5. Nature and contents of the packaging
6, 12, 24, or 36 lozenges in blister packs (PVC/PVDC/Aluminum).
Not all pack sizes may be marketed.

6.6. Special precautions for disposal and handling
No special requirements.

7. MARKETING AUTHORIZATION HOLDER
LABORATOIRES URGO HEALTHCARE
42 RUE DE LONGVIC
21300 CHENOVE, FRANCE

8. MARKETING AUTHORIZATION NUMBERS

• 34009 300 397 4 8: 6 lozenges in blister packs.
• 34009 300 397 5 5: 12 lozenges in blister packs.
• 34009 300 397 6 2: 24 lozenges in blister packs.
• 34009 300 397 7 9: 36 lozenges in blister packs.

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
First authorization: December 9, 2015.
Last renewal: December 9, 2020 (unlimited duration).

10. DATE OF TEXT REVISION
[To be completed by the marketing authorization holder].

11. DOSIMETRY
Not applicable.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.

CONDITIONS OF PRESCRIPTION AND DISPENSING
Medicinal product not subject to medical prescription.