Cooper Vocadys Lozenges for Throat Irritation - Ages 12 and Up, Mandarin Flavor 30 Lozenges

Cooper Vocadys Lozenges for Throat Irritation - Ages 12 and Up, Mandarin Flavor

Product Overview
Cooper Vocadys Lozenges provide fast-acting relief for throat irritation, with each lozenge combining local anesthetic (lidocaine hydrochloride, 0.8 mg) and anti-inflammatory properties (enoxolone, 10 mg). Additionally, each lozenge includes a soothing aqueous extract of erysimum officinale (4 mg) for enhanced throat comfort.

Indications
Vocadys lozenges are specially formulated to relieve throat discomfort in adults and children aged 12 and up. The mandarin-flavored lozenges dissolve slowly, providing targeted relief and leaving a pleasant, refreshing taste.

Ingredients
Each lozenge contains:

• Active Ingredients: Lidocaine hydrochloride (0.8 mg), enoxolone (10 mg), and erysimum officinale extract (4 mg)
• Excipients: Levomenthol, mandarin essential oil, glycerol, sucrose, liquid glucose, gelatin, and purified water

Directions for Use

• Adults: Slowly dissolve 4 to 8 lozenges in the mouth over 24 hours, with at least 1 hour between each.
• Ages 12-15: Use 2 to 4 lozenges per day, with a 2-hour interval between each dose.
• Below 12 Years: Use only under medical advice.

Avoid eating or drinking immediately before or after using Vocadys lozenges to prevent any risk of choking. Treatment should not exceed 5 days. If symptoms persist, or if you develop a fever or a productive cough, consult your doctor.

Precautions

• Do not use if you have allergies to any ingredients in the formula.
• Avoid combining with other medications containing enoxolone, lidocaine, or erysimum to prevent exceeding recommended doses.
• Not suitable for children under 6 years old or individuals with epilepsy, history of seizures, fructose intolerance, glucose-galactose malabsorption, or sucrase/isomaltase deficiency.
• Avoid use while breastfeeding.
• Repeated, excessive intake can lead to nervous system and heart-related effects, especially in infants and children.

Packaging
Each box contains 30 lozenges.

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

Product Summary

ANSM – Updated on: 14/05/2024

1. Product Name
VOCADYS, Lozenges for Sore Throat

2. Qualitative and Quantitative Composition

• Enoxolone: 10.0 mg
• Lidocaine hydrochloride: 0.8 mg
• Aqueous dry extract of erysimum officinale on maltodextrin: 4.0 mg
• Max maltodextrin in extract: 1.6 mg

Each lozenge weighs 3 g.

Notable excipients:

• Sucrose (1.26 g per lozenge)
• Glucose (0.99 g per lozenge)
  For a full list of excipients, see section 6.1.

3. Pharmaceutical Form
Lozenge for slow dissolving in the mouth.

4. Clinical Data

4.1. Therapeutic Indications
Used to relieve throat irritation.

4.2. Dosage and Administration

Dosage

• Adults: 4 to 8 lozenges per day, spaced at least 1 hour apart.
• Children (ages 6-15): 2 to 4 lozenges per day, with a minimum of 2 hours between doses.

Administration Method
Take lozenges between meals. Slowly dissolve in the mouth without chewing.

4.3. Contraindications

• Hypersensitivity to local anesthetics, enoxolone, or other components.
• Not for children under 6 years old.
• History of seizures or epilepsy.

4.4. Special Warnings and Precautions

Warnings
Risk of choking due to anesthesia effect in the oropharyngeal area:

• Use cautiously in children under 12 years.
• Avoid use before meals or drinks.

Repeated or prolonged treatment on mucous membranes may lead to systemic toxicity, including central nervous system effects (risk of seizures) and cardiovascular depression.

Contains terpenes that may lower the seizure threshold, increasing the risk of neurological issues such as seizures, particularly in children and in cases of excessive doses or improper use. Do not use in children under 6 or patients with a history of seizures (see section 4.3).

Strict adherence to dosage, usage instructions, and treatment duration is essential to minimize side effects.

Precautions
If symptoms persist beyond 5 days or fever appears, reevaluate treatment. In cases of epilepsy history or lowered seizure threshold, consider the presence of terpenes.

Notable Excipients
Each lozenge contains 1.26 g of sucrose and 0.99 g of glucose, important for those with diabetes. Not suitable for patients with fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

4.5. Interactions with Other Medicines
None applicable.

4.6. Fertility, Pregnancy, and Breastfeeding

Pregnancy:
Limited data on enoxolone and erysimum use in pregnant women; animal studies on reproductive toxicity are insufficient. Vocadys is not recommended during pregnancy.

Breastfeeding:
Not recommended due to lack of data on the transfer of erysimum, enoxolone, and terpenes into breast milk and potential neurological toxicity to infants.

Fertility:
No or limited data on effects on fertility for enoxolone, erysimum, and lidocaine.

4.7. Effects on Driving and Operating Machinery
No impact on driving or machinery use has been observed.

4.8. Adverse Reactions
Adverse effects, by system and frequency:

• Immune System Disorders: Sensitivity to local anesthetics (frequency unknown).
• Psychiatric Disorders: Agitation, confusion, particularly in the elderly.
• Nervous System Disorders: Seizures, convulsions, particularly in children.
• Respiratory Disorders: Risk of choking.
• Gastrointestinal Disorders: Temporary tongue numbness.

Reporting of Adverse Reactions
Report suspected adverse reactions to monitor the benefit-risk ratio continuously through the national reporting system (ANSM) and Regional Pharmacovigilance Centers via https://signalement.social-sante.gouv.fr

4.9. Overdose
Not applicable.

5. Pharmacological Properties

5.1. Pharmacodynamic Properties
Pharmacotherapeutic class: LOCAL ANESTHETIC/LOCAL ANTI-INFLAMMATORY (Respiratory System); ATC code: R02AD. Contains terpenes that may lower seizure threshold.

6. Pharmaceutical Data

6.1. List of Excipients
Levomenthol, reconstituted mandarin essential oil (mandarin, clementine, and orange oils), glycerol, sucrose, liquid glucose, gelatin, purified water, sucrose for coating.

6.2. Incompatibilities
None applicable.

6.3. Shelf Life
3 years.

6.4. Special Storage Precautions
Store below 25°C.

6.5. Packaging
Box of 30 lozenges (Polypropylene).

6.6. Disposal Precautions
No special requirements.

7. Marketing Authorization Holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT, 77020 MELUN CEDEX

8. Marketing Authorization Number(s)
34009 326 844 7 2: Box of 30 lozenges (Polypropylene).

9. Date of First Authorization/Renewal
[To be completed by the holder]

10. Date of Text Revision
[To be completed by the holder]

Prescription and Supply Conditions
Non-prescription medication.