Perubore Inhalation Capsules for Cold, Rhinitis, Rhinopharyngitis Relief - Adult & Adolescent Use (12+ Years) - MAYOLY SPINDLER - 15 Capsules

Product Description: Perubore Inhalation Capsules are a specially formulated medicine containing a blend of essential oils. Designed to decongest the respiratory tract in cases of colds, rhinitis, or rhinopharyngitis, these capsules provide relief through inhalation therapy. Suitable for adults and adolescents over 12 years.

Key Ingredients: Each capsule contains essential oils of Lavender (18 mg), Red Thyme (34 mg), Rosemary (48 mg), and Thymol (2 mg), combined with paraffin oil. The capsule shell is made of gelatin and glycerol for safe and effective delivery.

Usage Instructions: For inhalation, use a whole Perubore capsule in a sinusitis inhaler or bowl, or cut the end and pour into hot water. Inhale the vapors 1 to 3 times daily, ensuring at least 4 hours between sessions. Limit to 3 inhalations per day and a maximum of 5 days of treatment.

Precautions: Strictly for inhalation; do not ingest. Not for children under 12 or with seizure history. Avoid if allergic to ingredients or if breastfeeding. Consult a doctor if pregnant. Monitor for worsening symptoms or infections. Do not exceed recommended dosage or combine with similar essential oil products.

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

PRODUCT CHARACTERISTICS SUMMARY

ANSM - Updated on: 26/10/2018

1. NAME OF THE MEDICINE

   • PERUBORE INHALATION, capsule for steam inhalation

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

   • Lavender essential oil.......................................................................................... 18.0 mg
   • Red thyme essential oil..................................................................................... 34.0 mg
   • Rosemary essential oil...................................................................................... 48.0 mg
   • Thymol............................................................................................................... 2.0 mg
   • For one capsule.
   • For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

   • Capsule for steam inhalation.

4. CLINICAL DATA

   1. Therapeutic Indications
      • Adjuvant treatment in congestive states of the upper airways.
   2. Dosage and Method of Administration
      • RESERVED FOR ADULTS AND CHILDREN OVER 12 YEARS.
      • Inhalation by fumigation - DO NOT SWALLOW.
      • Adult and child over 12 years:
      • For inhalation: 1 capsule morning, noon, and evening in an inhaler or a bowl of boiling water.
      • The duration of treatment should not exceed 5 days without medical advice.
   3. Contraindications
      • Hypersensitivity to the active substances or to any of the excipients.
      • Due to the presence of terpene derivatives: children with a history of seizures (febrile or not).
   4. Special Warnings and Precautions for Use
      • Special Warnings:
        • This specialty contains terpene derivatives (essential oils and thymol) which can lead to excessive doses:
        • Convulsions in infants and children.
        • Respiratory pauses and collapse in infants.
      • Follow usage advice and dosages, especially: never exceed recommended doses.
      • Not to be used in children under 12 years without medical advice.
      • Precautions for Use:
        • In case of allergic reaction, stop treatment.
        • Do not swallow.
        • If symptoms persist and/or signs of superinfection appear, reevaluate therapeutic conduct.
        • Consider the presence of terpene derivatives in case of a history of epilepsy.

5. PHARMACOLOGICAL PROPERTIES

   1. Pharmacodynamic Properties
      • Pharmacotherapeutic class: DECONGESTANT, (R: respiratory system).
      • ATC code: R07AX.
      • Terpene derivatives (essential oils and thymol) can lower the epileptogenic threshold.
   2. Pharmacokinetic Properties
      • Not provided.
   3. Preclinical Safety Data
      • Not provided.

6. PHARMACEUTICAL DATA

   1. List of Excipients
      • Paraffin oil.
      • Capsule shell: Gelatin, glycerol.
   2. Incompatibilities
      • Not applicable.
   3. Shelf Life
      • 3 years.
   4. Special Precautions for Storage
      • No special storage precautions.
   5. Nature and Contents of Outer Packaging
      • 15 capsules in thermoformed blisters (PVC/Aluminium).
   6. Special Precautions for Disposal and Handling
      • No special requirements.

7. MARKETING AUTHORIZATION HOLDER

   • LABORATOIRES MAYOLY SPINDLER
   • 6 AVENUE DE L'EUROPE
   • 78400 CHATOU

8. MARKETING AUTHORIZATION NUMBER(S)

   • 493 170-6 or 34009 493 170 6 6: 15 capsules in blisters (PVC/Aluminium).

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION

   • [to be completed later by the holder]

10. DATE OF TEXT REVISION

    • [to be completed later by the holder]

11. DOSIMETRY

    • Not applicable.

12. INSTRUCTIONS FOR PREPARING RADIOPHARMACEUTICALS

    • Not applicable.

PRESCRIPTION AND DISPENSATION CONDITIONS

• Medication not subject to medical prescription.