In this manual :
1. WHAT IS PERUBORE INHALATION, capsule for steam inhalation AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING PERUBORE INHALATION, capsule for steam inhalation?
3. HOW DO I USE PERUBORE INHALATION, capsule for steam inhalation?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE PERUBORE INHALATION, capsule for steam inhalation?
6. ADDITIONAL INFORMATION
1. WHAT IS PERUBORE INHALATION, capsule for steam inhalation AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
This medicine has a decongestant action, i.e. it helps to clear the airways.
This medicine is used as a decongestant for common respiratory diseases (colds, rhinitis, rhinopharyngitis) in adults and children over 12 years of age.
2. WHAT DO YOU NEED TO KNOW BEFORE USING PERUBORE INHALATION, capsule for steam inhalation?
List of information needed before taking the medicine
Not applicable.
Never use PERUBORE INHALATION, capsule for inhalation by steam:
- if you are allergic (hypersensitive) to any of the active ingredients (lavender essential oil, red thyme essential oil, rosemary essential oil or thymol) or to any of the other components contained in PERUBORE INHALATION(refer to section 6 for a full list of components).
- In children with a history of seizures due to fever or not as this medicine contains essential oils and thymol.
Precautions for use; special warnings
Take care with PERUBORE INHALATION, capsule for steam inhalation:
Special warnings
This product contains essential oils and thymol (terpene derivatives) which may cause, in excessive doses
- Convulsions, malaise and/or temporary cessation of breathing (respiratory pauses) in infants.
- Convulsions in children.
The recommended dosage and duration of treatment should be observed(see Dosage and Administration).
In case of occurrence of general signs of infection such as:
- high fever (>38.5°C) and persistent (more than 3 days);
- development of other symptoms such as: severe sore throat or headache, nausea, vomiting, ear pain or discharge, facial pain, purulent nasal discharge or sputum;
- development of breathing difficulties, hacking cough, signs of allergy;
- persistence or worsening of symptoms without improvement after 5 days of treatment.
CONSULT YOUR DOCTOR
Precautions for use
- Do not swallow.
- In case of allergic reaction, STOP THE TREATMENT.
- In adults, if you have a history of epileptic seizures, SEEK ADVICE FROM YOUR DOCTOR.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other drugs
Taking or using other medicines
|
This medicine contains lavender, red thyme and rosemary essential oils and thymol.
Other medications contain them. Do not combine them, so as not to exceed the maximum recommended doses (See section 3).
|
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
This medicine should only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can judge whether it is necessary to continue treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Breastfeeding
If you are breast-feeding, it is preferable not to use this medicine.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Not applicable.
3. HOW TO USE PERUBORE INHALATION, capsule for steam inhalation
Instructions for proper use
Beware of the risk of burns when handling very hot water.
DO NOT SWALLOW but INSPIRE the steam released.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 12 YEARS.
In all cases, respect the dose recommended in this leaflet. If you have any doubt, consult your doctor or pharmacist.
The usual dose is 1 capsule in an inhaler or a bowl of boiling water.
You should not exceed 3 inhalations per day.
Method of administration
This medicine is used by inhalation. You should NOT swallow the capsules but inhale the vapour.
For the best use of this medicine you should follow the steps below:
1 Insert the capsule directly into the inhaler or bowl, or cut off the end of the capsule before inserting it into the inhaler or bowl.
2 Pour boiling water over the capsule.
3 Inhale the vapours.
Ask your pharmacist to explain how to inhale if you have any doubts.
Frequency of administration
Repeat inhalations 3 times a day, spaced at least 4 hours apart. For example: one inhalation in the morning, one at noon and one in the evening.
Duration of treatment
The duration of treatment is limited to 5 days.
If the condition persists beyond 5 days of treatment or worsens, consult a doctor.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
If you forget to use PERUBORE INHALATION, capsule for steam inhalation:
Do not take a double dose to make up for the one you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, PERUBORE INHALATION may cause side effects, although not everyone is susceptible.
The following effects may occur:
- possible local irritation and allergy;
- due to the presence of terpene derivatives (essential oils and thymol) and if the recommended doses are not respected:
o risk of convulsions in children,
o possibility of agitation and confusion in the elderly.
DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.
5. HOW TO USE PERUBORE INHALATION, capsule for steam inhalation
Keep out of the reach and sight of children.
Do not use PERUBORE INHALATION after the expiry date stated on the box. The expiry date refers to the last day of the month.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does PERUBORE INHALATION, capsule for steam inhalation, contain?
The active ingredients are:
Lavender essential oil, red thyme essential oil, rosemary essential oil, thymol.
The other components are:
Paraffin oil.
Capsule shell: gelatine, glycerol.
Pharmaceutical form and contents
What is PERUBORE INHALATION, capsule for steam inhalation and what does it contain?
This medicine is in the form of a capsule for steam inhalation.
Each box contains 15 capsules.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
LABORATOIRES MAYOLY SPINDLER
6 AVENUE DE L'EUROPE
BP 51
78401 CHATOU CEDEX
Operator
LABORATOIRES MAYOLY SPINDLER
6 AVENUE DE L'EUROPE
BP 51
78401 CHATOU CEDEX
Manufacturer
LABORATOIRES MAYOLY SPINDLER
6 AVENUE DE L'EUROPE
BP 51
78401 CHATOU CEDEX
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package leaflet was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
HEALTH EDUCATION ADVICE:
To avoid contaminating those around you, it is important to:
- wash your hands regularly, especially before and during the preparation of meals;
- cover your mouth when you cough;
- blow your nose often with disposable tissues (so as not to recontaminate yourself) and dispose of them in a wastebasket immediately after use, then wash your hands;
- Avoid visiting a young mother and her newborn, an elderly person, or a person being treated with immunosuppressants (corticosteroids, medication for a blood disease or cancer...). In these cases, wearing a mask is recommended.
For your comfort:
- drink enough fluids;
- moisten the nasal mucosa with suitable washing solutions (saline solution, thermal water or sea water sprays). Avoid using the same nasal tip for the whole family;
- Avoid smoking or breathing in other people's smoke;
- sleep with your head elevated to improve airflow through blocked nostrils and get enough sleep;
- protect the skin of the upper lip and nostrils with a cream if necessary, as repeated nose blowing tends to irritate the skin;
- Avoid air conditioners, which dehumidify the air and dry out the nasal mucous membranes; the ideal room temperature should be around 18-20°C;
- air the rooms regularly.
YOUR PHARMACIST AND DOCTOR ARE FAMILIAR WITH THE MEDICINES.
DO NOT HESITATE TO ASK THEM FOR DETAILS.
NEVER LEAVE A MEDICINE WITHIN THE REACH OF CHILDREN.
Français
English
