NOTICE
ANSM - Last updated: 19/08/2010
Name of the medicinal product
PERUBORE INHALATION, steam inhalation capsule
Essential oil of lavender, essential oil of red thyme, essential oil of rosemary, thymol
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist after 5 days, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT PERUBORES INHALATION, Vapor Inhalation Capsule AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE PERUBORATE INHALATION, BEFORE USING, steam inhalation capsule?
3. HOW TO USE PERUBORATE INHALATION, steam inhalation capsule?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE PERUBORE INHALATION, steam inhalation capsule?
6. ADDITIONAL INFORMATION
1. WHAT PERUBORES INHALATION, Vapor Inhalation Capsule AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
This medication has a decongestant action, that is to say it facilitates the release of the respiratory tracts.
Therapeutic indications
This medication is used as a decongestant during common respiratory infections (colds, rhinitis, rhinopharyngitis) in adults and children over 12 years of age.
2. BEFORE YOU USE PERUBORATE INHALATION, BEFORE USING, steam inhalation capsule?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use PERUBORE INHALATION, steam inhalation capsule:
· if you are allergic (hypersensitive) to any of the active ingredients (essential oil of lavender, essential oil of red thyme, rosemary essential oil or thymol) or to any of the other ingredients of PERUBORE INHALATION ( Refer to Section 6 for a complete list of ingredients ).
· In children with convulsions due to fever or not because this medicine contains essential oils and thymol.
Precautions for use; special warnings
Take special care with PERUBORE INHALATION, steam inhalation capsule:
Special warnings
This specialty contains essential oils and thymol (terpene derivatives) which can lead, in excessive doses:
· Convulsions, malaise and / or temporary arrest of breathing (breathing breaks) in the infant.
· Convulsions in children.
Observe the recommended dosage and duration of treatment ( see Dosage and Administration ).
In case of general signs of infection such as:
· high fever (> 38.5 ° C) and persistent (> 3 days);
· onset of other symptoms such as: severe sore throat or headache, nausea, vomiting, ear pain or discharge, face pain, nasal discharge or expectoration purulent;
· onset of respiratory discomfort, harsh cough, signs of allergy;
· persistence or aggravation of symptoms without improvement beyond 5 days of treatment.
CONSULT YOUR DOCTOR
Precautions for use
· Do not swallow.
· In case of allergic reaction, STOP TREATMENT.
· In adults, if there is a history of epileptic seizures, ASK YOUR DOCTOR ADVICE.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
This medicine contains essential oils of lavender, red thyme and rosemary and thymol. Other medicines contain it. Do not combine them, so as not to exceed the maximum recommended doses ( see section 3 ). |
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
This medication will only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
If you are breast-feeding, it is best not to use this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE PERUBORATE INHALATION, steam inhalation capsule?
Instructions for proper use
Be aware of the risk of burns when handling very hot water.
DO NOT TAKE INSPIRATION but the released steam.
Dosage, Mode 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, observe the recommended dose 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 must not exceed 3 inhalations per day.
Administration mode
This medication is used by the respiratory route (by inhalation). You should NOT swallow the capsules but INSPIRE the steam released.
For the best use of this medication you must observe the following steps:
1 Insert the capsule directly into the inhaler or bowl, or cut the end of the capsule before inserting it into the inhaler or bowl.
2 Pour boiling water over the capsule.
3 Inhale the vapors.
Ask your pharmacist to explain how to inhale if you have any doubts.
Frequency of Administration
Repeat inhalation 3 times a day, spacing them at least 4 hours. For example: inhalation in the morning, lunchtime and evening.
Duration of treatment
The duration of treatment is limited to 5 days.
If the condition persists beyond 5 days of treatment or becomes worse, consult a doctor.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
If you forget to use PERUBORE INHALATION, steam inhalation capsule:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, PERUBORE INHALATION can cause side effects, although not everybody gets them.
The following effects may occur:
· possibility of local irritation and allergy;
· due to the presence of terpene derivatives (essential oils and thymol) and in case of non-respect of recommended doses:
o risk of convulsions in children,
o possibility of agitation and confusion in the elderly.
DO NOT HESITATE TO REQUEST THE OPINION OF YOUR DOCTOR OR PHARMACIST.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE PERUBORE INHALATION, steam inhalation capsule?
Keep out of the reach and sight of children.
Expiration date
Do not use PERUBORE INHALATION after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What contains PERUBORE INHALATION, steam inhalation capsule?
The active substances are:
Essential oil of lavender, essential oil of red thyme, essential oil of rosemary, thymol.
The other components are:
Paraffin oil.
Envelope of the capsule : gelatin, glycerol.
Pharmaceutical form and content
What is PERUBORE INHALATION, steam inhalation capsule and contents of the pack?
This medication is in the form of a vapor inhalation capsule.
Each box contains 15 capsules.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
MAYOLY SPINDLER LABORATORIES
6 AVENUE OF EUROPE
BP 51
78401 CHATOU CEDEX
exploiting
MAYOLY SPINDLER LABORATORIES
6 AVENUE OF EUROPE
BP 51
78401 CHATOU CEDEX
Maker
MAYOLY SPINDLER LABORATORIES
6 AVENUE OF 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 notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
SANITARY EDUCATION COUNCILS:
To avoid contaminating your surroundings, it is important to:
· Wash hands regularly, especially before meals or during preparation;
· cover your mouth when you cough;
· blow your nose often with disposable handkerchiefs (not to recontaminate) and dispose of them in a trash can immediately after use and then wash your hands;
· avoid visiting a young child and her newborn, an elderly person, or a person treated with immunosuppressive drugs (corticosteroids, medicines for blood or cancer). In these cases, wearing the mask is recommended.
For your comfort:
· drink enough;
· moisten the nasal mucosa with suitable washing solutions (physiological saline, sprays of thermal water or sea water). Avoid using the same nosepiece for the whole family;
· avoid smoking or breathing the smoke of others;
· sleeping the raised head to improve the airflow in the nostrils and sleeping enough;
· protect the skin of the upper lip and nostrils by a cream if the repetition of the flies tends to irritate the skin;
· avoid air conditioners that dehumidify the air and dry the nasal mucous membranes, the ideal room temperature should be around 18-20 ° C;
· aerate the parts regularly.
YOUR PHARMACIST, YOUR DOCTOR KNOWS THE MEDICINES WELL.
DO NOT HESITATE TO ASK FOR THEM.
NEVER LEAVE A MEDICINE TO THE REACH OF CHILDREN.