BALSOLÈNE INHALATION SOLUTION - BOTTLE 100ML

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BALSOLÈNE INHALATION SOLUTION - BOTTLE 100ML: The drug is indicated as Balsolène decongestant treatment in the common respiratory ailments (colds, rhinitis, nasopharyngitis) in adults and children over 12 years.

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BALSOLÈNE INHALATION SOLUTION - BOTTLE 100ML

Description BALSOLÈNE INHALATION SOLUTION - BOTTLE 100ML

The drug is indicated as Balsolène decongestant treatment in the common respiratory ailments (colds, rhinitis, nasopharyngitis) in adults and children over 12 years.

Balsolène inhalation solution is recommended as a decongestant in the common respiratory illnesses (colds, rhinitis, nasopharyngitis) in adults and children over 12 years.


Application advice and opinions on BALSOLÈNE INHALATION SOLUTION - BOTTLE 100ML

For adults and children over 12 years.
Pour a teaspoon of solution in a very hot but not boiling water and inhale the steam water bowl.
Repeat three times daily inhalations.

  • Method and route of administration

Inhalation by fumigation.

Do not swallow.

  • Duration of treatment

Do not exceed a few days of treatment.

If symptoms persist, consult your doctor.

Soil composition balsolene 100ml inh

  • Active substances

Eucalyptus essential oil: 1.165 g

Tea Tree essential oil: 0.720 g

Levomenthol: 0.720 g

Benzoin from Laos: 1,350 g

For 100 ml solution for inhalation.

  • Excipients

Excipients: Ethanol 96% purified water.

Alcohol: 60% v / v.

Precaution for use with BALSOLÈNE INHALATION SOLUTION - BOTTLE 100ML

  • Special warnings


This medicine contains terpene derivatives (eucalyptus, melaleuca, levomenthol) that can lead to excessive doses:
Crashes type of convulsions in infants and children.
Pauses in breathing and discomfort in infants.
Follow the instructions for use and dosage, in particular: never exceed the recommended dosage.
  • Precautions


Do not swallow.

In case of fever, purulent nasal discharge, purulent expectoration, consult your doctor.

In case of old or recent epilepsy, consult your doctor.

If an allergic reaction, stop treatment.

If in doubt, do not hesitate to ask your doctor or pharmacist.

Pregnancy and lactation

If breastfeeding, it is best not to use Balsolène solution for inhalation.

Ask your doctor or pharmacist before taking any medicine.

Cons-indications

Never use Balsolène inhalation solution in the following cases:

  • Allergy to the product.
  • Due to the presence of terpene derivatives: Children with a history of seizures (febrile or not).

In case of doubt, it is essential to seek the advice of your doctor or pharmacist.

Adverse effects

Like all medicines, Balsolène is likely to have side effects, although not everybody there is not about:

Possible local irritation and allergy.
Due to the presence of terpene derivatives and in case of non-compliance with recommended doses:

  • risk of seizures in children.
  • possibility of agitation and confusion in the elderly.

If you notice any side effects not listed in this leaflet, or if the side effects gets serious, please tell your doctor or pharmacist.

Introducing BALSOLÈNE INHALATION SOLUTION - BOTTLE 100ML

Balsolène solution for inhalation is in the form of solution for inhalation by fumigation. Box of 1 bottle of 100 ml.


VIDAL OF THE FAMILY

BALSOLÈNE

Inhalation for decongestant use

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

BALSOLENE: solution for inhalation ; bottle of 100 ml.
-

French Pharmaceutical Cooperation Laboratory

COMPOSITION (summary)
pc to c
Benzoin 67.5 mg
Eucalyptus, gasoline 58.25 mg
levomenthol 36 mg
Niaouli, gasoline 36 mg
Alcohol +

INDICATIONS (summary)
This solution for inhalation is a combination of substances and plant essences ( terpenes ) which has a decongestant local action on the mucous membranes of the respiratory tracts .
It is used to clear the airways in case of colds or chills.
CONTRAINDICATIONS (summary)
This drug should not be used in case of a history of seizures or epilepsy .
WARNING (Contents)
This medicinal product contains terpenes which can cause serious adverse effects if dosages are exceeded: adhere to the recommended doses, especially in children or in cases of epilepsy .
The solution should not be swallowed; do not leave the vial within reach of children.
PREGNANCY AND BREAST-FEEDING (summary)
The effect of this medication during pregnancy or lactation is not well known. The assessment of the possible risk associated with its use is individual: ask your pharmacist or doctor for advice.
DIRECTIONS FOR USE AND DOSAGE (summary)
Inhalations are made with 1 teaspoon of solution in a bowl of very hot water or in an inhaler.

Usual dosage:

  • Adult and child over 12 years: 1 to 3 inhalations per day.
TIPS (summary)
It is important to fight against the dryness of the ambient air (humidifier ...) to avoid the drying of the nasal and bronchial secretions.
Before inhalation , it is essential to wait a few seconds for the evaporation of the alcohol after dilution in hot water.
POSSIBLE ADVERSE EFFECTS (summary)
Local irritation, allergic reaction .
If the usual dosage is exceeded, terpenes may cause:
  • convulsions in children,
  • agitation, confusion of ideas (especially in the elderly).


GLOSSARY (summary)


alcohol
General name designating a family of substances that have the property of being able to be mixed with water and fatty substances. The most common alcohol is ethyl alcohol (ethanol), but there are many other alcohols: methanol, butanol, etc. The degree of alcoholic solution corresponds to the volume of pure alcohol present in 100 ml of solution, knowing that 1 glass of wine or 1/2 of beer (25 cl) contains about 8 g of alcohol.
When alcohol is used as an antiseptic, an unpleasant odor denaturant is often added to prevent drinking. Contrary to a widespread belief, alcohol at 70o (or even at 60o) is a better antiseptic than alcohol at 90o.


antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


convulsions
Involuntary contractions limited to a few muscles or generalized to the whole body. They are due to excessive pain or stimulation of the brain: fever, poisoning, lack of oxygen, brain damage. Convulsions may be due to an epileptic seizure or high fever in young children.


epilepsy
A chronic seizure disorder associated with abnormal electrical activity of a group of brain cells. Its manifestations, varying in intensity, range from the sudden drop in attention (absences, or small evil) to loss of consciousness accompanied by abnormal muscle movements (convulsions, or great evil). Partial epilepsy, as its name implies, does not concern the whole body: the jerky movements only touch one or more muscle groups.


inhalation
  • A general term for the absorption through the mouth and nose of gaseous substances or suspended particles that diffuse into the respiratory tract after deep breathing.
  • Method of administration of volatile substances, dissolved in hot water. These substances are intended to act on the respiratory tract. Unlike the aerosol, which requires electrical equipment, inhalation is practiced in a simple way: by breathing the vapors of a solution contained in a bowl, the head covered with a towel. There are inexpensive inhaler bowls in pharmacies with a mouthpiece covering the mouth and nose.


mucous
Tissue (membrane) that lines the cavities and ducts of the body communicating with the outside (digestive tract, respiratory tract, urinary tract, etc.).


dosages
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


terpenes
A general term for aromatic substances of vegetable origin. These are traditionally used for their respiratory properties (stimulating, expectorant, antiseptic) and their revulsive power when applied to the skin. The most used are camphor, menthol, eucalyptol, essential oils of mint, turpentine, niaouli, pine, anise, etc.
Some terpenes, and especially camphor, have been responsible for convulsions, respiratory pauses in the infant, in case of overdose. They can also cause behavioral problems in the elderly. These products should be used with caution at the extreme ages of life.


way
  • Pathway (route of administration) used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
  • Set of hollow organs allowing passage of air (respiratory tract), food (digestive tract), urine (urinary tract), bile (bile ducts), etc.

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NOTICE

ANSM - Last updated: 26/09/2011

Name of the medicinal product

BALSOLENE, solution for inhalation by fumigation

Eucalyptus essential oil, Niaouli essential oil, Levomenthol, Benjoin of laos

framed

Read this leaflet carefully before you start using 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, 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 IS BALSOLENE, Fumigating Inhalation Solution AND IN WHAT CASES IS IT USED?

2. BEFORE YOU USE BALSOLENE, Fumigating Inhalation Solution?

3. HOW TO USE BALSOLENE, Fumigating Inhalation Solution?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE BALSOLENE, Fumigating Inhalation Solution?

6. ADDITIONAL INFORMATION

1. WHAT IS BALSOLENE, Fumigating Inhalation Solution AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group

A DISCONTINUING SCREEN

(R. respiratory system)

Therapeutic indications

This medication is recommended as decongestant during common respiratory infections (colds, rhinitis, nasopharyngitis) in adults and children over 12 years.

2. BEFORE YOU USE BALSOLENE, Fumigating Inhalation Solution?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never use BALSOLENE, fumigating inhalation solution in the following cases:

· allergy to the product.

· due to the presence of terpene derivatives: children with a history of convulsions (febrile or not).

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

Precautions for use; special warnings

Take special care with BALSOLENE, solution for inhalation by fumigation:

Special warnings

This specialty contains terpene derivatives (eucalyptus, niaouli, levomenthol) which can lead to excessive doses:

· seizure-type accidents in infants and children,

· respiratory breaks and discomfort in the infant.

Do not exceed the recommended doses ( see How to use BALSOLENE, solution for inhalation by fumigation? ).

Precautions for use

· Do not swallow.

· In case of fever, purulent nasal discharge, purulent expectoration, CONSULT YOUR DOCTOR.

· In case of epilepsy old or recent, REQUEST ADVICE TO YOUR DOCTOR.

· In case of allergic reaction, STOP TREATMENT.

IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.

Interaction with other medicines

Use of other medicines

TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

If you are breast-feeding, you should not use this medication.

Ask your doctor or pharmacist for advice before taking any medicine.

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using machines

No effects on the ability to drive and use machines have been observed.

List of excipients with known effect

Not applicable.

3. HOW TO USE BALSOLENE, Fumigating Inhalation Solution?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

RESERVED FOR ADULTS AND CHILDREN OVER 12 YEARS.

Pour a teaspoon of solution into a bowl of very hot but not boiling water and inhale the vapors.

Repeat inhalation 3 times daily.

Method and route of administration

Inhalation by fumigation

DO NOT SWALLOW

Duration of treatment

Do not exceed a few days of treatment.

If the symptoms persist, consult your doctor.

Symptoms and Instructions for Overdose

If you have used more BALSOLENE, fumigating inhalation solution than you should:

Not applicable.

Instructions for omission of one or more doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, BALSOLENE, a fumigating inhalation solution, is likely to have side effects, although not everyone is affected.

· possibility of local irritation and allergy,

· by virtue of the presence of terpene derivatives and in case of non-respect of the recommended doses :

o risk of convulsions in children,

o possibility of agitation and confusion in the elderly.

If you notice any side effects not listed in this leaflet, or if certain side effects become serious, please tell your doctor or pharmacist.

5. HOW TO STORE BALSOLENE, Fumigating Inhalation Solution?

Keep out of the reach and sight of children.

Expiration date

Do not use BALSOLENE, fumigating inhalation solution after the expiry date which is stated on the outer packaging

Storage conditions

Store at a temperature below 25 ° C.

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 does BALSOLENE, Fumigating Inhalation Solution contain?

The active substances are :

Eucalyptus essential oil ............................................. .................................................. 1,165 g

Niaouli essential oil .............................................. .................................................. ................ 0.720 g

Levomenthol ................................................. .................................................. ................................. 0.720 g

Benjoin du laos ............................................... .................................................. ............................... 1,350 g

For 100 ml of solution for inhalation.

The other components are :

Excipients : 96% ethanol, purified water.

Alcoholic strength: 60% v / v.

Pharmaceutical form and content

What is BALSOLENE, solution for inhalation by fumigation and contents of the pack?

This medicinal product is in the form of a solution for inhalation by fumigation. Box of 1 bottle of 100 ml or 125 ml.

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

FRENCH PHARMACEUTICAL COOPERATION

PLACE LUCIEN-AUVERT

77020 MELUN CEDEX

exploiting

FRENCH PHARMACEUTICAL COOPERATION

PLACE LUCIEN AUVERT

77020 MELUN

Maker

FRENCH PHARMACEUTICAL COOPERATION

PLACE LUCIEN AUVERT

77020 MELUN

or

FARMACLAIR

440 AVENUE OF THE GENERAL DE GAULLE

14200 HEROUVILLE SAINT CLAIR

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

Not applicable.

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