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AEROL

AEROL 100 micrograms / dose, suspension for inhalation in pressurized canister

AEROL

AEROL 100 micrograms / dose, suspension for inhalation in pressurized canister

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient: Salbutamol sulfate 120.50 micrograms

Quantity corresponding to salbutamol base 100.00 micrograms

Excipients: Oleic acid, anhydrous ethanol.

Propellant gas : Norflurane (tetrafluoroethane or HFA 134a)

THERAPEUTIC INDICATIONS

– Symptomatic treatment of the asthma attack.

– Symptomatic treatment of exacerbations during asthma or chronic obstructive bronchitis.

– Prevention of exercise-induced asthma.
– Reversibility test for bronchial obstruction during respiratory functional explorations

POSOLOGY

-Asthma attacks or breathing difficulties: when first symptoms appear, inhale 1 to 2 inhalations. This dose can be eventually repeated some minutes later if necessary. If the disorders are not relieved, consult your doctor immediately.

– Exercise induced asthma: inhale 1 to 2 inhalations, 15 to 30 minutes before the exercise.

– The daily dose should usually not exceed 8 inhalations

-In the event of a severe asthma attack, inhalations can be renewed at the rate of 2 to 6 puffs every 5 to 10 minutes until possible hospital care. In these situations, the use of an inhalation chamber is recommended to facilitate administration.

Whatever the age:

-Prevention of exercise-induced asthma: inhalation of 1 to 2 puffs, 15 to 30 minutes before exercise.
– Treatment of asthma attack and exacerbations: From the first symptoms, inhale 1 to 2 puffs.
The dose of 1 to 2 puffs is generally sufficient to treat respiratory discomfort.
If symptoms persist, it can be repeated a few minutes later.
The duration of bronchodilating action of inhaled salbutamol is 4 to 6 hours.
If symptoms reappear, the doses can be renewed.

The daily dose should usually not exceed 8 puffs per 24 hours. Above this dose, the patient must be informed that a medical consultation is necessary in order to reassess the therapeutic course

In these situations, the use of an inhalation chamber is recommended because it helps to improve the pulmonary diffusion of salbutamol administered by inhalation.

However, since the triggering of the metered dose inhaler in the inhalation chamber may decrease the total inhaled dose, the patient should inhale the product immediately after each triggering (or possibly each series of two successive triggerings) of the aerosol metering device in the inhalation chamber.

The administration will then be repeated in successive cycles. Severe acute asthma requires hospitalization. Oxygen therapy and the initiation of systemic corticosteroid therapy should be considered.

Inhaled via a pressurized canister device fitted with a mouthpiece.
For correct use, it is desirable that the doctor ensures the correct use of the device by the patient.
Use of the inhalation device

After shaking the device and removing the cap, the patient should:

-Check the absence of foreign bodies inside the inhaler including in the mouthpiece,
– Shake the inhaler well to make sure that the components of the solution contained in the cartridge have been properly mixed,

– Exhale deeply,
– Present the mouthpiece at the entrance of the mouth, the bottom of the metal cartridge directed upwards,

– Start breathing by pressing on the metal cartridge while continuing to breathe slowly and deeply,

– Remove the mouthpiece and hold your breath for at least 10 seconds,

– The mouthpiece of the propulsion unit must, for hygienic reasons, be cleaned after use

– Allergy to one of the constituents.

– Intolerance to this drug (occurrence of cough or bronchospasm after inhalation of the product).

In this case, this treatment should be stopped and other therapies or other forms of administration prescribed.

Special warnings and precautions for use

In case of asthma attack or breathing difficulties, the relief normally obtained should be observed rapidly after this drug administration. In case of failure, you should immediately consult your doctor.

If the usually efficient dose becomes insufficient, if the breathing difficulties attacks are becoming more frequent, a worsening of the disease is to be considered. You should rapidly consult your doctor who would readjust your treatment.

This product, active by inhalation route, must reach the extremity of small bronchi. In case of respiratory airways obstruction (micosal hyper secretion) or infection, its efficiency can be decreased. It is advised to rapidly consult your doctor in order to initiate an adapted treatment.

Inform your doctor if:
-you have problems of thyroid gland

-you have diabetes

-you have cardiovascular problems, in particular certain cardiac rhythm disturbances, angina pectoris (feeling of tightness in the chest and severe pain localized in the chest and which may extend into the left arm), or high blood pressure (increased blood pressure in the arteries)

Interaction with other medicinal products and other forms of interaction

Associations not recommended

+ Non-selective beta-blockers
+ Halogenated anesthetics (halothane)

Associations subject to precautions for use

+ Antidiabetics

This drug, in normal conditions, can be used during pregnancy.
In case of pregnancy or breastfeeding ask your doctor’s advice.

Be careful, this drug contains an active ingredient which can induce a positive reaction in anti-dumping control tests.

Aerol has no effect on the ability to drive vehicles

As for all active products, this drug can give to some persons, some effects more or less uncomfortable.
Frequently

Trembling extremities, increased and abnormal heart rhythm and headache.

Uncommon

Muscle cramps, palpitations and irritation of the mouth or throat

Very rarely:

Hot flushes, redness of the skin, nervousness, restlessness, hypersensitivity reactions (may include tightness in the chest, wheezing, swelling of the eyelids, face and / or lips and rash, hypotension go to the discomfort)

Decreased levels of potassium in the blood have been reported very rarely with very high doses of salbutamol.

Reversible elevation of blood glucose can be observed with very high doses of salbutamol.

As for the other inhaled products, possibility in rare cases of occurrence of cough or an increase of the breathing difficulties after the product inhalation. In this case do not repeat the inhalation and contact your doctor.
In case of doubt do not hesitate to contact your doctor or your pharmacist.

Hypokalemia may occur following an overdose of salbutamol. The serum potassium should therefore be monitored in the event of an overdose.

Nausea, vomiting and hyperglycemia have been reported, especially in children and when the overdose is due to oral salbutamol.

In case of overdosing Consult a doctor

Pressurized canister:
Do not expose to an excessive heat (25°C)
Do not pierce nor throw in fire even when empty.