Medicinal Products

ASMELOR NOVOLIZER 12 μg / dose

Generic drug of the therapeutic class: Pneumology
active ingredients: Formoterol
laboratory: Meda Pharma

Inhalation powder
Box of 1 Cartridge of 60 Doses
All forms

Indication

Continuous symptomatic treatment of moderate to severe persistent asthma in patients requiring continuous bronchodilator therapy with a long-acting beta-2-agonist in combination with inhaled corticosteroid therapy (with or without oral corticosteroid) ).

The associated steroids should be kept in regular doses.

Symptomatic treatment of bronchial obstruction in patients with chronic obstructive pulmonary disease (COPD) requiring long-acting bronchodilator therapy.

Dosage ASMELOR NOVOLIZER 12 μg / dose Powder for inhalation Box of 1 Cartridge of 60 Doses

Inhaled way.

Taking additional doses compared to the usual dosage more than 2 days a week, is a sign of insufficient control and the background treatment must then be re-evaluated.

The treatment will be administered twice daily.

ASTHMA:

Adults (including the elderly) and adolescents over 12:

The usual dosage is 1 inhalation (12 micrograms) twice daily. For severe asthma, the dosage may be increased up to 2 inhalations (24 micrograms) twice daily.

The maximum daily dose is 4 inhalations (2 inhalations twice daily) corresponding to 48 micrograms.

Children 6 years old and over:

The usual dosage is 1 inhalation (12 micrograms) twice daily. For severe asthma, the dosage may be increased up to 2 inhalations (24 micrograms) twice daily, after evaluation by the physician.

In continuous regular treatment, the daily dose not to exceed is 2 inhalations (24 micrograms). However, occasionally it may be increased to 4 inhalations spread over a 24-hour period.

Asmelor Novolizer is not recommended for children under 6 years of age due to insufficient data in this age group.

Inhaled formoterol is indicated in patients receiving inhaled corticosteroid therapy when continued symptomatic treatment of asthma is required in addition to inhaled corticosteroid.

Although formoterol has a rapid onset of action, the use of long-acting inhaled bronchodilators (such as formoterol) should be reserved for ongoing symptomatic treatment of the substance only in regular dosing.

Formoterol is not intended for the treatment of asthma attacks. In the event of an asthma attack, a short-acting b 2 agonist must be used.

Patients should be cautioned not to discontinue or change their corticosteroid therapy when treatment with Asmelor Novolizer is initiated.

OBSTRUCTIVE CHRONIC BRONCHOPNEUMOPATHY (COPD):

Adults (including the elderly) and adolescents over 12:

The usual dosage in continuous regular treatment is 1 inhalation (12 micrograms) twice daily.

The usual daily dose not to be exceeded in continuous regular treatment is 2 inhalations (24 micrograms). However, if necessary, additional inhalations at the usual dosage prescribed as part of continuous regular therapy may be taken to relieve symptoms, but may not exceed the maximum total dose of 4 inhalations per day (48 micrograms for continuous treatment and additional inhalations included). At each dose, do not exceed more than 2 inhalations.

Specific populations:

No dose adjustment is necessary in elderly patients or patients with renal or hepatic impairment (see section 4.4 ).

Treatment modalities

In order to ensure an optimal intrabronchial diffusion of the active ingredient, the inhalation should be carried out with a steady flow by inspiring as deeply and as quickly as possible (up to the maximum inspiration amplitude). The device is equipped with an audible click system and a color change of the control window if the inhalation has been performed correctly.

If the device does not signal by clicking and changing the color of the control window that the inhalation has been performed correctly, the patient should repeat the inhalation.

The inhaler remains blocked until the inhalation is done properly.

Instructions for use and handling

Reloading

Lightly press the ribbed surfaces on both sides of the cover, push the cover forward and remove.

Remove the protective aluminum foil from the cartridge case and take a new cartridge.

Insert the cartridge into the Novolizer, orienting the dose counter facing the mouthpiece.

Replace the cover in its side guides and push it horizontally towards the button until it fits into its housing. The cartridge can be left in the Novolizer inhaler until it is empty or for up to 6 months after insertion.

Note: Asmelor Novolizer 12 micron cartridges can only be used with the Novolizer Powder Inhaler.

How to use the device

1. For inhalation, it is best to sit or stand. When using the Novolizer device, always hold it horizontally. First remove the protective cap.

2. Press the colored button all the way down. You can hear a double click sound and the color of the control window (bottom) changes from red to green. Then release the colored button. The green color in the window indicates that the Novolizer is ready for use.

3. Exhale thoroughly (out of the inhaler)

4. Close the lips around the mouthpiece. Inhale the powder with a deep breath. During this inhalation, an audible click must be heard to prove that the inhalation has been properly performed. Hold your breath for a few seconds and then breathe normally.

Note: If the patient requires multiple inhalations, repeat steps 2 to 4.

5. Replace the protective cap on the mouthpiece. Inhalation is now complete.

6. The number that appears in the upper window indicates the number of remaining doses, from 10 to 10 from 60 to 0 remaining doses.

Note: The colored button should not be pressed until immediately before inhalation.

With the Novolizer device, involuntary inhalation of a double dose is impossible. The audible click and the color change in the control window indicate that the inhalation has been performed correctly. If the color of the control window remains unchanged, repeat inhalation. If inhalation is not done properly after several attempts, the patient should consult his doctor.

Cleaning

The Novolizer device should be cleaned at regular intervals and at least every time the cartridge is changed. For instructions on cleaning the appliance, refer to the instructions for use contained in the box.

Note: To ensure proper use of the inhaler, patients should be clearly instructed in the instructions for use of the device. When using this medicine in children, it should be ensured that an adult is supervising the administration of the drug.

Against indications

· Hypersensitivity (allergy) known to the active substance or lactose (which may contain milk proteins).

Asmelor Novolizer side effects

The most common side effects such as tremors and palpitations are mild and disappear after a few days of treatment.

Frequent (1 to 10%):

Cardiovascular disorders: palpitations.

Nervous system disorders: headache, tremors.

Uncommon (0.1 to 1%):

Cardiovascular disorders: tachycardia.

Musculoskeletal and connective tissue disorders: muscle cramps.

Psychiatric disorders: agitation, nervousness, sleep disorders.

Respiratory disorders: Oropharyngeal irritation.

Rare (0, 01 to 0.1%):

Cardio-vascular disorders: cardiac arrhythmias such as atrial fibrillation, supraventricular tachycardia, extrasystoles.

Gastrointestinal disorders: nausea.

Immune system disorders: hypersensitivity reactions such as bronchospasm, exanthema, urticaria, pruritus, angioedema.

Metabolism and nutrition disorders: hypokalemia, hyperkalemia.

Nervous system disorders: hyperexcitability.

Very rare (<0, 01%):

Cardiovascular disorders: angina pectoris.

Investigative examinations: lengthening QT space c .

Metabolism and nutrition disorders: hyperglycemia.

Nervous system disorders: taste disorder, dizziness.

Vascular disorders: change in blood pressure.

Rarely: As with any inhalation therapy, administration of the product may result in paradoxical bronchospasm.

Treatment with beta-2 agonists may induce an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.

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