Medicinal Products

ATIMOS 12 μg / dose

Generic drug of the therapeutic class: Pneumology
active ingredients: Formoterol
laboratory: Chiesi SA

Solution for oral inhalation
Pressurized bottle of 100 Doses
All forms

Indication

Continuous symptomatic treatment of persistent, moderate to severe asthma in patients requiring daily bronchodilators; in combination with continuous anti-inflammatory therapy (inhaled and / or oral glucocorticoids).

The associated steroids should be kept in regular doses.

Symptomatic treatment of bronchial obstruction during chronic obstructive pulmonary disease.

Dosage ATIMOS 12 μg / dose Solution for oral inhalation Pressurized bottle of 100 Doses

The dosage depends on the severity of the disease.

The drug should not be used more than 3 months after the date of dispensing to the patient by the pharmacist (see section Special precautions for storage ).

Although Atimos acts rapidly, it is a long-acting inhaled bronchodilator and should therefore be reserved for continuous regular therapy.

Dosage in the treatment of asthma

Adults (including elderly subjects) and adolescents aged 12 and over:

Usual dose: one morning and evening puff (24 micrograms of formoterol fumarate dihydrate per day).

In severe cases: up to two puffs morning and evening at most (ie 48 micrograms of formoterol fumarate dihydrate per day).

The maximum daily dose is 4 puffs (48 micrograms of formoterol fumarate dihydrate).

Atimos does not treat the acute asthma attack.

For the treatment of acute attacks of asthma, it is recommended to use a bronchodilator β 2 mimetic inhaled short-acting.

Patients should be warned not to stop or change their corticosteroid therapy when initiating therapy with Atimos.

Persistence or increase in symptoms or insufficient control with recommended doses of Atimos indicates instability of the underlying disease.

Chronic Obstructive Pulmonary Disease (COPD)

Adult (aged 18 and over)

The usual dose is 1 inhalation 2 times daily (1 inhalation in the morning and 1 inhalation in the evening, 24 micrograms of formoterol fumarate per day).

In continuous treatment, the daily dose should not exceed 2 inhalations.

If necessary, additional inhalations may nevertheless be taken occasionally to relieve symptoms, but may not exceed a maximum total dose of 4 inhalations per day (continuous treatment and additional inhalations included). Do not exceed more than 2 inhalations each time.

Hepatic and renal insufficiency

There was no clinical study in these populations, however, existing data do not suggest the need for dose adjustment in renal or hepatic impairment.

Manual

In order to limit the risk of mishandling of the device by the patient, it is useful for the physician or health professional to ensure that the patient uses the inhaler correctly.

Before the first use of the inhaler and after three days or more of non-use, a puff will be released into the air to ensure proper function of the device.

Whenever possible, patients should be upright, standing or sitting while operating the inhaler.

1. Remove the protective cap from the mouthpiece.

2. Exhale out of the device as deeply as possible.

3. Hold the cartridge vertically, pointing the bottom up, and insert the mouthpiece between the tight lips.

4. Inhale deeply through the mouth while pressing the bottom of the cartridge (top) to release a puff.

5. Hold your breath for as long as possible without effort and, finally, remove the inhaler from your mouth.

If another puff is inhaled, hold the inhaler upright for approximately 30 seconds and repeat steps 2-5.

Always close after use with the protective cap.

IMPORTANT : Steps 2 to 4 should not be done too quickly.

If some of the gas escapes from the top of the inhaler or mouthpiece side, start again from step 2.

In patients with poor grasping ability, the inhaler will be held with both hands. In this case, the upper part of the inhaler will be held between the two indexes and the lower part between the two thumbs.

In case of difficulty for the patient to synchronize inspiration with the triggering of the device, an inhalation chamber should be used. Nevertheless, no clinical data are available concerning the use of Atimos with an inhalation chamber.

Against indications

· Hypersensitivity (allergy) known to the active substance or to any of its excipients.

Atimos side effects

The frequency of adverse reactions was classified as follows: frequent (> 1/100, 1/1000, 1/10000, <1/1000), very rare (<1/10000) including isolated cases.

Hematologic and lymphoid disorders

· Very rare, including isolated cases: thrombocytopenia

Heart conditions

· Frequent: palpitations

· Uncommon: tachycardia, tachyarrhythmia

· Rare: Ventricular extrasystoles, angina

· Very rare, including isolated cases: atrial fibrillation

Gastrointestinal disorders

· Uncommon: nausea, dysgeusia

General disorders and administration site conditions

· Very rare, including isolated cases: peripheral edema

Immune system disorders

· Rare: Quincke's edema

Anomalies of tests and examinations of explorations:

· Uncommon: increased insulinemia, blood free fatty acids and blood ketones

· Rare: increase or decrease in blood pressure,

Metabolism and nutrition disorders

· Uncommon: hypokalemia, hyperglycemia

Musculoskeletal and connective tissue disorders

· Uncommon: muscle cramps, myalgia

Nervous system disorders

· Frequent: tremor, headache

· Uncommon: agitation, dizziness

· Very rare, including isolated cases: CNS stimulant effects have been reported sporadically after inhalation of beta2-sympathomimetics; these effects are manifested by hyperexcitability. They were mainly observed in children under 12 years old.

Psychiatric disorders

· Very rare, including isolated cases: abnormal behavior, sleep disorders, hallucinations

Renal and urinary disorders

· Rare: Nephrite

Respiratory, thoracic and mediastinal disorders

· Frequent: cough

· Uncommon: throat irritation

· Rare: paradoxical bronchospasm

· Very rare, including isolated cases: dyspnea, exacerbation of asthma

Skin and subcutaneous tissue disorders

· Uncommon: pruritus, rash, hyperhidrosis.

· Rare: urticaria.

Tremor, nausea, dysgeusia, throat irritation, hyperhidrosis, agitation, headache, dizziness and muscle cramps may resolve spontaneously after 1 to 2 weeks of treatment.

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