Medicinal Products

ALVESCO 80 μg / dose

Generic drug of the therapeutic class: Pneumology
active ingredients: Ciclesonide
laboratory: Takeda Gmbh

Solution for oral inhalation
Pressurized bottle of 60 doses
All forms

Indication

Continuous treatment of persistent asthma in adults and adolescents (12 years and older).

Dosage ALVESCO 80 μg / dose Solution for oral inhalation Pressurized bottle of 60 Doses

Inhaled route only.

Dosage in adults and adolescents:

The recommended dose of Alvesco is 160 micrograms once a day, which allows control of asthma in the majority of patients. Nevertheless, in severe asthma, a 12-week study showed a reduction in the frequency of exacerbations with a dose of 640 micrograms per day (320 micrograms twice daily) but without any evidence of improvement in function pulmonary (see section 5.1 Pharmacodynamic properties ). In some patients, a reduced dose of up to 80 micrograms once a day may be sufficient for maintenance therapy.

The intake of Alvesco will preferably be in the evening but it is also possible in the morning depending on the clinical case left to the discretion of the doctor.

When asthma is controlled, the dosage should be adjusted to the minimum effective dose to control the symptoms of asthma.

Patients with severe asthma are particularly prone to the onset of acute asthma attacks. They will have to be regularly followed on the clinical plan with possibly a surveillance by means of respiratory explorations if necessary. Increasing the use of fast-acting bronchodilators to relieve asthma symptoms should be a sign of destabilization of asthma. Patients should be informed that medical consultation is necessary if they do not obtain sufficient improvement in their symptoms with the fast-acting bronchodilators they usually use or if they need to increase their daily consumption. Therapeutic management should be reassessed and an increase in anti-inflammatory treatment should be considered (examples: increase in the dose of Alvesco for a limited time (see section on Pharmacodynamic properties ) or oral corticotherapy treatment). In the event of severe exacerbations, conventional adapted treatment should be initiated.

In case of difficulty of hand / lung synchronization to use the device, Alvesco can be used with the AeroChamber Plus inhalation chamber Ò.

Alvesco is not recommended for use in children under 12 years of age due to lack of efficacy and safety data.

Elderly patients or patients with hepatic or renal insufficiency:

There is no need to adjust the dosage in elderly patients or in patients with hepatic or renal impairment.

Instructions for use / handling:

Reserved for inhalation use.

The patient should be told how to properly use the inhaler.

When using the device for the first time or if it has not been used for more than a week, the device will be primed by triggering it beforehand in a vacuum. It is unnecessary to shake the bottle before use because the product is in the form of solution.

Inhalation should be performed preferably in a sitting or standing position by holding the inhaler upright with the thumb on the base of the inhaler under the mouthpiece.

Remove the cap from the mouthpiece, place the inhaler into the mouth by enclosing the mouthpiece between the lips and inhale slowly and deeply while pressing on the top of the inhaler.

Remove the inhaler from the mouth by holding its breath for at least 10 seconds or until breathing becomes difficult. Do not exhale in the device.

Then, slowly exhale out of the device and replace the mouthpiece cap.

The mouthpiece should be cleaned with absorbent paper or a dry cloth once a week.

The inhaler should not be rinsed with water or immersed in water.

For detailed instructions, refer to the manual in the box.

Against indications

Hypersensitivity to ciclesonide or any of the excipients.

Alvesco side effects

In clinical trials, adverse events have been reported in approximately 5% of patients treated with Alvesco at doses ranging from 40 to 1280 micrograms per day. In the majority of cases, they were mild and did not require discontinuation of Alvesco treatment.

Frequency

Organ system

Rare

( ≥1 / 1, 000, <1/100)

Rare

( ≥1 / 10, 000, <1/1000)

Frequency of occurrence undetermined (can not be estimated from available data)

Cardiac disorders

palpitations **

Gastrointestinal disorders

Nausea, vomiting *

Sensation of bad taste in the mouth

Abdominal pain*

Dyspepsia*

General disorders and administration site conditions

Local reactions

Local drought

Immune system disorders

Hypersensitivity reactions

Quincke's edema

Infections and infestations

Oral fungal infection *

Nervous system disorders

headache *

Psychiatric disorders

Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavior modification (especially in children)

Respiratory, thoracic and mediastinal disorders

dysphonia

Cough after inhalation *

Paradoxical bronchospasm *

Skin and subcutaneous tissue disorders

Irritation and eczema

Vascular disorders

Hypertension

* Equal or lower frequency versus placebo.

** palpitations in clinical trials have been observed for concomitant use with drugs with known cardiac effects (theophylline or salbutamol).

Bronchospasm may occur immediately after inhalation. This is a nonspecific acute reaction, which is possible with all inhaled drugs, and may be related to the active ingredient, excipients or cooling associated with the aerosolization of pressurized metered dose aerosol products. In severe cases, treatment with Alvesco should be discontinued.

Systemic effects may occur with inhaled corticosteroids, especially with long-term and high-dose therapies. Potential systemic effects include Cushing's syndrome, Cushingoid symptoms, Adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataract and glaucoma (see also Warnings and Precautions section). precautions for use ).

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