Medicinal Products

BEMEDREX EASYHALER 200 μg / dose

Generic drug of the therapeutic class: Pneumology
active ingredients: Beclometasone
laboratory: Orion Pharma

Inhalation powder
Box of 1 bottle of 200 doses
All forms

Indication

Treatment of persistent asthma (mild, moderate and severe).

Dosage BEMEDREX EASYHALER 200 μg / dose Inhalation powder Box of 1 bottle of 200 doses

Inhaled route only.

To be effective, Bemedrex Easyhaler must be used regularly.

The initial dose administered to the patient will be determined according to the severity of the disease before treatment.

The recommended starting dose for patients with mild asthma (stage 2) is 400 micrograms / day and can be increased to 800 micrograms / day if necessary.

In patients with moderate (stage 3) to severe (stage 4) asthma, the initial dose may be 800 to 1600 micrograms / day. The dose will then be adjusted according to individual results, always looking for the minimum dosage to maintain control of asthma.

(Note: doses up to 2000 micrograms / day of beclometasone in adults and up to 1000 micrograms per day of beclometasone in children are recommended in the international consensus report on the treatment of asthma).

Bemedrex Easyhaler 200 micrograms / dose:

In adults: the usual maintenance dose is one to two inhalations (200 to 400 micrograms) twice a day. If necessary, the dose can be increased to 1600 micrograms / day, in two to four doses, and then reduced when the asthma is stabilized.

Child from 6 to 12 years old: one inhalation (200 micrograms) twice a day depending on the clinical response. In the most severe cases, the daily dose may be increased to 800 micrograms / day, divided into two to four doses per day, and reduced when asthma is stabilized.

The therapeutic effect is observed after a few days of treatment and reaches a maximum after a few weeks.

When starting treatment with Easyhaler in a patient previously treated with another device, the treatment should be adapted. The nature of the active ingredient and the method of administration must be taken into account.

The patient should be instructed how to use the device, recommending that the device be fully inhaled and never exhale into the device.

Against indications

History of hypersensitivity to beclometasone dipropionate or to any of the components (see section Composition ).

Bemedrex Easyhaler side effects

The reported adverse effects are presented in the table below:

Common side effects (> 1/100, <1/10)

Rare side effects (> 1/10 000, <1/1000)

Not known frequency

Immune system disorders

Allergic reactions with anaphylactic shock, urticaria, rash, angioedema

Endocrine system disorders

Hypophyso-adrenal axis suppression, growth retardation in children and adolescents, Cushing's syndrome, Cushingoid manifestations *

Psychiatric disorders

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

Eye disorders

Cataract, glaucoma *

Respiratory, thoracic and mediastinal disorders

Oropharyngeal candidiasis, hoarseness, coughing, irritation and sore throat

Bronchospasm (see section Warnings and precautions for use )

Eosinophilic pneumonia

Skin and subcutaneous tissue disorders

Cutaneous hematomas, cutaneous thinning

Musculoskeletal and connective tissue disorders

Decreased bone mineral density *

* Inhaled corticosteroids may have systemic effects, especially in case of prolonged high doses.

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