Medicinal Products

BECLOMETASONE CHIESI 400 micrograms / 1 ml

Generic drug of Beclospin
Therapeutic class: Pneumology
active ingredients: Beclometasone
laboratory: Chiesi Sas

Suspension for inhalation by nebulizer
box of 20 single-dose containers of 1 mL
All forms

Indication

BECLOMETASONE CHIESI is indicated:

· In continuous treatment of asthma in adults and children, when pressurized or dry powder inhalers can not be used or are unsuitable;

· In treatment of children aged 5 years or younger with recurrent episodes of wheezing (see sections Posology and method of administration and Warnings and Precautions for Pediatric Use).

Dosage BECLOMETASONE CHIESI 400 micrograms / 1 ml suspension for inhalation by nebulizer box of 20 single-dose 1 mL containers

BECLOMETASONE CHIESI is indicated:

· In continuous treatment of asthma in adults and children, when pressurized or dry powder inhalers can not be used or are unsuitable;

· In treatment of children aged 5 years or younger with recurrent episodes of wheezing (see sections Posology and method of administration and Warnings and Precautions for Pediatric Use).

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Adverse effects Beclometasone Chiesi

Summary of the security profile:

The most common adverse events observed in clinical trials with beclometasone dipropionate in the treatment of asthma and in children with bronchial wheezing were laryngitis, pharyngitis, and oral and pharyngeal candidiasis.

Rare cases of serious hypersensitivity reactions including edema of the eyelids, face, lips and throat (Quincke's edema) have been reported.

Paradoxical bronchospasm may occur following administration of the product.

Tabulated summary of adverse effects:

Adverse events observed in clinical trials with inhaled beclometasone in the treatment of asthma and bronchial wheezing in children are listed in the table below by MedDRA system organ class and frequencies: very frequent (≥ 1/10); frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1 / 10, 000), not known (can not be estimated based on available data).

Class of organ systems

Undesirable effect

Frequency

Infections and infestations

Laryngitis, pharyngitis

Very common

Oropharyngeal candidiasis

Frequent

Herpes simplex

*Rare

Endocrine disorders

Inhibition of overrenal function **

Very rare

Immune system disorders

Hypersensitivity reactions: angioedema, rash, urticaria, pruritus

*Rare

Psychiatric disorders

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

Not known frequency

Nervous system disorders

cephalalgia

Rare

tremor

*Rare

Respiratory, thoracic and mediastinal disorders

Cough

Frequent

Throat irritation, hoarseness, dysphonia, paradoxical bronchospasm, sibilants

Rare

Dyspnea

Rare

Eye disorders

Cataract **, glaucoma **

Very rare

Gastrointestinal disorders

Nausea, dyspepsia

Frequent

Musculoskeletal and Connective Tissue Disorders

Growth retardation * (in children and adolescents), decreased bone mineral density *

Very rare

General disorders and administration site conditions

Asthenia

*Rare

* adverse effects from spontaneous notifications

** systemic effects of inhaled corticosteroids

Description of some adverse effects:

The systemic effects of inhaled corticosteroids (such as beclometasone dipropionate) may occur particularly with long-term administration of high doses. Inhibition of adrenal function, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma are reported (see Warnings and Precautions for Use "Special Warnings and Precautions"). employment).

Precautions to reduce the risk of developing oral candidiasis, hoarseness, and paradoxical bronchospasm are described in the Warnings and Precautions for Use section .

Pediatric population

Stunting and behavioral problems are more common in children than in adults, especially when long-term high doses are used.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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