Aerius Generic Drug
Therapeutic class: Allergology
active ingredients: Desloratadine, Desloratadine
laboratory: Sandoz
box of 30
All forms
Indication
Desloratadine is indicated for the symptomatic treatment of:
· Allergic rhinitis (see section on Pharmacodynamic properties ),
· Urticaria (see section 5.1 ).
Dosage DESLORATADINE SANDOZ 5 mg film-coated tablet box of 30
Desloratadine is indicated for the symptomatic treatment of:
· Allergic rhinitis (see section on Pharmacodynamic properties ),
· Urticaria (see section 5.1 ).
Against indications
Hypersensitivity to the active substance, to any of the excipients listed under Composition, or to loratadine.
Side effects Desloratadine Sandoz
In clinical trials conducted in allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, adverse events were reported in 3% more patients than those treated with placebo. The most commonly reported adverse events with an incidence greater than placebo were: asthenia (1.2%), dry mouth (0.8%) and headache (0.6%). In a clinical study in 578 adolescent patients aged 12 to 17, the most common adverse event was headache; it occurred in 5.9% of patients treated with desloratadine and in 6.9% of patients receiving placebo.
Other adverse effects reported very rarely since marketing are listed in the following table:
Psychiatric disorders | hallucinations |
Nervous system disorders | Dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions |
Heart conditions | Tachycardia, palpitations |
Gastrointestinal disorders | Abdominal pain, nausea, vomiting, dyspepsia, diarrhea |
Hepatobiliary disorders | Increases in liver enzymes, increased bilirubin, hepatitis |
Musculoskeletal and systemic disorders | myalgia |
General disorders | Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnea, pruritus, rash and urticaria |
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.
