Medicinal Products

DESLORATADINE SANDOZ 5 mg

Aerius Generic Drug
Therapeutic class: Allergology
active ingredients: Desloratadine, Desloratadine
laboratory: Sandoz

Coated tablet
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.

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