Medicinal Products

DESLORATADINE EVOLUGEN 5 mg

Aerius Generic Drug
Therapeutic class: Allergology
Active ingredients: Desloratadine
laboratory: Evolupharm

Coated tablet
Box of 30
All forms

Indication

DESLORATADINE EVOLUGEN is indicated in adults and adolescents aged 12 and over for the symptomatic treatment of:

· Allergic rhinitis (see section on Pharmacodynamic properties ),

· Urticaria (see section 5.1 ).

Dosage DESLORATADINE EVOLUGEN 5 mg Film-coated tablet Box of 30

Dosage

Adults and adolescents (12 years and older): The recommended dose of DESLORATADINE EVOLUGEN is one tablet once a day.

The modalities of treatment of intermittent allergic rhinitis (presence of symptoms over a period of less than 4 days per week or over a period of less than 4 weeks) should take into account the evolution of the symptoms, the treatment being interrupted after the disappearance of symptoms, and restored to their reappearance.

For persistent allergic rhinitis (presence of symptoms over a period of 4 days or more per week and for more than 4 weeks), continuous treatment may be offered to patients during periods of allergen exposure.

Pediatric population

In adolescents aged 12 to 17 years, experience of the use of desloratadine in clinical studies of efficacy is limited (see sections 4.8 Undesirable effects and Pharmacodynamic properties ).

The safety and efficacy of DESLORATADINE EVOLUGEN have not been established in children under 12 years of age. No data available.

Administration mode

Oral voice.

The tablet can be taken at the moment or outside the places.

Against indications

Hypersensitivity to the active substance, to any of the excipients (see section Composition ), or to loratadine.

Adverse effects Desloratadine Evolugen

Summary of the security profile

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%), oral dryness (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.

Summary of adverse effects

Other adverse effects that have been reported very rarely since marketing are listed in the following table. The frequencies of occurrence of undesirable effects are defined as very frequent (≥ 1/10 patients), frequent (≥ 1/100 to <1/10 patients), infrequent (≥ 1/1000 to <1 / 100 patients), rare (≥ 1/10 000 to <1/1000 patients) and very rare (<1/10 000 patients).

C lasses of organs

Frequency

Adverse effect of s with desloratadine

Trouble is psychiatric

Very rare

hallucinations

Nervous system disorders

Very rare

Dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions

Cardiac disorders

Very rare

Tachycardia, palpitations

Gastrointestinal disorders

Very rare

Abdominal discomfort, nausea, vomiting, dyspepsia, diarrhea

Hepatobiliary disorders

Very rare

Increases in liver enzymes, increased bilirubin, hepatitis

Musculoskeletal and systemic disorders

Very rare

myalgia

General disorders

Very rare

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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