DASERGIN Film-coated tablet Ref.[50435] Active ingredients: Desloratadine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: HCS bvba, H.Kennisstraat 53, Edegem 2650, Belgium

4.1. Therapeutic indications

Dasergin is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with:

  • allergic rhinitis (see section 5.1),
  • urticaria (see section 5.1).

4.2. Posology and method of administration

Posology

Adults and adolescents (12 years of age and over)

The recommended dose of Dasergin is one tablet once a day.

Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.

In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.

Paediatric population

There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1).

The safety and efficacy of Dasergin 5 mg film-coated tablets in children below the age of 12 years have not been established.

Method of administration

Oral use.

The tablet can be taken with or without food.

4.9. Overdose

The adverse event profile associated with overdosage, as seen during postโ€‘marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.

Treatment

In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended.

Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.

Symptoms

Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.

Paediatric population

The adverse event profile associated with overdosage, as seen during postโ€‘marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store in the original package in order to protect from moisture.

6.5. Nature and contents of container

Blister (OPA/Alu/PVC//Alu): 10, 30 or 100 film-coated tablets, in a box.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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