Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: KRKA, d.d., Novo mesto, ล marjeลกka cesta 6, 8501 Novo mesto, Slovenia
Dasselta is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with:
The recommended dose of Dasselta 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.
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 Dasselta 5 mg film-coated tablets in children below the age of 12 years have not been established.
Oral use.
The tablet can be taken with or without food.
The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.
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.
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.
The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.
5 years.
Shelf life after first opening of the tablet container: 3 months.
Store in the original package in order to protect from moisture.
Blister (OPA/Alu/PVC//Alu): 7, 10, 20, 30, 50, 90 and 100 film-coated tablets, in a box.
Tablet container (HDPE, volume 60 ml), PP closure with desiccant: 250 film-coated tablets, in a box.
Not all pack sizes may be marketed.
No special requirements.
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