Neoclarityn 5 mg film-coated tablets Ref.[2727] Active ingredients: Desloratadine

Adults and adolescents (12 years of age and over): one tablet once a day, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).

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).

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.

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

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.

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

2 years.

Do not store above 30°C.

Store in the original package.

Neoclarityn is supplied in unit dose blisters comprised of laminant blister film with foil lidding.

The materials of the blister consist of a polychlorotrifluoroethylene (PCTFE)/Polyvinyl Chloride (PVC) film (product contact surface) with an aluminium foil lidding coated with a vinyl heat seal coat (product contact surface) which is heat sealed.

Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 tablets.

Not all pack sizes may be marketed.

No special requirements.