DASSELTA Film-coated tablet Ref.[28232] Active ingredients: Desloratadine

Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Dasselta 5 mg film-coated tablets.

Pharmaceutical Form
Film-coated tablet. Light blue, round, film-coated tablets with beveled edges (diameter: 6.5 mm, thickness: 2.3-3.5 mm).

Qualitative and quantitative composition

Each film-coated tablet contains 5 mg desloratadine.

Excipient with known effect: Each film-coated tablet contains 16.15 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Desloratadine	Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H₁-receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine Η₁-receptors because the substance is excluded from entry to the central nervous system.

List of Excipients
Tablet core: Microcrystalline cellulose (E460) Hypromellose (E464) Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (E524) (for pH adjustment) Maize starch Lactose monohydrate Talc (E553b) Film coating: Hypromellose (E464) Macrogol Lactose monohydrate Titanium dioxide (E171) Indigo carmine (E132)

Pack sizes and marketing

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.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

7 film-coated tablets: EU/1/11/739/001
10 film-coated tablets: EU/1/11/739/002
20 film-coated tablets: EU/1/11/739/003
30 film-coated tablets: EU/1/11/739/004
50 film-coated tablets: EU/1/11/739/005
90 film-coated tablets: EU/1/11/739/006
100 film-coated tablets: EU/1/11/739/007
250 film-coated tablets: EU/1/11/739/008

Date of first authorisation: 28 November 2011
Date of latest renewal: 16 August 2016

Drugs

Drug	Countries
DASSELTA	Austria, Cyprus, Germany, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Italy, Lithuania, Poland, Romania

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