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

Product name and form

Dasergin 5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (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) and 0.201 mg (0.00875 mmol) sodium.

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
Hypromellose
Hydrochloric acid (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)
Maize starch
Lactose monohydrate
Talc

Film coating:

Hypromellose
Macrogol 400
Lactose monohydrate
Titanium dioxide (E171)
Indigo carmine (E132)

Pack sizes and marketing

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

Not all pack sizes may be marketed.

Marketing authorization holder

HCS bvba, H.Kennisstraat 53, Edegem 2650, Belgium

Marketing authorization dates and numbers

PA2096/006/001

Date of first authorisation: 6th July 2018

Drugs

Drug Countries
DASERGIN Estonia, Ireland, Poland, Romania
 
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