EBASTEL Film-coated tablet Ref.[49512] Active ingredients: Ebastine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: Almirall , S.A., General Mitre, 151, 08022 Barcelona, Spain

Product name and form

EBASTEL 10 mg Film-coated tablets.

Pharmaceutical Form

EBASTEL 10 mg Film-coated tablets: White to almost white, round, film-coated tablets engraved E10 on one side.

Qualitative and quantitative composition

Each EBASTEL 10 mg Film-coated tablet contains: Ebastine (INN) 10 mg.

Excipient (s) with known effect: Lactose monohydrate 88.5 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ebastine

Ebastine has been shown to produce a rapid and long-lasting inhibition of histamine-induced effect and to have a strong affinity towards H1-receptors.
List of Excipients

EBASTEL 10 mg Film-coated tablets

Tablet core:

Microcrystalline cellulose
Pregelatinized maize starch
Lactose monohydrate
Croscarmellose sodium
Magnesium stearate

Coating:

Hydroxypropyl methylcellulose
Macrogol
Titanium dioxide (E-171)

Pack sizes and marketing

EBASTEL 10 mg Film-coated tablets: Package with 20 × 10 mg tablets.

Marketing authorization holder

Almirall , S.A., General Mitre, 151, 08022 Barcelona, Spain

Marketing authorization dates and numbers

EBASTEL 10 mg Film-coated tablets: 19242

2 May 2001 / 16 February 2011

Drugs

Drug Countries
EBASTEL Brazil, Cyprus, Germany, Spain, Japan
 
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