EBASTINE Oral orodispersible tablet Ref.[8262] Active ingredients: Ebastine

Publisher: QualitecFarma, S.L., Ochandiano 10, Ed. 10, 28023 – Madrid, Spain

Product name and form

Ebastine 10 mg orodispersible tablets.

Pharmaceutical Form

Oral orodispersible tablet.

The orodipsersible tablet is white, round tablet of 6.5 mm of diameter.

Qualitative and quantitative composition

Ebastine 10 mg orodispersible tablets

Each orodispersible tablet contains 10 mg of ebastine.

Excipient(s) with known effect: Each 10 mg orodispersible tablet contains 50.30 mg of lactose monohydrate and 2.5 mg of aspartame.

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

Lactose monohydrate
Cellulose microcrystalline 101
Sodium croscarmellose
Aspartame (E951)
Magnesium stearate
Silica colloidal anhydrous
Peppermint flavour

Pack sizes and marketing

Aluminium/PA/PVC-Aluminium blisters containing 10, 20, 30, 50 or 100 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

QualitecFarma, S.L., Ochandiano 10, Ed. 10, 28023 – Madrid, Spain

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