FEXOFAST Film-coated tablet Ref.[50417] Active ingredients: Fexofenadine

Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Cipla Europe NV, De Keyserlei 58-60, Box-19, 2018 Antwerp, Belgium

Product name and form

Fexofast 120 mg Film-coated Tablets.

Pharmaceutical Form
Film-coated tablet. Peach coloured, oblong, biconvex, film coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 120mg of fexofenadine hydrochloride, which is equivalent to 112mg of fexofenadine.

For a full list of excipients, see section 6.1.

Active Ingredient	Description
Fexofenadine	Fexofenadine is a non-sedating H₁ antihistamine. Fexofenadine is a pharmacologically active metabolite of terfenadine.

List of Excipients
Tablet core: Microcrystalline cellulose Maize starch Magnesium stearate Croscarmellose sodium Povidone Film-coating: Hypromellose (E464) Macrogol (PEG 400) Macrogol (PEG 4000) Titanium dioxide (E171) Iron oxide yellow (El72)

Pack sizes and marketing

PVC/PVDC foil blister packs of 7, 10, 15, 20, 30, 50, 100 or 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Cipla Europe NV, De Keyserlei 58-60, Box-19, 2018 Antwerp, Belgium

Marketing authorization dates and numbers

PA1963/014/001

Date of first authorisation: 21^st October 2005
Date of last renewal: 25^th March 2016

Drugs

Drug	Countries
FEXOFAST	Ireland, New Zealand, Poland

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