TELFAST Film-coated tablet Ref.[7820] Active ingredients: Fexofenadine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Opella Healthcare France SAS T/A Sanofi, 82 Avenue Raspail, 94250 Gentilly, France

Product name and form

Telfast 120 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Peach, modified capsule-shaped, film-coated tablet of 6.1 × 15.8 mm debossed with “012” on one side and a scripted “e” on the other side.

Qualitative and quantitative composition

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

For the 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
Pregelatinised maize starch
Croscarmellose sodium
Magnesium stearate

Film coat:

Hypromellose
Povidone K30
Titanium dioxide (E171)
Colloidal anhydrous Silica
Macrogol 400
Red iron oxide (E172)
Yellow iron oxide (E172)

Pack sizes and marketing

PVC/PE/PVDC/Al or PVC/PVDC/Al blisters, packaged into cardboard boxes. 2(sample only), 7, 10, 15, 20, 30, 50, 100 and 200 (as 10x20) tablets per package.

Not all pack sizes may be marketed.

Marketing authorization holder

Opella Healthcare France SAS T/A Sanofi, 82 Avenue Raspail, 94250 Gentilly, France

Marketing authorization dates and numbers

PA23180/003/002

Date of first authorisation: 11 November 1997
Date of last renewal: 20 July 2020

Drugs

Drug Countries
TELFAST Australia, Cyprus, Germany, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Malta, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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