TERBINAFINE ACCORD Tablet Ref.[7465] Active ingredients: Terbinafine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

Terbinafine 250mg Tablets.

Pharmaceutical Form

Tablet.

White, round, flat, 11 mm tablets, scored on both sides with side scores, marked “T” above and “1” below the score on one side.

Qualitative and quantitative composition

Each tablet contains 250 mg terbinafine, as terbinafine hydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Terbinafine

Terbinafine is an allylamine which has a broad spectrum of antifungal activity. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. The activity versus yeasts is fungicidal or fungistatic depending on the species.

List of Excipients

Magnesium stearate
Silica, colloidal anhydrous
Croscarmellose sodium
Hypromellose
Microcrystalline cellulose

Pack sizes and marketing

Al/PVC-PVdC blister and HDPE tablet container with LDPE cap.

Pack Sizes:

HDPE bottles: 14, 28, 500 tablets.

Blisters: 7, 14, 20, 28, 30, 42, 50, 60, 84, 90, 98, 100, 50 × 1 (unit dose) tablets.

* Not all container types or pack sizes may be marketed.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 00142/0628

26/02/2009

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