MEDOFLORAN Tablet Ref.[28281] Active ingredients: Terbinafine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

MEDOFLORAN 250 mg tablets.

Pharmaceutical Form

Tablet.

For oral administration.

White, round, flat, scored tablet, with diameter 10.5 mm.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains terbinafine HCL equivalent to 250 mg terbinafine.

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

Sodium starch glycollate, HPMC E5, microcrystalline cellulose 101, colloidal silicon dioxide, magnesium stearate

Pack sizes and marketing

PVC-A1 blisters of 7 tablets each. Packs of 14 and 28 tablets are available.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

20373

17/07/08

Drugs

Drug Countries
MEDOFLORAN Cyprus, Hong Kong, Malta

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