TEFIN Suppository Ref.[110140] Active ingredients: Butenafine Ibuprofen

Source: Health Products Regulatory Authority (IE)  Revision Year: 2024  Publisher: Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, E91 D768, Ireland

Product name and form

Tefin 75 mg Suppositories.

Pharmaceutical Form

Suppository.

White, odourless, torpedo-shaped suppository.

Qualitative and quantitative composition

Each suppository contains 75 mg of ibuprofen.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Butenafine

Butenafine is a benzylamine derivative with a mode of action similar to that of the allylamine class of antifungal drugs. Butenafine HCl is hypothesized to act by inhibiting the epoxidation of squalene, thus blocking the biosynthesis of ergosterol, an essential component of fungal cell membranes. It is indicated for the topical treatment of the dermatologic infection, tinea (pityriasis) versicolor due to M. furfur (formerly P. orbiculare).

Ibuprofen

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

List of Excipients

Hard fat

Pack sizes and marketing

Blister strips of aluminium/polyethylene containing five suppositories.

Pack sizes of 10 suppositories and hospital-only 100 pack sizes (10 × 10).

Not all pack sizes may be marketed.

Marketing authorization holder

Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, E91 D768, Ireland

Marketing authorization dates and numbers

PA0126/330/001

Date of first authorisation: 31st August 2012
Date of last renewal: 30th August 2017

Drugs

Drug Countries
TEFIN Brazil, Ireland

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