TERBASIL 250 Base Milligrams Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TERBINAFINE HYDROCHLORIDE

Available from:

Actavis Group PTC ehf

ATC code:

D01BA02

INN (International Name):

TERBINAFINE HYDROCHLORIDE

Dosage:

250 Base Milligrams

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antifungals for systemic use

Authorization status:

Authorised

Authorization date:

2008-01-18

Patient Information leaflet

TERBASIL 250 MG TABLETS
Terbinafine
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 
START TAKING THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
•      Keep this leaflet. You may need to read it again.
•       If you have further questions, please ask your 
doctor or your pharmacist. 
•        This medicine has been prescribed for you only. 
Do not pass it on to others. It may harm them, 
even if their signs of illness are the same as 
yours. 
•        If you get any side effects talk to your doctor 
or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET: 
1
    WHAT TERBASIL TABLETS ARE AND WHAT THEY 
ARE USED FOR
2
    WHAT YOU NEED TO KNOW BEFORE YOU USE 
TERBASIL TABLETS 
3
  HOW TO USE TERBASIL TABLETS 
4
  POSSIBLE SIDE EFFECTS 
5
  HOW TO STORE TERBASIL TABLETS 
6
   CONTENTS OF THE PACK AND OTHER 
INFORMATION

1
   WHAT TERBASIL TABLETS ARE AND WHAT THEY 
ARE USED FOR

Terbasil Tablets contain terbinafine which is an 
anti-fungal agent. Terbasil Tablets are used for the 
treatment of infections such as: 
• fungal infections of the skin and nails 
• ringworm 
2
    WHAT YOU NEED TO KNOW BEFORE YOU USE 
TERBASIL TABLETS
DO NOT USE TERBASIL TABLETS:

•  if you are ALLERGIC to terbinafine or any of the other 
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using 
Terbasil Tablets if you:
•  have or had any LIVER PROBLEMS. If test of liver 
functionality shows an increase, then terbinafine 
should be discontinued immediately.
•   have  KIDNEY PROBLEMS consult your doctor before 
taking these tablets.
•  are taking any OTHER MEDICATIONS.
•  have previously suffered from psoriasis or lupus 
erythematosus (skin conditions). If you notice that 
skin rash occurs, stop taking Terbasil 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Terbasil 250mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250mg Terbinafine (as Terbinafine hydrochloride)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White, round, scored, flat tablet marked "T" above and "1" below the score on one side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fungal infections of the skin and nails caused by _Trichophyton _(e.g. _T. rubrum, T.mentagrophytes, T. verrucosum, T._
_violaceum_), _Microsporum canis _and _Epidermophyton floccosum_.
Oral terbinafine is indicated in the treatment of ringworm (tinea corporis, tinea cruris and tinea pedis) where oral
therapy is considered appropriate due to the site, severity or extent of the infection.
Onychomycosis (nail infections) caused by dermatophyte fungi.
Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS: 250mg once daily.
The duration of treatment varies according to the indication and the severity of the infection.
Skin infections
Likely durations of treatment are as follows:
Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks
Tinea corporis: 4 weeks
Tinea cruris: 2 to 4 weeks
Onychomycosis
The duration of treatment for most patients is between 6 weeks and 3 months. Treatment periods of less than 3 months
can be anticipated in patients with fingernail infection, toenail infection other than of the big toe, or patients of younger
age. In the treatment of toenail infections, 3 months is usually sufficient although a few patients may require treatment
of 6 months or longer. Poor nail outgrowth