Terbinaforce-250 Uncoated Tablets

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Terbinafine Hydrochloride

Available from:

Mankind Pharma Limited, INDIA

ATC code:

Antifungals systemic preparations

INN (International Name):

Terbinafine Hydrochloride

Dosage:

250

Pharmaceutical form:

Uncoated Tablets

Manufactured by:

MANKIND PHARMA LIMITED, UNIT II, INDIA

Product summary:

Physical description: White to off-white coloured, round, biconvex, uncoated tablets, plain on both sides.; Local technical representative: Phillips Pharmaceuticals (Tanzania) Limited (2404)

Authorization status:

Registered/Compliant

Authorization date:

2021-08-20

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
TERBINAFORCE 250 (Terbinafine Tablets USP 250 mg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TERBINAFORCE-250: Each uncoated tablet contains: Terbinafine
Hydrochloride USP
equivalent to Terbinafine 250 mg
Excipients: For a full list of excipients, please refer Section 6.1.
3.
PHARMACEUTICAL FORM
TERBINAFORCE-250: White to off-white coloured, round, biconvex,
uncoated tablets,
plain on both sides.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Indicated for the treatment of fungal infections of the skin and nails
caused _by _
_Trichophyton (T.rubrum, _
_T.mentagrophytes, _
_T. v e r r u c o s u m , _
_T.violaceum)_, _Microsporum canis _and _Epidermophyton floccosum_.
1.
Indicated for 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.
2.
Indicated in the treatment of onychomycosis
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults: 250 mg once daily
The duration of treatment varies according to the indication and
severity of the
infection
_Skin Infections _
Likely duration of treatment are as follows:
_ Onychomycosis _
For most patients, the duration of treatment is between 6 weeks and 3
months although
treatment periods of less than 3 months can be anticipated in younger
patients or those
with fingernail infections or toenail infections other than the big
toe. 3 months is usually
sufficient in the treatment of toenail infections although some
patients may require 6
months of treatment or longer. Poor nail outgrowth during the first
weeks of treatment may
Tinea pedis (interdigital, plamtar/moccoasin type):
Tinea corporis:
Tinea cruris:
2 to 6 weeks
4 weeks
2
to 4
weeks
indicate those patients where longer therapy is required.
The complete resolution of signs and symptoms of infection may not
occur until several
weeks after mycological cure.
_Additional information on special population _
Liver impairment
TERBINAFORCE-250 tablet