Terbinafine 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Terbinafine hydrochloride

Available from:

Consilient Health Ltd

ATC code:

D01BA02

INN (International Name):

Terbinafine hydrochloride

Dosage:

250mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020500; GTIN: 5391512450120 5391512450304

Patient Information leaflet

PATIENT INFORMATION LEAFLET
TERBINAFINE 250 MG TABLETS
(TERBINAFINE HYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
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. Do not pass it on to
others. It may harm them, even if their symptoms are
the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor
or pharmacist.
IN THIS LEAFLET:
1.
What Terbinafine 250 mg Tablets are and what they are used for
2.
Before you take Terbinafine 250 mg Tablets
3.
How to take Terbinafine 250 mg Tablets
4.
Possible side effects
5.
How to Store Terbinafine 250 mg Tablets
6.
Further Information
1. WHAT TERBINAFINE 250 MG TABLETS ARE AND WHAT THEY ARE USED FOR
Terbinafine 250 mg Tablets act by attacking and killing fungus which
causes infection. Your doctor has prescribed the medicine
for you to treat fungal infections of the skin and nails or for the
treatment of ringworm.
2. BEFORE YOU TAKE TERBINAFINE
DO NOT TAKE TERBINAFINE 250 MG TABLETS IF:
•
You are allergic (hypersensitive) to terbinafine or any of the other
ingredients of Terbinafine 250 mg Tablets
•
You suffer from severe liver problems
•
You suffer from severe kidney problems
TAKE SPECIAL CARE WITH TERBINAFINE 250 MG TABLETS
PLEASE TELL YOUR DOCTOR OR PHARMACIST IF:
•
You have psoriasis
•
You have liver problems or you have had a history of liver disease
•
You have kidney problems
TAKING OTHER MEDICINES
Please inform your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription. Some medicines can interfere with
terbinafine so consult your doctor or pharmacist before
taking any other medication. In particular, tell your doctor if you
are taking any of the following medicines
- Rifampicin (an antibiotic)
- Cimetidine (for treating exce

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Terbinafine 250mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 281.25mg terbinafine hydrochloride, equivalent to
250mg
terbinafine
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, round, flat, 11mm tablets, scored on both sides with side
scores,
marked “T” above and “1” below the score on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
The
treatment
of
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_.
-
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.
-
The treatment of onychomycosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration:
Via the oral route
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. For 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
during
the
first
weeks
of
treatment
may
enable
identification of those patients in whom longer therapy is required.
Complete resolution of the signs and symptoms of infection may not
occur
until several weeks after mycological cure.
Children
The use of Terbinafine is not recommended in children.
Use in the elderly
There is no evidence