Lamisil 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Terbinafine hydrochloride

Available from:

DE Pharmaceuticals

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

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMISIL
® 250MG TABLETS
(terbinafine hydrochloride)
WHAT YOU NEED TO KNOW ABOUT LAMISIL TABLETS
Your doctor has decided that you need this medicine to
help treat your condition.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO
TAKE YOUR MEDICINE. IT CONTAINS IMPORTANT INFORMATION.
Keep the leaflet in a safe place because you may want to
read it again.
If you have any other questions, or if there is something
you don’t understand, please ask your doctor or
pharmacist.
This medicine has been prescribed for you.
Never give it to someone else. It may not be the right
medicine for them even if their symptoms seem to be the
same as yours.
If any side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
The name of your medicine is Lamisil 250mg Tablets, but
will be referred to as Lamisil Tablets throughout out the
remainder of the leaflet.
IN THIS LEAFLET:
1.
What Lamisil Tablets are, and what they are used for
2.
Things to consider before you start to take Lamisil
Tablets
3.
How to take Lamisil Tablets
4.
Possible side effects
5.
How to store Lamisil Tablets
6.
Further information
1.
WHAT LAMISIL TABLETS ARE AND WHAT THEY ARE USED FOR
Terbinafine, the active ingredient in Lamisil Tablets, is an
antifungal medicine.
Lamisil Tablets are used to treat a number of fungal
infections of the skin and nails.
2. THINGS TO CONSIDER BEFORE YOU START TO TAKE LAMISIL
TABLETS
SOME PEOPLE MUST NOT TAKE LAMISIL
TABLETS. TALK TO YOUR DOCTOR IF:
•
you think you may be allergic to terbinafine or to any
of the other ingredients of Lamisil Tablets. (These are
listed in Section 6.)
•
you have or have had any liver problems
•
you are breast-feeding
YOU SHOULD ALSO ASK YOURSELF THESE
QUESTIONS BEFORE TAKING LAMISIL TABLETS.
If the answer to any of these questions is YES, tell your
doctor or pharmacist because Lamisil Tablets might not be
the right medicine for you.
•
Are you pregnant or trying to become pregnant?
�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lamisil® Tablets 250mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 281.25mg terbinafine hydrochloride, equivalent to
250mg
terbinafine
3.
PHARMACEUTICAL FORM
Tablets for oral administration.
LAMISIL Tablets 250mg:
Whitish to yellow tinged white, circular, biconvex tablets, scored on
one side and coded
LAMISIL 250 on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fungal infections of the skin and nails caused by _Trichophyton _(eg.
_T. rubrum_,
_T.mentagrophytes, T. verrucosum, T. violaceum_), _ Microsporum canis
_ and
_Epidermophyton floccosum _
1.
Oral LAMISIL 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.
2.
Oral LAMISIL is indicated in the treatment of onychomycosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 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.
Additional information on special population
_Liver impairment _
Lamisil tablets are contraindicated for patients with chro