Terbinafine 250mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Terbinafine hydrochloride

Disponible depuis:

Milpharm Ltd

Code ATC:

D01BA02

DCI (Dénomination commune internationale):

Terbinafine hydrochloride

Dosage:

250mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 05020500; GTIN: 8901175011599 8901175011605

Notice patient

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 any further questions, ask
your doctor or pharmacist.
•
This medicine has been prescribed for
you. 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 Terbinafine is and what it is used
for
2.
What you need to know before you take
Terbinafine
3.
How to take Terbinafine
4.
Possible side effects
5.
How to store Terbinafine
6.
Contents of the pack and other
information
1.
WHAT TERBINAFINE IS AND WHAT IT IS
USED FOR
Terbinafine belongs to a group of medicines
called antifungals. It is used for the
treatment of fungal infections of the skin
(including those in between the fingers and
toes) and of the nails.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE TERBINAFINE
DO NOT TAKE TERBINAFINE
•
if you are allergic to terbinafine or any
of the other ingredients of this medicine
(listed in section 6).
•
if you have a severe kidney problem.
•
if you have a severe liver problem
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Terbinafine.
•
if you have liver problems or a disease
which may affect your liver.
•
if you have psoriasis (skin disease with
raised red patches of skin covered with
silvery scales).
•
if you have kidney problems.
•
develop severe reduction in the number
of white blood cells which make
infections more likely (agranulocytosis)
or serious illness with blistering of the
skin (toxic epidermal necrolysis). You
should stop taking Terbinafine and
see your doctor immediately if you
experience these side effects which are
known to occur very rarely (see
section 4).
•
if you have (cutaneous and systemic
lupus erythematosus)
If any of the above warnings applies

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Terbinafine 250 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg terbinafine (as 281.250 mg terbinafine
hydrochloride).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, round, uncoated, biconvex bevelled edge tablets
with breakline
and ‘D’ debossed on one side and ‘74’ on the other side.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of fungal infections of the skin caused by terbinafine
sensitive
dermatophytes in cases of _tinea corporis_, _tinea cruris_ and _tinea
pedis_, when oral
therapy is considered appropriate due to the site, severity or extent
of the infection.
Treatment of onychomycosis caused by terbinafine sensitive
dermatophytes.
Consideration should be given to official guidance concerning the
appropriate use and
prescription of antifungals.
In contrast to topical terbinafine, oral terbinafine is not effective
in Pityriasis
versicolor
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_ _
_ADULTS:_
250 mg once daily however, the duration of treatment will vary
according to the
indication and the severity of the infection.
_SKIN INFECTIONS: _
Duration of the treatment
The likely durations of treatments are as follows:
_Tinea pedis_ (interdigital, plantar/moccasin type): 2 to 6 weeks
_Tinea corporis_: 2 to 4 weeks
_Tinea cruris_: 2 to 4 weeks
Complete resolution of the signs and symptoms of infection may not
occur until
several weeks after mycological cure.
ONYCHOMYCOSIS
The duration of treatment is usually between 6 weeks and 3 months.
Treatment of 6
weeks for onychomycosis of the finger nails is generally sufficient.
Regarding
onychomycosis of the toe nails, a 12 week treatment is usually
sufficient, although a
few patients with poor nail outgrow may require a longer treatment
duration (6
months or longer).
Complete resolution of the signs and symptoms of infection may not
occur unt