Terbinafine 250mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Terbinafine hydrochloride

Dostępny od:

Noumed Life Sciences Ltd

Kod ATC:

D01BA02

INN (International Nazwa):

Terbinafine hydrochloride

Dawkowanie:

250mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 05020500; GTIN: 05060453460337 05060453465042

Ulotka dla pacjenta

4.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Serious side effects
Stop taking the tablets and contact your doctor or hospital emergency
department IMMEDIATELY if you develop any of the following symptoms:
•
Difficulty breathing, dizziness, swelling mainly of the face and
throat,
flushing, crampy abdominal pain, stiffness, rash, fever or swollen /
enlarged lymph nodes (possible signs of severe allergic reactions)
•
Symptoms such as rash, fever, itching, tiredness or if you notice
appearance of purplish spots under the skin surface (signs of blood
vessel inflammation)
•
Severe upper stomach pain which spreads to the back (possible signs of
pancreas inflammation)
•
Unexplained muscle weakness or pain, or dark (red-brown) urine
(possible signs of muscle breakdown)
•
Severe skin reactions including rash, light sensitivity, blistering
and
wheals
•
Weakness, unusual bleeding, bruising, abnormal pale skin, unusual
tiredness, or weakness or
•
breathlessness on exertion or frequent infections (these may be signs
of
a blood disorder)
•
Yellowing of your skin or eyes, unusually dark urine or pale stools,
unexplained persistent nausea, stomach problems, loss of appetite or
unusual tiredness or weakness (this may indicate serious liver
problems),
increase in liver enzymes which may be noted on a blood test result.
Other side effects
The following side effects may also occur:
Very common: may affects more than 1 in 10 people
•
Feeling of fullness, loss of appetite, mild stomach pains,
indigestion,
nausea (feeling sick) and diarrhoea
•
Skin reactions like itching, rash or hives
•
Muscle and joint pains
Common: may affects up to 1 in 10 people
•
Headache
Uncommon: may affects up to 1 in 100 people
•
Taste loss and taste disturbance. This usually disappears within
several
weeks after you stop taking the medicine. However, a very small number
of people, (less than 1 in 10,000), have reported that the taste
disturbance lasts for some ti

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Terbinafine 250 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 281.25 mg terbinafine hydrochloride equivalent to
250 mg
terbinafine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM:
Tablets.
White, round tablet with the letter ‘T’ and breakline on opposite
face.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses
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. _
Treatment of ringworm (tinea corporis, tinea cruris and tinea pedis)
where oral
therapy is considered appropriate due to the site, severity or extent
of infection.
Treatment of onychomycosis.
Consideration
should
be
given
to
official
guidance
on
the
appropriate
use
of
antifungal agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
POSOLOGY
ADULTS
250 mg 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.