Itraconazole 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Itraconazole

Available from:

Waymade Healthcare Plc

ATC code:

J02AC02

INN (International Name):

Itraconazole

Dosage:

100mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020100

Patient Information leaflet

Itraconazole capsules contain a medicine
called itraconazole. This belongs to a group of
medicines called ‘antifungals’.
Itraconazole capsules are used for infections
caused by fungi or yeasts. They are used for:
•
Infections of the mouth or vagina causing
‘thrush’
•
Skin and nail infections
Patches of skin may take a few weeks to
completely clear up after you have finished
your treatment with Itraconazole. Finger and
toe nails may take several months to
completely clear up. This is because your skin
or nail will only look normal after new skin or
nail has grown, even though the medicine has
killed the fungus that caused the infection.
DO NOT TAKE ITRACONAZOLE
•
if you are ALLERGIC to itraconazole or to any
of the other ingredients of this medicine
(listed in section 6)
•
if you are TAKING ANY OF THE FOLLOWING
MEDICINES:
-
medicines that are degraded via the
enzyme cytochrome P450 3A4 and which
can change the heart rhythm, such as
-
ASTEMIZOLE, MIZOLASTINE, TERFENADINE,
medicines against allergies
-
BEPRIDIL, a medicine against narrowed
heart vessels
-
QUINIDINE, DOFETILIDE, medicines
against disorders in the heart rhythm
-
CISAPRIDE, a stomach and bowel agent
-
LEVACETYLMETHADOLE or LEVOMETHADYL,
used for the therapy of opiate
dependents
-
PIMOZIDE and SERTINDOLE, used in
schizophrenia
-
certain medicines to lower cholesterol
levels, such as ATORVASTATIN, LOVASTATIN
and SIMVASTATIN
-
TRIAZOLAM, a medicine against sleep
disturbances
-
MIDAZOLAM for oral intake, a medicine for
sedation before examinations, or
operations or in intensive care units
-
DIHYDROERGOTAMINE, used in case of low
blood pressure or certain headaches
-
ERGOMETRINE or ERGONOVINE,
METHYLERGOMETRINE or
METHYLERGONOVINE, medicines
staunching bleeding used after birth
-
ERGOTAMINE and ELETRIPTAN, medicines
against migraine
-
NISOLDIPINE a medicine against high blood
pressure and narrowed heart vessels
•
in case of signs of HEART DYSFUNCTION or
PREVIOUS HEART FAILURE, except for the
treatment of life-threatening or serious
fungal

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Itraconazole 100mg Capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains 100 mg of itraconazole.
Excipient with known effect: Each hard capsule contains 224.31 mg
sucrose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
No. 0 hard gelatin capsules, opaque green cap and body, containing
yellowish-beige
spherical micro-granules
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vulvovaginal candidiasis,
_-_
Oral candidiasis
_-_
Dermatophytoses caused by organisms susceptible to itraconazole
(Trichophyton spp., Microsporum spp., Epidermophyton floccosum) e.g.
tinea pedis, tinea cruris, tinea corporis, tinea manuum,
-
Pityriasis versicolor,
-
Onychomycoses caused by dermatophytes and/or yeasts,
-
Systemic candidiasis,
-
Cryptococcal infections (including cryptococcal meningitis). In
immunosuppressed patients suffering from cryptococcosis and in
patients
with cryptococcosis of the CNS Itraconazole is indicated only if the
usually
recommended initial therapy seems to be inappropriate or ineffective
-
Histoplasmosis.
-
Aspergillosis. Itraconazole can be used to treat patients suffering
from
invasive aspergillosis who were found to be refractory or intolerant
to
Amphotericin B
-
Maintenance therapy in AIDS patients to prevent relapse of underlying
fungal
infection who were found to be refractory or intolerant to first-line
systemic
anti-fungal therapy is inappropriate or has proved ineffective.
Due to PK properties, orally administered itraconazole (capsules)
should not be used
as the initial treatment in patients with severe life-threatening
forms of systemic
mycoses. Oral forms should be used as a continuation therapy, after
initial treatment
with i.v. itraconazole (see section 4.4).
Consideration should be given to official guidance regarding the
appropriate use of
antifungal_ _agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology.
INDICATIONS
DOSE
DURATION
OF
TREATMENT
Gynecol