Itraconazole 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Itraconazole

Available from:

Zentiva Pharma UK Ltd

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; GTIN: 5060222600063 5060222600469

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPORANOX ®
100MG CAPSULES
(itraconazole)
Sporanox is a registered trademark
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 only. 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.
The name of your medicine is Sporanox 100mg capsules but will be
referred to as Sporanox throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
WHAT SPORANOX IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPORANOX
3.
HOW TO TAKE SPORANOX
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SPORANOX
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT SPORANOX IS AND WHAT IT IS USED FOR
Sporanox contains a medicine called itraconazole. This belongs to a
group of medicines called ‘antifungals’.
Sporanox is used for infections caused by fungi or yeasts in adults.
It is
used for:
Infections of the mouth or vagina causing ‘thrush’
Skin infections
Infections affecting other parts of the body
Patches of skin may take a few weeks to completely clear up after you
have finished your treatment with Sporanox. 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPORANOX
DO NOT TAKE SPORANOX:
If you are allergic to anything in Sporanox (listed in section 6
overleaf)
If you are pregnant or could become pregnant unless your doctor
has told you to (see ‘Pregnancy and breast-feeding’ below)
Do not take this medicine if any of the above applies to you. If

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