SPORANOX Itraconazole 100mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

itraconazole, Quantity: 100 mg

Available from:

Janssen-Cilag Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: macrogol 20000; titanium dioxide; Gelatin; hypromellose; indigo carmine; erythrosine; maize starch; sucrose

Administration route:

Oral

Units in package:

4 capsules, 60 capsules, 15 capsules, 6 capsules, 28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Sporanox is indicated for use in adults for the treatment of: Superficial dermatomycoses not responding to topical treatment. Fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. Pityriasis versicolor not responding to any other treatment. Vulvovaginal candidiasis not responding to topical treatment. Oral candidiasis in immunocompromised patients. Onychomycosis caused by dermatophytes. Systemic mycoses: -Systemic aspergillosis, histoplasmosis, sporotrichosis. -Treatment and maintenance therapy in AIDS patients with disseminated or chronic pulmonary histoplasmosis infection. -Treatment of oropharyngeal and/or oesophageal candidiasis when fist line systemic antifungal therapy is inappropriate or has proven ineffective. -Treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. This may be due to underlying pathology, insensitivity of the pathogen or drug toxicity.

Product summary:

Visual Identification: Cream-coloured, coated sugar spheres filled into capsules with an opaque blue cap and pink transparent body.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1994-02-02

Patient Information leaflet

SPORANOX® CAPSULES
1
SPORANOX
® CAPSULES
_Itraconazole _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SPORANOX
capsules. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking SPORANOX
capsules against the benefits this
medicine is expected to have for you.
If you have any concerns about
taking SPORANOX capsules, ask
your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT SPORANOX
CAPSULES ARE USED FOR
SPORANOX capsules are used to
treat certain fungal infections which
include the following:
•
persistent infections of the nails,
skin, hands, feet or groin;
•
persistent candida (yeast)
infections of the vagina;
•
eye infections which have not
responded to other treatment or
which may be affecting vision;
•
candida (yeast) infections of the
mouth or throat in patients with
lower resistance to disease;
•
generalised infections.
SPORANOX works by killing or
stopping the growth of the fungus
that causes the infection.
Your doctor may have prescribed
SPORANOX capsules for another
reason. Ask your doctor if you have
any questions about why this
medicine has been prescribed for
you.
BEFORE YOU TAKE
SPORANOX CAPSULES
_WHEN YOU MUST NOT TAKE IT _
Do not take SPORANOX capsules if:
•
you are pregnant or may become
pregnant.
If there is any chance of you
becoming pregnant, talk to your
doctor about the need for highly
effective contraception. Once you
have finished taking
SPORANOX, you should
continue using highly effective
contraception until you have had
your next period. Tell your doctor
immediately if you do become
pregnant while taking
SPORANOX.
•
you have a condition called heart
failure (also called congestive
heart failure or CHF),
SPORANOX could make it
worse. If your doctor decides that
you need to take SPORANOX
even if you have this condition,
be sur

Summary of Product characteristics

16.220321
Page 1 of 28
SPORANOX(220617)API
AUSTRALIAN PRODUCT INFORMATION
SPORANOX
 (ITRACONAZOLE)
CAPSULES
1. NAME OF THE MEDICINE
Itraconazole
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg of itraconazole.
Excipients with known effect: sucrose
For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Capsule
Blue opaque cap and pink transparent body containing beads.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SPORANOX is indicated for use in adults for the treatment of:
•
Superficial dermatomycoses not responding to topical treatment.
•
Fungal keratitis which has failed to respond to topical treatment or
where the disease is
either progressing rapidly or is immediately sight threatening.
•
Pityriasis versicolor not responding to any other treatment.
•
Vulvovaginal candidiasis not responding to topical treatment.
•
Oral candidiasis in immunocompromised patients.
•
Onychomycosis caused by dermatophytes.
•
Systemic mycoses, only in the following fungal infections:
־
Systemic aspergillosis, histoplasmosis, lymphocutaneous/cutaneous
sporotrichosis.
־
Treatment and maintenance therapy in AIDS patients with disseminated
or chronic
pulmonary histoplasmosis infection.
־
Treatment of oropharyngeal and/or oesophageal candidiasis when first
line systemic
antifungal therapy is inappropriate or has proven ineffective.
־
Treatment of non-invasive candidiasis in non-neutropenic patients when
first-line
systemic antifungal therapy is inappropriate or has proven
ineffective. This may be
due to underlying pathology, insensitivity of the pathogen or drug
toxicity.
16.220321
Page 2 of 28
SPORANOX(220617)API
4.2 DOSE AND METHOD OF ADMINISTRATION
It is essential that SPORANOX capsules are taken immediately after a
meal for maximal
absorption. The capsules must be swallowed whole. Treatment schedules
are as follows:
_SUPERFICIAL DERMATOMYCOSES: _
•
Tinea corporis, tinea cruris: 1 capsule (100 mg) daily for 2 weeks.
•
Tinea pedis, tinea manus: