Sporanox

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Itraconazole 100mg;  

Disponibbli minn:

Janssen-Cilag (New Zealand) Ltd

INN (Isem Internazzjonali):

Itraconazole 100 mg

Dożaġġ:

100 mg

Għamla farmaċewtika:

Capsule

Kompożizzjoni:

Active: Itraconazole 100mg   Excipient: Erythrosine Gelatin   Hypromellose Indigo carmine Macrogol 20000 Sugar spheres Titanium dioxide

Unitajiet fil-pakkett:

Blister pack, 15 capsules

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Janssen Pharmaceutical Sciences Unlimited Company (JPSUC)

Indikazzjonijiet terapewtiċi:

SPORANOX capsules are indicated for the following conditions: - Treatment of vulvovaginal candidiasis. - Treatment of pityriasis versicolor. - Treatment of dermatomycosis – including highly keratinised regions as in plantar tinea pedis and palmer tinea manus. - Treatment of fungal keratitis. - Treatment of oral candidiasis. - Treatment of onychomycosis caused by dermatophytes and/or yeasts. - Systemic mycoses, only in the following fungal infections: o Treatment of systemic aspergillosis and candidiasis, o Treatment of histoplasmosis, o Histoplasmosis, maintenance therapy only in AIDS patients. o Treatment of sporotrichosis (including lymphocutaneous/cutaneous and extracutaneous), o Treatment of paracoccidioidomycosis, o Treatment of chromomycosis, o Treatment of blastomycosis.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Blister pack, - 15 capsules - 36 months from date of manufacture stored at or below 30°C

Data ta 'l-awtorizzazzjoni:

1989-08-28

Fuljett ta 'informazzjoni

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
•
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 have an allergy to
SPORANOX capsules or any of
the ingredients. See Product
Description at the end of this
leaflet.
Signs of allergy may include skin
rash, itching, shortness of breath,
and/or swollen face or tongue.
•
you are pregnant or planning to
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 cal

Karatteristiċi tal-prodott

CCDS180629v014
1
SPORANOXcaps(180928)ADS
SPORANOX
®
ITRACONAZOLE
DATA SHEET
1. PRODUCT NAME
SPORANOX™ itraconazole 100 mg capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains itraconazole 100mg.
For a full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
Capsule
Blue opaque cap and pink transparent body containing beads.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SPORANOX capsules are indicated for the following conditions:
-
Treatment of vulvovaginal candidiasis.
-
Treatment of pityriasis versicolor.
-
Treatment of dermatomycosis – including highly keratinised regions
as in plantar tinea pedis
and palmer tinea manus.
-
Treatment of fungal keratitis.
-
Treatment of oral candidiasis.
-
Treatment of onychomycosis caused by dermatophytes and/or yeasts.
-
Systemic mycoses, only in the following fungal infections:
o
Treatment of systemic aspergillosis and candidiasis,
o
Treatment of histoplasmosis,
o
Histoplasmosis, maintenance therapy only in AIDS patients.
o
Treatment
of
sporotrichosis
(including
lymphocutaneous/cutaneous
and
extracutaneous),
o
Treatment of paracoccidioidomycosis,
o
Treatment of chromomycosis,
o
Treatment of blastomycosis.
CCDS180629v014
2
SPORANOXcaps(180928)ADS
4.2 DOSE AND METHOD OF ADMINISTRATION
For optimal absorption, it is essential to administer SPORANOX
capsules immediately after a full
meal.
The capsules must be swallowed whole.
Treatment schedules are as follows:
INDICATION
DOSE
DURATION
Treatment of vulvovaginal
candidiasis
200 mg twice daily
or 200 mg once daily
1 day
3 days
Treatment of pityriasis
versicolor
100 mg twice daily
or 200 mg once daily
5 - 7 days
Treatment of dermatomycosis
100 mg once daily
or 200 mg once daily
15 days
or 7 days
Treatment of dermatomycosis
in highly keratinised regions as
in plantar tinea pedis and
palmar tinea manus
200 mg twice daily
or 100 mg once daily
7 days
or 30 days
Treatment of oral candidiasis
100 mg once daily
15 days
Treatment of fungal keratitis
200 mg once daily
21 days
The duration of treatment
s