Sporanox 100mg Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Itraconazole

Available from:

Janssen Sciences Ireland UC

ATC code:

J02AC; J02AC02

INN (International Name):

Itraconazole

Dosage:

100 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Triazole derivatives; itraconazole

Authorization status:

Marketed

Authorization date:

1996-12-16

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPORANOX
®
100 MG CAPSULES
Itraconazole
Sporanox is a registered trademark
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
WHAT IS IN THIS LEAFLET
1. What Sporanox capsules are and what they are used for
2. What you need to know before you use Sporanox capsules
3. How to use Sporanox capsules
4. Possible side effects
5. How to store Sporanox capsules
6. Contents of the pack and other information
1. WHAT SPORANOX CAPSULES ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Sporanox 100 mg capsules. It is called
‘Sporanox capsules’ in this
leaflet.
Sporanox capsules contain a medicine called itraconazole. This belongs
to a group of medicines
called ‘antifungals’.
Sporanox capsules are used in adults for infections caused by fungi or
yeasts. They are 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 capsules. 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 USE SPORANOX CAPSULES
DO NOT USE SPORANOX CAPSULES:
•
IF YOU ARE ALLERGIC (hypersensitive) to any of the ingredients in
SPORANOX CAPSULES (listed in
section 6)
•
IF YOU ARE PREGNANT, THINK YOU MI

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sporanox 100mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains itraconazole 100 mg.
Excipient: Contains 192mg sucrose.
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Capsule, hard
Capsule (size 0): opaque blue cap and pink transparent body containing
coated beads.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. Vulvovaginal candidosis
2. Pityriasis versicolor
3. Dermatophytoses caused by organisms susceptible to itraconazole
4. Oral candidosis
5. Fungal keratitis
6. Systemic mycoses
7. Onychomycosis
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Sporanox is for oral administration and must be taken immediately
after a meal for maximal absorption. The capsules must be
swallowed whole.
Treatment schedules in adults for each indication are as follows:
INDICATION
DOSE
Vulvovaginal candidosis
200 mg twice daily for 1 day or 200 mg once daily for 3 days.
Pityriasis versicolor
200 mg once daily for 7 days
Tinea corporis, tinea cruris
100 mg once daily for 2 weeks or 200 mg once daily for 7 days
Tinea pedis, tinea manuum 100 mg once daily for 4 weeks
Oral candidosis
100 mg once daily for 2 weeks
Fungal keratitis
200 mg once daily for 3 weeks
Dosage recommendations vary according to the infection treated.
INDICATION
DOSE
MEDIAN DURATION
Onychomycosis
200 mg once daily
3 months
Treatment of
aspergillosis
200 mg once daily
Increase dose to 200 mg twice daily in patients who have invasive or
disseminated disease and who have failed or are intolerant to
amphotericin B
or voriconazole.
2-5 months
Treatment of
candidosis
100-200 mg once daily
3 weeks - 7 months
Treatment of
non-meningeal
200 mg once daily
1-6 months
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cryptococcosis
Treatment of
cryptococcal meningitis
200 mg twice daily
2 months - 1 year
Histoplasmosis
200 mg once daily - 200 mg twice daily
8 mon