SPORANOX 100 Milligram Capsules Hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
17-05-2024
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Active ingredient:
ITRACONAZOLE
Available from:
G & A Licensing Limited
INN (International Name):
ITRACONAZOLE
Dosage:
100 Milligram
Pharmaceutical form:
Capsules Hard
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2012-03-13
Summary of Product characteristics
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 Sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
_Imported from Greece:_
Sporanox capsules have an 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:
_Short-Term Usage_
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
Treatment should not exceed 4 weeks.
_Long Term Usage_
Dosage recommendations vary according to the infection treated.
INDICATION
DOSE
MEDIAN DURATION
Onychomycosis
200 mg od
3 months
Aspergillosis
200 mg od
2-5 months
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/10/2011_
_CRN 2106776_
_page number: 1_
_Use in Children (below 12 years):_
Clinical data on the use of Sporanox capsules in pediatric patients are limit
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