Sporanox 100mg Capsules

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Itraconazole

Fáanlegur frá:

Janssen-Cilag Ltd

ATC númer:

J02AC; J02AC02

INN (Alþjóðlegt nafn):

Itraconazole

Skammtar:

100 milligram(s)

Lyfjaform:

Capsule, hard

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Triazole derivatives; itraconazole

Leyfisstaða:

Marketed

Leyfisdagur:

1991-12-16

Upplýsingar fylgiseðill

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 to itraconazole or any of the other ingredients of
this
medicine (listed in section 6)

You are pregnant or could become

Vara einkenni

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:
Dosage recommendations vary according to the infection treated.
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
INDICATION
DOSE
MEDIAN DURATION
Onychomycosis
200 mg od
3 months
Aspergillosis
200 mg od
2-5 months
Candidosis
100-200 mg od
3 weeks - 7 months
Non-meningeal cryptococcosis
200 mg od
1-6 months
Cryptococcal meningitis
200 mg bid
2 months - 1 year
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