Itraconazole 100mg capsules

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Itraconazole

Saadav alates:

Crescent Pharma Ltd

ATC kood:

J02AC02

INN (Rahvusvaheline Nimetus):

Itraconazole

Annus:

100mg

Ravimvorm:

Oral capsule

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 05020100; GTIN: 5017123113406

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPORANOX ®
100MG CAPSULES
(itraconazole)
Sporanox is a registered trademark
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
The name of your medicine is Sporanox 100mg capsules but will be
referred to as Sporanox throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
WHAT SPORANOX IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPORANOX
3.
HOW TO TAKE SPORANOX
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SPORANOX
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT SPORANOX IS AND WHAT IT IS USED FOR
Sporanox contains a medicine called itraconazole. This belongs to a
group of medicines called ‘antifungals’.
Sporanox is used for infections caused by fungi or yeasts in adults.
It is
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. 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 TAKE SPORANOX
DO NOT TAKE SPORANOX:
If you are allergic to anything in Sporanox (listed in section 6
overleaf)
If you are pregnant or could become pregnant unless your doctor
has told you to (see ‘Pregnancy and breast-feeding’ below)
Do not take this medicine if any of the above applies to you. If

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Itraconazole 100mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 100 mg itraconazole.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Opaque green capsule, containing yellowish-beige beads.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Itraconazole is indicated for the treatment of the
following fungal infections when thought likely to be
susceptible:
•
Vulvovaginal candidiasis.
•
Pityriasis versicolor.
•
Dermatophytoses caused by organisms susceptible to itraconazole
(Trichophyton spp. Microsporum spp. Epidermophyton floccosum) e.g.
tinea
pedis, tinea cruris, tinea corporis, tinea manuum.
•
Oral candidiasis.
•
Onychomycosis caused by dermatophytes and/or yeasts.
Consideration should be given to official guidance regarding the
appropriate use of
antifungal agents.
For further information please refer to section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment schedules in adults for each indication are as follows:
INDICATION
DOSE
Vulvovaginal candidiasis
200 mg twice daily for 1 day
Pityriasis versicolor
200 mg once daily for 7 days
Tinea corporis, tinea cruris
100 mg once daily for 15 days
Tinea pedis,
tinea manuum
100 mg once daily for 30 days
Oral candidiasis
100 mg once daily for 14 days
Onychomycosis
200 mg once daily for 3 months
For skin infections, optimal clinical and mycological effects are
reached at 1 - 4
weeks after cessation of treatment and for nail infections at 6 - 9
months after the
cessation of treatment. This is because elimination of itraconazole
from skin and nails
is slower than from plasma.
In Acquired Immune Deficiency Syndrome and neutropenic patients: for
the
treatment of oral candidiasis 200 mg once daily for 14 days is
recommended due to
the impaired absorption of itraconazole in these patient groups.
The length of treatment for systemic fungal infections should be
dictated by the
mycological and clinical response to ther