Sporal 100mg capsules

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

ITRACONAZOLE

Disponible depuis:

Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium

Code ATC:

J02AC02

DCI (Dénomination commune internationale):

ITRACONAZOLE 100 mg

forme pharmaceutique:

HARD CAPSULE

Composition:

ITRACONAZOLE 100 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

ANTIMYCOTICS FOR SYSTEMIC USE

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2007-07-06

Notice patient

SPORAL
® 100MG CAPSULES
Itraconazole
PACKAGE LEAFLET: INFORMATION FOR THE USER
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. Do not pass it on to
others. It may harm them, even
if their symptoms 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 Sporal capsules are and what they are used for
2.
What you need to know before you use Sporal capsules
3.
How to use Sporal capsules
4.
Possible side effects
5.
How to store Sporal capsules
6.
Contents of the pack and other information
1.
WHAT SPORAL CAPSULES ARE AND WHAT THEY ARE USED FOR
Sporal capsules contain a medicine called itraconazole. This belongs
to a group of medicines called
‘antifungals’.
Sporal capsules are used for infections caused by fungi or yeasts.
They are used for:
•
Infections of the mouth or vagina causing ‘thrush’
•
Skin infections, including those of the hands and feet
•
Nail 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 Sporal 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 SPORAL CAPSULES
DO NOT USE SPORAL CAPSULES IF:
•
YOU ARE ALLERGIC
(hypersensitive) to any of the ingredients in
SPORAL CAPSULES
(listed in section
6 Contents of the pack and other information)
•
YOU ARE PREGNANT, THINK YOU MIGHT BE PREGNANT OR COULD BECOME PREGNANT
(see section
‘Pregnancy and breast-feeding’)
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Résumé des caractéristiques du produit

1.
NAME OF THE MEDICINAL PRODUCT
SPORAL™ 100mg Capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains itraconazole 100 mg.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Capsules, 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
_(Trichophyton spp._
,
_Microsporum _
_spp._
,
_Epidermophyton floccosum_
) e.g. tinea pedis, tinea cruris, tinea corporis, tinea manuum.
4. Treatment of oral candidosis.
5. Onychomycosis caused by dermatophytes and/or yeasts.
6. The treatment of histoplasmosis.
7. Sporal is indicated in the following systemic fungal conditions
when first-line systemic anti-fungal
therapy is inappropriate or has proved ineffective. This may be due to
underlying pathology, insensitivity
of the pathogen or drug toxicity.
-
Treatment of aspergillosis and candidosis
-
Treatment of cryptococcosis (including cryptococcal meningitis); in
immunocompromised patients
with cryptococcosis and in all patients with cryptococcosis of the
central nervous system
-
Maintenance therapy for penicilliosis and histoplasmosis only in AIDS
patients.
-
Maintenance therapy of cryptococcal meninigitis only in AIDS patients.
Sporal is also indicated for prophylaxis of fungal infections in
immunocompromised patients with severe
neutropenia when standard therapy is considered inappropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sporal 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_
_REMARKS_
Vulvovaginal
candidosis
200mg twice daily for 1 day
Pityriasis versicolor
200mg once daily for 7 days
Tinea corporis, tinea
cruris
100mg once daily for 15
days or 200mg once daily
for 7 days
Tinea pedis, tinea
manuum
100mg once daily for 30
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