Sporanox Capsule 100mg

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

ITRACONAZOLE

Disponible depuis:

JOHNSON & JOHNSON SDN BHD

DCI (Dénomination commune internationale):

ITRACONAZOLE

Unités en paquet:

4Capsule Capsules; 14Capsule Capsules; 28Capsule Capsules

Fabriqué par:

JANSSEN CILAG SPA

Notice patient

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SPORANOX
® CAPSULES
Itraconazole (100mg)
1
WHAT IS IN THIS LEAFLET
1.
What SPORANOX
®
is used for
2.
How SPORANOX
®
works
3.
Before you use SPORANOX
®
4.
How to use SPORANOX
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
SPORANOX
®
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
11.
Serial number
WHAT SPORANOX
® IS USED FOR
SPORANOX capsules are used to
treat certain fungal infections which
include the following:
•
persistent infections of the nails,
skin, hands, feet or groin;
•
persistent candida (yeast) infections
of the vagina;
•
eye infections which have not
responded to other treatment or
which may be affecting vision;
•
candida (yeast) infections of the
mouth or throat in patients with
lower resistance to disease;
•
generalised infections.
Your doctor may have prescribed
SPORANOX capsules for another
reason. Ask your doctor if you have
any questions about why this medicine
has been prescribed for you.
HOW SPORANOX
® WORKS
SPORANOX works by killing or
stopping the growth of the fungus that
causes the infection.
BEFORE YOU USE SPORANOX
®
-
_When you must not use it _
Do not use SPORANOX:
-
if you know you are
hypersensitive (allergic) to it;
-
if you are pregnant (unless your
doctor knows you are pregnant
and decides you need
SPORANOX);
-
if you are of child bearing age and
could become pregnant, you
should take adequate
contraceptive precautions to make
sure that you do not become
pregnant while you are taking
your medicine. As SPORANOX
remains in the body for some time
after you stop taking it, you
should continue to use
contraception until your next
period after your treatment with
SPORANOX capsules is finished.
If you are breast-feeding, tell your
doctor before taking
SPORANOX.
-
if you have a condition called
heart failure (also called
congestive heart failure or CHF),
SPORANOX could make it
worse. If your doctor decides that
you need to take SPORANOX
even if you have

Résumé des caractéristiques du produit

1
PRODUCT NAME
SPORANOX
®
Capsule 100mg
GENERIC NAME/INTERNATIONAL NON-PROPRIETARY NAME
Itraconazole
DOSAGE FORMS AND STRENGTHS
Each capsule, for oral administration, contains 100 mg itraconazole in
a pellet formulation,
and is available as a blue opaque cap and pink transparent body.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
SPORANOX capsules are indicated for the following conditions:
•
Gynecological indications:
-
Treatment of vulvovaginal candidosis.
•
Dermatological/mucosal/ophthalmological indications:
-
Treatment of dermatomycosis, including highly keratinized regions as
in plantar
tinea pedis and palmar tinea manus;
-
Treatment of pityriasis versicolor;
-
Treatment of oral candidosis;
•
Treatment of onychomycosis, caused by dermatophytes and/or yeasts.
•
Systemic mycoses, only in the following fungal infections:
-
Treatment of systemic aspergillosis and candidosis;
-
Cryptococcosis (including cryptococcal meningitis):
-
Treatment of immunocompromised patients with cryptococcosis and in all
patients with cryptococcosis of the central nervous system, only when
first line
treatment is considered inappropriate or has proven ineffective;
-
For maintenance therapy of cryptococcal meningitis in AIDS patients,
only when
first line treatment is considered inappropriate or has proven
ineffective.
-
Treatment of histoplasmosis;
-
Histoplasmosis, maintenance therapy only in AIDS patients;
-
Treatment of blastomycosis;
-
Treatment
of
sporotrichosis,
including
lymphocutaneous/cutaneous
and
extracutaneous;
-
Treatment of paracoccidioidomycosis;
-
Treatment of chromomycosis.
DOSAGE AND ADMINISTRATION
For optimal absorption, administer SPORANOX capsules immediately after
a full meal.
The capsules must be swallowed whole.
GYNECOLOGICAL INDICATION
INDICATION
DOSE
TREATMENT DURATION
2
Treatment of vulvovaginal
candidosis
200 mg twice daily
or
200 mg once daily
1 day
or
3 days
DERMATOLOGICAL/MUCOSAL/OPHTHALMOLOGICAL INDICATIONS
INDICATION
DOSE
TREATMENT DURATION
Treatment of dermatom