ITRANOL

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

ITRACONAZOLE

Disponible desde:

RAFA LABORATORIES LTD

Código ATC:

J02AC02

formulario farmacéutico:

CAPSULES

Composición:

ITRACONAZOLE 100 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricado por:

LABORATORIOS LICONSA S.A., SPAIN

Grupo terapéutico:

ITRACONAZOLE

Área terapéutica:

ITRACONAZOLE

indicaciones terapéuticas:

Blastomycosis (pulmonary and extrapulmonary). Histoplasmosis. Onchomycosis caused by dermatophytes and/or yeast. Dermatomycoses. Vulvovaginal candidosis. Oral candidosis.

Fecha de autorización:

2020-04-30

Información para el usuario

Patient Leaflet According to the Pharmacists' Regulations
(Preparations) – 1986
1
This medicine is sold with a doctor's prescription only
Itranol
Capsules
Active ingredient:
Each capsule contains: Itraconazole 100 mg.
For the list of the additional ingredients, see section 6. See also
'Important information about
some of the medicine's ingredients' in section 2.
Read this entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine. If you
have any further questions,
please refer to your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
This medicine is not intended for children under the age of 12 years
and for the elderly, unless
the doctor has expressly instructed so.
1. What is the medicine intended for?
The medicine is intended for treating fungal infections of the mouth,
throat and esophagus, the
vagina, the skin and the nails and a systemic fungal infection.
Therapeutic group:
Anti-fungal from the triazole group.
2. Before using the medicine
Do not use the medicine if:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients
the medicine contains (for a list of the other ingredients, see
section 6).
•
You are pregnant, think you are pregnant, or may get pregnant (See
'Pregnancy
and breastfeeding' section).
•
You have evidence of impaired heart ventricular (chambers) functioning
such as heart
failure, or you had heart failure, except in life-saving cases or for
treatment of severe
infection. See 'Warnings' section below.
•
You are taking certain medicines as specified below, as there are
medicines that must
not be taken concurrently with Itranol. Tell your doctor before (and
during) the use of
Itranol of every medicine that you are taking. Do not use Itranol if
you are taking the
medicines in the list below. You must also wait at least two weeks
from stopping
treatment with I

Ficha técnica

1
Itranol-DL-July 2022-02
DOCTOR LEAFLET
1.
NAME OF THE MEDICINAL PRODUCT
ITRANOL CAPSULES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg itraconazole.
For excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsules for oral administration.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Itranol capsules are indicated for the treatment of the following
conditions:
•
VULVOVAGINAL CANDIDOSIS.
•
DERMATOMYCOSIS
•
ORAL CANDIDOSIS
•
ONYCHOMYCOSIS CAUSED BY DERMATOPHYTES AND/OR YEASTS.
•
BLASTOMYCOSIS (PULMONARY AND EXTRAPULMONARY)
.
•
HISTOPLASMOSIS
.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For optimal absorption, administer Itranol capsules immediately after
a full meal. The
capsules must be swallowed whole.
GYNECOLOGICAL INDICATION
INDICATION
DOSE
TREATMENT DURATION
Vulvovaginal candidosis
200 mg b.i.d.
or
200 mg once daily
1 day
or
3 days
DERMATOLOGICAL / MUCOSAL / OPHTHALMOLOGICAL INDICATIONS
INDICATION
DOSE
TREATMENT DURATION
2
Dermatomycosis
200 mg once daily
or
100 mg once daily
7 days
or
15 days
Highly keratinized regions as in
plantar tinea pedis and palmar tinea
manus
200 mg b.i.d.
or
100 mg once daily
7 days
or
30 days
Pityriasis versicolor
200 mg once daily
7 days
Oral candidosis
100 mg once daily
15 days
In some immunocompromised patients (e.g. neutropenic, AIDS or organ
transplant patients), the oral bioavailability
of itraconazole from
itraconazole
capsules may be decreased. Therefore the doses may need doubling.
ONYCHOMYCOSIS, CAUSED BY DERMATOPHYTES AND/OR YEASTS
Onychomycosis
PULSE TREATMENT
Dose and Treatment duration
A pulse treatment consists of two capsules twice daily
(200 mg b.i.d.) for one week. Two pulse treatments are
recommended for fingernail infections, and three pulse
treatments for toenail infections. Pulse treatments are always
separated by a 3-week drug-free interval. Clinical response
will become evident as the nail re-grows, following
discontinuation of the treatment.
Site of
onychomycosis
Week 1
Week 2
Week 3
Week 4
Week 5
Week 6
Week 7