Itracim

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

itraconazole

Available from:

Acino Pharma AG

INN (International Name):

itraconazole

Dosage:

100mg

Pharmaceutical form:

capsules

Prescription type:

Prescription

Patient Information leaflet

Patient information leaflet
_Read this leaflet carefully before you take this medicine. _
_This medicine has been prescribed for you and you _
_should not pass it on to others. The medicine may harm _
_them, even if their symptoms are the same as yours._
_Keep this leaflet. You may need to read it again._
Itracim 100 mg, capsules
What Itracim is and what it is used for
Itracim is a medicine used to treat various fungal infec-
tions of the skin, the genitals and the mouth. A short
duration of treatment is usually sufficient to do so.
Itracim is also effective against certain fungal infections
of the nails and internal organs, but a longer duration of
treatment is needed for these conditions. It acts on the
metabolism of the membrane of fungal cells, causing
them to die or making it easier for the body’s own de-
fence mechanisms to eliminate them.
Itracim must be taken only if prescribed by a doctor.
Additional considerations
This medicine has been prescribed for you by your doc-
tor to treat your _current _condition.
The antifungal in Itracim is not effective against all micro-
organisms that cause infectious diseases. Using the
wrong choice of antifungal or an incorrect dosage may
cause complications. So you must never decide on your
own to use it to treat other illnesses or other people. You
must not use Itracim to treat later infections without
consulting a doctor again.
Do not use Itracim
Do not take Itracim if you have a known hypersensitivity
(allergy) to any of the ingredients.
Itracim must not be taken during pregnancy unless your
doctor is aware of your pregnancy and expressly pre-
scribes it. Pregnancy must be ruled out before you take
Itracim. Women of childbearing age must use a reliable
method of contraception during treatment with Itracim
and for an entire menstrual cycle after the end of treat-
ment (i.e. 5-7 weeks).
If you have impaired heart function (cardiac insufficien-
cy) you should not take Itracim unless your doctor has
been informed and expressly prescribes it. If, during the
treatment wi

Summary of Product characteristics

Itra_KA_SmPC_200313_e_CIS_1 (FI text in SmPC format)
Source: Itra_KA_FI_200313_e.doc (manuskript from 20.03.2013;
(Originator: Sporanox, SdI: Juni 2012) – approved
swissmedic 09.04.13 – mt-g geprüft
Page 1 SUMMARY OF PRODUCT CHARACTERISTICS
__________________________________________________________________________________
1.
NAME OF THE MEDICINAL PRODUCT
Itracim 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 capsule of Itracim contains 100 mg of itraconazole.
_Excipients:_ For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gelatin capsules (elongated, red opaque)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_a) Documented indications _
Treatment of the following fungal infections:
Dermatomycoses (Tinea corporis, Tinea cruris, Tinea pedis, Tinea
manus);
Pityriasis versicolor;
Oropharyngeal candidiasis;
Onychomycosis;
Vulvovaginal candidiasis.
_b) Possible uses _
Aspergillosis, as an alternative when standard therapy with
amphotericin B is ineffective or poorly
tolerated;
Histoplasmosis (non-meningeal);
Sporotrichosis (cutaneous and lymphatic);
Paracoccidioidomycosis;
Chromomycosis;
Blastomycosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Itra_KA_SmPC_200313_e_CIS_1 (FI text in SmPC format)
Source: Itra_KA_FI_200313_e.doc (manuskript from 20.03.2013;
(Originator: Sporanox, SdI: Juni 2012) – approved
swissmedic 09.04.13 – mt-g geprüft
Page 2
To ensure maximum absorption of the active substance, Itracim capsules
must be taken directly after a
main meal.
Usual dosage:
_Dermatomycoses _
_Tinea corporis, Tinea cruris: _1 x 1 capsule daily. Treatment
duration: 2 weeks.
_Tinea pedis, Tinea manus: _1 x 1 capsule daily. Treatment duration: 4
weeks_. _
_Pityriasis versicolor: _1 x 2 capsules daily. Treatment duration: 1
week.
_Oropharyngeal candidiasis: _1 x 1 capsule daily. Treatment duration:
2 weeks_. _
_Onychomycosis: _pulse therapy or continuous therapy.
_ _
_Pulse therapy _
2 capsules twice daily for 1 week followed by 3 treatment-free weeks.
In the case of fungal infecti