ITRACAP itraconazole 100 mg capsule blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

itraconazole, Quantity: 100 mg

Disponible depuis:

Arrotex Pharmaceuticals Pty Ltd

DCI (Dénomination commune internationale):

Itraconazole

forme pharmaceutique:

Capsule

Composition:

Excipient Ingredients: hypromellose; macrogol 20000; sucrose; hydrolysed maize starch; titanium dioxide; purified water; Gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Mode d'administration:

Oral

Unités en paquet:

60 capsules, 28 capsules, 15 capsules, 4 capsules, 6 capsules

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

ITRACAP is indicated for use in adults for the treatment of: ? Superficial dermatomycoses not responding to topical treatment. ? Fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. ? Pityriasis versicolor not responding to any other treatment. ? Vulvovaginal candidiasis not responding to topical treatment. ? Oral candidiasis in immunocompromised patients. ? Onychomycosis caused by dermatophytes. ? Systemic mycoses: - Systemic aspergillosis, histoplasmosis, sporotrichosis. - Treatment and maintenance therapy in AIDS patients with disseminated or chronic pulmonary histoplasmosis infection. - Treatment of oropharyngeal and/or oesophageal candidiasis when first line systemic antifungal therapy is inappropriate or has proven ineffective. - Treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. This may be due to underlying pathology, insensitivity of the pathogen or drug toxicity.

Descriptif du produit:

Visual Identification: Size 0el hard gelatin white opaque capsules filled with off-white to cream colored pellets and imprinting with ITR on cap and 100 on body; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Statut de autorisation:

Licence status A

Date de l'autorisation:

2016-08-09

Notice patient

ITRACAP ITRACONAZOLE CAPSULE
ITRACAP
_Itraconazole_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ITRACAP
Itraconazole capsules.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and risks.
Your doctor has weighed the risks of
you taking ITRACAP against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ITRACAP IS
USED FOR
ITRACAP 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 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.
ITRACAP works by killing or
stopping the growth of fungus that
causes the infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
BEFORE YOU TAKE
ITRACAP
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ITRACAP IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
itraconazole
•
any of the ingredients listed at the
end of this leaflet. See Product
Description at the end of this
leaflet.
Some of the symptoms of an allergic
reaction may include
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
•
add any other specific reactions
listed in the PI.
DO NOT TAKE THIS MEDICINE IF YOU ARE
PREGNANT OR MAY BECOME PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
If there is any chance of you becoming
pregnant, talk to your doctor about the
ne

Résumé des caractéristiques du produit

1
AUSTRALIAN PRODUCT INFORMATION
ITRACAP
(Itraconazole) capsules
1
NAME OF THE MEDICINE
Itraconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ITRACAP capsules contain itraconazole 100 mg.
EXCIPIENTS
Each capsule contains sucrose. For the full list of excipients, see
Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ITRACAP is available as white opaque capsules printed with ITR on the
cap and 100 on the body.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ITRACAP is indicated for use in adults for the treatment of:
•
Superficial dermatomycoses not responding to topical treatment.
•
Fungal keratitis which has failed to respond to topical treatment or
where the disease is
either progressing rapidly or is immediately sight threatening.
•
Pityriasis versicolor not responding to any other treatment.
•
Vulvovaginal candidiasis not responding to topical treatment.
•
Oral candidiasis in immunocompromised patients.
•
Onychomycosis caused by dermatophytes.
•
Systemic mycoses, only in the following fungal infections:
-
Systemic aspergillosis, histoplasmosis, lymphocutaneous/cutaneous
sporotrichosis.
-
Treatment and maintenance therapy in AIDS patients with disseminated
or chronic
pulmonary histoplasmosis infection.
-
Treatment of oropharyngeal and/or oesophageal candidiasis when first
line systemic
antifungal therapy is inappropriate or has proven ineffective.
-
Treatment of non-invasive candidiasis in non-neutropenic patients when
first-line
systemic antifungal therapy is inappropriate or has proven
ineffective. This may be due
to underlying pathology, insensitivity of the pathogen or drug
toxicity.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
It is essential that ITRACAP capsules are taken immediately after a
meal for maximal absorption. The
capsules must be swallowed whole. Treatment schedules are as follows:
_ _
_SUPERFICIAL DERMATOMYCOSES:_
•
Tinea corporis, tinea cruris: 1 capsule (100 mg) daily for 2 weeks
•
Tinea pedis, tinea manus: 1 capsule (100 mg) daily for 4 weeks
_ _
_FUNGAL KERATITIS: