Itraconazole 100mg capsules

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Itraconazole

متاح من:

Accord-UK Ltd

ATC رمز:

J02AC02

INN (الاسم الدولي):

Itraconazole

جرعة:

100mg

الشكل الصيدلاني:

Oral capsule

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 05020100; GTIN: 5012617019172 5012617024138

نشرة المعلومات

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ITRACONAZOLE 100MG 15 & 60 TABLETS PIL - UK
Black
Profile
BBBA1065
C.Grant
19/07/17
24/07/17
C.Grant
140x540
9pt 8pt in the table
Linconsa
19/07/17
24/07/17
02
ITRACONAZOLE 100MG CAPSULES, HARD
PACKAGE LEAFLET: INFORMATION FOR THE USER
BBBA1065
_continued top of next column_
_continued over page_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING 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 only. Do not pass it on to others. It
may harm them, even if their symptoms
are the same as yours.
• If you get any of the 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 ITRACONAZOLE CAPSULES ARE
AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ITRACONAZOLE CAPSULES
3. HOW TO TAKE ITRACONAZOLE CAPSULES
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ITRACONAZOLE CAPSULES
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT ITRACONAZOLE CAPSULES ARE
AND WHAT THEY ARE USED FOR
Itraconazole capsules are indicated for the
treatment of fungal infections of the vagina,
skin, mouth, eyes, nails and internal organs.
The active substance is itraconazole, a
member of the following pharmaco-
therapeutic class of drugs: Antimycotic for
systemic use, triazole derivatives.
Itraconazole is very effective against a variety
of infections caused by yeasts and

خصائص المنتج

OBJECT 1
ITRACONAZOLE 100MG CAPSULES, HARD
Summary of Product Characteristics Updated 24-Aug-2017 | Accord-UK Ltd
1. Name of the medicinal product
Itraconazole 100mg Capsules, hard
2. Qualitative and quantitative composition
Each capsule, hard contains 100mg of itraconazole.
Excipient with known effect: Each capsule, hard contains 224.31mg
sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard.
No. 0 hard gelatin capsules, opaque green cap and body, containing
yellowish-beige spherical micro-
granules
4. Clinical particulars
4.1 Therapeutic indications
- Vulvovaginal candidiasis,
_-_ Oral candidiasis
_-_ Dermatophytoses caused by organisms susceptible to itraconazole
(Trichophyton spp., Microsporum
spp., Epidermophyton floccosum) e.g. tinea pedis, tinea cruris, tinea
corporis, tinea manuum,
- Pityriasis versicolor,
- Onychomycoses caused by dermatophytes and/or yeasts,
- Systemic candidiasis,
- Cryptococcal infections (including cryptococcal meningitis). In
immunosuppressed patients suffering
from cryptococcosis and in patients with cryptococcosis of the CNS
Itraconazole is indicated only if the
usually recommended initial therapy seems to be inappropriate or
ineffective
- Histoplasmosis.
- Aspergillosis. Itraconazole can be used to treat patients suffering
from invasive aspergillosis who were
found to be refractory or intolerant to Amphotericin B
- Maintenance therapy in AIDS patients to prevent relapse of
underlying fungal infection who were found
to be refractory or intolerant to first-line systemic anti-fungal
therapy is inappropriate or has proved
ineffective.
Due to PK properties, orally administered itraconazole (capsules)
should not be used as the initial
treatment in patients with severe life-threatening forms of systemic
mycoses. Oral forms should be used
as a continuation therapy, after initial treatment with i.v.
itraconazole (see section 4.4).
Consideration should be given to official guidance regarding the
appropriate use of antifungal agents.
4.2 Posology an