Itraconazole 100mg capsules

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Itraconazole

Saadav alates:

A A H Pharmaceuticals Ltd

ATC kood:

J02AC02

INN (Rahvusvaheline Nimetus):

Itraconazole

Annus:

100mg

Ravimvorm:

Oral capsule

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 05020100; GTIN: 5025903000310 5025903019244

Infovoldik

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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

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Itraconazole 100mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 100 mg itraconazole.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Opaque green capsule, containing yellowish-beige beads.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Itraconazole is indicated for the treatment of the
following fungal infections when thought likely to be
susceptible:
•
Vulvovaginal candidiasis.
•
Pityriasis versicolor.
•
Dermatophytoses caused by organisms susceptible to itraconazole
(Trichophyton spp. Microsporum spp. Epidermophyton floccosum) e.g.
tinea
pedis, tinea cruris, tinea corporis, tinea manuum.
•
Oral candidiasis.
•
Onychomycosis caused by dermatophytes and/or yeasts.
Consideration should be given to official guidance regarding the
appropriate use of
antifungal agents.
For further information please refer to section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment schedules in adults for each indication are as follows:
INDICATION
DOSE
Vulvovaginal candidiasis
200 mg twice daily for 1 day
Pityriasis versicolor
200 mg once daily for 7 days
Tinea corporis, tinea cruris
100 mg once daily for 15 days
Tinea pedis,
tinea manuum
100 mg once daily for 30 days
Oral candidiasis
100 mg once daily for 14 days
Onychomycosis
200 mg once daily for 3 months
For skin infections, optimal clinical and mycological effects are
reached at 1 - 4
weeks after cessation of treatment and for nail infections at 6 - 9
months after the
cessation of treatment. This is because elimination of itraconazole
from skin and nails
is slower than from plasma.
In Acquired Immune Deficiency Syndrome and neutropenic patients: for
the
treatment of oral candidiasis 200 mg once daily for 14 days is
recommended due to
the impaired absorption of itraconazole in these patient groups.
The length of treatment for systemic fungal infections should be
dictated by the
mycological and clinical response to ther