Itraconazole 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Itraconazole

Available from:

Sigma Pharmaceuticals Plc

ATC code:

J02AC02

INN (International Name):

Itraconazole

Dosage:

100mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020100

Patient Information leaflet

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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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Itraconazole 100mg Capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains 100 mg of itraconazole.
Excipient with known effect: Each hard capsule contains 224.31 mg
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 AND METHOD OF ADMINISTRATION
Posology.
INDICATIONS
DOSE
DURATION
OF
TREATMENT
Gynecol