Itraconazole 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Itraconazole

Available from:

Teva UK Ltd

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; GTIN: 5017007035794 5017007035817 5017007035831

Patient Information leaflet

ITRACONAZOLE
100 MG CAPSULES
(ITRACONAZOLE)
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, pharmacist or nurse.
•
This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
•
If you get any of the side effects, talk to
your doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
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
WHAT ITRACONAZOLE CAPSULES ARE
AND WHAT THEY ARE USED FOR
Itraconazole Capsules belong to a group of
medicines called antimycotics for systemic
use, also known as "antifungals", which are
used to treat infections caused by fungi
including yeasts.
•
Itraconazole Capsules are used to treat
fungal infections of the:
• vagina
• skin
• lungs
• mouth
• nails
• internal organs.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ITRACONAZOLE CAPSULES
DO NOT TAKE ITRACONAZOLE IF YOU ARE:
•
allergic to itraconazole or any of the
other ingredients of this medicine (listed
in section 6)
•
taking any hay fever antihistamine
products containing terfenadine,
astemizole or mizolastine
•
taking certain medicines used to treat
angina (chest pain) and high blood
pressure, such as bepridil and nisoldipine
•
taking cisapride (a drug used for certain
digestive problems)
•
taking midazolam (by mouth) or
triazolam, medicines taken for anxiety or
to help you to sleep (tranquillisers)
•
taking certain cholesterol lowering drugs,
for example, atorvastatin, lovastatin or
simvastatin
•
taking pimozide or sertindole (drugs for
certain conditions affecting th

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ITRACONAZOLE 100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg itraconazole.
Excipient(s) with known effect: Sucrose 224.31 mg per capsule.
For the full list excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard
Hard gelatin capsules (size 0) with a green opaque cap and body
containing
yellowish-beige spherical microgranules
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Vulvovaginal candidosis.
2.
Pityriasis versicolor.
3.
Dermatophytoses caused by organisms susceptible to itraconazole
_(Trichophyton spp._, _Microsporum spp._, _Epidermophyton floccosum_)
e.g.
tinea pedis, tinea cruris, tinea corporis, tinea manuum.
4.
Oropharyngeal candidosis.
5.
Onychomycosis caused by dermatophytes and/or yeasts.
6.
The treatment of histoplasmosis.
7.
Itraconazole is indicated in the following systemic fungal conditions
when
first-line systemic anti-fungal therapy is inappropriate or has proved
ineffective. This may be due to underlying pathology, insensitivity of
the
pathogen or drug toxicity.
- Treatment of aspergillosis, candidosis
- Treatment of cryptococcosis (including cryptococcal meningitis) : in
immunocompromised patients with cryptococcosis and in all patients
with cryptococcosis of the central nervous system.
- Maintenance therapy in AIDS patients to prevent relapse of
underlying fungal infection. Itraconazole is also indicated in the
prevention of fungal infection during prolonged neutropenia when
standard therapy is considered inappropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Itraconazole is for oral administration and must be taken immediately
after a meal for
maximal absorption.
Treatment schedules in adults for each indication are as follows:
_INDICATION_
_DOSE_
_REMARKS_
Vulvovaginal candidosis
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
or 200 mg once daily for 7