Sporanox 100mg capsules

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Itraconazole

Boleh didapati daripada:

Janssen-Cilag Ltd

Kod ATC:

J02AC02

INN (Nama Antarabangsa):

Itraconazole

Dos:

100mg

Borang farmaseutikal:

Oral capsule

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 05020100; GTIN: 5012674059401 5012674059456 5012674436035

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPORANOX® 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 or pharmacist
•
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 side effects, talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Sporanox 100 mg Capsules but will be
referred to as Sporanox capsules throughout the remainder of the
leaflet.
WHAT IS IN THIS LEAFLET
1. What Sporanox capsules are and what they are used for
2. What you need to know before you take Sporanox capsules
3. How to take Sporanox capsules
4. Possible side effects
5. How to store Sporanox capsules
6. Contents of the pack and other information
1. WHAT SPORANOX CAPSULES ARE AND WHAT THEY ARE USED FOR
Sporanox capsules contain a medicine called itraconazole. This belongs
to a group of medicines called ‘antifungals’.
Sporanox capsules are used for infections caused by fungi or yeasts in
adults. They are used for:
•
Infections of the mouth or vagina causing ‘thrush’
•
Skin infections
•
Infections affecting other parts of the body
Patches of skin may take a few weeks to completely clear up after you
have finished your treatment with Sporanox capsules. Finger and toe
nails may take several months to completely clear up. This is because
your skin or nail will only look normal after new skin or nail has
grown,
even though the medicine has killed the fungus that caused the
infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPORANOX CAPSULES
DO NOT TAKE SPORANOX CAPSULES:
•
If you are allergic to anything in Sporanox capsules (listed in
section 6
below)
•
If you are pregnant or could become pregnant unless your doc

Ciri produk

OBJECT 1
SPORANOX CAPSULES
Summary of Product Characteristics Updated 23-Apr-2013 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Sporanox 100 mg Capsules.
2. Qualitative and quantitative composition
Each capsule contains itraconazole 100 mg.
For excipients, see 6.1.
3. Pharmaceutical form
Capsules, hard
Capsule (Size 0): opaque blue cap and pink transparent body containing
coated beads.
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. Sporanox 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 and 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.
Sporanox 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
Sporanox is for oral administration and must be taken immediately
after a meal for maximal absorption.
The capsules must be swallowed whole.
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 days
Tinea pedis, tinea manuum
100 mg on