Sporanox 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Itraconazole

Available from:

Waymade Healthcare 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

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
SPORANOX™ 100mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Itraconazole 100mg.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
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 once daily for 30 days
Oropharyngeal candidosis
100 mg once daily for 15 days
Increase dose to 200 mg
once d