SPORANOX

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ITRACONAZOLE

Available from:

Janssen-Cilag Ltd

ATC code:

J02AC02

INN (International Name):

ITRACONAZOLE

Dosage:

10mg/ml Mg/Ml

Pharmaceutical form:

Oral Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

itraconazole

Authorization status:

Marketed

Authorization date:

1997-09-05

Patient Information leaflet

Page 1
PACKAGE LEAFLET: INFORMATION FOR THE USER SPORANOX 10 MG/ML ORAL SOLUTION
(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 symptoms 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.
WHAT IS IN THIS LEAFLET:
1.
WHAT SPORANOX ORAL SOLUTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SPORANOX ORAL SOLUTION
3.
HOW TO USE SPORANOX ORAL SOLUTION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SPORANOX ORAL SOLUTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT SPORANOX ORAL SOLUTION IS AND WHAT IT IS USED FOR
Sporanox is one of a group of medicines called “antifungals”.
These medicines are used to treat and stop
you from getting infections caused by fungi including yeasts.
You may be given Sporanox to:

treat yeast infections of the mouth, throat or gullet if you have a
poor immune system

stop you from getting certain fungal infections if you have a poor
immune system due to a major
blood disorder or bone marrow transplantation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SPORANOX ORAL SOLUTION
DO NOT USE SPORANOX ORAL SOLUTION IF YOU ARE:

ALLERGIC (hypersensitive) to itraconazole or to any of the ingredients
in Sporanox oral solution (listed
in Section 6
Contents of the pack and other information)

PREGNANT, think you might be pregnant or could become pregnant (see
the section on Pregnancy)

TAKING ANY OF THE FOLLOWING MEDICINES:
o
terfenadine or mizolastine (antihistamines for allergies)
o
bepridil, ivabradine or ranolazine - used to treat angina (crushing
chest pain)
o
nisoldipine, lercanidipine or eplerenone (used for high blood
pressure)
o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sporanox 10 mg/ml oral solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml Sporanox oral solution contains 10mg Itraconazole.
Sorbitol E420 (190 microlitre per ml).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Sporanox oral solution is clear, yellow to slightly amber solution
with an odour of cherry.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SPORANOX Oral Solution is indicated:
o
for the treatment of oral and/or oesophageal candidosis in
HIV-positive or other immunocompromised patients.
o
as prophylaxis of deep fungal infections anticipated to be susceptible
to itraconazole, when standard therapy is
considered inappropriate, in patients with haematological malignancy
or undergoing bone marrow transplant, and
who are expected to become neutropenic (i.e.
<
500 cells/µl). At present there are insufficient clinical efficacy
data in
the prevention of aspergillosis.
Consideration should be given to national and/or local guidance
regarding the appropriate use of antifungal agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For optimal absorption, SPORANOX Oral Solution should be taken without
food (patients are advised to refrain from
eating for at least 1 hour after intake).
For the treatment of oral and/or oesophageal candidosis, the liquid
should be swished around the oral cavity (approx. 20
seconds) and swallowed. There should be no rinsing after swallowing.
Treatment of oral and/or oesophageal candidosis: 200 mg (2 measuring
cups) per day in two intakes, or
alternatively in one intake, for 1 week.
If there is no response after 1 week, treatment should be continued
for
another week.
Treatment of fluconazole resistant oral and/or oesophageal candidosis:
100 to 200 mg (1-2 measuring cups)
twice daily for 2 weeks. If there is no response after 2 weeks,
treatment should be continued for another 2
weeks. The 400 mg daily dose should not be used for longer than 14
days if there are no signs of improveme