Sporanox 10 mg/mL oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Itraconazole

Available from:

Janssen Sciences Ireland UC

ATC code:

J02AC; J02AC02

INN (International Name):

Itraconazole

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Therapeutic area:

Triazole derivatives; 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 any of the ingredients in
SPORANOX oral solution (listed in
Section 6)
•
If you are pregnant, think you might be pregnant or could become
pregnant (see the section on
Pregnancy)
Tell your doctor
if you are taking any medicines, before you use SPORANOX oral
solution.
•
DO NOT USE SPORANOX ORAL SOLUTION IF
you are taking certain medicines, or within 2 weeks of
stopping SPORANOX oral solution. The following list contains examples
of medicines you must
not take with SPORANOX oral solutio

Summary of Product characteristics

HealthProductsRegulatoryAuthority
19October2023
CRN00DFD9
Page1of20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sporanox10mg/mLoralsolution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1mLSPORANOXOralSolutioncontains10mgitraconazole.
Excipients with known effect
EachmLofSPORANOXOralSolutioncontains:
400 mghydroxypropyl-β(cyclodextrin);
198 mgsorbitol;
104 mgpropyleneglycol;
0.005 mgethanol.
Forthe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:

forthetreatmentoforaland/oroesophagealcandidosisinHIV-positiveorotherimmunocompromisedpatients.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Solutionshould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liquidshouldbeswishedaroundtheoralcavity(approx.20
seconds)andswallowed.Thereshoul