Itraconazole 10mg/ml oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Itraconazole

Available from:

Athlone Pharmaceuticals Limited

ATC code:

J02AC; J02AC02

INN (International Name):

Itraconazole

Pharmaceutical form:

Oral solution

Therapeutic area:

Triazole derivatives; itraconazole

Authorization status:

Marketed

Authorization date:

2013-05-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ITRACONAZOLE 10MG/ML ORAL SOLUTION
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.
WHAT IS IN THIS LEAFLET:
1.
What Itraconazole Oral Solution is and what it is used for
2.
What you need to know before you take Itraconazole Oral Solution
3.
How to take Itraconazole Oral Solution
4.
Possible side effects
5.
How to store Itraconazole Oral Solution
6.
Contents of the pack and other information
1.
W
HAT
I
TRACONAZOLE ORAL SOLUTION IS AND WHAT IT IS USED FOR
Itraconazole 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 this medicine:
•
To treat yeast infections of the mouth, throat or food pipe
(oesophagus)
if you have a poor immune system
•
To stop you from getting certain fungal infections if you have blood
cancer or have had a bone marrow transplant and have a poor immune
system.
2.
W
HAT YOU NEED TO KNOW BEFORE YOU TAKE
I
TRACONAZOLE ORAL
SOLUTION
DO NOT USE ITRACONAZOLE ORAL SOLUTION IF YOU:
•
ARE ALLERGIC (hypersensitive) to itraconazole or any of the other
ingredients (listed in section 6 Contents of the pack and other
information)
•
have, or have a history of, congestive heart failure, unless you have
a
very serious fungal infection
•
ARE PREGNANT, think you might be pregnant or could become pregnant
(see the section on Pregnancy)
Do not use this medicine if any of the above applies to you. If you
are not
sure, talk to your doctor or pha

Summary of Product characteristics

Health Products Regulatory Authority
17 November 2023
CRN00DXZV
Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Itraconazole 10mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml Itraconazole oral solution contains 10mg itraconazole. Excipients
with known effect:
Each ml of Itraconazole oral solution contains
247mg of sorbitol E420,
400 mg hydroxypropyl-β (cyclodextrin),
103.6mg of propylene glycol (E 1520).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Itraconazole oral solution is a clear, yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Itraconazole 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/microlitre).
At present there are insufficient clinical
efficacy data in the prevention of aspergillosis.
Itraconazole oral solution is indicated for use in adults.
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, Itraconazole oral solution should be taken
without food (patients are advised to refrain from eating for
at least 1 hour after intake).
A graduated measuring cup is provided to measure out the correct dose.
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 (20 ml) 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