ITRACONAZOLE 10 Mg/Ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ITRACONAZOLE

Available from:

Beacon Pharmaceuticals Ltd

ATC code:

J02AC02

INN (International Name):

ITRACONAZOLE

Dosage:

10 Mg/Ml

Pharmaceutical form:

Oral Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

itraconazole

Authorization status:

Authorised

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.
•
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.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Itraconazole Oral Solution is and what it
is used for
2.
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.
Further 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.
B
EFORE YOU TAKE
I
TRACONAZOLE ORAL
SOLUTION
DO NOT TAKE ITRACONAZOLE ORAL SOLUTION IF
YOU:
•
are allergic (hypersensitive) to itraconazole or
any of the other ingredients (listed in section
6)
•
have, or have a history of, congestive heart
failure, unless you have a very serious fungal
infection (see under ‘Take special care’)
•
are pregnant, think you might be pregnant or
could become pregnant (see the section on
Pregnancy)
•
are taking any of the following medicines:
o
terfenadine, astemizole or mizolastine
(antihistamine for allergies)
o
bepridil used to treat angina (crushing chest
pain)
o
nisoldipine (used for high blood pressure)
o
cisapride (used for stomach upsets)
o

Summary of Product characteristics

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.
Excipient: Sorbitol E420 (190 microlitre per ml), ethanol.
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/µl). 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 week.
Treatment of fluconazole resistant oral and/or oesophageal candidosis:
100 to 200 mg (10-20 ml) twice daily for 2
weeks. If there is no response after 2 weeks, treatment should be
continued for another 2 we