Itraconazole Sugar Free Oral Solution 10mg/ml

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

ITRACONAZOLE

Prieinama:

Syri Limited

ATC kodas:

J02AC02

INN (Tarptautinis Pavadinimas):

ITRACONAZOLE

Vaisto forma:

ORAL SOLUTION

Sudėtis:

ITRACONAZOLE 10 mg

Recepto tipas:

POM

Gydymo sritis:

ANTIMYCOTICS FOR SYSTEMIC USE

Autorizacija statusas:

Authorised

Pakuotės lapelis

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ITRACONAZOLE 10MG/ML SUGAR FREE 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.
The name of your medicine is Itraconazole 10mg/ml Sugar Free Oral
Solution but it will be referred
to as ‘Itraconazole’ throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Itraconazole is and what it is used for
2. What you need to know before you take Itraconazole
3. How to take Itraconazole
4. Possible side effects
5. How to store Itraconazole
6. Contents of the pack and other information
1. WHAT ITRACONAZOLE 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 Itraconazole 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 TAKE ITRACONAZOLE
DO NOT USE ITRACONAZOLE ORAL SOLUTION IF YOU ARE:

ALLERGIC
(hypersensitive) to itraconazole or to any of the ingredients in
Itraconazole oral solution
(listed in Section 6)

PREGNANT
, think you might be pregnant or could become pregnant (see the
section on Pregnancy)

taking any of the following medicines:
•
terfenadine, astemizole or mizolastine (antihistamine for allergies)
•
bepridil - used to treat angina (crushing chest

Prekės savybės

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Itraconazole 10mg/ml Sugar Free Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 10mg itraconazole.
_Excipient(s) with known effect: _
Each ml of oral solution contains 172mg sorbitol (E420) and 0.7124mg
sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral solution
Itraconazole oral solution is clear, colourless to yellow colour
solution with an odour of
cherry.
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
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undergoing bone marrow transplant, and who are expected to become
neutropenic (ie < 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, Itraconazole 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_
: 200mg (20ml) 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 200mg
(10-20ml) twice daily for 2 weeks. If there is no response after 2
weeks, treatment
should be continued for another