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ITRACONAZOLE 10MG/ML ORAL SOLUTION

Active substance(s): ITRACONAZOLE

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Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects, you can help provide more
information on the safety of this medicine.
5. HOW TO STORE ITRACONAZOLE ORAL
SOLUTION








KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN
Do not store above 25°C.
Do not use Itraconazole after the expiry date
which is stated on the bottle label or carton.
Use within one month of first opening.
If your medicine becomes discoloured or shows
any signs of deterioration, ask your pharmacist
who will advise you what to do.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Itraconazole Oral Solution contains
• Each ml contains 10mg of itraconazole.
• The other ingredients are
hydroxypropyl-β-cyclodextrin, sorbitol,
propylene glycol, cherry flavour, caramel
flavour, sodium saccharin, hydrochloric acid,
sodium hydroxide and purified water.
What Itraconazole Oral Solution looks like and
contents of the pack
Itraconazole Oral Solution is a clear, yellow to
slightly amber solution with an odour of cherry,
available in bottles containing 150ml of oral
solution together with a graduated measuring cup,
in a cardboard carton.
Manufacturer and Licence Holder
This medicine is manufactured by Janssen
Pharmaceutica, N.V. Turnhoutseweg, 30 - B-2340,
Beerse - Belgium and is procured from within the
EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

PATIENT INFORMATION LEAFLET
POM
PL 15184/1493 - Itraconazole 10mg/ml Oral
Solution
Leaflet revision date: 28/10/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 1493/281014/1/F

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 only.
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.
Your medicine is called Itraconazole 10mg/ml Oral
Solution and will be referred to as Itraconazole
Oral Solution throughout the rest of this leaflet.
In this leaflet:
1. What Itraconazole Oral Solution is and what it is
used for
2. Before you use Itraconazole Oral Solution
3. How to use Itraconazole Oral Solution
4. Possible side effects
5. How to store Itraconazole Oral Solution
6. Further information
1. WHAT ITRACONAZOLE 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 Itraconazole Oral Solution 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. BEFORE YOU USE ITRACONAZOLE ORAL
SOLUTION
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 Further information)
• 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
pain)
• nisoldipine (used for high blood pressure)
• cisapride (used for stomach upsets)
• midazolam by mouth or triazolam (used to
help you sleep or for anxiety)
• lovastatin, simvastatin or atorvastatin (used to
lower cholesterol)







pimozide and sertindole (for conditions
affecting thoughts, feelings and/or behaviour)
levacetylmethadol - for treatment of drug
abuse (opioid dependency)
dihydroergotamine, ergotamine and eletriptan
(for migraine headaches)
ergometrine (ergonovine) and
methylergometrine (methylergonovine) used
after giving birth
quinidine and dofetilide (for irregular
heart beat rhythms).

Take special care with Itraconazole Oral
Solution
Stop taking Itraconazole Oral Solution and see
your doctor immediately if any of the following
symptoms of severe liver problems appear
during your course of treatment:
• Severe lack of appetite, feeling sick, being sick,
unusual tiredness, abdominal (stomach) pain,
unusually dark urine or pale stools.
Tell your doctor immediately:
• If you have any unusual feelings of tingling,
numbness or weakness in your hands or feet
whilst taking Itraconazole Oral Solution
• If you experience any hearing loss symptoms.
In very rare cases patients taking itraconazole
have reported temporary or permanent hearing
loss.
Tell your doctor if you have:
• had an allergic reaction to any other antifungal
medicines
• a heart problem, including heart failure (also
called congestive heart failure or CHF),
Itraconazole Oral Solution could make it worse.
If your doctor decides to give you Itraconazole
Oral Solution, you should be told about the
symptoms listed below to watch out for. If you
get any of the following stop taking Itraconazole
Oral Solution and tell your doctor straight away.
These may be signs of heart failure:
- shortness of breath
- unexpected weight gain
- swelling of your legs or stomach
- feel unusually tired
- wake up short of breath at night
• a liver problem, such as jaundice (yellowing of
the skin) as your dose of Itraconazole Oral
Solution may have to be changed. Your doctor
should give you instructions on symptoms to
watch out for. If you have to take Itraconazole
Oral Solution continuously for more than one
month, your doctor may want to check your liver
by doing blood tests
• a kidney disorder as your dose of Itraconazole
Oral Solution may have to be changed.

Taking other medicines
There are some medicines that you should not
take whilst taking Itraconazole Oral Solution.
These are listed under the heading “Do not use
Itraconazole Oral Solution if you are:”.
Tell your doctor if you are using the following
medicines as they may stop itraconazole from
working properly:
• rifampicin, rifabutin and isoniazid (antibiotics
used for tuberculosis)
• phenytoin, carbamazepine and phenobarbital
(anti-epileptics)
• St. John’s wort
Do not use Itraconazole Oral Solution within 2
weeks of taking these medicines.
Tell your doctor before taking any of the
following medicines as the dose of Itraconazole
Oral Solution or other treatments may need to be
altered:
• clarithromycin and erythromycin (antibiotics for
infections)
• medicines that act on the heart and blood
vessels (digoxin, disopyramide and calcium
channel-blockers such as dihydropyridines,
verapamil and cilostazol)
• drugs that slow down blood clotting or thin the
blood, such as warfarin
• methylprednisolone, budesonide, fluticasone and
dexamethasone, medicines given by mouth and
injection for inflammation, asthma and allergies
• ciclosporin, tacrolimus and rapamycin (also
known as sirolimus), which are usually given
after an organ transplant
• medicines used in HIV-infected patients, such as
ritonavir, indinavir and saquinavir
• medicines for cancer (such as busulphan,
docetaxel, trimetrexate and a group of
medicines known as vinca alkaloids)
• alfentanil and fentanyl (for pain)
• buspirone, alprazolam, brotizolam and
midazolam when given by injection into a vein
(for anxiety or to help you sleep)
• reboxetine (for depression)
• loperamide (for diarrhoea)
• an antihistamine containing ebastine
• halofantrine (for malaria)
• repaglinide (for diabetes).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a
prescription.
Using Itraconazole Oral Solution with food and
drink
Do not take Itraconazole Oral Solution with food
or drink as it reduces your body’s ability to absorb
the medicine. Always take Itraconazole Oral
Solution one hour before any food or drink as this
helps the body absorb the medicine.

Children and the elderly
Itraconazole Oral Solution is not normally given to
children or the elderly. Your doctor may prescribe
it in special cases.
Pregnancy
Do not take Itraconazole Oral Solution if you are
pregnant, unless your doctor has told you to.
If you are of child bearing age and could become
pregnant, you should use contraceptives to make
sure that you do not become pregnant while you
are taking your medicine. As itraconazole remains
in the body for some time after you stop taking it,
you should continue to use some form of
contraception until your next period after your
treatment Itraconazole Oral Solution has finished.

How to take Itraconazole Oral Solution
• Treatment of yeast infections of the mouth,
throat or gullet
The usual dose is 2 measuring cups (20ml) per
day for one week. This may be taken either all at
once or in two divided doses during the day.
If after one week of using Itraconazole your
infection has not cleared, your doctor may
decide to continue your treatment for one more
week.

• Treatment of yeast infections of the mouth,

throat or gullet, that have already been
treated with another antifungal but have still
not cleared
The usual dose is 1-2 measuring cups
(10-20 ml) twice daily for two weeks. The
treatment may be continued for an additional
two weeks, if the infection does not clear in the
initial two weeks of treatment. For patients on
the higher dose of 400 mg (4 measuring cups)
daily, treatment should be limited to 14 days, if
there are no signs of improvement during this
time.

If you do find that you are pregnant after starting a
course of Itraconazole Oral Solution, stop taking it
and tell your doctor straight away.
Before taking any medicine - always tell your
doctor if you are pregnant, think you might be
pregnant or are trying to become pregnant.
Breast feeding
If you are breast-feeding do not take Itraconazole
Oral Solution, as small amounts of the medicine
could be present in your breast milk.
Driving and using machines
Itraconazole Oral Solution can sometimes cause
dizziness, blurred/double vision or hearing loss. If
you have these symptoms, do not drive or use
machines.
Important information about some of the
ingredients of Itraconazole Oral Solution
Tell your doctor if you are intolerant to fructose (a
type of sugar) as this is in sorbitol, one of the
ingredients of Itraconazole Oral Solution.
3. HOW TO USE ITRACONAZOLE ORAL
SOLUTION
Always take Itraconazole Oral Solution one hour
before any food or drink as this helps the body
absorb the medicine.
You should swish the oral solution around in your
mouth for approximately 20 seconds before
swallowing it. Do not rinse your mouth after
swallowing the oral solution.
Always take Sporanox exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
A measuring cup graduated to indicate 10ml is
provided. Ensure you fill the cup to the 10ml mark.



Prevention of fungal infections
The dose is calculated according to your body
weight (5 mg per kg) given in two divided doses.
Your doctor will tell you exactly how much you
should take.

Directions for opening the bottle
The bottle comes with a
child-proof cap, and should
be opened as follows: push
the plastic screw cap down,
while turning it counter
clockwise.

If you take too much Itraconazole Oral Solution
If you, or anyone else, take more Itraconazole
than you were told to, contact your doctor or local
hospital without delay.
If you forget to take Itraconazole Oral Solution
If you forget to take your medicine, take the next
dose as usual and continue your medicine as
directed by your doctor. Do not take a double
dose.
If you have any further questions on the use of
Itraconazole, ask your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS
Like all medicines, Itraconazole Oral Solution can
cause side effects, although not everybody gets
them.

Medicines can cause serious allergic
reactions. Stop taking Itraconazole Oral
Solution and contact your doctor immediately
if you have:
• any sudden wheeziness, difficulty in breathing,
swelling of the face, rash, itching (especially
affecting the whole body) or a severe skin
disorder (widespread rashes with peeling skin
and blisters in the mouth, eyes and genitals, or
rashes with small pustules or blisters).
• severe lack of appetite, feeling sick, being sick,
unusual tiredness, abdominal (stomach) pain,
unusually dark urine, or pale stools. These may
be symptoms of severe liver problems.
You should also let your doctor know immediately
if you have any of the side effects below:
• Symptoms that resemble heart failure such as
shortness of breath, unexpected weight gain,
swelling of the legs, unusual fatigue (tiredness),
repeated waking at night
• A tingling sensation, sensitivity to light,
numbness or weakness in the limbs
• Blurred vision/double vision, ringing in your ears,
lose the ability to control your urine or increased
need to urinate (pass water)
• If you experience any hearing loss symptoms
Other side effects include:
Common side effects (occur in less than 1 in 10
patients) are:
• headache
• stomach ache, feeling sick (nausea), being sick
(vomiting), diarrhoea, unpleasant taste
• increases in specific liver function tests (hepatic
enzyme increased)
• rash
• fever or high temperature.
• shortness of breath
Uncommon side effects (occur in less than 1 in
100 patients) are:
• certain blood disorders which may increase the
risk of bleeding, bruising or infections
• muscle weakness (possible symptom of low
blood levels of potassium)
• dizziness
• indigestion, constipation
• inflammation of the liver (hepatitis), yellowing of
the skin (jaundice)
• itching
• general swelling.
The following side effects have been reported in
patients taking itraconazole with unknown
frequency:
• excess of triglycerides in the blood
• hair loss
• muscle pain, painful joints
• menstrual disorders
• erectile dysfunction.
• severe upper stomach pain, often with nausea
and vomiting due to inflammation of the
pancreas (pancreatitis)
Ref: 1493/281014/1/B

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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