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ITRACONAZOLE 10MG/ML ORAL SOLUTION

Active substance(s): ITRACONAZOLE / ITRACONAZOLE / ITRACONAZOLE

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constipation
itching, hives
general swelling
muscle cramps or irregular heart beat (possible
symptoms of low blood levels of potassium)
muscle pain, painful joints
abnormal menstrual bleeding
decreased feeling or sensitivity, especially in the
skin

The following side effects have been reported in
patients taking Itraconazole oral solution with
unknown frequency:
• excess of triglycerides (fats) in the blood
• hair loss
• increase in blood creatine phosphokinase levels
The following side effects have been
reported in patients taking other formulations
of Itraconazole oral solution:
• infection of the upper respiratory tract
• inflammation of the nose
• inflammation of the sinuses
• certain blood disorder which may increase the
risk of infections (possible symptom of low
levels of granulocytes)
• high blood sugar levels
• muscle cramps or irregular heart beat
(possible symptoms of low blood levels of
magnesium)
• muscle cramps or irregular heart beat
(possible symptoms of high blood levels of
potassium)
• confusion
• sleepiness
• tremors
• increase in heart rate
• high blood pressure
• low blood pressure
• fluid in the lungs
• difficulty speaking
• excess gas in the intestinal tract
• increases in specific liver function tests
(hepatic enzyme increased)
• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• excess sweating
• kidney problems
• excessive urine production
• erectile dysfunction
• general swelling
• facial swelling
• chest pain
• pain
• chills
• fatigue
• increase in blood urea levels
• abnormal urine findings
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. CONTENTS OF THE PACK AND OTHER
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.

POM

PL 15184/1493 - Itraconazole 10mg/ml
oral solution

Leaflet revision date: 20/03/17

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited,
Tel: 01527 505414
to obtain the leaflet in a
format suitable for you.

Package leaflet - Information for the user

Ref: 1493/200317/1/F

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 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.
Your medicine is called Itraconazole 10mg/ml oral
solution and will be referred to as Itraconazole oral
solution throughout the rest of this leaflet.
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 use
Itraconazole oral solution
3. How to use Itraconazole oral solution
4. Possible side effects
5. How to store Itraconazole oral solution
6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW 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 Contents of the pack
and other information)
• pregnant, think you might be pregnant or could
become pregnant (see the section on
Pregnancy)
• taking any of the following medicines:
• terfenadine or mizolastine (antihistamines for
allergies)
• bepridil, ivabradine or ranolazine - used
to treat angina (crushing chest pain)
• nisoldipine, lercanidipine or eplerenone
(used for high blood pressure)
• cisapride (used for stomach upsets)
• domperidone (for nausea and vomiting)
• midazolam by mouth or triazolam
(used to help you sleep or for anxiety)
• lovastatin or simvastatin (used to lower
cholesterol)
• pimozide or sertindole (for conditions affecting
thoughts, feelings and/or behaviour)
• dihydroergotamine or ergotamine
(for migraine headaches)



ergometrine (ergonovine) or
methylergometrine (methylergonovine)
used after giving birth
• disopyramide, dronedarone, quinidine
or dofetilide (for irregular heart beat
rhythms)
• colchicine (for gout) when used in
patients with kidney or liver problems
• halofantrine (for malaria)
• irinotecan (for cancer)
• dabigatran (for blood thinning)
• quetiapine (for psychosis)
• aliskiren (for hypertension)
• fesoterodine (for irritated urinary bladder) when
used in patients with certain kidney or liver
problems
• sildenafil (for pulmonary arterial hypertension)
• solifenacin (for irritated urinary bladder) when
used in patients with certain kidney or liver
problems
• vardenafil (for erectile dysfunction) when
used in men older than 75 years of age
Also, upon completing your course of Itraconazole
oral solution, do not take any of the medicines
listed above for 2 weeks.
Warnings and precautions
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
oral solution 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 In addition, there may be specific
medication you may not be able to take.



a kidney disorder as your dose of traconazole
oral solution may have to be changed.
In addition, there may be specific medication
you may not be able to take.



Other medicines and Itraconazole oral
solution.
There are some medicines that you should
not take whilst taking Itraconazole oral solution.
These are listed above 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 oral
solution from working properly:
• rifampicin, rifabutin or isoniazid (antibiotics used
for tuberculosis)
• phenytoin, carbamazepine or phenobarbital
(anti-epileptics)
• efavirenz or nevirapine (medicines used for
HIV/AIDS)
• St. John’s wort (a herbal medicine)
Do not use Itraconazole oral solution within 2
weeks of taking these medicines.
Tell your doctor if you are using the following
medicines as they are not recommended with
Itraconazole oral solution unless your doctor feels
it is necessary:
• medicines for cancer (namely dasatinib,
lapatinib, nilotinib, or trabectedin)
• rifabutin (for tuberculosis)
• carbamazepine (for epilepsy)
• colchicine (for gout)
• everolimus or temsirolimus (given after an
organ transplant)
• fentanyl (for pain)
• rivaroxaban (for blood clots)
• salmeterol (for breathing problems)
• tamsulosin (for male urinary incontinence)
• vardenafil (for erectile dysfunction) when used
in men 75 years of age and younger
• atorvastatin (for lowering levels of cholesterol)
• ciclesonide (for inflammation, asthma and
allergies)
• ebastine (for allergies)
• eletriptan (for migraine headaches)
• tolterodine (for irritated urinary bladder)
• felodipine (for the heart or blood vessels)
Also, upon completing your course of Itraconazole
oral solution, do not take any of the medicines
listed above for 2 weeks.
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:
• ciprofloxacin, clarithromycin or erythromycin
(antibiotics for infections)
• medicines that act on the heart or blood vessels
(digoxin, nadolol, calcium channel-blockers such
as dihydropyridines, verapamil)
• medicines that slow down blood clotting or thin
the blood, such as the coumarins (eg, warfarin)
or cilostazol




















methylprednisolone, budesonide, fluticasone or
dexamethasone, medicines given by mouth and
injection for inflammation, asthma and allergies
ciclosporine, tacrolimus or rapamycin
(also known as sirolimus), which are usually
given after an organ transplant
medicines used in HIV-infected patients, such as
maraviroc, ritonavir, ritonavirboosted darunavir,
ritonavir-boosted fosamprenavir, indinavir and
saquinavir
medicines for cancer (such as bortezomib,
busulphan, docetaxel, erlotinib, gefitinib,
imatinib, ixabepilone, trimetrexate or a group of
medicines known as vinca alkaloids)
alfentanil, buprenorphine or oxycodone (for pain)
methadone for treatment of drug abuse
(opioid-dependency)
buspirone, alprazolam, brotizolam, perospirone
or midazolam when given by injection into a vein
(for anxiety or to help you sleep)
reboxetine (for depression)
repaglinide or saxagliptin (for diabetes)
aripiprazole, haloperidol or risperidone
(for psychosis)
aprepitant (for nausea and vomiting)
fesoterodine or solifenacin (for irritated
urinary bladder)
sildenafil or tadalafil (for erectile dysfunction)
praziquantel (for fluke and tapeworms)
meloxicam (for joint inflammation and pain)
cinacalcet (for an over active parathyroid)
tolvaptan (for low blood sodium levels)
alitretinoin (oral) (for eczema)

Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a
prescription.
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 oral solution 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 with
Itraconazole oral solution has finished.
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.
Itraconazole oral solution contains sorbitol
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 Itraconazole oral solution 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.
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 oral
solution 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.

• 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.

How to use the measuring cup
Use the measuring cup just as it sits on the bottle.
Make sure that the side with the graduations (the
side that holds less) is uppermost; that is the side
you have to fill. When the arrow on the side points
up, the correct side is uppermost.
If you take too much Itraconazole oral solution
If you, or anyone else, take more Itraconazole oral
solution 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 oral solution, 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
• Severe upper stomach pain, often with nausea
and vomiting due to inflammation of the
pancreas (pancreatitis)
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, indigestion, unpleasant
taste
• rash
• fever or high temperature
• shortness of breath
• dizziness
• cough
Uncommon side effects (occur in less than 1 in
100 patients) are:
• certain blood disorders which may increase the
risk of bleeding or bruising (possible symptoms
of low levels of platelets), or infections (possible
symptom of low levels of white blood cells)
Ref: 1493/200317/1/B

Expand Transcript

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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