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SPORANOX 10MG/ML ORAL SOLUTION

Active substance(s): ITRACONAZOLE / ITRACONAZOLE / ITRACONAZOLE

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Package leaflet - Information for the user

Sporanox® 10mg/ml oral solution
(itraconazole)
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.

What is in this leaflet:
1

What Sporanox is and what it is used for

2

What you need to know before you use Sporanox

3

How to use Sporanox

4

Possible side effects

5

How to store Sporanox

6

Contents of the pack and other information

The name of your medicine is Sporanox 10mg/ml oral solution but it
will be referred as Sporanox throughout the leaflet.

1 What Sporanox is and what it is used for
Sporanox 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.

2 What you need to know before you use Sporanox
Do not use Sporanox if you are:
 allergic (hypersensitive) to itraconazole or to any of the
ingredients in Sporanox (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 Sporanox, do not take any of
the medicines listed above for 2 weeks.
Warnings and precautions
Stop taking Sporanox 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 Sporanox.
 If you experience any hearing loss symptoms. In very rare
cases patients taking Sporanox 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), Sporanox could make it worse. If your
doctor decides to give you Sporanox, you should be told about
the symptoms listed below to watch out for. If you get any of the
following stop taking Sporanox 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 Sporanox may have to be changed. Your doctor should
give you instructions on symptoms to watch out for. If you have
to take Sporanox 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 Sporanox may have to be
changed. In addition, there may be specific medication you may
not be able to take.
Other medicines and Sporanox
There are some medicines that you should not take whilst taking
Sporanox. These are listed above under the heading ‘Do not use
Sporanox if you are’:
Tell your doctor if you are using the following medicines as they
may stop Sporanox 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)

You may be given Sporanox 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.

 St. John’s wort (a herbal medicine)
Do not use Sporanox within 2 weeks of taking these medicines.
Tell your doctor if you are using the following medicines as they
are not recommended with Sporanox 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 infl ammation, 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 Sporanox 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 Sporanox 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, ritonavir-boosted 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.
Sporanox with food and drink
Do not take Sporanox with food or drink as it reduces your body’s
ability to absorb the medicine. Always take Sporanox one hour
before any food or drink as this helps the body absorb the medicine.
Children and the elderly
Sporanox is not normally given to children or the elderly. Your
doctor may prescribe it in special cases.
Pregnancy
Do not take Sporanox 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
Sporanox 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 Sporanox has finished.
If you do find that you are pregnant after starting a course of
Sporanox, 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 Sporanox, as small amounts of
the medicine could be present in your breast milk.

3 How to use Sporanox
Always take Sporanox 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.
How to take Sporanox
 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 Sporanox 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
(10-20ml) 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 400mg (4 measuring cups) daily, treatment
should be limited to 14 days, if there are no signs of
improvement during this time.

Driving and using machines
Sporanox can sometimes cause dizziness, blurred/double vision or
hearing loss. If you have these symptoms, do not drive or use
machines.
Sporanox 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 Sporanox



Prevention of fungal infections
The dose is calculated according to your body weight (5mg 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 Sporanox
If you, or anyone else, take more Sporanox than you were told to,
contact your doctor or local hospital without delay.
If you forget to take Sporanox
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 Sporanox, ask your
doctor or pharmacist.

4 Possible side effects
Like all medicines, Sporanox can cause side effects, although not
everybody gets them.
Medicines can cause serious allergic reactions. Stop taking
Sporanox 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)
 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
Sporanox 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 Sporanox:
 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 Sporanox
Keep out of the sight and reach of children.
Do not store above 25°C.
Use within one month of first opening.
Do not use the solution after the expiry date which is stated on the
carton and bottle label after ‘Exp’. The expiry date refers to the last
day of the month.

If the solution becomes discoloured or shows any signs of
deterioration, seek the advice of your pharmacist.
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 Sporanox contains:
Each 1ml of Sporanox solution contains 10mg itraconazole. The
other ingredients are: hydroxypropyl--cyclodextrin, hydrochloric
acid, propylene glycol, sodium hydroxide, sodium saccharin
dihydrate, sorbitol E420, cherry flavour 1, cherry flavour 2, caramel
and purified water.
What Sporanox looks like and the contents of the pack:
Sporanox is a clear, yellow to slightly amber solution. It is available
in 150ml amber glass bottles, with child-resistant screw cap.

A measuring cup graduated to indicate 2.5ml, 5ml and 10ml is
provided.
Manufactured by: Janssen Pharmaceutica N.V., Turnhoutseweg
30, B-2340 Beerse, Belgium.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Sporanox® 10mg/ml oral solution, PL 18799/2813
Leaflet date: 29.11.2016

POM

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 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.

What is in this leaflet:
1

What Itraconazole is and what it is used for

2

What you need to know before you use Itraconazole

3

How to use Itraconazole

4

Possible side effects

5

How to store Itraconazole

6

Contents of the pack and other information

The name of your medicine is Itraconazole 10mg/ml oral solution
but it will be referred as Itraconazole throughout the leaflet.

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.

2 What you need to know before you use Itraconazole
Do not use Itraconazole if you are:
 allergic (hypersensitive) to itraconazole or to any of the
ingredients in Itraconazole (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, do not take any
of the medicines listed above for 2 weeks.
Warnings and precautions
Stop taking Itraconazole 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.
 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 could make it worse. If your
doctor decides to give you Itraconazole, you should be told
about the symptoms listed below to watch out for. If you get any
of the following stop taking Itraconazole 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 may have to be changed. Your doctor
should give you instructions on symptoms to watch out for. If
you have to take Itraconazole 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 Itraconazole may have to be
changed. In addition, there may be specific medication you may
not be able to take.
Other medicines and Itraconazole
There are some medicines that you should not take whilst taking
Itraconazole. These are listed above under the heading ‘Do not
use Itraconazole if you are’:
Tell your doctor if you are using the following medicines as they
may stop Itraconazole 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)

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.

 St. John’s wort (a herbal medicine)
Do not use Itraconazole 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 infl ammation, 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 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, ritonavir-boosted 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 with food and drink
Do not take Itraconazole with food or drink as it reduces your body’s
ability to absorb the medicine. Always take Itraconazole one hour
before any food or drink as this helps the body absorb the medicine.
Children and the elderly
Itraconazole is not normally given to children or the elderly. Your
doctor may prescribe it in special cases.
Pregnancy
Do not take Itraconazole 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 with Itraconazole has finished.
If you do find that you are pregnant after starting a course of
Itraconazole, 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, as small
amounts of the medicine could be present in your breast milk.

3 How to use Itraconazole
Always take Itraconazole 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 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.
How to take Itraconazole
 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
(10-20ml) 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 400mg (4 measuring cups) daily, treatment
should be limited to 14 days, if there are no signs of
improvement during this time.

Driving and using machines
Itraconazole can sometimes cause dizziness, blurred/double vision
or hearing loss. If you have these symptoms, do not drive or use
machines.
Itraconazole 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



Prevention of fungal infections
The dose is calculated according to your body weight (5mg 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
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
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 can cause side effects, although
not everybody gets them.
Medicines can cause serious allergic reactions. Stop taking
Itraconazole 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)
 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 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:
 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
Keep out of the sight and reach of children.
Do not store above 25°C.
Use within one month of first opening.
Do not use the solution after the expiry date which is stated on the
carton and bottle label after ‘Exp’. The expiry date refers to the last
day of the month.

If the solution becomes discoloured or shows any signs of
deterioration, seek the advice of your pharmacist.
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 contains:
Each 1ml of Itraconazole solution contains 10mg itraconazole. The
other ingredients are: hydroxypropyl--cyclodextrin, hydrochloric
acid, propylene glycol, sodium hydroxide, sodium saccharin
dihydrate, sorbitol E420, cherry flavour 1, cherry flavour 2, caramel
and purified water.
What Itraconazole looks like and the contents of the pack:
Itraconazole is a clear, yellow to slightly amber solution. It is
available in 150ml amber glass bottles, with child-resistant screw

cap. A measuring cup graduated to indicate 2.5ml, 5ml and 10ml is
provided.
Manufactured by: Janssen Pharmaceutica N.V., Turnhoutseweg
30, B-2340 Beerse, Belgium.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Itraconazole® 10mg/ml oral solution, PL 18799/2813
Leaflet date: 29.11.2016

POM

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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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