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ITRACONAZOLE 10 MG/ML ORAL SOLUTION

Active substance(s): ITRACONAZOLE / ITRACONAZOLE / ITRACONAZOLE

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PATIENT INFORMATION LEAFLET

2928
22.02.17[3]

Sporanox® 10 mg/ml Oral Solution
(itraconazole)
Read all of this leaflet carefully before you start taking your
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 will be referred to as Sporanox throughout this leaflet.
In this leaflet:
1. What Sporanox is and what it is used for
2. Before you use Sporanox
3. How to use Sporanox
4. Possible side effects
5. How to store Sporanox
6. Further information
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.
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.
2. Before you use Sporanox
Do not use Sporanox if you are:
 allergic (hypersensitive) to itraconazole or to any of the ingredients in
Sporanox 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
 sildenafi l (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 oral solution, 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 oral solution
There are some medicines that you should not take whilst taking
Sporanox. These are listed above under the heading “Do not use
Sporanox oral solution if you are:”
Tell your doctor if you are using the following medicines as they may
stop Sporanox 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 Sporanox 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 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 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 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 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,
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 oral solution 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 oral solution 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.
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 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 Sporanox oral solution.
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 (10-20 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 Sporanox oral solution
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 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 Sporanox, ask your doctor
or pharmacist.
4. Possible side effects
Like all medicines, Sporanox oral solution 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
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 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.
Do not use the Sporanox after the expiry date printed on the packaging.
The expiry date refers to the last day of that month.
Use within one month of first opening.
Always return any leftover medicine to your pharmacist. Only keep it if your
doctor tells you to.
If the solution becomes discoloured or shows any other signs of
deterioration, please tell your doctor or pharmacist before taking your
medicine.
Do not throw away any medicine via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6. Further information
What Sporanox contains
 The active ingredient is itraconazole.
 Each ml contains 10 mg itraconazole.
 The other ingredients are hydroxypropyl- β-cyclodextrin, sorbitol (E420),
propylene glycol (E490), hydrochloric acid, cherry flavour, caramel
flavour, sodium saccharin, sodium hydroxide and water.
What Sporanox looks like and contents of the pack
Sporanox is a clear yellow to slightly amber solution. It is available in
bottles containing 150 ml together with a measuring cup.
Manufacturer and Product Licence Holder
Manufactured by Janssen Pharmaceutica N.V., Turnhoutseweg 30,
B-2340 Beerse, Belgium.
Procured from within the EU by Product Licence holder Star
Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2928

Leaflet revision and issue date (Ref) 22.02.17[3]
Sporanox is a trademark of Johnson & Johnson.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

PATIENT INFORMATION LEAFLET

2928
22.02.17[3]

Itraconazole 10 mg/ml Oral Solution
Read all of this leaflet carefully before you start taking your
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 will be referred to as Itraconazole throughout this leaflet.
In this leaflet:
1. What Itraconazole is and what it is used for
2. Before you use Itraconazole
3. How to use Itraconazole
4. Possible side effects
5. How to store Itraconazole
6. Further 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. Before you use Itraconazole
Do not use Itraconazole 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
 sildenafi l (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 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 oral solution
There are some medicines that you should not take whilst taking
Itraconazole. 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,
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 oral solution 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 oral solution 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.
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 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
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 (10-20 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 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 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 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:
 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.
Do not use the Itraconazole after the expiry date printed on the packaging.
The expiry date refers to the last day of that month.
Use within one month of first opening.
Always return any leftover medicine to your pharmacist. Only keep it if your
doctor tells you to.
If the solution becomes discoloured or shows any other signs of
deterioration, please tell your doctor or pharmacist before taking your
medicine.
Do not throw away any medicine via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6. Further information
What Itraconazole contains
 The active ingredient is itraconazole.
 Each ml contains 10 mg itraconazole.
 The other ingredients are hydroxypropyl- β-cyclodextrin, sorbitol (E420),
propylene glycol (E490), hydrochloric acid, cherry flavour, caramel
flavour, sodium saccharin, sodium hydroxide and water.
What Itraconazole looks like and contents of the pack
Itraconazole is a clear yellow to slightly amber solution. It is available in
bottles containing 150 ml together with a measuring cup.
Manufacturer and Product Licence Holder
Manufactured by Janssen Pharmaceutica N.V., Turnhoutseweg 30,
B-2340 Beerse, Belgium.
Procured from within the EU by Product Licence holder Star
Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2928

Leaflet revision and issue date (Ref) 22.02[173]

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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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