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SPORANOX 10 MG/ML ORAL SOLUTION

Active substance(s): ITRACONAZOLE / ITRACONAZOLE / ITRACONAZOLE

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Package leaflet - Information for the user

© J-C 2016

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 oral solution is and
what it is used for
2 What you need to know before you
use Sporanox oral solution
3 How to use Sporanox oral solution
4 Possible side effects
5 How to store Sporanox oral solution
6 Contents of the pack and other
information

1 What Sporanox oral solution 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 What you need to know before you use Sporanox
oral solution
Do not use Sporanox oral solution
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
- 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 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:”

• 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, 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.

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

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.

If you are breast-feeding do not take
Sporanox, as small amounts of the medicine
could be present in your breast milk.

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)

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.

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

3 How to use Sporanox oral solution
Always take Sporanox oral solution one
hour before any food or drink as this helps
the body absorb the medicine.
You should swish the oral solution around
in your mouth for approximately 20 seconds
before swallowing it. Do not rinse your
mouth after swallowing the oral solution.
Always take Sporanox exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
A measuring cup graduated to indicate
10ml is provided. Ensure you fill the cup
to the 10ml mark.

How to take Sporanox 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 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.

© J-C 2016

3 How to use Sporanox oral solution (continued)
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 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.

If you, or anyone else, take more Sporanox
than you were told to, contact your doctor
or local hospital without delay.

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.
In the UK, you can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
In Ireland, you can also report side effects
directly via: HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2, Tel:
+353 1 6764971, Fax: +353 1 6762517,
Website: www.hpra.ie, E-mail:
medsafety@hpra.ie
By reporting side effects you can help
provide more information on the safety
of this medicine.

5 How to store Sporanox oral solution
Keep out of the reach and sight of children.
Do not store Sporanox oral solution
above 25°C.
Do not use the Sporanox oral solution after
the expiry date printed on the packaging.
The expiry date refers to the last day of that
month.

The oral solution should not be used for
longer than 1 month after the bottle has
first been opened.
Always return any left over medicine to your
pharmacist. Only keep it if your doctor tells
you to.

6 Contents of the pack and other information
What Sporanox oral solution
contains:

• The active ingredient is itraconazole
(10mg of itraconazole per ml).
• The other ingredients are hydroxypropylβ-cyclodextrin, sorbitol, propylene glycol,
hydrochloric acid, cherry flavour, caramel
flavour, sodium saccharin, sodium
hydroxide and water.

What Sporanox oral solution looks
like and the contents of the pack:
Sporanox oral solution is a clear yellow to
slightly amber solution. It is available
in bottles containing 150 ml together with
a measuring cup.
Marketing Authorisation Holder:
Janssen-Cilag Ltd, 50-100 Holmers Farm
Way, High Wycombe, Buckinghamshire
HP12 4EG, UK.
Manufacturer:
Sporanox oral solution is manufactured by:
Janssen Pharmaceutica NV,
Turnhoutseweg 30,
B-2340 Beerse,
Belgium.

This medicinal product is authorised
in the member states of the EEA under
the following names:
Austria:
SPORANOX®
Belgium:
SPORANOX®
Germany:
SEMPERA®
Spain:
SPORANOX®
Finland:
SPORANOX®
Ireland:
SPORANOX®
Italy:
SPORANOX®
Luxembourg: SPORANOX®
Netherlands: TRISPORAL®
Portugal:
SPORANOX®
Sweden:
SPORANOX®
UK:
SPORANOX®

For information in large
print, tape, CD or Braille,
phone 0800 731 8450 (UK)
or 1800 709122 (IRE)
®

Registered trademark

This leaflet was last revised in
September 2016

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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