SPORANOX 10 MG/ML ORAL SOLUTION

Active substance: ITRACONAZOLE

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Package leaflet - Information for the user

10mg/ml Oral Solution
(itraconazole)
Read all of this leaflet carefully
before you start taking your
medicine:

In this leaflet:

• 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.

2 Before you use Sporanox oral

1 What Sporanox oral solution is and
what it is used for
solution

3 How to use Sporanox oral solution
4 Possible side effects
5 How to store Sporanox oral
solution

6 Further 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 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 Further
information)
• pregnant, think you might be pregnant
or could become pregnant (see the
section on Pregnancy)
• taking any of the following medicines:
• terfenadine, astemizole or mizolastine
(antihistamine for allergies)
• bepridil - used to treat angina
(crushing chest pain)
• nisoldipine (used for high blood pressure)
• cisapride (used for stomach upsets)
• midazolam by mouth or triazolam
(used to help you sleep or for anxiety)
• lovastatin, simvastatin or atorvastatin
(used to lower cholesterol)
• pimozide and sertindole (for conditions
affecting thoughts, feelings and/or
behaviour)
• levacetylmethadol - for treatment of
drug abuse (opioid dependency)
• dihydroergotamine, ergotamine and
eletriptan (for migraine headaches)
• ergometrine (ergonovine) and methylergometrine (methylergonovine) used
after giving birth
• quinidine and dofetilide (for irregular
heart beat rhythms).

Take special care with Sporanox
oral solution

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
• a kidney disorder as your dose of
Sporanox may have to be changed.

Taking other medicines

There are some medicines that you
should not take whilst taking Sporanox.
These are listed 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 and isoniazid
(antibiotics used for tuberculosis)
• phenytoin, carbamazepine and
phenobarbital (anti-epileptics)
• St John’s wort
Do not use Sporanox oral solution
within 2 weeks of taking these medicines.

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:
• clarithromycin and erythromycin
(antibiotics for infections)
• medicines that act on the heart and
blood vessels (digoxin, disopyramide
and calcium channel-blockers such as
dihydropyridines, verapamil and
cilostazol)
• drugs that slow down blood clotting
or thin the blood, such as warfarin
• methylprednisolone, budesonide
fluticasone and dexamethasone,
medicines given by mouth and injection
for inflammation, asthma and allergies
• ciclosporin, tacrolimus and rapamycin
(also known as sirolimus), which are
usually given after an organ transplant
• medicines used in HIV-infected patients,
such as ritonavir, indinavir and saquinavir
• medicines for cancer (such as busulphan,
docetaxel, trimetrexate and a group of
medicines known as vinca alkaloids)
• alfentanil and fentanyl (for pain)
• buspirone, alprazolam, brotizolam and
midazolam when given by injection into
a vein (for anxiety or to help you sleep)
• reboxetine (for depression)
• loperamide (for diarrhoea)
• an antihistamine containing ebastine
• halofantrine (for malaria)
• repaglinide (for diabetes)
Please tell your doctor or pharmacist
if you are taking or have recently taken
any other medicines, including medicines
obtained without a prescription.

Using 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 oral solution can sometimes
cause dizziness, blurred/double vision or
hearing loss. If you have these symptoms,
do not drive or use machines.

Important information about some
of the ingredients of Sporanox oral
solution
Tell your doctor if you are intolerant to
fructose (a type of sugar) as this is in
sorbitol, one of the ingredients of
Sporanox oral solution.

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.

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 oral
solution and contact your doctor
immediately if you have:
• any sudden wheeziness, difficulty in
breathing, swelling of the face, rash,
itching (especially affecting the whole
body) or a severe skin disorder
(widespread rashes with peeling skin
and blisters in the mouth, eyes and
genitals, or rashes with small pustules or
blisters).
• severe lack of appetite, feeling sick,
being sick, unusual tiredness, abdominal
(stomach) pain, unusually dark urine,
or pale stools. These may be symptoms
of severe liver problems.
You should also let your doctor know
immediately if you have any of the side
effects below:
• Symptoms that resemble heart failure
such as shortness of breath, unexpected
weight gain, swelling of the legs, unusual
fatigue (tiredness), repeated waking
at night
• A tingling sensation, sensitivity to light,
numbness or weakness in the limbs
• Blurred vision/double vision, ringing in
your ears, lose the ability to control your
urine or increased need to urinate
(pass water)
• If you experience any hearing loss
symptoms

• stomach ache, feeling sick (nausea),
being sick (vomiting), diarrhoea,
unpleasant taste
• increases in specific liver function tests
(hepatic enzyme increased)
• rash
• fever or high temperature
• shortness of breath
Uncommon side effects (occur in less
than 1 in 100 patients) are:
• certain blood disorders which may
increase the risk of bleeding, bruising
or infections
• muscle weakness (possible symptom
of low blood levels of potassium)
• dizziness
• indigestion, constipation
• inflammation of the liver (hepatitis),
yellowing of the skin (jaundice)
• itching
• general swelling
The following side effects have been
reported in patients taking Sporanox oral
solution with unknown frequency:
• excess of triglycerides in the blood
• hair loss
• muscle pain, painful joints
• menstrual disorders
• erectile dysfunction
• severe upper stomach pain, often with
nausea and vomiting due to inflammation
of the pancreas (pancreatitis)
If any of these side effects get serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

Other side effects include:
Common side effects (occur in less than
1 in 10 patients) are:
• headache

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 Further 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:
The UK Product Licence and Irish Product
Authorisation for this medicine are held
by:
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®
®

Registered trademark

Date of revision of leaflet 02/2013

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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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