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SPORANOX 10MG/ML ORAL SOLUTION

Active substance(s): ITRACONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
SPORANOX® 10mg/ml oral solution
(itraconazole)
Your medicine is available as the above name but will be referred to as
Sporanox oral solution throughout this leaflet.
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.
In this leaflet:
1. What Sporanox oral solution is and what it is used for
2. 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. 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 (opioiddependency)
ͦ
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 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 400mg (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 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
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, 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
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)
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 oral solution
Keep out of the sight and reach of children.

Do not store 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.

If your solution become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.

Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6.

Further information

What Sporanox oral solution contains:
 The active ingredient is itraconazole. Each millilitre of oral solution
contains 10mg of itraconazole.
 The other ingredients are hydroxypropyl-β-cyclodextrin, sorbitol,
propylene glycol, cherry flavour I, cherry flavour II, caramel
flavour, sodium saccharin, sodium hydroxide, hydrochloric acid
and purified water.
What Sporanox oral solution looks like and the contents of the
pack:
Sporanox oral solution is a clear, yellow to slightly amber solution with
an odour of cherry. A measuring cup is also provided.
Each bottle contains 150ml oral solution.
Manufacturer and Product Licence holder
Sporanox oral solution is manufactured by Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium. Procured from within the
EU and repackaged by the Product Licence holder:
G-Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1452
Date of revision of this leaflet: 10th January 2014
Sporanox is a registered trademark of Johnson & Johnson

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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