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SPORANOX I.V. 10 MG/ML CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

Active substance(s): ITRACONAZOLE / ITRACONAZOLE / ITRACONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

I.V. 10 mg/ml
concentrate and solvent for solution for infusion
(itraconazole)
Read all of this leaflet carefully
before you are given 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 nurse.
• If you get any side effects, talk to your
doctor or nurse. This includes any possible
side effects not listed in this leaflet.

What is in this leaflet:
1 What Sporanox I.V. is and what it is
used for
2 What you need to know before you
are given Sporanox I.V.
3 How you will be given Sporanox I.V.
4 Possible side effects
5 How Sporanox I.V. is stored
6 Contents of the pack and other
information

1 What Sporanox I.V. is and what it is used for
Sporanox I.V. is one of a group of medicines
called "antifungals". These medicines are
used to treat infections caused by fungi
including yeasts.

Sporanox I.V. is used to:

• Treat fungal infections of the internal
organs.

2 What you need to know before you are given
Sporanox I.V.
You should not be given
Sporanox I.V. if:

• You are allergic (hypersensitive) to any of the
ingredients in Sporanox I.V. (listed in section 6
Contents of the pack and other information)
• You are pregnant, think you might be
pregnant or are trying to become pregnant,
(see the section on Pregnancy)
• Your kidney function is seriously reduced
• You cannot have sodium chloride by injection.
• You are 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)
- methadone -for treatment of drug abuse
(opioid-dependency)
- 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 I.V., do not take any of the
medicines listed above for 2 weeks.

Warnings and precautions

Tell your doctor immediately:
If you have any unusual feelings of tingling,
numbness or weakness in your hands or feet
whilst taking Sporanox I.V.
If you experience any hearing loss symptoms.
In very rare cases patients taking Sporanox have
reported temporary or permanent hearing loss.
You must tell your doctor before you are
given Sporanox I.V. if you suffer from or have
suffered in the past from any of the following:
• Any liver problems or jaundice (yellowing
of the skin). If your doctor decides to give
you Sporanox I.V. the dose may have
to be changed. Your doctor may give you
instructions on symptoms to watch out for
and ask you to have your blood checked.
In addition, there may be specific
medication you may not be able to take.
• An allergic reaction to any other antifungal
medicine.
• Heart problems, including heart failure
(also called congestive heart failure or CHF),
Sporanox I.V. could make it worse. If your
doctor decides to give you Sporanox I.V.
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
• Are on a low salt diet.
• A kidney disorder, you may be monitored more
closely or 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 I.V.

There are some medicines that you should
not take whilst being given Sporanox.
These are listed above under the heading
“You should not be given Sporanox I.V. if:”
Tell your doctor if you are using the
following as they may stop Sporanox I.V.
from working properly:
• rifampicin, rifabutin or isoniazid (antibiotics
used to treat 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 I.V. within 2 weeks
of taking these medicines.

Tell your doctor if you are using the
following medicines as they are not
recommended with Sporanox I.V. 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 I.V., 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
I.V. or other treatments may need to be altered:
• ciprofloxacin, clarithromycin or
erythromycin (anitibiotics 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
(e.g., warfarin) or cilostazol
• methylprednisolone, budesonide,
fluticasone or dexamethasone, medicines
given by mouth and injection for
inflammation, asthma and allergies
• cyclosporine, 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 or 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 or herbal medicines.

Children and the elderly

Sporanox I.V. is not normally given to
children or the elderly. Your doctor may
prescribe it in special cases.

Pregnancy

Do not take Sporanox I.V. 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 receiving your medicine.
As Sporanox I.V. remains in the body for
some time after you stop receiving it, you
should continue to use some form of
contraception until your next period after
your treatment with Sporanox I.V. has finished.
If you do find that you are pregnant after
receiving a course of Sporanox I.V., 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

You should stop breast-feeding before you are
given 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.

© J-C 2016

3 How you will be given Sporanox I.V.
Your medicine will be given to you by your
doctor or nurse. Sporanox I.V. concentrate
is mixed with the sodium chloride solution
in the bag and is then given by slow injection
into a vein. This is called an intravenous (I.V.)
infusion and will usually take about an hour.
For the first two days, you will be given two
infusions each day. From Day three onwards
you will be given one infusion each day.

From Day 3
onwards:

How much you will be given

If a dose is missed or you are
given too much Sporanox l.V.

The recommended dosage is as follows:
Adults:
Day 1 and Day 2
of the treatment:

Two 1-hour infusions
of 200 mg Sporanox I.V.
will be given each day
as a 60 ml infusion.

Children:
Not recommended.

One 1-hour infusion
of 200 mg Sporanox I.V.
will be given each day
as a 60 ml infusion.

Elderly:
Not recommended.

Since this medicine will be given to you by
a doctor or nurse, it is unlikely that you will be
given too much or that a dose will be missed.
However, if you are worried, tell your doctor
or nurse.

4 Possible side effects
Like all medicines, Sporanox I.V. can cause
side effects, although not everybody gets them.
Medicines can cause serious allergic reactions.
Stop taking Sporanox I.V. 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 symptoms of hearing
loss
• Severe upper stomach pain, often with
nausea and vomiting due to inflammation
of the pancreas (pancreatitis)
Other side effects include:
Very common side effects (occur in more
than 1 in 10 patients)
• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea
• cough
• rash
• general swelling
Common side effects (occur in less than
1 in 10 patients) are:
• headache, dizziness
• stomach ache, constipation
• increases in specific liver function tests
(hepatic enzyme increased), inflammation
of the liver (hepatitis), yellowing of the skin
(jaundice)
• itching, hives
• fever or high temperature
• shortness of breath
• 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)
• confusion
• sleepiness
• tremors
• increase in heart rate

• high blood pressure
• low blood pressure
• fluid in the lungs
• indigestion
• hair loss
• excess sweating
• muscle pain
• kidney problems
• chest pain
• pain
• chills
• fatigue
• increase in blood urea levels
• abnormal urine findings
• injection site swelling
Uncommon side effects (occur in less than
1 in 100 patients) are:
• unpleasant taste
• muscle cramps or irregular heart beat
(possible symptoms of high blood levels
of potassium)
• certain blood disorder which may increase
the risk of bleeding or bruising (possible
symptoms of low levels of platelets)
• difficulty speaking
• decreased feeling or sensitivity, especially
in the skin
• increase in blood creatine phosphokinase
levels
The following side effects have been reported
in patients taking Sporanox with unknown
frequency:
• excess of triglycerides (fats) in the blood
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 white blood cells)
• muscle cramps or irregular heart beat
(possible symptoms of low blood levels
of potassium)
• excess gas in the intestinal tract
• painful joints
• excessive urine production
• abnormal menstrual bleeding
• erectile dysfunction

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 I.V.
Keep out of the reach and sight of children.
Sporanox I.V. will be kept in the hospital
pharmacy.
The product should not be used after the
expiry date printed on the inner and outer
packaging. The expiry date refers to the last
day of that month.

Do not store Sporanox I.V. concentrate
above 25°C.
Store in the original container.
Do not store the bag containing Sodium
Chloride above 25°C. Do not freeze.
Protect the mixed solution from direct sunlight.
Once mixed, the product should be used
immediately.

6 Contents of the pack and other information
What Sporanox I.V. contains:

• The active ingredient in Sporanox I.V is
itraconazole (10mg of itraconazole per ml).
• The other ingredients are hydroxypropyl-βcyclodextrin, propylene glycol, hydrochloric
acid concentrated, sodium hydroxide and
water for injections.

What 0.9% Sodium Chloride
Injection contains:

• Sodium Chloride, water for injections

What Sporanox I.V. looks like and
the contents of the pack

It is a kit containing a clear, colourless
concentrated solution for intravenous (I.V.)
infusion, which means the solution needs
to be diluted before use. Sporanox I.V. comes
in a 25 millilitre (ml) ampoule, together with
a bag containing a clear, colourless Sodium
Chloride solution and an extension line.
These two solutions will be mixed together
to give a clear, colourless solution before
they are given directly into your veins.
One ml of Sporanox I.V. concentrate contains
10 milligrams (mg) of itraconazole. When the
Sporanox I.V. concentrate is added to the
bag containing sodium chloride solution,
each ml of the mixed solution contains
3.33 mg itraconazole.
The Sodium Chloride bag is a plastic
polypropylene infusion bag, which contains
50 ml of Sodium Chloride solution. One ml
of solution contains 9 mg sodium chloride.
It is used to dilute the Sporanox I.V.
concentrate making it easier to be given.
Marketing Authorisation Holder:
Janssen-Cilag Ltd
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK

Manufacturer:
Sporanox I.V. 10mg/ml concentrate and solvent
for solution for infusion are manufactured by:
Lusomedicamenta
Sociedade Técnica Farmacêutica S.A.
Estrada Consiglieri Pedroso, 69-B
Queluz
2730-055 Barcarena
Portugal
This medicinal product is authorised
in the member states of the EEA under
the following names:
Germany: SEMPERA®
Spain:
SPORANOX®
Ireland:
SPORANOX®
Italy:
SPORANOX®
Portugal: SPORANOX®
Greece:
SPORANOX®
U.K:
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
August 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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