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SPORANOX - PULSE

Active substance(s): ITRACONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

-Pulse
Itraconazole
Sporanox is a registered trademark

Read all of this leaŲ
Ųet carefully
before you start using this medicine
because it contains important
information for you.

• Keep this leaŲŲet. 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.
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 eŮ
Ůects, talk to your doctor
or pharmacist. This includes any possible
side eŮ
Ůects not listed in this leaŲet.

What is in this leaŲ
Ųet
1 What Sporanox-Pulse is and what it is
used for
2 What you need to know before you use
Sporanox-Pulse
3 How to use Sporanox-Pulse
4 Possible side eŮ
Ůects
5 How to store Sporanox-Pulse
6 Contents of the pack and other
information

1 What Sporanox-Pulse is and what it is used for
Sporanox-Pulse contains a medicine called
itraconazole. This belongs to a group of
medicines called ‘antifungals’.
Sporanox-Pulse is used for infections caused
by fungi or yeasts. It is used for:
• Nail infections
• Skin infections of the hands or feet

Patches of skin may take a few weeks to
completely clear up after you have Űnished
your treatment with Sporanox-Pulse. This is
because your skin will only look normal after
new skin has grown, even though the medicine
has killed the fungus that caused the infection.

2 What you need to know before you use Sporanox-Pulse
Do not use Sporanox-Pulse if:

• You are allergic to anything in Sporanox-Pulse
(listed in section 6 below)
• You are pregnant or could become pregnant
(see ‘Pregnancy and breast-feeding’ below)
Do not use this medicine if any of the above
applies to you. If you are not sure, talk to your
doctor or pharmacist before using SporanoxPulse.

Warnings and precautions

Check with your doctor or pharmacist before
using this medicine if:
• You have ever had kidney problems. Your dose
of Sporanox-Pulse may have to be changed
• You have ever had liver problems such as yellow
skin (jaundice). Your dose of Sporanox-Pulse
may have to be changed. If after taking this
medicine you have a severe lack of appetite,
feel sick (nausea), are sick (vomiting), feel
unusually tired, get stomach pain, muscle
weakness, yellowing of the skin or whites of
the eyes, unusually dark urine, pale stools or
hair loss, stop taking Sporanox-Pulse and tell
your doctor straight away
• You have ever had a heart problem including
heart failure (also called congestive heart
failure or CHF). Sporanox-Pulse could make
it worse. If after taking this medicine you get
any of the following:
- shortness of breath
- unexpected weight gain
- swelling of your legs or tummy
- feel unusually tired
- wake up short of breath at night
stop taking Sporanox-Pulse and tell your
doctor straight away. These may be signs of
heart failure
• You have Acquired ImmunodeŰŰciency
Syndrome (AIDS) or your immune system is
not working as well as it should
• You have had an allergic reaction to another
antifungal product in the past
If you are not sure if any of the above applies
to you, talk to your doctor or pharmacist before
taking Sporanox-Pulse.

Children and the elderly

Sporanox-Pulse is not normally given to children
under the age of 12 or the elderly. However,
your doctor may prescribe it in special cases.

Blood tests

If your Sporanox-Pulse course is for more than
one month, your doctor may want to check
your liver by testing your blood.

Other medicines and Sporanox-Pulse
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines. This includes medicines that you
buy without a prescription or herbal medicines.

In particular, do not take the following list
of medicines with Sporanox-Pulse and tell
your doctor if you are taking any of these:
• Medicines for hay fever or allergy called
terfenadine, astemizole or mizolastine
• Medicines to lower cholesterol called lovastatin
or simvastatin
• Medicines for an irregular heart beat called
quinidine, disopyramide, dronedarone or
dofetilide
• Medicines used to treat angina (crushing
chest pain) and high blood pressure called
bepridil, felodipine, lercanidipine, ivabradine,
ranolazine and nisoldipine
• Medicines for migraine headaches called
dihydroergotamine and ergotamine
• Medicines for the treatment of drug abuse
called levacetylmethadol and methadone
• Cisapride - for digestive problems
• Colchicine (in patients with kidney and liver
problems as well) – for gout
• Eplerenone – a diuretic
• Ergometrine (ergonovine) and
methylergometrine (methylergonovine) used after giving birth
• Halofantrine - for malaria
• Irinotecan – for cancer
• Midazolam (by mouth) or triazolam - for anxiety
or to help you sleep
• Pimozide, lurasidone and sertindole - for
conditions aŮ
Ůecting thoughts, feelings and
behaviour
Do not start taking Sporanox-Pulse and tell your
doctor if you are taking any of the above. Also,
upon completing your course of Sporanox-Pulse,
do not take any of the medicines listed above
for 2 weeks.
Tell your doctor if you are using the
following medicines as they are not
recommended with Sporanox-Pulse
unless your doctor feels it is necessary.
• Medicines for the treatment of cancer called
dasatinib, nilotinib and trabectedin
• Aliskiren – for high blood pressure
• Colchicine – for gout
• Everolimus – usually given after an organ
transplant

• Fentanyl – a strong painkiller
• Rivaroxaban – a medicine to thin blood
• Salmeterol – for asthma and other breathing
problems
• Tamsulosin - for urinary incontinence in men
• VardenaŰŰl – for erection problems
Also, upon completing your course of
Sporanox-Pulse, do not take any of the
medicines listed above for 2 weeks.
Do not take any of following medicines
2 weeks before and while you are taking
Sporanox-Pulse unless your doctor tells
you otherwise:
• Medicines for tuberculosis called rifampicin,
rifabutin or isoniazid
• Medicines for epilepsy called
carbamazepine, phenytoin or phenobarbital
• Medicines to treat viral infections called
efavirenz or nevirapine
Tell your doctor before taking, or if you are
already taking, any of the following
medicines. They may stop Sporanox-Pulse from
working properly. Your doctor may need to alter the
dose of Sporanox-Pulse or your other medicine:
• Strong painkillers called alfentanil,
buprenorphine (by injection or under your
tongue) and oxycodone
• Medicines for indigestion, stomach ulcers or
heartburn can aŮ
Ůect the stomach producing
acid. There must be enough acid in your
stomach to make sure that your body can use
the medicine. For this reason you should wait
at least an hour after taking one of these other
medicines before taking Sporanox-Pulse or wait
for two hours after taking Sporanox-Pulse before
taking any of these other medicines. If you
take medicines that stop the production of
stomach acid, you should take Sporanox-Pulse
with a drink of cola (not diet cola)
• Medicines used for anxiety or to help you
sleep (tranquillisers), such as buspirone,
alprazolam or brotizolam
• Medicines used in the treatment of cancer such
as bortezomib, busulphan, docetaxel, erlotinib,
ixabepilone, lapatinib, trimetrexate and a group
of medicines known as ‘vinca alkaloids’
• Medicines for conditions aŮ
Ůecting thoughts,
feelings and behaviour called aripiprazole,
haloperidol, perospirone, quetiapine,
ramelteon and risperidone
• Medicines to thin the blood (anticoagulants)
such as warfarin, cilostazol and dabigatran
• Medicines for HIV infection such as ritonavir,
darunavir, indinavir, fosamprenavir and
saquinivir. (They are called ‘antiviral protease
inhibitors’) Also maraviroc
• Medicines for bacterial infections called
ciproŲoxacin,
Ų
clarithromycin or erythromycin
• Medicines that act on the heart and blood
vessels called nadolol, digoxin, cilostazol or
‘calcium channel-blockers’ such as
dihydropyridines or verapamil
• Medicines for inŲŲammation, asthma or
allergies (given by mouth or injection) called
methylprednisolone or Ųuticasone,
budesonide or dexamethasone
• Medicines that are usually given after an
organ transplant called ciclesonide, ciclosporin,
tacrolimus, rapamycin(also known as sirolimus)
or temsirolimus
• Medicines to treat and overactive bladder –
fesoterodine, imidafenacin, solifenacin or
tolterodine
• Alitretinoin (by mouth) – for eczema
• Aprepitant and domperidone – to stop you
feeling and being sick
• Atorvastatin – to lower cholesterol
• Cinacalcet – for an over active parathyroid gland
• Ebastine - for allergy
• Eletriptan - for migraine headaches
• Mozavaptan or tolvaptan – for low sodium
blood levels
• Praziquantel – for treatment of worms
• Reboxetine - for depression
• Repaglinide or saxagliptin - for diabetes
• Midazolam - to help you relax or sleep when
given into a vein
• SildenaŰŰl and tadalaŰl – for erection problems
Tell your doctor before taking, or if you are
already taking any of the above. They may
need to alter the dose of Sporanox-Pulse or
your other medicine.

Taking Sporanox-Pulse with food
and drink

Always take Sporanox-Pulse straight after a meal
as this helps your body to use the medicine.

Pregnancy and breast-feeding

• Do not take Sporanox-Pulse if you are pregnant.
You should use contraception to make sure
that you do not become pregnant when
taking this medicine

© J-C 2013

2 What you need to know before you use Sporanox-Pulse
(continued)
• The medicine in Sporanox-Pulse stays in your
body for some time after you have stopped
taking it. After your treatment has Űnished,
you must use contraception up until your next
period (menstrual bleed). Ask your doctor for
advice on what type of contraception to use
• If you become pregnant after starting a course
of Sporanox-Pulse, stop taking them and tell
your doctor straight away
• Do not breast-feed if you are taking
Sporanox-Pulse, as small amounts of the
medicine could pass into your milk. Ask your
doctor for advice
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or
breast-feeding.

Driving and using machines

Sporanox-Pulse 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-Pulse

Sporanox-Pulse contains sucrose. If your doctor
has told you that you are intolerant of some
sugars, contact them before taking this medicine.

3 How to use Sporanox-Pulse
Always use this medicine exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.

Skin infections on hands or feet
• Take 2 capsules of Sporanox-Pulse twice
a day for one week

Taking Sporanox-Pulse

Fingernail infections only (see table below)
• Week 1: take 2 capsules of Sporanox-Pulse
twice a day for this week
• Weeks 2, 3 and 4: do not take Sporanox-Pulse
for these next 3 weeks
• Week 5: take 2 capsules of Sporanox-Pulse
twice a day for this week. This completes the
treatment course

• Always take Sporanox-Pulse straight after
a meal as this helps your body to use the
medicine
• Swallow the capsules whole with some liquid
• There must be enough acid in your stomach to
make sure that your body can use the medicine.
Medicines for indigestion, stomach ulcers or
heartburn can aŮ
Ůect the stomach producing
acid. For this reason you should wait two hours
after taking Sporanox-Pulse before taking any of
these other medicines. If you do take medicines
that stop the production of stomach acid, you
should take Sporanox-Pulse with a drink of cola

How much to take

Your doctor will tell you how many SporanoxPulse capsules to take and for how long. They
may recommend the following treatment courses.

Toenail infections with or without
Űngernail infections (see table below)
• Week 1: take 2 capsules of Sporanox-Pulse
twice a day for this week
• Weeks 2, 3 and 4: do not take Sporanox-Pulse
for these next 3 weeks
• Week 5: take 2 capsules of Sporanox-Pulse
twice a day for this week
• Weeks 6, 7 and 8: do not take Sporanox-Pulse
for these next 3 weeks
• Week 9: take 2 capsules of Sporanox-Pulse
twice a day for this week. This completes the
treatment course

Week
Week Week Week
Week Week Week Week
Week
Week
1
2
3
4
5
6
7
8
9
10
Take 2
Take 2
Finger capsules
capsules
No Sporanox-Pulse
nails only
twice
twice
Stop
a dayy
a dayy
Toe nails
Take 2
Take 2
Take 2
with or
capsules
capsules
capsules
without
No Sporanox-Pulse
Stop
twice
twice
No Sporanox-Pulse
twice a
Űnger nail
a day
a day
day
infections

If you take too much of your medicine

If you take more Sporanox-Pulse than you were
told to, talk to your doctor or go to the nearest
hospital casualty department straight away.

If you forget to take Sporanox-Pulse
• If you forget to take your capsules, take them
as soon as you remember. However, if it is
nearly time for the next capsules, skip the
missed capsules
• Do not take a double dose to make up for
a forgotten dose

When to stop using Sporanox-Pulse
Keep taking Sporanox-Pulse for as long as your
doctor has told you. Do not stop your treatment
just because your skin or nails have improved.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4 Possible side eŮ
Ůects
Like all medicines, Sporanox-Pulse can cause
side eŮ
Ůects, although not everybody gets them.
Stop using Sporanox-Pulse and tell your
doctor straight away if you notice or
suspect any of the following. You may
need urgent medical treatment.
• Sudden signs of allergy such as rash, hives
(also known as nettle rash or urticaria), severe
irritation of your skin, swelling of the face, lips,
tongue or other parts of the body. These may
be signs of a severe allergic reaction. This
only happens in a small number of people
• Severe skin disorders with peeling and/or
rashes with small pustules (with a fever) or
blistering of the skin, mouth, eyes and genitals,
with fever, chills, aching muscles and generally
feeling unwell. (This occurs rarely)
• A tingling sensation, numbness or weakness
in your limbs. (This occurs rarely)
• Severe lack of appetite, feeling sick (nausea),
being sick (vomiting), unusual tiredness,
stomach pain, muscle weakness, yellowing
of your skin or whites of your eyes (jaundice),
unusually dark urine, pale stools or hair loss.
These may be signs of a liver problem. (This
only happens in a small number of people)
• Shortness of breath, unexpected weight gain,
swelling of your legs or abdomen, feeling
unusually tired or waking up short of breath
at night. These may be signs of heart failure.
Shortness of breath can also be a sign of
Ųuid on the lungs. (This occurs rarely)
Tell your doctor or pharmacist if you
notice any of the following side eŮ
Ůects:

Common (aŮ
Ůects less than 1 in 10 people)
• Stomach ache, feeling sick (nausea)
• Headache
Uncommon (aŮ
Ůects less than 1 in
100 people)
• Problems with periods
• Sinusitis, runny nose, coughs and colds
• Constipation, diarrhoea, wind, being sick
(vomiting), indigestion
Rare (aŮ
Ůects less than 1 in 1000 people)
• Increases in liver function tests (shown by
blood tests)
• Unexpected passing of urine or need to
urinate (pass water) more often
• Problems with sight including blurred vision
and double vision
• Change in taste
• Certain blood disorders which may increase
the risk of infections
• Ringing in your ears
• Hearing loss (may be permanent)
• Severe upper stomach pain, often with nausea
and vomiting (inŲŲammation of the pancreas)
• Swelling due to Ųuid under the skin
• Unusual hair loss or thinning (alopecia)
• High levels of triglycerides in the blood
(shown by blood tests)
• Red, itchy, Ųaking or peeling skin
• Sensitivity of the skin to light
• Erection diů
ůculties
If you get any side eŮ
Ůects, talk to your doctor
or pharmacist. This includes any possible
side eŮ
Ůects not listed in this leaŲet.

5 How to store Sporanox-Pulse
Keep out of the reach and sight of children.
• Store the capsules in their carton
• Keep the carton in a dry place out of strong
sunlight
• Do not store above 30oC
• Do not use Sporanox-Pulse after the expiry
date which is stated on the label. The expiry
date refers to the last day of that month

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
protect the environment.

6 Contents of the pack and other information
The active substance in Sporanox-Pulse is
itraconazole. Each capsule contains 100 mg of
itraconazole.
The other ingredients are sugar spheres,
hypromellose and macrogol. The capsule is
made of gelatin and the colours titanium
dioxide (E171), indigotin disulphonate sodium
(E132) and erythrosine (E127).

What Sporanox-Pulse looks like
and contents of the pack

Sporanox-Pulse capsules are pink and blue.
They are supplied in blister packs of 28 capsules.
The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers
Farm Way, High Wycombe, Buckinghamshire
HP12 4EG, UK

Sporanox-Pulse is made by:
Janssen Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium
OR
Janssen-Cilag SpA, Via C Janssen,
04010
04100 Borgo San Michele, Latina, Italy

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaŲŲet was last revised in 12/2012.
May 2015

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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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