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SPORANOX-PULSE 100MG CAPSULES

Active substance(s): ITRACONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sporanox®-Pulse 100mg Capsules
(itraconazole)
Your medicine is available using the name Sporanox-Pulse 100mg
Capsules but will be referred to as Sporanox-Pulse throughout this
leaflet.

Read all of this leaflet carefully before you
start using 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. 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.
2.
3.
4.
5.
6.

What Sporanox-Pulse is and what it is used for
What you need to know before you use Sporanox-Pulse
How to use Sporanox-Pulse
Possible side effects
How to store Sporanox-Pulse
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 finished 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
Sporanox-Pulse.


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 Immunodeficiency 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

Medicines for bacterial infections called ciprofloxacin,
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 inflammation, asthma or allergies (given by
mouth or injection) called methylprednisolone or fluticasone,
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

Sildenafil and tadalafil – 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.


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 affecting
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

Vardenafil – 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
affect 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 SporanoxPulse 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 affecting 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
Page 1 of 2

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

The medicine in Sporanox-Pulse stays in your body for some
time after you have stopped taking it. After your treatment
has finished, 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.

Taking Sporanox-Pulse




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 affect 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 Sporanox-Pulse capsules to
take and for how long. They may recommend the following
treatment courses.
Skin infections on hands or feet

Take 2 capsules of Sporanox-Pulse twice a day for one week
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

Toenail infections with or without fingernail 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
Finger
nails only
Week 1

Take 2 capsules
twice a day

Toe nails with or
without finger nail
infections
Take 2 capsules
twice a day

No Sporanox-Pulse

No Sporanox-Pulse

Take 2 capsules
twice a day

Take 2 capsules
twice a day

Week 2
Week 3

Uncommon (affects less than 1 in 100 people)




Rare (affects less than 1 in 1000 people)












Week 4
Week 5
Week 6
No Sporanox-Pulse

Week 7
Week 8

Stop

Week 9
Week 10

Take 2 capsules
twice a day
Stop

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 effects
Like all medicines, Sporanox-Pulse can cause side effects,
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 fluid on the lungs.
(This occurs rarely)

Problems with periods
Sinusitis, runny nose, coughs and colds
Constipation, diarrhoea, wind, being sick (vomiting),
indigestion





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
(inflammation of the pancreas)
Swelling due to fluid under the skin
Unusual hair loss or thinning (alopecia)
High levels of triglycerides in the blood (shown by blood
tests)
Red, itchy, flaking or peeling skin
Sensitivity of the skin to light
Erection difficulties

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-Pulse
Keep out of the sight and reach of children.
Do not use Sporanox-Pulse after the expiry date (Exp) which is
stated on the carton and the blister. The expiry date refers to the
last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from moisture
and light.
If your doctor decides to stop the treatment, return any leftover
medicine to the pharmacist. Only keep it if your doctor tells you
to.
If your medicine appears to be discoloured or show any other
signs of deterioration, please return to your pharmacist who will
advise you further.
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. Contents of the pack and other
information
What Sporanox-Pulse contains

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

What Sporanox-Pulse looks like and contents of the
pack

Sporanox-Pulse are hard gelatin capsules with an opaque blue cap
and a pink transparent body containing coated beads.
Sporanox-Pulse is supplied in blister packs of 28 capsules.

Manufacturer

Manufactured by: Janssen-Cilag, SpA, Via C. Janssen,
04010 Borgo San Michele, Latina, Italy.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0617

POM

Tell your doctor or pharmacist if you notice any of
the following side effects:

Leaflet revision and issue date: 08.01.15

Common (affects less than 1 in 10 people)

Sporanox® is a registered trademark of Janssen-Cilag Limited.




Stomach ache, feeling sick (nausea)
Headache

If you wish to receive this leaflet in Braille, large font or audio
format please contact 01302 365000 and ask for the Regulatory
Department.

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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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