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SPORANOX - PULSE

Active substance(s): ITRACONAZOLE / ITRACONAZOLE / ITRACONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2015

GB-IE - 672419

-Pulse
Itraconazole
Sporanox is a registered trademark

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 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 effects
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 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:

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

Warnings and precautions

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 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 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
• 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.

• 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.
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

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 SporanoxPulse, do not take any of the medicines listed above
for 2 weeks.

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.

672419.pdf - Page 1 of 3 - January 6, 2017 - 12:17:42

© J-C 2015

GB-IE - 672419

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 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

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

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.

Finger nails
only
Toe nails with
or without finger
nail infections

Week
1
Take 2
capsules
twice
a day
Take 2
capsules
twice
a day

Week
2

Week
3

Week
4

No Sporanox-Pulse

No Sporanox-Pulse

Week
5
Take 2
capsules
twice
a day
Take 2
capsules
twice
a day

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

Week
6

Week
7

Week
8

Week
9

Week
10

Take 2
capsules
twice a
day

Stop

Stop

No Sporanox-Pulse

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)

Tell your doctor or pharmacist if you notice any
of the following side effects:
Common (affects less than 1 in 10 people)
• Stomach ache, feeling sick (nausea)
• Headache
Uncommon (affects less than 1 in 100 people)
• Problems with periods
• Sinusitis, runny nose, coughs and colds
• Constipation, diarrhoea, wind, being sick
(vomiting), indigestion
Rare (affects 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 (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
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.

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

672419.pdf - Page 2 of 3 - January 6, 2017 - 12:17:42

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

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

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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