SPORANOX 100MG CAPSULES

Active substance: ITRACONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GB-IE - AW_86636
© J-C 2013

100 mg capsules
Itraconazole
Sporanox is a registered trademark

Read all of this leaflet carefully
before you start taking 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
only. Do not pass it on to others. It may harm
them, even if their signs of illness 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. See section 4.

What is in this leaflet
1 What Sporanox capsules are and what
they are used for
2 What you need to know before you take
Sporanox capsules
3 How to take Sporanox capsules
4 Possible side effects
5 How to store Sporanox capsules
6 Contents of the pack and other
information

1 What Sporanox capsules are and what they are
used for
Sporanox capsules contain a medicine called
itraconazole. This belongs to a group of
medicines called ‘antifungals’.
Sporanox capsules are used for infections caused
by fungi or yeasts in adults. They are used for:
• Infections of the mouth or vagina causing ‘thrush’
• Skin infections
• Infections affecting other parts of the body

Patches of skin may take a few weeks to
completely clear up after you have finished
your treatment with Sporanox capsules. Finger
and toe nails may take several months to
completely clear up. This is because your skin
or nail will only look normal after new skin or
nail has grown, even though the medicine has
killed the fungus that caused the infection.

2 What you need to know before you take Sporanox
capsules
Do not take Sporanox capsules:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking
this medicine:
• If you have ever had kidney problems.
Your dose of Sporanox capsules may have
to be changed
• If you have ever had liver problems such as
yellow skin (jaundice). Your dose of Sporanox
capsules 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
capsules and tell your doctor straight away
• If you have ever had a heart problem including
heart failure (also called congestive heart
failure or CHF). Sporanox capsules 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 capsules and tell your
doctor straight away. These may be signs of
heart failure
• If you have Acquired Immunodeficiency
Syndrome (AIDS) or your immune system is
not working as well as it should
• If 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 capsules.

Children and the elderly

Sporanox capsules are not normally given to
children under the age of 12 or the elderly.
However, your doctor may prescribe them in
special cases.

Blood tests

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

Other medicines and Sporanox
capsules

Tell your doctor or pharmacist if you are taking
or have recently taken or might take 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 capsules 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 capsules and tell
your doctor if you are taking any of the above.
Also, upon completing your course of Sporanox
capsules, do not take any of the medicines
listed above for 2 weeks.

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Tell your doctor if you are taking the
following medicines as they are not
recommended with Sporanox capsules
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
capsules, 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 capsules 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
capsules from working properly. Your doctor
may need to alter the dose of Sporanox
capsules 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
capsules or wait for two hours after taking
Sporanox capsules before taking any of
these other medicines. If you take medicines
that stop the production of stomach acid, you
should take Sporanox capsules 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 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 and cilostazol
or ‘calcium channel-blockers’ such as
dihydropyridines and verapamil
• Medicines for inflammation, asthma or
allergies (given by mouth or injection) called
methylprednisolone, 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
• Meloxicam – to reduce inflammation and pain
• 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 capsules
or your other medicine.

© J-C 2013

GB-IE - AW_86636

2 What you need to know before you take Sporanox
capsules (continued)
Sporanox capsules with food and
drink

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

Pregnancy, breast-feeding and
fertility

• Do not take Sporanox capsules if you are
pregnant unless your doctor has told you to.
You should use contraception to make sure
that you do not become pregnant when
taking this medicine
• The medicine in Sporanox capsules stays in
your body for some time after you have stopped
taking them. 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 capsules, stop taking them and
tell your doctor straight away

• Do not breast-feed if you are taking Sporanox
capsules, 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 capsules can sometimes cause
dizziness, blurred/double vision or hearing loss.
If you have these symptoms do not drive or
use machines.

Sporanox capsules contain sucrose
(sugar)

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

3 How to take Sporanox capsules
Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.

Taking Sporanox capsules

• Always take Sporanox capsules 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 capsules
before taking any of these other medicines.
If you do take medicines that stop the production
of stomach acid, you should take Sporanox
capsules with a drink of cola

How much to take

Your doctor will tell you how many Sporanox
capsules to take and for how long. The
recommended dose is:
Yeast infection of the vagina (thrush)
• Take 2 capsules in the morning and two
capsules 12 hours later for one day only
Yeast infection of the mouth (oral thrush)
• Take 1 capsule each day for 15 days
Fungal infections of the skin
The dosage depends on your infection.
Your doctor might tell you to take:
• 2 capsules each day for 7 days, or
• 1 capsule each day for 15 days, or
• 1 capsule each day for 30 days

Fungal infections in other parts of the body
Your doctor will tell you how many Sporanox
capsules to take and for how long depending
on your infection.

If you take more Sporanox capsules
than you should
If you take more Sporanox capsules 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
capsules

• 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

If you stop taking Sporanox
capsules

Keep taking Sporanox capsules for as long as
your doctor has told you. Do not stop your
treatment just because you feel better.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets them.
Stop taking Sporanox capsules 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
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 capsules
Keep out of the sight and reach of children.
• Store the capsules in their carton to protect
from light
• Do not store above 30°C
• Do not use this medicine after the expiry date
which is stated on the label. The expiry date
refers to the last day of that month

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help
protect the environment.

6 Contents of the pack and other information
What Sporanox capsules contains

The active substance 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).
See section 2 ‘Sporanox capsules contain
sucrose (sugar)’ for further information.

What Sporanox capsules looks like
and contents of the pack

Sporanox capsules are hard capsules coloured
pink and blue. They are supplied in blister packs
of 4, 15 or 60 capsules.
Marketing Authorisation Holder:
JANSSEN-CILAG LTD, 50-100 Holmers
Farm Way, High Wycombe, Buckinghamshire
HP12 4EG, UK

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Manufacturer:
Janssen-Cilag SpA, Via C Janssen, 04010
Borgo San Michele, Latina, Italy
OR
McGregor Cory Limited, Middleton Close,
Banbury, Oxfordshire OX16 4RS, UK

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last revised in 07/2013.

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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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