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SPORANOX 100MG CAPSULES

Active substance(s): ITRACONAZOLE / ITRACONAZOLE / ITRACONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2015

GB-IE - 672418

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.
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.

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 breastfeeding.

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.

672418.pdf - Page 1 of 3 - January 6, 2017 - 10:55:18

© J-C 2015

GB-IE - 672418

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.

672418.pdf - Page 2 of 3 - January 6, 2017 - 10:55:19

Marketing Authorisation Holder:
JANSSEN-CILAG LTD, 50-100 Holmers Farm Way,
High Wycombe, Buckinghamshire HP12 4EG, UK
Manufacturer:
Janssen-Cilag SpA, Via C Janssen, 04100 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 May 2015.

Expand view ⇕

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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