SPORANOX 100MG CAPSULES

Active substance: ITRACONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GB-IE - AW_79421
© J-C 2012

100 mg capsules
Itraconazole
Sporanox is a registered trademark

Read all of this leaflet carefully
before you start using this medicine.
• 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 side effects and they become
serious or if you notice any side effects not
listed in this leaflet, please tell your doctor
or pharmacist

In this leaflet
1 What Sporanox capsules are and what
they are used for
2 Before you use Sporanox capsules
3 How to use Sporanox capsules
4 Possible side effects
5 How to store Sporanox capsules
6 Further 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. 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 Before you use Sporanox capsules
Do not use Sporanox capsules if:

• You are allergic to anything in Sporanox
capsules (listed in section 6 below)
• You are pregnant or could become pregnant
unless your doctor has told you to
(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
capsules.

Take special care with Sporanox
capsules

Check with your doctor or pharmacist before
using this medicine if:
• You have ever had kidney problems.
Your dose of Sporanox capsules may have
to be changed
• 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
• 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
• 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 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.

Taking other medicines

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 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
atorvastatin, lovastatin or simvastatin
• Medicines for an irregular heart beat called
quinidine or dofetilide
• Medicines used to treat angina
(crushing chest pain) and high blood
pressure called bepridil and nisoldipine
• Medicines for migraine headaches called
eletriptan, hydroergotamine and ergotamine
• Cisapride - for digestive problems
• Ergometrine (ergonovine) and
methylergometrine (methylergonovine) used after giving birth
• Levacetylmethadol - for treatment of drug
abuse (opioid-dependency)
• Midazolam (by mouth) or triazolam for anxiety or to help you sleep
• Pimozide 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 before taking, or if you are
already taking, any of the following medicines.
They may stop Sporanox capsules from
working properly:
• Medicines for tuberculosis called rifampicin,
rifabutin or isoniazid
• Medicines for epilepsy called phenytoin,
carbamazepine or phenobarbital
• St. John’s Wort (a herbal medicine)

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Do not use Sporanox capsules within 2 weeks
of taking these medicines.
• 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 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
Tell your doctor before taking, or if you are
already taking any of the above. They may
stop Sporanox capsules from working properly.
Tell your doctor before taking, or if you are
already taking any of the following medicines.
They may need to alter the dose of Sporanox
capsules or your other medicine:
• 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 busulphan, docetaxel, trimetrexate
and a group of medicines known as ‘vinca
alkaloids’
• Medicines to thin the blood (anticoagulants)
such as warfarin
• Medicines for HIV infection such as ritonavir,
indinavir and saquinivir. They are called
‘antiviral protease inhibitors’
• Medicines for bacterial infections called
clarithromycin or erythromycin
• Medicines that act on the heart and blood
vessels called digoxin and disopyramide,
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 ciclosporin,
tacrolimus or rapamycin. Another name for
rapamycin is sirolimus
• Alfentanil and fentanyl - for pain
• Ebastine - for allergy
• Halofantrine - for malaria
• Reboxetine - for depression
• Repaglinide - for diabetes
• Midazolam - to help you relax or sleep when
given into a vein
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.

Taking Sporanox capsules with
food and drink

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

Pregnancy and breast-feeding

• 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.

Important information about some
of the ingredients of Sporanox
capsules
Sporanox capsules contain sucrose. If your
doctor has told you that you are intolerant
of some sugars, contact them before taking
this medicine.

© J-C 2012

GB-IE - AW_79421

3 How to use Sporanox capsules
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 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. They may
recommend the following treatment courses.
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 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 too much of your
medicine

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

When to stop using 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.

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

4 Possible side effects
Like all medicines, Sporanox capsules can
cause side effects, although not everybody
gets them.
Stop using 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. (The precise
frequency of how often these may occur
is not known)
• A tingling sensation, numbness or weakness
in your limbs (The precise frequency of how
often this may occur is not known)
• 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 only
happens in a small number of people)

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)
Uncommon (affects less than 1 in
100 people)
• Problems with periods
• Headache, dizziness
• Constipation, diarrhoea, wind, being sick
(vomiting), indigestion, change in taste.
• Swelling due to fluid under the skin
• Unusual hair loss or thinning (alopecia)
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
• Certain blood disorders which may increase
the risk of bleeding, bruising or infections
• Ringing in your ears
• Severe upper stomach pain, often with
nausea and vomiting
• Fever or high temperature
The following side effects have been reported,
however the precise frequency cannot
be identified and therefore how often they
occur is classed as unknown:
• High levels of triglycerides in the blood
(shown by blood tests)
• Muscle pain, painful joints
• Red, itchy, flaking or peeling skin
• Erection difficulties
• Sensitivity of the skin to light
• Hearing loss (may be permanent)
• Lower levels of potassium in your blood
(shown by blood tests)
If you notice any other side effects not listed
in this leaflet, please tell your doctor
or pharmacist.

5 How to store Sporanox capsules
Keep out of the reach and sight of children.
• Store the capsules in their carton to protect
from light
• Do not store above 30oC
• Do not use Sporanox capsules 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 Further information
The active substance in Sporanox capsules
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 capsules looks like and
contents of the pack
Sporanox capsules are pink and blue. They are
supplied in blister packs of 4, 15 or 60 capsules.
The product licence is held by:
Janssen-Cilag Ltd, 50-100 Holmers Farm Way,
High Wycombe, Buckinghamshire, HP12 4EG,
UK
Sporanox capsules is made by:
Janssen-Cilag SpA, Via C Janssen,
04010 Borgo San Michele, Latina, Italy
OR
McGregor Cory Limited, Middleton Close,
Banbury, Oxfordshire, OX16 4RS, UK

AW_79421.pdf - Page 2 of 3 - July 23, 2012 - 14:26:44

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last revised in August 2012

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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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