ITRACONAZOLE 100MG CAPSULES

Active substance: ITRACONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sporanox ® 100mg 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.
The name of your medicine is Sporanox 100mg capsules but will be
referred to as Sporanox throughout this leaflet.

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

1. What Sporanox is and what it is used for
Sporanox contains a medicine called itraconazole. This belongs to a
group of medicines called ‘antifungals’.
Sporanox is used for infections caused by fungi or yeasts in adults. It is
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. 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
Do not take Sporanox:
If you are allergic to anything in Sporanox (listed in section 6
overleaf)
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 using Sporanox.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
If you have ever had kidney problems. Your dose of Sporanox may
have to be changed
If you have ever had liver problems such as yellow skin (jaundice).
Your dose of Sporanox 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 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 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 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.
Children and the elderly
Sporanox is 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 course is for more than one month, your doctor may
want to check your liver by testing your blood.
Other medicines and Sporanox
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 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 and tell your doctor if you are taking any of
the above.
Also, upon completing your course of Sporanox, 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 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, 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 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 from working
properly. Your doctor may need to alter the dose of Sporanox 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 or wait for two hours after taking
Sporanox before taking any of these other medicines. If you take
medicines that stop the production of stomach acid, you should take
Sporanox 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 or your other
medicine.
Sporanox with food and drink
Always take Sporanox straight after a meal as this helps your body to use
the medicine.

Pregnancy, breast-feeding and fertility
Do not take Sporanox 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 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, stop
taking them and tell your doctor straight away
Do not breast-feed if you are taking Sporanox, 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 can sometimes cause dizziness, blurred/double vision or
hearing loss. If you have these symptoms do not drive or use machines
Sporanox contains 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
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Taking Sporanox
Always take Sporanox 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 before taking any of these
other medicines. If you do take medicines that stop the production of
stomach acid, you should take Sporanox with a drink of cola

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 to take and for how long
depending on your infection.

If you take more Sporanox than you should

How much to take

If you take more Sporanox than you were told to, talk to your doctor or
go to the nearest hospital casualty department straight away.

Your doctor will tell you how many Sporanox to take and for how long.
The recommended dose is:

If you forget to take Sporanox

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

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 using Sporanox
Keep taking Sporanox 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 using Sporanox 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
Keep out of the sight and reach of children.
Protect from light.
Store in a dry place.
Store between 15°C and 30°C.

Do not use the capsules after the expiry date printed on the packaging.
Always return any left over medicine to your pharmacist. Only keep it
if your doctor tells you to.
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 is itraconazole.
Each capsule contains 100mg of itraconazole.
The other ingredients sugar spheres, hypromellose, macrogol,
titanium dioxide (E171), indigotine (E132), erythrosine (E127) and
gelatin.
Sporanox is one of a group of medicines called "antifungals" which are
used to treat infections caused by fungi including yeasts.

Manufactured by: FAMAR ABE (Lab. B'), Anthousis Avenue 15344,
Athens, Greece.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU.
Sporanox 100mg capsules, PL No: 18799/1148

What Sporanox capsules looks like and contents of the pack
Each capsule with an opaque blue cap and pink transparent body
containing coated beads. Sporanox capsules are supplied in blister
packs of 15 capsules.

Leaflet date: 29.12.2013

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Itraconazole ® 100mg capsules
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.
The name of your medicine is Itraconazole 100mg capsules but will be
referred to as Itraconazole throughout this leaflet.

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

1. What Itraconazole is and what it is used for
Itraconazole contains a medicine called itraconazole. This belongs to a
group of medicines called ‘antifungals’.
Itraconazole is used for infections caused by fungi or yeasts in adults. It
is 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 Itraconazole. 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 Itraconazole
Do not take Itraconazole:
If you are allergic to anything in Itraconazole (listed in section 6
overleaf)
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 using Itraconazole.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
If you have ever had kidney problems. Your dose of Itraconazole may
have to be changed
If you have ever had liver problems such as yellow skin (jaundice).
Your dose of Itraconazole 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 Itraconazole and tell your
doctor straight away
If you have ever had a heart problem including heart failure (also called
congestive heart failure or CHF). Itraconazole 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 Itraconazole 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 Itraconazole.
Children and the elderly
Itraconazole is 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 Itraconazole course is for more than one month, your doctor may
want to check your liver by testing your blood.
Other medicines and Itraconazole
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
Itraconazole 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 Itraconazole and tell your doctor if you are taking any
of the above.
Also, upon completing your course of Itraconazole, 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 Itraconazole 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 Itraconazole, 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 Itraconazole 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 Itraconazole from working
properly. Your doctor may need to alter the dose of Itraconazole 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 Itraconazole or wait for two hours after taking
Itraconazole before taking any of these other medicines. If you take
medicines that stop the production of stomach acid, you should take
Itraconazole 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 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
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 Itraconazole or your other
medicine.
Itraconazole with food and drink
Always take Itraconazole straight after a meal as this helps your body to
use the medicine.

Pregnancy, breast-feeding and fertility
Do not take Itraconazole 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 Itraconazole 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 Itraconazole, stop
taking them and tell your doctor straight away

Ask your doctor or pharmacist for advice before taking any medicine if
you are pregnant or breast-feeding.
Driving and using machines
Itraconazole can sometimes cause dizziness, blurred/double vision on
hearing loss. If you have these symptoms do not drive or use machines
Itraconazole contains sucrose (sugar)
If your doctor has told you that you are intolerant of some sugars,
contact them before taking this medicine.

Do not breast-feed if you are taking Itraconazole, as small amounts of
the medicine could pass into your milk. Ask your doctor for advice

3. How to take Itraconazole
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Taking Itraconazole
Always take Itraconazole 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 Itraconazole before taking any of
these other medicines. If you do take medicines that stop the
production of stomach acid, you should take Itraconazole with a drink
of cola
How much to take
Your doctor will tell you how many Itraconazole 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 Itraconazole to take and for how long
depending on your infection.

If you take more Itraconazole than you should
If you take more Itraconazole than you were told to, talk to your doctor
or go to the nearest hospital casualty department straight away.

If you forget to take Itraconazole
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 using Itraconazole
Keep taking Itraconazole 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 using Itraconazole 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 Itraconazole
Keep out of the sight and reach of children.
Protect from light.
Store in a dry place.
Store between 15°C and 30°C.

Do not use the capsules after the expiry date printed on the packaging.
Always return any left over medicine to your pharmacist. Only keep it
if your doctor tells you to.
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 Itraconazole is itraconazole.
Each capsule contains 100mg of itraconazole.
The other ingredients sugar spheres, hypromellose, macrogol,
titanium dioxide (E171), indigotine (E132), erythrosine (E127) and
gelatin.
Itraconazole is one of a group of medicines called "antifungals" which
are used to treat infections caused by fungi including yeasts.

Manufactured by: FAMAR ABE (Lab. B'), Anthousis Avenue 15344,
Athens, Greece.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU.
Itraconazole 100mg capsules, PL No: 18799/1148

What Itraconazole capsules looks like and contents of the pack
Each capsule with an opaque blue cap and pink transparent body
containing coated beads. Itraconazole capsules are supplied in blister
packs of 15 capsules.

Leaflet date: 29.12.2013

POM

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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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