SPORANOX CAPSULES 100MG

Active substance: ITRACONAZOLE

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319 LEAFLET Sporanox 20121120 (manu 1)



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

PACKAGE LEAFLET: INFORMATION FOR THE USER

SPORANOX CAPSULES 100mg
ITRACONAZOLE CAPSULES 100mg
(itraconazole)
This medicine is known by either of the above names but will be
referred to as Sporanox Capsules in this leaflet.



Cisapride - for digestive problems

Read all of this leaflet carefully before you start using this
medicine.





Ergometrine (ergonovine) and methylergometrine
(methylergonovine) - used after giving birth

Keep this leaflet. You may need to read it again





If you have any further questions, ask your doctor or pharmacist

Levacetylmethadol - for treatment of drug abuse (opioiddependency)



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



Midazolam (by mouth) or triazolam - for anxiety or to help you
sleep





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

Pimozide and sertindole - for conditions affecting thoughts,
feelings and behavior

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’.

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)

Do not use Sporanox capsules within 2 weeks of taking these
medicines.


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.

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

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:



Reboxetine - for depression



Repaglinide - for diabetes



Midazolam - to help you relax or sleep when given into a vein

-

shortness of breath

-

unexpected weight gain

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.

-

swelling of your legs or tummy

-

feel unusually tired

-

wake up short of breath at night

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



stop taking Sporanox capsules and tell your doctor straight away.
These may be signs of heart failure


You have had an allergic reaction to another antifungal product
in the past

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

You have Acquired Immunodeficiency Syndrome (AIDS) or your
immune system is not working as well as it should



Taking Sporanox capsules with food and drink

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

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.

3. HOW TO USE SPORANOX CAPSULES

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

Taking Sporanox capsules



Problems with sight including blurred vision and double vision



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



Certain blood disorders which may increase the risk of
bleeding, bruising or infections



Swallow the capsules whole with some liquid



Ringing in your ears

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



Severe upper stomach pain, often with nausea and vomiting



Fever or high temperature

Always use this medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.



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

How much to take



Red, itchy, flaking or peeling skin

Your doctor will tell you how many Sporanox capsules to take and
for how long. They may recommend the following treatment
courses.



Erection difficulties



Sensitivity of the skin to light



Hearing loss (may be permanent)



Lower levels of potassium in your blood (shown by blood tests)

Yeast infection of the vagina (thrush)


Take 2 capsules in the morning and two capsules 12 hours later
for one day only

If you notice any other side effects not listed in this leaflet, please
tell your doctor or pharmacist.

Yeast infection of the mouth (oral thrush)

5. HOW TO STORE SPORANOX CAPSULES





KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30C in a dry place. Protect from light.

Fungal infections of the skin



Do not use after the date shown on the carton or blister label.

The dosage depends on your infection.



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.

Take 1 capsule each day for 15 days

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 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

6. FURTHER INFORMATION
What Sporanox Capsules contains


Sporanox capsules contain 100mg of the active ingredient
itraconazole.



Sporanox capsules also contain sucrose, maize starch, liquid
glucose, hypromellose and macrogol. The capsule shell is
made of gelatin and coloured with titanium dioxide, indigo
carmine and erythrosine.

What Sporanox Capsules looks like and contents of the pack
Sporanox capsules are blue/pink capsules.
Sporanox capsules are available in blister packs containing 15 or
60 capsules.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.

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.
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)

Manufacturer
This product is manufactured by Janssen Biotech N. V.
Lammerdries 55, B-2250 Olen, Belgium.
POM

PL No: 8747/0319

Leaflet revision date: 20 November 2012
Sporanox is a registered trade mark of Johnson & Johnson, USA.
319 LEAFLET Sporanox 20121120 (manu 1)

319 LEAFLET Sporanox 20121120 (manu 2)



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 (opioiddependency)

PACKAGE LEAFLET: INFORMATION FOR THE USER

SPORANOX CAPSULES 100mg
ITRACONAZOLE CAPSULES 100mg
(itraconazole)
This medicine is known by either of the above names but will be
referred to as Sporanox Capsules in this leaflet.
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

Midazolam (by mouth) or triazolam - for anxiety or to help you
sleep



Pimozide and sertindole - for conditions affecting thoughts,
feelings and behavior



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

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:

5. How to store Sporanox capsules
6. Further information



Medicines for tuberculosis called rifampicin, rifabutin or
isoniazid



Medicines for epilepsy called phenytoin, carbamazepine or
phenobarbital



4. Possible side effects

St. John’s Wort (a herbal medicine)

1. WHAT SPORANOX CAPSULES ARE AND WHAT THEY ARE
USED FOR

Do not use Sporanox capsules within 2 weeks of taking these
medicines.

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

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

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:

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 need to alter the dose of Sporanox capsules or
your other medicine.

-

shortness of breath

-

unexpected weight gain

Taking Sporanox capsules with food and drink

-

swelling of your legs or tummy

-

feel unusually tired

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

-

wake up short of breath at night

Pregnancy and breast-feeding



You have had an allergic reaction to another antifungal product
in the past

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

You have Acquired Immunodeficiency Syndrome (AIDS) or your
immune system is not working as well as it should







stop taking Sporanox capsules and tell your doctor straight away.
These may be signs of heart failure

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.

Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.
Driving and using machines

Taking other medicines

Sporanox capsules can sometimes cause dizziness, blurred/double
vision or hearing loss. If you have these symptoms do not drive or
use machines.

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.

Important information about some of the ingredients of
Sporanox capsules

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

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

3. HOW TO USE SPORANOX CAPSULES

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

Taking Sporanox capsules



Problems with sight including blurred vision and double vision



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



Certain blood disorders which may increase the risk of
bleeding, bruising or infections



Swallow the capsules whole with some liquid



Ringing in your ears

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



Severe upper stomach pain, often with nausea and vomiting



Fever or high temperature

Always use this medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.



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

How much to take



Red, itchy, flaking or peeling skin

Your doctor will tell you how many Sporanox capsules to take and
for how long. They may recommend the following treatment
courses.



Erection difficulties



Sensitivity of the skin to light



Hearing loss (may be permanent)



Lower levels of potassium in your blood (shown by blood tests)

Yeast infection of the vagina (thrush)


Take 2 capsules in the morning and two capsules 12 hours later
for one day only

If you notice any other side effects not listed in this leaflet, please
tell your doctor or pharmacist.

Yeast infection of the mouth (oral thrush)

5. HOW TO STORE SPORANOX CAPSULES





KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30C in a dry place. Protect from light.

Fungal infections of the skin



Do not use after the date shown on the carton or blister label.

The dosage depends on your infection.



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.

Take 1 capsule each day for 15 days

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 too much of your medicine

6. FURTHER INFORMATION
What Sporanox Capsules contains


Sporanox capsules contain 100mg of the active ingredient
itraconazole.



Sporanox capsules also contain sucrose, maize starch, liquid
glucose, hypromellose and macrogol. The capsule shell is
made of gelatin and coloured with titanium dioxide, indigo
carmine and erythrosine.

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.

What Sporanox Capsules looks like and contents of the pack

If you forget to take Sporanox capsules

Product Licence holder



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

Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.



Do not take a double dose to make up for a forgotten dose

Manufacturer

Sporanox capsules are blue/pink capsules.
Sporanox capsules are available in blister packs containing 4, 15 or
60 capsules.

When to stop using Sporanox capsules

This product is manufactured by Famar ABE, Anthousa, Attikis,
Greece.

Keep taking Sporanox capsules for as long as your doctor has told
you. Do not stop your treatment just because you feel better.

Leaflet revision date: 20 November 2012

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 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)

POM

PL No: 8747/0319

Sporanox is a registered trade mark of Johnson & Johnson, USA.
319 LEAFLET Sporanox 20121120 (manu 2)

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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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