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SPORANOX CAPSULES 100MG

Active substance: ITRACONAZOLE

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Medicines to lower cholesterol called lovastatin or simvastatin

PACKAGE LEAFLET: INFORMATION FOR THE USER



SPORANOX CAPSULES 100mg
ITRACONAZOLE CAPSULES 100mg
(Itraconazole)

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

319 LEAFLET Sporanox 20150205

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 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



Eplerenone – a diuretic



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

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.



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 behavior



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

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

Sporanox capsules contain a medicine called itraconazole. This
belongs to a group of medicines called ‘antifungals’.



Aliskiren – for high blood pressure



Colchicine – for gout

Sporanox capsules are used for infections caused by fungi or
yeasts in adults. They are used for:



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



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

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

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

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)

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



Medicines used for anxiety or to help you sleep (tranquillisers),
such as buspirone, alprazolam or brotizolam



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:

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

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



Medicines for bacterial infections called ciprofloxacin,
clarithromycin or erythromycin



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

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

Blood tests



Alitretinoin (by mouth) – for eczema

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



Aprepitant and domperidone – to stop you feeling and being
sick

Other medicines and Sporanox capsules



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



- shortness of breath
- unexpected weight gain
- swelling of your legs or tummy
- feel unusually tired
- wake up short of breath at night

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.

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



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



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.

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.

These may be signs of a liver problem. (This only happens in a
small number of people)

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

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)



If you become pregnant after starting a course of Sporanox
capsules, stop taking them and tell your doctor straight away



 Headache
Uncommon (affects less than 1 in 100 people)

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



Problems with periods



Sinusitis, runny nose, coughs and colds

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

 Constipation, diarrhoea, wind, being sick (vomiting), indigestion
Rare (affects less than 1 in 1000 people)


Increases in liver function tests (shown by blood tests)

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



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

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



Swelling due to fluid under the skin

Taking Sporanox capsules



Unusual hair loss or thinning (alopecia)



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



High levels of triglycerides in the blood (shown by blood tests)





Red, itchy, flaking or peeling skin

Swallow the capsules whole with some liquid





Sensitivity of the skin to light

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.

 Erection difficulties
Reporting of side-effects

Sporanox capsules contain sucrose (sugar)
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 TAKE SPORANOX CAPSULES

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.

(inflammation of the pancreas)

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.



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



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



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.

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

6. FURTHER INFORMATION

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

What Sporanox Capsules contain


Sporanox capsules contain 100mg of the active ingredient
itraconazole.

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.



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 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

What Sporanox Capsules look like and contents of the pack
Sporanox capsules are blue/pink capsules.

 Do not take a double dose to make up for a forgotten dose
If you stop taking Sporanox capsules

Sporanox capsules are available in blister packs containing 15 or
60 capsules.

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

Product Licence holder

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

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

4. POSSIBLE SIDE EFFECTS
Manufacturer
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

This product is manufactured by


Janssen Biotech N. V. Lammerdries 55, B-2250 Olen, Belgium.



Famar ABE, Anthousa, Attikis, Greece.

POM

PL No: 08747/0319

Leaflet revision date: 05 February 2015
Sporanox is a registered trade mark of Johnson & Johnson, USA.
319 LEAFLET Sporanox 20150205

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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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