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Active substance(s): ITRACONAZOLE

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Itraconazole 100 mg capsules, hard



Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. See section 4.

What is in this leaflet
1. What 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


What Itraconazole is and what it is
used for

Itraconazole belongs to a group of medicines called

Itraconazole is used in cases of:
• Superficial fungal infections if external treatment is
not effective or not appropriate.
These include fungal infections
- of the skin
- Pityriasis versicolor. This is a fungal infection of the
skin where branny scales develop after scratching.
The affected skin parts are paler or darker than
normal skin.
• Fungal infections of mucosa and/or inner organs
caused by certain types of fungi.


What you need to know before you
take Itraconazole

Do not take Itraconazole
• if you are allergic to itraconazole or to any of the
other ingredients of this medicine (listed in section 6).
• if you are taking any of the following medicines:
- astemizole, mizolastine, terfenadine, medicines
against allergies
- bepridil, felodpine, lercarnidipine, nisoldipine,
ivabrandine or ranolazine medicines against high
blood pressure and/or narrowed heart vessels
- quinidine, disopyramide, dronedarone or dofetilide,
medicines against disorders in the heart rhythm
- cisapride, a stomach and bowel agent
- levacetylmethadole or levomethadyl and
methadone, used for the therapy of opiate dependents
- pimozide, lurasidone and sertindole, used in
- certain medicines to lower cholesterol levels, such
as lovastatin and simvastatin
- colchicine in patients with kidney or liver
problems, a medicine against gout
- eplerenone, a diuretic
- triazolam, a medicine against sleep disturbances
- midazolam for oral intake, a medicine for sedation
before examinations, or operations or in intensive
care units
- dihydroergotamine, used in case of low blood
pressure or certain headaches
- ergometrine or ergonovine, methylergometrine
or methylergonovine, medicines staunching
bleeding used after birth
- ergotamine and eletriptan, medicines against
- halofantrine, a medicine against malaria
- irinotectan, used to treat cancer
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.
• in case of signs of heart dysfunction or previous
heart failure, except for the treatment of
life-threatening or serious fungal infections
• if you are pregnant or could become pregnant
unless your doctor has told you to (see ʻPregnancy
and breast-feedingʼ below)

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Warnings and precautions
Talk to your doctor before taking Itraconazole if any of
the following items applies to you:
• Taking other medicines
See also section “Other medicines and Itraconazole”
• Heart problems or if you have had heart problems in
your medical history. Immediately inform a doctor if
shortness of breath, unexpected weight gain, swollen
legs or swollen abdomen, unusual exhaustion occur
or if an inability to stay asleep newly occurs
• Lowered acid content in the stomach
In patients with too little gastric juice, in certain AIDS
patients or in case of drug use to prevent the
production of gastric acid, an acidic drink such as
non-diet cola is recommended when taking
Itraconazole (see also section “Other medicines and
Itraconazole” below).
• Increased liver enzymes or existing liver disease
Treatment may be started only if the expected benefit
is higher than the risk of liver damage. In such cases,
your doctor will monitor the liver enzymes and adjust
the dose, if necessary. If after taking this medicine
you have signs of liver damage (see section 4), stop
taking Itraconazole and tell your doctor straight away.
• Impaired kidney function
Your doctor will adjust the dose, if necessary
• Suppressed defence system, such as in case of a
reduced number of white blood cells, AIDS or after
organ transplantations
• AIDS patients who are treated because of inner
fungal infections and who are at risk of relapse.
The attending physician will check whether
continuous therapy is necessary
• Previous allergic reactions to medicines for the
therapy of fungal infections. Medicines the active
substances of which end with “azole” are
predominantly concerned
• Women who may become pregnant need to use
contraception while taking Itraconazole (see section
ʻPregnancy and breast-feedingʼ below).

Children and older patients
Itraconazole is not normally given to children or older
patients. However, your doctor may prescribe it in
special cases.

Other medicines and Itraconazole
Tell your doctor or pharmacist if you are using, have
recently used or might use any other medicines.

• Medicines listed further above under “Do not take
Concomitant treatment with these medicines and
Itraconazole must not be performed. Also, upon
completing your course of Itraconazole do not take
any of these medicines for 2 weeks
• Concomitant use with Itraconazole is not
recommended, unless your doctor feels it is
necessary, when taking:
- 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, a medicine to treat erectile dysfunction
Also, upon completing your course of Itraconazole,
do not take any of the medicines listed above for 2
• Do not take any of following medicines 2 weeks
before and while you are taking Itraconazole
unless your doctor tells you otherwise:
- rifampicin, rifabutin, medicines against
tuberculosis and leprosy
- phenytoin, a medicine against convulsive attacks
and nerve-induced states of pain
- carbamazepine, phenobarbital medicines against
convulsive attacks and certain pain
- isoniazid, a medicine against tuberculosis and leprosy
- efavirenz, nevirapine, medicines to treat HIV
• 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).
- alprazolam, a medicine against states of excitation
and anxiety
- brotizolam, a medicine against sleep disturbances
marked by difficulties in falling asleep and
awakening too early
- buspirone, a medicine against states of excitation
and anxiety
- medicines used in the treatment of cancer such
as bortezomib, busulfan, docetaxel, erlotinib,
ixabepilone, lapatinib, trimetrexate and vinca alkaloids.
- medicines for conditions affecting thoughts,
feelings and behaviour called aripiprazole,
haloperidol, perospirone, quetiapine, ramelteon and
- medicines inhibiting blood coagulation, such as
phenprocoumon, warfarin, cilostazol and dabigatran
- medicines against HIV infection such as ritonavir,
darunavir, indinavir, fosamprenavir and saquinivir
and maraviroc
- medicines against bacterial infections called
ciprofloxacin, clarithromycin or erythromycin
- medicines that act on the heart and blood
vessels called nadolol, digoxin and cilostazol
- verapamil, nifedipine and similar medicines
against high blood pressure
- certain cortisones such as budesonide,
dexamethasone, fluticasone and methylprednisolone,
used against various inflammations
- medicines to suppress the defence system and
to avoid rejection of transplanted organs called
ciclosporin, rapamycin, also known as sirolimus,
tacrolimus, ciclesonide or temsirolimus
- medicines to treat an overactive bladder:
fesoterodine, imidafenacin, solifenacin or tolterodine
- alitretinoin (by mouth), a medicine to treat eczema
- aprepitant and domperidone, medicines to stop
you feeling and being sick
- atorvastatin, a medicine to lower cholesterol
- cinacalcet, a medicine for an over active
parathyroid gland
- ebastine, a medicine against allergies and itching
- eletriptan, a medicine to treat migraine headaches
- mozavaptan or tolvaptan, medicines to treat low
sodium blood levels
- praziquantel, for treatment of worms
- reboxetine, a medicine against depression
- repaglinide or saxagliptin, medicines in case of
- meloxicam, a medicine to reduce inflammation
and pain
- midazolam, injected into the vein, for sedation
before examinations or operations
- sildenafil and tadalafil, medicines to treat erectile
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.

Continued on the next page >>

Pregnancy and breast-feeding
• Itraconazole must not be used during pregnancy,
with the exception of life-sustaining therapies of inner
fungal infections if the potential benefit outweighs the
Experience regarding use during pregnancy is low;
cases of malformations are known. Short-term
therapies (in fungal infections of female genital
organs) in the first three months of pregnancy did not
lead to an increased risk of malformations.

For women who may become pregnant: Use
contraception while taking this medicine and until your
next period after the end of treatment.
Tell your doctor straight away if you become pregnant
while taking this medicine.

• Itraconazole may be taken during breast-feeding
only after the doctor has allowed it. Only very low
quantities of itraconazole pass into breast milk.

Ask your doctor or pharmacist for advice before
taking/using any medicine.

Driving and using machines
Itraconazole may make you feel dizzy and you may
experience visual disturbances or hearing loss. Do not
drive or operate machinery if this applies to you.

Itraconazole contains the sugar sucrose
This medicine contains sucrose (saccharose). If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking Itraconazole.


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.
The recommended dose and duration of treatment are:
Superficial fungal infections
• of the skin
1 capsule once daily, for 2 weeks
• of the palms and soles of the feet
1 capsule once daily, for 4 weeks
• Pityriasis versicolor
2 capsules once daily, for 7 days.

The doctor can double the dose in case of
suppressed defence system, such as in reduced
number of white blood cells, AIDS and after organ

Itraconazole remains in the skin considerably longer
than in the blood. Optimal healing is therefore achieved
in fungal infections of the skin 2-4 weeks after the end of
Fungal infections of mucosa and/or inner organs
caused by:
• Aspergillus
2 capsules once daily, for 2 to 5 months

If the fungi spread into adjacent tissues or the whole
body, 2 capsules twice daily

• Candida
1-2 capsules once daily, for 3 weeks up to 7 months

If the fungi spread into adjacent tissues or the whole
body, 2 capsules twice daily

• Histoplasma
2 capsules once to twice daily, for 8 months.

Method of use
Please take the capsules without chewing with a glass
of water directly after a meal, and if possible, always at
the same time of the day.
Take the capsules in the morning and in the evening if
your intake is twice daily.

If you take medicines that stop the production of
stomach acid, you should take Itraconazole with a drink
of non-diet cola (see section 2 “Other medicines and
Itraconazole” above.
If you take more Itraconazole than you should
Please immediately consult your doctor in this case.

If you forget to take Itraconazole
Take the forgotten dose as soon as you remember unless
it is nearly time for the next dose. Do not take a double
dose if you have forgotten to take your previous dose.
If you stop taking Itraconazole
Terminate therapy or change the dosage only after
explicit agreement of your doctor. Otherwise, the
therapeutic success could be endangered.

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


Possible side effects

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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. The
frequency of these side effects is rare.
• severe allergic reactions with signs such as:
- sudden difficulty in breathing, speaking and swallowing
- rash, hives (also known as nettle rash or urticaria),
severe irritation of your skin
- swelling of the lips, tongue, face and neck
- extreme dizziness or collapse
• severe or itchy skin rash, which may show blistering,
peeling and pain in the eyes, mouth or genital organs
(life-threatening toxic epidermal necrolysis,
Stevens-Johnson syndrome, acute generalised
exanthematous pustulosis, erythema multiforme,
exfoliative dermatitis, leukocytoclastic vasculitis)
• liver damage with possible signs such as
- loss of appetite
- nausea, vomiting

- unusual tiredness
- abdominal pain
- yellowing of your skin or whites of your eyes
- unusually dark urine, pale stools or
- hair loss
Severe liver damage including some fatal cases of
acute liver failure and inflammation of the liver
(hepatitis) have been reported
• heart failure with signs such as:
- shortness of breath
- unexpected weight gain
- swelling of legs or abdomen
- feeling unusually tired
- waking up short of breath at night
- shortness of breath can also be a sign of fluid on
the lungs
• nerve disturbances called peripheral neuropathy,
which manifest themselves as sensation of numbness,
furry sensation or tingling in arms and legs
• inflammation of the pancreas with signs such as
severe upper stomach pain, often with nausea and

Other side effects can occur with the following

Common, affects 1 to 10 per 100 users
• abdominal pain
• feeling sick (nausea)
• headache.

Uncommon, affects 1 to 10 per 1,000 users
• allergic reactions of different severity
• sinusitis, runny nose, coughs and colds
• being sick (vomiting)
• diarrhoea
• constipation
• indigestion
• wind
• increase in liver function tests
• nettle rash (urticaria)
• itching
• problems with menstrual periods.

Rare, affects 1 to 10 per 10,000 users
• reduction in the number of white blood cells which
may increase the risk of infections
• serum disease; this disease is a hypersensitivity
reaction of the body to foreign substances
• elevated blood fat values of triglycerides
• disturbed taste sensation
• visual disturbances including blurred vision and
double vision
• hearing loss (may be permanent)
• noises in the ear (tinnitus)
• difficulty breathing
• need to urinate (empty bladder) more often
• swelling due to fluid under the skin
• unusual hair loss or thinning
• red, itchy, flaking or peeling skin
• sensitivity of the skin to light
• erection disturbances in men

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme: By reporting side effects,
you can help provide more information on the safety of
this medicine.


How to store Itraconazole

Keep this medicine out of the sight and reach of

Do not use this medicine after the expiry date which is
stated on the carton and outer carton. The expiry date
refers to the last day of that month.

Storage conditions
Do not store above 30°C.

Store the blister in the outer carton in order to protect
from light.

Do not throw away any medicines via wastewater. Ask
your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the


Contents of the pack and other

What Itraconazole contains
The active substance is: itraconazole.

Each hard capsule contains 100 mg itraconazole.

The other ingredients are:
Gelatin, hypromellose, macrogol, sucrose, maize starch,
titanium dioxide (E 171).

What Itraconazole looks like and contents of the
Hard gelatin capsules, size 0, filled with white to off
white pellets.
Capsule cap: white, opaque. Capsule body: white,

Itraconazole 100 mg capsules are packed in
PVC-Aluminium or PVC/PVDC-Aluminium blister. The
blister strips are packed in a carton box.

Packs containing 4, 6, 7, 8, 14, 15, 18, 20, 28, 30, 60,
84, 90 or 100 capsules, hard.

Not all pack sizes may be marketed.

Marketing authorisation holder
Sandoz Ltd, Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, UK.

Salutas Pharma GmbH, Otto-Von-Guericke-Allee 1,
39179 Barleben, Germany.
This leaflet was last revised in 09/2013.


Artwork Proof Box
Ref: V009 - CDS update for SPC & PIL
Proof no.

Date prepared:

Dimensions: 165 x 500 mm

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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.