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ITRACONAZOLE 10 MG/ML ORAL SOLUTION

Active substance(s): ITRACONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ITRACONAZOLE 10mg/ml ORAL
SOLUTION
Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.What Itraconazole Oral Solution is and what it
is used for
2.What you need to know before you take
Itraconazole Oral Solution
3.How to take Itraconazole Oral Solution
4.Possible side effects
5.How to store Itraconazole Oral Solution
6.Contents of the pack and other information
1. WHAT ITRACONAZOLE ORAL SOLUTION IS AND
WHAT IT IS USED FOR

Itraconazole is one of a group of medicines
called “antifungals”. These medicines are used
to treat and stop you from getting infections
caused by fungi including yeasts.
You may be given this medicine:
• To treat yeast infections of the mouth, throat
or food pipe (oesophagus) if you have a poor
immune system
• To stop you from getting certain fungal
infections if you have blood cancer or have
had a bone marrow transplant and have a
poor immune system.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ITRACONAZOLE ORAL SOLUTION
DO NOT TAKE Itraconazole Oral Solution if
you:
• are allergic (hypersensitive) to itraconazole or
any of the other ingredients (listed in section
6)
• have, or have a history of, congestive heart
failure, unless you have a very serious fungal
infection (see under ‘Take special care’)
• are pregnant, think you might be pregnant or
could become pregnant (see the section on
Pregnancy)
• are taking any of the following medicines:
o terfenadine, astemizole or mizolastine
(antihistamine for allergies)
o bepridil used to treat angina (crushing chest
pain)
o nisoldipine (used for high blood pressure)
o cisapride (used for stomach upsets)
o midazolam by mouth or triazolam (used to
help you sleep or for anxiety)
o lovastatin, simvastatin or atorvastatin (used
to lower cholesterol)
o pimozide and sertindole (for conditions
affecting thoughts, feelings and/or
behaviour)
o levacetylmethadol (used for treatment of
drug abuse (opioid-dependency))
o dihydroergotamine, ergotamine and
eletriptan (used for migraine headaches)
o ergometrine (ergonovine) and
methylergometrine (methylergonovine) used
after giving birth
o quinidine and dofetilide (used for irregular
heart beat rhythms).
TAKE SPECIAL CARE with Itraconazole Oral
Solution
Stop taking Itraconazole Oral Solution and
see your doctor immediately if any of the
following symptoms of severe liver problems
appear during your course of treatment:
• Severe lack of appetite, feeling sick, being
sick, unusual tiredness, abdominal (stomach)
pain, unusually dark urine or pale stools.
Tell your doctor immediately if you:
• have any unusual feelings of tingling,
numbness or weakness in your hands or feet
whilst taking Itraconazole Oral Solution
• experience any hearing loss symptoms. In
very rare cases patients taking itraconazole
have reported temporary or permanent
hearing loss.
Tell your doctor if you have:
• had an allergic reaction to any other antifungal
medicines
• a heart problem, including heart failure (also
called congestive heart failure or CHF),
Itraconazole Oral Solution could make it
worse. If your doctor decides to give you
Itraconazole, you should be told to watch out
for any of the symptoms listed below. If you
get any of the following stop taking
Itraconazole Oral Solution and tell your
doctor straight away. These may be signs of
heart failure:
o shortness of breath
o unexpected weight gain
o swelling of your legs or stomach
o feel unusually tired
o wake up short of breath at night

• a liver problem, such as jaundice (yellowing of
the skin), as your dose of Itraconazole may
have to be changed. Your doctor should give
you instructions on symptoms to watch out
for. If you have to take Itraconazole Oral
Solution continuously for more than one
month, your doctor may want to check your
liver by doing blood tests
• a kidney disorder, as your dose of
Itraconazole may have to be changed.
OTHER MEDICINES AND ITRACONAZOLE
There are some medicines that you should not
take whilst taking Itraconazole Oral Solution.
These are listed under the heading “Do not
take Itraconazole Oral Solution if you:
• are taking any of the following medicines”
Tell your doctor if you are using the following
medicines as they may stop itraconazole from
working properly:
• rifampicin, rifabutin and isoniazid (antibiotics
used for tuberculosis)
• phenytoin, carbamazepine and phenobarbital
(anti-epileptics)
• St. John’s wort (a herbal medicine).
Do not use Itraconazole Oral Solution within 2
weeks of taking these medicines.
Tell your doctor before taking any of the
following medicines as the dose of Itraconazole
Oral Solution or other treatments may need to
be altered:
• clarithromycin and erythromycin (antibiotics
for infections)
• medicines that act on the heart and blood
vessels (digoxin, disopyramide and calcium
channel-blockers such as dihydropyridines,
verapamil and cilostazol)
• drugs that slow down blood clotting or thin the
blood, such as warfarin
• methylprednisolone, budesonide, fluticasone
and dexamethasone, medicines for
inflammation, asthma and allergies
• ciclosporin, tacrolimus and rapamycin (also
known as sirolimus), which are usually given
after an organ transplant
• medicines used in HIV-infected patients, such
as ritonavir, indinavir and saquinavir
• medicines for cancer (such as busulfan,
docetaxel, trimetrexate and a group of
medicines known as vinca alkaloids)
• alfentanil and fentanyl (for pain)
• buspirone, alprazolam, brotizolam and
midazolam when given by injection into a vein
(for anxiety or to help you sleep)
• reboxetine (for depression)
• loperamide (for diarrhoea)
• an antihistamine containing ebastine
• halofantrine (for malaria)
• repaglinide (for diabetes).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
Taking Itraconazole Oral Solution with food
and drink
• Do not take Itraconazole Oral Solution with
food or drink as it reduces your body’s ability
to absorb the medicine.
• Always take it one hour before any food or
drink as this helps the body absorb the
medicine.
PREGNANCY AND BREAST-FEEDING
Pregnancy
• Do not take Itraconazole Oral Solution if you
are pregnant, unless your doctor has told you
to.
• If you are of child bearing age and could
become pregnant, you should use
contraceptives to make sure that you do not
become pregnant while you are taking your
medicine.
• As itraconazole remains in the body for some
time after you stop taking it, you should
continue to use some form of contraception
until your next period after your treatment has
finished.
• If you become pregnant after starting a course
of Itraconazole Oral Solution, stop taking it
and tell your doctor straight away.
Breastfeeding
• Do not take Itraconazole Oral Solution if you
are breast-feeding, as small amounts of the
medicine could be present in your breast milk.
DRIVING AND USING MACHINES
Itraconazole can sometimes cause dizziness,
blurred/double vision or hearing loss. Do not
drive or use machines if you have these
symptoms.
IMPORTANT INFORMATION ABOUT SOME
OF THE INGREDIENTS
This medicine contains sorbitol. If you have
been told by your doctor that you have an
intolerance to some sugars, tell your doctor
before taking this medicine.
This medicinal product contains a small amount
of ethanol (alcohol) less than 100mg per 20ml.

3. HOW TO TAKE ITRACONAZOLE ORAL SOLUTION
Always take Itraconazole Oral Solution exactly
as your doctor has told you. You should check
with your doctor or pharmacist if you are not
sure.
• Always take the solution one hour before any
food or drink as this helps the body absorb the
medicine.
• A graduated measuring cup is provided.
Ensure you fill the cup to the correct mark.
• You should swish the oral solution around in
your mouth for approximately 20 seconds
before swallowing it.
• Do not rinse your mouth after swallowing the
oral solution.
Treatment of yeast infections of the mouth,
throat or food pipe (oesophagus)
The usual dose is 20 ml per day for one week.
This may be taken either all at once or in two
divided doses during the day.
If after one week of using the oral solution, your
infection has not cleared, your doctor may
decide to continue your treatment for one more
week.
Treatment of yeast infections of the mouth,
throat or food pipe (oesophagus), that have
already been treated with another antifungal
but have still not cleared
The usual dose is 10-20 ml twice daily for two
weeks. If the infection has not cleared, the
treatment may be continued for an additional
two weeks. The higher dose of 400mg (40 ml)
daily should not be used for more than 14 days
if there are no signs of improvement during this
time.
Prevention of fungal infections
The dose is calculated according to your body
weight (5 mg per kg) given in two divided doses.
Your doctor will tell you exactly how much you
should take.
Use in children and the elderly
Itraconazole Oral Solution is not normally given
to children or the elderly. Your doctor may
prescribe it in special cases.
If you take more Itraconazole Oral Solution
than you should contact your doctor or local
hospital without delay
If you forget to take Itraconazole Oral
Solution, take the next dose as usual and
continue your medicine as directed by your
doctor. Do not take a double dose to make up
for a forgotten dose
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS
Like all medicines, Itraconazole Oral Solution
can cause side effects, although not everybody
gets them.
Serious side effects
Stop taking Itraconazole Oral Solution and
contact your doctor immediately if you have:
• any sudden wheeziness, difficulty in
breathing, swelling of the face, rash, itching
(especially affecting the whole body) OR a
severe skin disorder including blistering and
peeling of the skin, fever, sore throat and
tiredness. These may be symptoms of a
severe hypersensitivity or allergic reaction.
• severe lack of appetite, feeling or being sick,
unusual tiredness, abdominal (stomach) pain,
unusually dark urine, or pale stools. These
may be symptoms of severe liver problems
• severe upper stomach pain, often with nausea
and vomiting due to inflammation of the
pancreas (pancreatitis).
Tell your doctor immediately if you have any
of the side effects below:
• symptoms of heart failure such as shortness
of breath, unexpected weight gain, swelling of
the legs, unusual fatigue (tiredness), repeated
waking at night
• symptoms of nerve damage such as any
unusual tingling sensation, numbness or
weakness in the limbs
• blurred vision/double vision
• increased sensitivity of the skin to light
• loss of control of urination or increased need
to urinate (pass water)
• any symptoms of hearing loss, ringing in your
ears.
Other side effects
Tell your doctor if any of the following symptoms
get worse or you are worried.
Common side effects (occur in less than 1 in
10 patients) are:
• headache
• stomach ache, feeling sick (nausea), being
sick (vomiting), diarrhoea, unpleasant taste
• increases in specific liver function tests
(hepatic enzyme increased)
• rash
• fever or high temperature
• shortness of breath.
Uncommon side effects (occur in less than 1
in 100 patients) are:
• certain blood disorders which may increase
the risk of bleeding, bruising or infections
• muscle weakness (possible symptom of low
blood levels of potassium)

• dizziness
• indigestion, constipation
• inflammation of the liver (hepatitis), yellowing
of the skin (jaundice)
• itching
• general swelling.
The following side effects have been
reported in patients taking itraconazole with
unknown frequency:
• excess of triglycerides in the blood
• skin inflammation, hives, sensation of tingling,
prickling of the skin, numbness
• pustular rash with fever
• rash or discolouring of the skin due to
inflammation of blood vessels
• hair loss
• muscle pain, painful joints
• menstrual disorders
• erectile dysfunction.
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 national
reporting system listed below. By reporting side
effects you can help provide more information
on the safety of this medicine.
United Kingdom
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Centre,
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971; Fax: +353 1 6762517
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
5. HOW TO STORE ITRACONAZOLE ORAL SOLUTION
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use Itraconazole after the expiry date
which is stated on the packaging. The expiry
date refers to the last day of that month.
The oral solution should not be used for longer
than 1 month after the bottle has first been
opened.
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 to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION

What Itraconazole Oral Solution contains
• The active substance is itraconazole 10mg
per ml.
• The other ingredients are hydroxypropyl-βcyclodextrin, sorbitol (E420), propylene glycol,
cherry flavour, caramel flavour (contains
ethanol and propylene glycol), sodium
saccharin dihydrate, hydrochloric acid, sodium
hydroxide, purified water.
What Itraconazole Oral Solution looks like
and contents of the pack
It is a clear yellow solution, available in bottles
containing 150 ml together with a graduated
measuring cup, in a cardboard carton.
Marketing Authorisation Holder
Beacon Pharmaceuticals Ltd, High Street,
Tunbridge Wells, Kent TN1 1YG, UK
Manufacturer
Kleva S.A., 189 Parnithos Avenue, 136 75
Acharnai Attiki, Greece
This leaflet was last revised 07/2014

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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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