Skip to Content

ITRACONAZOLE 10MG/ML SUGAR FREE ORAL SOLUTION

Active substance(s): ITRACONAZOLE / ITRACONAZOLE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

Itraconazole 10mg/ml Sugar Free Oral Solution
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 10mg/ml
Sugar Free Oral Solution but it 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 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 Itraconazole to:
 treat yeast infections of the mouth, throat or gullet if
you have a poor immune system
 stop you from getting certain fungal infections if you
have a poor immune system due to a major blood
disorder or bone marrow transplantation.

2. What you need to know before you take
Itraconazole
Do not use Itraconazole oral solution if you are:
 allergic (hypersensitive) to itraconazole or to any of
the ingredients in Itraconazole oral solution (listed in
Section 6)
 pregnant, think you might be pregnant or could
become pregnant (see the section on Pregnancy)
 taking any of the following medicines:













terfenadine, astemizole or mizolastine
(antihistamine for allergies)
bepridil - used to treat angina (crushing chest pain)
nisoldipine (used for high blood pressure)
cisapride (used for stomach upsets)
midazolam by mouth or triazolam (used to help you
sleep or for anxiety)
lovastatin, simvastatin or atorvastatin (used to
lower cholesterol)
pimozide and sertindole (for conditions affecting
thoughts, feelings and/or behaviour)
levacetylmethadol - for treatment of drug abuse
(opioid dependency)
dihydroergotamine, ergotamine and eletriptan (for
migraine headaches)
ergometrine (ergonovine) and methyl-ergometrine
(methylergonovine) used after giving birth
quinidine and dofetilide (for irregular heart beat
rhythms).

Warnings and precautions
Stop taking Itraconazole 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
 if you 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 could
make it worse. If your doctor decides to give you
Itraconazole, you should be told about the symptoms
listed below to watch out for. If you get any of the
following stop taking Itraconazole and tell your doctor
straight away. These may be signs of heart failure:








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

PIL/UK/MFG130/01/v2





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 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
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicine including medicines
obtained without a prescription (including herbal
medicines). This is because Itraconazole can affect the
way some other medicines work. Also some other
medicines can affect the way Itraconazole works.
There are some medicines that you should not take
whilst taking Itraconazole. These are listed under the
heading “Do not use Itraconazole oral solution if you
are:”
Tell your doctor if you are using the following
medicines as they may stop Itraconazole oral solution from
working properly:
 rifampicin, rifabutin and isoniazid (antibiotics used for
tuberculosis)
 phenytoin, carbamazepine and phenobarbital (antiepileptics)
 St John’s wort.
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 given by mouth and
injection 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 busulphan, 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.
Itraconazole with food, drinks and alcohol
Do not take Itraconazole with food or drink as it reduces
your body’s ability to absorb the medicine. Always take
Itraconazole oral solution one hour before any food or
drink as this helps the body absorb the medicine.
Children and the elderly
Itraconazole is not normally given to children or the
elderly. Your doctor may prescribe it in special cases.
Pregnancy
Do not take Itraconazole 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 with Itraconazole has finished.
If you do find that you are pregnant after starting a course
of Itraconazole, stop taking it and tell your doctor straight
away.
Before taking any medicine, always tell your doctor if you
are pregnant, think you might be pregnant or are trying to
become pregnant.
Breast-feeding
If you are breast-feeding do not take Itraconazole, as
small amounts of the medicine could be present in your
breast milk.
Driving and using machines
Itraconazole oral solution can sometimes cause dizziness,
blurred/double vision or hearing loss. If you have these
symptoms, do not drive or use machines.
Itraconazole contains:
Sorbitol (E420): If you have been told by your doctor that
you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
TURN OVER

Sodium: The product contains 0.03mmol (or 0.7124mg)
sodium per ml. To be taken into consideration by patients
on a controlled sodium diet.





3. How to take Itraconazole
Always take Itraconazole exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
The recommended dose for:






Treatment of yeast infections of the mouth,
throat or gullet
The usual dose is 200mg (20ml) 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 Itraconazole 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 gullet, that have already been treated
with another antifungal but have still not cleared
The usual dose is 100 – 200mg (10-20ml) twice daily for
two weeks. The treatment may be continued for an
additional two weeks, if the infection does not clear in the
initial two weeks of treatment. For patients on the higher
dose of 400mg (40ml) daily, treatment should be limited
to 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
(5mg (0.5ml) per kg) given in two divided doses. Your
doctor will tell you exactly how much you should take.

Route and method of administration:
This medicinal product must be taken orally.
Always take Itraconazole oral solution one hour before
any food or drink as this helps the body absorb the
medicine.
 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.
 A 30ml measuring cup graduated with 5ml (including
2.5ml and 7.5ml intermediate graduation) markings
is provided. Ensure you fill the cup to the required
dosing mark.



Directions for opening the bottle
The bottle comes with a child-proof cap, and should be
opened as follows: push the plastic screw cap down, while
turning it counter clockwise.

Other side effects include:
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 oral solution with unknown frequency:
 excess of triglycerides in the blood
 hair loss
 muscle pain, painful joints
 menstrual disorders
 erectile dysfunction
 severe upper stomach pain, often with nausea and
vomiting due to inflammation of the pancreas
(pancreatitis).
If any of these side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
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 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









If you take more Itraconazole than you should
If you, or anyone else, take more Itraconazole than you
were told to, contact your doctor or local hospital without
delay. Always take any leftover medicine with you, as well
as the container and/or the labelled bottle so that the
doctor can easily tell what medicine you have taken.
If you forget to take Itraconazole
If you forget to take your medicine, take the next dose as
usual and continue your medicine as directed by your
doctor.
Do not take a double dose.
If you have any further questions on the use of
Itraconazole, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Itraconazole oral solution can cause
side effects, although not everybody gets them.
Medicines can cause serious allergic reactions. 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 (widespread rashes
with peeling skin and blisters in the mouth, eyes and
genitals, or rashes with small pustules or blisters)
 severe lack of appetite, feeling sick, being sick, unusual
tiredness, abdominal (stomach) pain, unusually dark
urine, or pale stools. These may be symptoms of
severe liver problems.
You should also let your doctor know immediately if you
have any of the side effects below:
 symptoms that resemble heart failure such as
shortness of breath, unexpected weight gain, swelling
of the legs, unusual fatigue (tiredness), repeated
waking at night
 a tingling sensation, sensitivity to light, numbness or
weakness in the limbs

PIL/UK/MFG130/01/v2

blurred vision/double vision, ringing in your ears, lose
the ability to control your urine or increased need to
urinate (pass water)
if you experience any hearing loss symptoms.

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the carton and bottle label after EXP. The
expiry date refers to the last day of that month.
Do not store above 25°C.
Discard 30 days after first opening.
Do not use this medicine if you notice that the solution
becomes discoloured or shows any signs of
deterioration. Seek the advice of your pharmacist.
Do not throw away any medicine via waste water or
household waste. Ask your pharmacist how to dispose
of medicines you no longer use. These measures will
help to protect the environment.

6. Contents of the pack and other
information
What Itraconazole oral solution contains:
The active ingredient is itraconazole.
Each ml of oral solution contains 10mg of itraconazole.
The other ingredients are hydroxypropyl-β-cyclodextrin
(E459), sorbitol, liquid (non-crystallising) (E420), propylene
glycol (E1520), sodium saccharin (E954), concentrated
hydrochloric acid (E507), cherry flavor (containing
propylene glycol (E1520)), sodium hydroxide (for pH
adjustment) and purified water.
What Itraconazole oral solution looks like and the
contents of the pack:
Itraconazole oral solution is clear, colourless to yellow
colour solution with an odour of cherry and is supplied in
amber glass bottles fitted with a tamper evident, child
resistant white plastic cap.
Itraconazole is supplied in a bottle containing 150ml oral
solution together with a 30ml measuring cup with 5ml
graduation (including 2.5ml and 7.5ml intermediate
graduation).
Marketing Authorisation Holder and Manufacturer:
Thame Laboratories,
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK
POM
This medicinal product is authorised in the Member
States of the EEA under the following names:
UK and MT: Itraconazole 10mg/ml Sugar Free Oral Solution
This leaflet was last revised in 04/2017.

Expand Transcript

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.

Hide