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ITRACONAZOLE 100MG CAPSULES HARD

Active substance(s): ITRACONAZOLE

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Package leaflet: information for the user

Itraconazole 100mg 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 symptoms
are the same as yours.
•  If you get any of the 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 capsules are
and what they are used for
2. What you need to know before you
take Itraconazole capsules
3. How to take Itraconazole capsules
4. Possible side effects
5. How to store Itraconazole capsules
6. C
 ontents of the pack and other
information
1  What Itraconazole capsules are

and what they are used for

Itraconazole capsules are indicated for the
treatment of fungal infections of the vagina,
skin, mouth, eyes, nails and internal organs.
The active substance is itraconazole, a
member of the following pharmacotherapeutic class of drugs: Antimycotic for
systemic use, triazole derivatives.
Itraconazole is very effective against a variety
of infections caused by yeasts and fungi.
It has great affinity for highly keratinized
tissues such as skin and nails, as well as for the
vaginal wall lining.
Therapeutic levels of itraconazole remain in
the skin for two to four weeks following the
end of treatment, depending on its duration.
In vaginal tissue, itraconazole can be found
for a period of two to three days, again
depending on the duration of treatment.

2 What you need to know before

you take Itraconazole capsules

Do not take Itraconazole capsules if:

• y ou are allergic to itraconazole or any of the
other ingredients of this medicine (listed in
section 6).
• y ou 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
itraconazole capsules.

Warnings and precautions

Talk to your doctor or pharmacist before
taking Itraconazole capsules if:
• y ou have ever had kidney problems.
Your dose of itraconazole capsules may have
to be changed
• y ou have ever had liver problems such
as yellow skin (jaundice). Your dose of
itraconazole 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 itraconazole capsules and tell
your doctor straight away
• y ou have ever had a heart problem
including heart failure (also called
congestive heart failure or CHF). Itraconazole
capsules could make it worse. If after taking
this medicine you get any of the following:
- shortness of breath
- unexpected weight gain
- swelling of your legs or tummy
- feel unusually tired
- wake up short of breath at night
stop taking itraconazole capsules and tell
your doctor straight away. These may be
signs of heart failure.

Children and the elderly:

Itraconazole capsules are not normally given
to children or the elderly. However, your
doctor may prescribe them in special cases.

Blood tests:

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

Other medicines and Itraconazole
capsules

Tell your doctor or pharmacist if you are
taking, 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 this medicine and
tell your doctor if you are taking any of the
following:
•M
 edicines for hay fever or allergy called
terfenadine, astemizole or mizolastine
•M
 edicines to lower cholesterol called
atorvastatin, lovastatin or simvastatin
•M
 edicines for an irregular heart beat called
quinidine or dofetilide
•M
 edicines used to treat angina (crushing
chest pain) and high blood pressure called
bepridil and nisoldipine
•M
 edicines for migraine headaches called
eletriptan, dihydroergotamine and
ergotamine
continued top of next column
AAAI0763

•C
 isapride - for digestive problems
• E rgometrine (ergonovine) and
methylergometrine (methylergonovine)
- used after giving birth
• L evacetylmethadol - for treatment of drug
abuse (opioid-dependency)
•M
 idazolam (by mouth) or triazolam - for
anxiety or to help you sleep
•P
 imozide and sertindole - for conditions
affecting thoughts, feelings and behaviour
Do not start taking itraconazole capsules and
tell your doctor if you are taking any of the
above.
Tell your doctor before taking, or if you
are already taking, any of the following
medicines. They may stop itraconazole
capsules from working properly:
•M
 edicines for tuberculosis called rifampicin,
rifabutin or isoniazid
•M
 edicines for epilepsy called phenytoin,
carbamazepine or phenobarbital
• St.
 John’s Wort (a herbal medicine)
Do not use itraconazole capsules within 2
weeks of taking these medicines.
•M
 edicines 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 itraconazole
capsules before taking any of these other
medicines. If you take medicines that stop
the production of stomach acid, you should
take itraconazole capsules with a drink of
cola
Tell your doctor before taking, or if you are
already taking any of the above. They may
stop itraconazole 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
itraconazole capsules or your other medicine:
•M
 edicines used for anxiety or to help you
sleep (tranquillisers), such as buspirone,
alprazolam or brotizolam
•M
 edicines used in the treatment of cancer
such as busulphan, docetaxel, trimetrexate
and a group of medicines known as ‘vinca
alkaloids’
•M
 edicines to thin the blood (anticoagulants)
such as warfarin
•M
 edicines for HIV infection such as ritonavir,
indinavir and saquinivir. They are called
‘antiviral protease inhibitors’
•M
 edicines for bacterial infections called
clarithromycin or erythromycin
•M
 edicines that act on the heart and blood
vessels called digoxin and disopyramide,
cilostazol or ‘calcium channel-blockers’ such
as dihydropyridines and verapamil
•M
 edicines for inflammation, asthma or
allergies (given by mouth or injection)
called methylprednisolone, fluticasone,
budesonide or dexamethasone
•M
 edicines that are usually given after
an organ transplant called ciclosporin,
tacrolimus or rapamycin. Another name for
rapamycin is sirolimus
•A
 lfentanil and fentanyl - for pain
• E bastine - for allergy
•H
 alofantrine - for malaria
•R
 eboxetine - for depression
•R
 epaglinide - for diabetes
•M
 idazolam - to help you relax or sleep when
given into a vein
Tell your doctor before taking, or if you
are already taking any of the above. They
may need to alter the dose of itraconazole
capsules or your other medicine.

Itraconazole capsules with food and
drink:

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

Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
a baby, ask your doctor for advice before
taking this medicine.
•D
 o not take itraconazole 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 itraconazole 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 itraconazole capsules, stop taking
them and tell your doctor straight away
A very small amount of itraconazole is
excreted in human milk. Your doctor will
decide whether the expected benefits of
itraconazole capsules therapy weighed
against the potential risk of breast-feeding.
In case of doubt, you should not breast-feed.

Driving and using machines:

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

Itraconazole capsules contains
sucrose:

This medicine contains the sugar sucrose. If
you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.

continued over page

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

Method and route of administration:
Itraconazole should be taken immediately
following a meal for maximum absorption.
Capsules must be swallowed whole with a
small amount of water.

Frequency and duration of treatment:
The number of capsules and the duration of
treatment will depend on the fungus and on
the location of infection. Your doctor will tell
you exactly what dose to take.
The following table lists some of the more
frequent dosages:
Type of Capsules per day
infection
Vaginal
2 capsules (200mg
infections itraconazole) twice a
day or

Duration
1 day

Tell your doctor or pharmacist if you notice
any of the following side effects:
Common (may affect up to 1 in 10 people)
• S tomach ache, feeling sick (nausea)

2 capsules (200mg
3 days
itraconazole) once a day
Skin
2 capsules (200mg
7 days
infections itraconazole) once a
day or
1 capsule (100mg
15 days
itraconazole) once a day
If there is a thin layer of callus on the
palms of the hands or soles of the
feet, it may be necessary to take 2
capsules (200mg itraconazole) twice
a day for 7 days or 1 capsule (100mg
itraconazole) once a day for one
month.
Infections 1 capsule (100mg
15 days
of the
itraconazole) once a day
mouth
Infections Higher doses
Longer
of the
periods
internal
organs
For nail infections, depending on your specific
requirements, your doctor may opt for
continuous or pulse treatment:
Type of
Capsules per day Duration
infection
Continuous
2 capsules (200mg 3 months
nail treatment itraconazole) once
a day
Pulse nail
treatment

Week
1

Toenails
with or
without
fingernail
involvement
Finger nails
only

Take 2
capsules
(200mg
itraconazole)
twice a day
Take 2
capsules
(200mg
itraconazole)
twice a day

W W W
2 3 4

W
5

No
Take 2
itraconazole Capsules
(200mg
itraconazole)
twice a day
No
Take 2
itraconazole capsules
(200 mg
itraconazole)
twice a day

W W W
6 7 8

W
9

W
10

No
Take 2
Suspend
itraconazole capsules treatment
(200mg
itraconazole)
twice a day
Suspend
treatment

When you should expect the results:
Drug effects are not immediate.

In skin infections, lesions normally disappear
a few weeks after treatment is suspended.
This is characteristic of fungus lesions as the
drug will eliminate the fungus but the lesions
will remain until new skin grows.
Nail lesions will disappear six to nine months
after treatment, as the drug will eliminate
the fungus but new nail growth takes several
months.
Do not worry if you see no improvement
during the treatment.
The drug will remain in your nails for several
months and is doing its job.
Suspend treatment as soon as your doctor
tells you to, even if you see no visible signs of
improvement.
For infections of internal organs higher doses
and longer treatment times may be required.
Do not forget to take your medication.
Follow these instructions unless your doctor
tells you otherwise.
Your doctor will tell you how long you should
take Itraconazole capsules.
Do not interrupt treatment before being
advised to do so by your doctor or cure may
not be complete.

If you take more Itraconazole capsules
than you should:
Immediately consult your doctor or
pharmacist if you take more Itraconazole
capsules than you should.

If you forget to take Itraconazole
capsules:

Take the missed dose as soon as you
remember it. However, if it is almost time
for the next dose, skip the missed dose and
continue your regular dosing schedule.
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Itraconazole capsules
Keep taking Itraconazole capsules 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 medicine, ask your doctor or
pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Stop using itraconazole capsules and tell
your doctor straight away if you notice
or suspect any of the following. You may
need urgent medical treatment.
• S udden 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
continued top of next column
AAAI0763

• S evere 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)
• S evere 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
• S hortness 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).

Uncommon (may affect up to 1 in 100
people)
•P
 roblems with periods
•H
 eadache, dizziness
•C
 onstipation, diarrhoea, wind, being sick
(vomiting), indigestion, change in taste
• S welling due to fluid under the skin
•U
 nusual hair loss or thinning (alopecia)
•R
 ed, itchy, flaking or peeling skin
Rare (may affect up to 1 in 1000 people)
• Increases in liver function tests (shown by
blood tests)
•C
 ertain blood disorders which may increase
the risk of bleeding, bruising or infections
•R
 inging in your ears
• S evere upper stomach pain, often with
nausea and vomiting
• F ever or high temperature
Not known (frequency cannot be
estimated from the available data)
The following side effects have been
reported, however the precise frequency
cannot be identified and therefore how often
they occur is classed as unknown:
•H
 igh levels of triglycerides in the blood
(shown by blood tests)
•M
 uscle pain, painful joints
• E rection difficulties
• S ensitivity of the skin to light
•H
 earing loss (may be permanent)
• L ower levels of potassium in your blood
(shown by blood tests)
•U
 nexpected passing of urine or need to
urinate (pass water) more often
•P
 roblems with sight including blurred vision
and double vision

Reporting of side effects

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 Itraconazole capsules
Keep this medicine out of the sight and reach
of children.
Do not store above 25ºC.
Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.
Do not use this medicine if you notice visible
signs of deterioration.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

6 Contents of the pack and other

information

What Itraconazole capsules contain:
The active substance is itraconazole. Each
capsule contains 100mg of itraconazole
(I.N.N.).
The other ingredients are:
Capsule contents: sugar spheres (maize
starch and sucrose), poloxamer 188 and
hypromellose
Capsule shell: indigo carmine (E 132),
quinoline yellow (E 104), titanium dioxide
(E 171) and gelatin.

What Itraconazole capsules look like
and contents of the pack:

Itraconazole capsules is presented in the form
of hard gelatin capsules containing microgranules.
Itraconazole Capsules are opaque green and
are available in blister packs of 15 and 60s
Marketing authorisation holder:
Actavis Group PTC ehf.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður
Iceland
Manufacturer:
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial
Miralcampo
19200 Azuqueca de Henares (Guadalajara),
SPAIN
This leaflet was last revised in:
April 2016

If you would like a
leaflet with larger
text, please contact
01271 385257.
Actavis, Barnstaple, EX32 8NS, UK

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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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