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ITRACONAZOLE100 MG CAPSULES HARD

Active substance(s): ITRACONAZOLE

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Itraconazole 100mg capsules
containing Itraconazole
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.

following organ transplantation
- Certain HIV Protease inhibitors (ritonavir, indinavir, saquinavir)
- Carbamazepine, rapamycin, alfentanil, alprazolam.
- Certain drugs used to treat cancer
- Certain anti-anxiety drugs, especially buspirone and alprazolam.
- Halofantrine – used for malaria.
Proper absorption of itraconazole by the human body requires an
adequate level of acidity. Therefore, drugs that inhibit stomach acid
must not be taken for a period of two hours preceding itraconazole.
For the same reason, if you are taking medication to decrease the
formation of stomach acids, take itraconazole with a cola drink.
Bear in mind that these instructions may also apply to medication you
took before or may take after.

In this leaflet:
1. What Itraconazole 100 mg capsules are and what they are
used for
2. Before you take Itraconazole 100 mg capsules
3. How to take Itraconazole 100 mg capsules
4. Possible side effects
5. How to store Itraconazole 100 mg capsules
6. Further information

Pregnancy:
Ask your doctor or pharmacist for advice before taking any
medicine.

1. WHAT ITRACONAZOLE 100 mg CAPSULES ARE AND
WHAT THEY ARE USED FOR

Contraception should be used through the first normal menstrual
cycle following termination of itraconazole treatment, as the drug
can remain in the system for some time.

Itraconazole 100 mg 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
pharmaco-therapeutic 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. BEFORE YOU TAKE ITRACONAZOLE 100 mg CAPSULES
Do not take Itraconazole 100 mg capsules:
- If you are pregnant (only your doctor is in a position to decide if you
need this drug).
- If you suffer from congestive heart failure.
- If you are hypersensitive to the active ingredient or any
of the other ingredients of the formulation.
Children:
Children should not be given itraconazole, except for exceptional
situations as assessed by the doctor.
Take special care with Itraconazole 100 mg capsules:
Please inform your doctor:
- if you have any type of liver disease:
The dose may have to be adjusted. Consult your doctor
immediately if you show any of the following symptoms when
taking itraconazole: lack of appetite, nausea, vomiting, tiredness,
abdominal pain or very dark urine.
If you are taking itraconazole continuously for periods in excess of
one month your doctor may ask for regular blood tests.
The purpose of these tests is to check for the appearance
of very rare liver problems resulting from drug use.
If you have any type of kidney disease.
The dose may have to be adjusted
- if you have a history of any reaction to antifungal medication.
- if you have Acquired Immunodeficiency Syndrome (AIDS)
or your immune system is not working as well as it should.
Taking other medicines:
Please inform your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

Do not take Itraconazole 100 mg capsules if you are pregnant.
Women of childbearing age who may become pregnant must use
proper contraception to ensure they do not get pregnant while
under treatment with itraconazole.

Breast-feeding:
Ask your doctor or pharmacist for advice before taking any
medicine.
Inform your doctor if you are breast-feeding and are prescribed
Itraconazole 100 mg capsules, as small amounts of the drug may
be present in milk.
Taking Itraconazole 100 mg capsules with food and drink
For maximum drug absorption itraconazole should be taken
immediately following a meal.
Driving and using machines:
Itraconazole 100 mg capsules can sometimes cause dizziness, blurred/
double vision or hearing loss. If you have these symptoms do not drive
or use machines.
Important information about some of the ingredients of
Itraconazole:
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.

3. HOW TO TAKE ITRACONAZOLE 100 mg CAPSULES
Always take Itraconazole exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
Method and route of administration:
Itraconazole must be taken immediately following a meal for
optimum absorption. Capsules should be swallowed 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
INFECTION

CAPSULES
PER DAY

DURATION

Vaginal
Infections

2 capsules (200
mg itraconazole)
twice a day or

1 day

2 capsules (200
mg itraconazole)
once a day

3 days

2 capsules (200
mg itraconazole)
once a day or

7 days

1 capsule (100
mg itraconazole)
once a day

2 weeks

Examples of drugs that should never be taken with itraconazole
include:
- Certain allergy medications, especially terfenadine,
astemizole and mizolastine
- Cisapride, a drug used to treat certain digestive problems
- Certain cholesterol lowering drugs such as, for example,
atorvastatin, simvastatin and lovastatin
- Sleep inducing drugs midazolam and oral triazolam
- Pimozide and sertindole, drugs to treat psychotic conditions
- Cardiac arrhythmia drugs quinidine and dofetilide
- Medicines used to treat angina (crushing chest pain) and
high blood pressure called bepridil and nisoldipine
- Medicines for migraine headaches called eletriptan,
dihydroergotamine and ergotamine
- Ergometrine (ergonovine) and methyl-ergometrine
(methylergonovine) - used after giving birth
- Levacetylmethadol - for treatment of drug abuse
(opioid-dependency)

Skin Infections

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 (200 mg
itraconazole) twice a day for 7
days or 1 capsule (100 mg
itraconazole) once a day for
one month

Certain drugs can drastically decrease the action of itraconazole.
This is particularly true of certain drugs used to treat epilepsy
(carbamazepine, phenytoin and phenobarbital) and tuberculosis
(rifampicin, riphabutin and isoniazid).
Inform your doctor if you are taking any of these drugs so that proper
measures may be taken.
Examples of drug combinations that may require adjusting the
dose of itraconazole or of the other drugs:
- Antibiotics clarithromycin and erythromycin
- Antineoplastic agents
- Certain drugs that act on the heart and blood vessels
(digoxin, disopyramide and some calcium channel blockers)
- Certain drugs used to regulate blood circulation
- Methylprednisolone, an oral or injectable anti-inflammatory
- Cyclosporin A, tacrolimus and rapamycin, normally used

Infections of the
mouth

1 capsule (1010 mg
itraconazole)
once a day

2 weeks

Infections of the
internal organs

Higher doses

Longer
periods

For nail infections, depending on your specific requirements,
you doctor may opt for continuous or pulse treatment:

TYPE OF
INFECTION

CAPSULES
PER DAY

DURATION

Continuous
nail
treatment

2 capsules (200 3 months
mg itraconazole)
once a day

Pulse nail
treatment

Week 1

Week 2

Toenails
with or
without
fingernail
involvement

Take 2
capsules (200
mg
itraconazole)
twice a day

Finger
nails
only

Take 2
capsules (200
mg
itraconazole)
twice a day

W
3

W
4

Week 5

W
6

No itraconazole

Take 2
capsules (200 mg
itraconazole)
twice a day

No itraconazole

No itraconazole

Take 2
capsules (200 mg
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 100 mg
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 100 mg capsules than you
should:
Immediately consult your doctor or pharmacist if you take more
Itraconazole 100 mg capsules than you should.
If you forget to take Itraconazole 100 mg 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 forgotten individual doses.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Itraconazole 100 mg can cause side effects,
although not everybody gets them.
Stop using Itraconazole 100 mg 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
- A tingling sensation, numbness or weakness in your limbs (the
precise frequency of how often this may occur is not known)
- 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. These may be signs of a liver problem. This only happens
in a small number of people
- 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 (the precise frequency of how often this
may occur is not known).
Tell your doctor or pharmacist if you notice any of the following
side effects:
Common (affects 1 to 10 users in 100):
- distortion or decrease of the sense of taste (dysgeusia)
Uncommon (affects 1to 10 users in 1,000):
- localised swelling (oedema)
Very rare (affects less than 1 user in 10,000):
- reduced number of white blood cells (leukopenia, neutropenia)
- reduced number of thrombocytes (thrombocytopenia)
- not enough potassium in the blood (hypokalemia)
- increase of triglycerides (a type of fat) in your blood
(hypertriglyceridemia )
- headache, dizziness
- pain, loss of sensation, and inability to control muscles
- visual disorders, including blurred or double vision (diplopia)
- ear buzzing (tinnitus)

W
7

W
8

Week 9

Week 10

Take 2 capsules
(200 mg
itraconazole)
twice a day

Suspend
treatment

- abdominal pain, vomiting, nausea, diarrhoea, uncomfortable
fullness after meals (dyspepsia), constipation
- hepatic enzyme increased
- increased sensitivity to sunlight
- muscular pain and joint pain
- frequent daytime urination, urinary incontinence
- menstrual disorders, erectile dysfunction
The following side effects have been reported, however the
precise frequency cannot be identified and therefore how often
they occur is classed as unknown:
- loss of sensitivity to pain or touch (hypoaesthesia)
- abnormal build up of fluid in the lungs, which leads to swelling
(pulmonary oedema)
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.

5. HOW TO STORE ITRACONAZOLE 100 mg CAPSULES
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Itraconazole 100 mg capsule after the expiry date
which is stated on the carton. The expiry date refers to the last
day of that month.
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. FURTHER INFORMATION
What Itraconazole capsules contains
Itraconazole 100mg capsules are presented in the form of hard
gelatin capsules containing micro-granules.
- The active substance is itraconazole. Each capsule contains
100 mg of itraconazole
- 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 100 mg capsules looks like and contents
of the pack
The product is available in blister packs of 15 or 28 capsules.
Not all pack sizes may be marketed.
Marketing authorisation holder:
UNIVERSAL FARMA, S.L.
Gran Via Carlos III, 98,
7th floor
08028 Barcelona
Spain
Manufacturer:
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), SPAIN
Distributed by:
Creo Pharma Ltd
Felsted Business Centre
Felsted, Essex, CM6 3LY
This leaflet was last approved in April 2011.

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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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