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ITRACONAZOLE100 MG CAPSULES HARD

Active substance(s): ITRACONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Itraconazole 100 mg capsules
containing Itraconazole
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 100 mg capsules is and what it is used for
2. What you need to know 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. Contents of the pack and other information
1. WHAT ITRACONAZOLE 100 mg CAPSULES IS AND WHAT IT IS USED FOR
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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ITRACONAZOLE 100 mg CAPSULES
Do not take Itraconazole 100 mg capsules:
- If you are allergic to itraconazole or any of the other ingredients of this medicine (listed in section 6).
- If you 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 100 mg capsules if:
- You have ever had kidney problems. Your dose of itraconazole capsules may have to be changed
- You 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
- If you 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 100 mg 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:
- Medicines for hay fever or allergy called terfenadine, astemizole or mizolastine
- Medicines to lower cholesterol called atorvastatin, lovastatin or simvastatin
- Medicines for an irregular heart beat called quinidine or 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
- Cisapride - for digestive problems
- Ergometrine (ergonovine) and methylergometrine (methylergonovine) - used after giving birth
- Levacetylmethadol - for treatment of drug abuse (opioid-dependency)
- Midazolam (by mouth) or triazolam - for anxiety or to help you sleep
- Pimozide 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:
- Medicines for tuberculosis called rifampicin, rifabutin or isoniazid
- Medicines 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.
- 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
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:
- Medicines used for anxiety or to help you sleep (tranquillisers), such as buspirone, alprazolam or brotizolam
- Medicines used in the treatment of cancer such as busulphan, docetaxel, trimetrexate and a group of medicines
known as ‘vinca alkaloids’
- Medicines to thin the blood (anticoagulants) such as warfarin
- Medicines for HIV infection such as ritonavir, indinavir and saquinivir. They are called ‘antiviral protease inhibitors’
- Medicines for bacterial infections called clarithromycin or erythromycin
- Medicines that act on the heart and blood vessels called digoxin and disopyramide, cilostazol or ‘calcium
channel-blockers’ such as dihydropyridines and verapamil
- Medicines for inflammation, asthma or allergies (given by mouth or injection) called methylprednisolone,
fluticasone, budesonide or dexamethasone
- Medicines that are usually given after an organ transplant called ciclosporin, tacrolimus or rapamycin. Another
name for rapamycin is sirolimus
- Alfentanil and fentanyl - for pain
- Ebastine - for allergy
- Halofantrine - for malaria
- Reboxetine - for depression
- Repaglinide - for diabetes
- Midazolam - 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 100 mg 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:
- Do 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
- Do not breast-feed if you are taking itraconazole capsules, as small amounts of the medicine could pass into your
milk. Ask your doctor for advice.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
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 100 mg 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.
3. HOW TO TAKE ITRACONAZOLE 100 mg 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 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.

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 a forgotten dose.
If you stop taking Itraconazole 100 mg capsules:
If you have any further questions on the use of this product, 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.
- 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
- Severe 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)
- 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 (this only happens in a small number of people).
Tell your doctor or pharmacist if you notice any of the following side effects:
Common (may affect up to 1 in 10 people)
- Stomach ache, feeling sick (nausea)
Uncommon (may affect up to 1 in 100 people)
- Problems with periods
- Headache, dizziness
- Constipation, diarrhoea, wind, being sick (vomiting), indigestion, change in taste
- Swelling due to fluid under the skin
- Unusual hair loss or thinning (alopecia)
- Red, itchy, flaking or peeling skin
Rare (may affect up to 1 in 1000 people)
- Increases in liver function tests (shown by blood tests)
- Certain blood disorders which may increase the risk of bleeding, bruising or infections
- Ringing in your ears
- Severe upper stomach pain, often with nausea and vomiting
- Fever or high temperature
The following side effects have been reported, however the precise frequency cannot be identified and therefore how
often they occur is classed as unknown:
- High levels of triglycerides in the blood (shown by blood tests)
- Muscle pain, painful joints
- Erection difficulties
- Sensitivity of the skin to light
- Hearing loss (may be permanent)
- Lower levels of potassium in your blood (shown by blood tests)
- Unexpected passing of urine or need to urinate (pass water) more often
- Problems with sight including blurred vision and double vision
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 100 mg 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. 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 100 mg capsules contains
Itraconazole 100 mg 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 (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 100 mg capsules looks like and contents of the pack
The product is available in blister packs of 4, 6, 7, 14, 15, 16, 18, 28, 32, 60 or 100 capsules, the larger packaging being for
hospital use.
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:
CRE-ITR-PIL-171_03
LABORATORIOS LICONSA, S.A.
29/07/2015
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo, 19200 Azuqueca de Henares (Guadalajara), Spain
This leaflet was last revised on: 11/2015

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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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