PROSPECTO: INFORMATION FOR THE USER

Itraconazole Normon 100 mg Hard Capsules EFG

Itraconazole

Read this prospectus carefully before starting to take this medicine because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

3. How to take Itraconazole Normon 100 mg Capsules

4. Possible adverse effects

5. Storage of Itraconazole Normon 100 mg Capsules

6. Contents of the package and additional information

Itraconazol Normon 100 mg capsules contain the active ingredient called itraconazol. It belongs to a group of medicines called “antifungals”.

Itraconazol Normon 100 mg capsules is indicated for fungal or yeast infections in adults. It is used for:

• Mouth or vaginal infections that cause “candidiasis”.
• Skin infections.
• Infections that affect other parts of the body.

Skin lesions may take several weeks to completely disappear after completing treatment with itraconazol capsules. Fingernails or toenails may take several months to completely clear up. This is because the skin or nail will only appear normal once new skin or nail has grown, despite the fact that the medicine eliminated the fungus causing the infection.

Do not take Itraconazol Normon

• If you are allergic to itraconazole or any of the other components of this medication (listed in section 6)
• If you are pregnant or may be pregnant, unless your doctor has told you to (see Pregnancy and Breastfeeding)

Do not take this medication if any of the above circumstances apply to you. If you are unsure, consult your doctor or pharmacist before taking itraconazole capsules.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Itraconazol Normon 100 mg capsules if:

• If you have ever had kidney problems. Your itraconazole dose may be adjusted.
• If you have ever had liver problems such as yellow skin (jaundice). Your itraconazole dose may be adjusted. If after taking this medication you have severe loss of appetite, feel sick (nausea), are vomiting, feel unusually tired, have abdominal pain, muscle weakness, yellow skin and white of the eyes, dark urine, pale stools, or hair loss, stop taking itraconazole capsules and consult your doctor immediately.
• If you have ever had heart problems, including congestive heart failure (CHF). Itraconazole capsules may worsen it. If after taking this medication:
• You have difficulty breathing,
• You gain weight unexpectedly,
• Your legs are swollen,
• You feel unusually tired
• You start waking up at night,

Stop taking itraconazole capsules and consult your doctor immediately. These may be signs of heart failure.

• If you have AIDS or your immune system is not working as well as it should.
• If you have had an allergic reaction to another antifungal product in the past.
• Itraconazole capsules are not usually given to older people. However, your doctor may prescribe them in special cases.

Children and Adolescents

Itraconazole capsules are not usually given to children under 12 years old. However, your doctor may prescribe them in special cases.

Blood Tests

If you take itraconazole capsules for more than a month, your doctor may want to check your liver through a blood test.

Use of Itraconazol Normon with Other Medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take these medications and consult your doctor if you are taking any of the following::

• Medications for hay fever or allergies, such as terfenadine, astemizol, or mizolastina.
• Medications used to lower cholesterol, such as atorvastatina, lovastatina, or simvastatina.
• Medications used to treat irregular heartbeat, known as quinidina, disopiramida, dronedarona, or dofetilida.
• Medications used to treat angina (oppressive chest pain) and high blood pressure, bepridil, felodipino, lercanidipino, ivabradina, ranolazina, and nisoldipino.
• Medications for migraines, dihidroergotamina, and ergotamina.
• Medications for drug abuse, levacetilmetadol, and metadona.
• Cisaprida, for digestive problems.
• Colchicina (also in patients with kidney and liver problems) – for gout treatment.
• Eplerenona – a diuretic
• Ergometrina (ergonovina) and metil-ergometrina (metilergonovina) used after delivery.
• Halofantrina - for malaria treatment.
• Irinotecan – for cancer
• Dabigatrán – a medication to thin the blood
• Ticagrelor - a medication to thin the blood
• Quetiapina - for conditions affecting thoughts, feelings, and behavior
• Aliskirén – for high blood pressure
• Dirafenacina- for urinary incontinence and/or increased urination frequency.

- Midazolam (oral) or triazolam, for anxiety or to help sleep.

- Pimozida, lurasidona, and sertindol, medications for alterations affecting thoughts, feelings, and behavior.

If you are taking any of the medications listed above, do not start taking itraconazole capsules and consult your doctor.

Additionally, after completing your treatment with itraconazole capsules, do not take any of the medications listed above for 2 weeks.

Consult your doctor if you are already taking any of the following medications, as they are not recommended with itraconazole capsules unless your doctor considers it necessary:

• Medications for cancer treatment such as axatinib, dabrafenib, dasatinib, ibrutinib, lapatinib, nilotinib, sunitinib, or trabectedin.
• Colchicina – for gout treatment
• Ebastina – for allergies
• Eletriptán – for migraine headaches
• Everolimus – usually administered after an organ transplant
• Fentanilo – a strong analgesic
• Rivaroxabán – a medication to thin the blood
• Salmeterol – for asthma and other respiratory problems
• Tamsulosina – for urinary incontinence in men
• Vardenafil – for erectile dysfunction
• Ciclesonida – usually administered after an organ transplant
• Temsirolimus – usually administered after an organ transplant

Additionally, after completing your treatment with itraconazole capsules, do not take any of the medications listed above for 2 weeks.

Do not take any of the following medications 2 weeks before and while taking itraconazole capsules, unless your doctor tells you otherwise:

• Medications for tuberculosis such as rifampicina, rifabutin, and isoniazida.
• Medications for epilepsy such as phenitoína, carbamazepina, or phenobarbital.
• Medications for viral infections such as efavirenz or nevirapina.
• St. John's Wort (a medicinal herb).

Consult your doctor before taking or if you are already taking any of the medications listed above. They may prevent itraconazole capsules from working correctly.

Your doctor may need to adjust the dose of itraconazole capsules or the other medication::

• Analgesics such as alfentanilo, buprenorfina (by injection or under the tongue), and oxicodona.
• Medications for indigestion, stomach ulcers, or acid reflux may affect stomach acid production. You need enough acid in your stomach to ensure your body can use the medication. Therefore, you should wait two hours after taking itraconazole before taking any of these other medications. If you take medications that stop stomach acid production, you should take itraconazole capsules with a cola drink (not diet).

• Medications for anxiety to help sleep (tranquilizers), such as buspirona, alprazolam, or brotizolam.
• Medications used in cancer treatment, such as bortezomib, busulfán, docetaxel, erlotinib, ixabepilona, trimetrexato, and a group of medications known as vinca alkaloids.
• Medications for conditions affecting thoughts, feelings, and behavior, such as aripiprazol, haloperidol, perospirona, ramelteón, and risperidona.
• Medications to thin the blood (anticoagulants) such as warfarina.
• Medications for HIV infection, such as ritonavir, darunavir, indinavir, fosamprenavir, and saquinavir. (They are called protease inhibitors). Also, maraviroc.
• Medications for bacterial infections such as ciprofloxacino, claritromicina, and eritromicina.
• Medications that act on the heart and blood vessels, such as nadolol, digoxina, and cilostazol or "calcium channel blockers" such as dihidropiridinas or verapamilo
• Medications for inflammation, asthma, or allergies (administered by mouth or injection), such as metilprednisolona, fluticasona, budesonida, or dexametasona.
• Medications usually used after an organ transplant, such as ciclosporina, tacrolimus, and rapamicina (also known as sirolimus).
• Medications for overactive bladder – fesoterodina, imidafenacina, solifenacina, or tolterodina.
• Alitretioína (by mouth) – for eczema
• Aprepitant and domperidona – for nausea and vomiting treatment
• Atorvastatina – to lower cholesterol
• Cinacalcet – for an overactive parathyroid gland
• Mozavaptan or tolvaptan – for low sodium levels in the blood
• Praziquantel - for tapeworm treatment
• Reboxetina, for depression.
• Repaglinida or saxagliptin, for diabetes.
• Meloxicam – to reduce inflammation and pain
• Midazolam, to help relax or sleep when administered through a vein.
• Sildenafil and taladafil – for erectile dysfunction

Consult your doctor before taking or if you are taking any of the medications listed above. You may need to adjust the dose of itraconazole capsules or the other medication.

Taking Itraconazol Normon with Food and Drinks

Take itraconazole capsules after a meal as it helps your body use the medication.

Pregnancy, Breastfeeding, and Fertility

• Do not take itraconazole capsules if you are pregnant, unless your doctor tells you to. You should take adequate contraceptive measures to ensure you do not become pregnant while on treatment with this medication.
• Itraconazole capsules remain in the body for some time after treatment is stopped. Once treatment with itraconazole is completed, you should continue using a useful contraceptive method until your next menstrual period.Consult your doctor about which contraceptive method to use.
• If you become pregnant after starting treatment with itraconazole capsules, stop taking it and consult your doctor immediately.
• Do not breastfeed while taking itraconazole capsules, as small amounts of the medication are excreted in breast milk. Ask your doctor for advice.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Operating Machines

Itraconazole capsules may cause dizziness, double vision, or hearing loss in some cases. If you have these symptoms, do not drive or operate machines.

Itraconazol Normon contains sacarose

This medication contains sacarose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for itraconazole Normon as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Method and route of administration:

• Take itraconazole capsules always immediately after meals, as this helps with its absorption.
• Swallow the capsules whole with a little liquid.

There must be sufficient acidity in the stomach to ensure the absorption of this medication. Medications for indigestion, stomach ulcers, and stomach acid can affect stomach acidity. For this reason, wait two hours after taking itraconazole capsules before taking any of these medications. If you are taking medications that regulate the production of acid in the stomach, take itraconazole capsules with a cola drink.

Frequency and duration of treatment:

Your doctor will tell you how many itraconazole capsules you should take and for how long. The recommended dose is:

Fungal infections of the vagina (vaginal candidiasis)

• Take 2 capsules in the morning and 2 capsules 12 hours later on the same day.

Fungal infection of the mouth (oral candidiasis)

• Take 1 capsule per day for 15 days.

Fungal skin infections

The dose depends on the infection. Your doctor may tell you to take:

• 2 capsules per day for 7 days, or
• 1 capsule per day for 15 days, or
• 1 capsule per day for 30 days

Fungal infections in other parts of the body

Your doctor will tell you how many itraconazole capsules you should take and for how long, depending on your infection.

If you take more itraconazole Normon than you should:

Inform your doctor immediately if you have taken more Itraconazole Normon than you should.

In case of overdose or accidental ingestion, consult theToxicology Information Service, Phone 91 562 04 20.

If you forget to take itraconazole Normon:

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and follow your normal dosing schedule. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Itraconazole Normon

Continue taking Itraconazole Normon for as long as your doctor has told you to. Do not stop treatment just because you feel better.

Like all medicines, itraconazol Normon may cause side effects, although not everyone will experience them.

Stop taking itraconazol capsules and consult your doctor immediately if you notice or suspect any of the following side effects. You may need urgent medical treatment:

• Signs of sudden allergy such as hives, severe skin irritation, swelling of the face, lips, tongue, or other parts of the body. This may be a sign of a severe allergic reaction. This only occurs in a very small number of people.
• Severe skin changes with peeling and/or hives with small pustules (with fever) or blistering on the skin, mouth, eyes, and genitals, with fever, chills, muscle pain, and generally feeling unwell (the exact frequency of how these side effects may occur is not known).
• Feeling of tingling, numbness, or weakness in the limbs (the exact frequency of how these side effects may occur is not known).
• Severe loss of appetite, feeling sick (nausea), being sick (vomiting), feeling unusually tired, with abdominal pain, muscle weakness, yellow skin and eye whites, dark urine, pale stools, or hair loss. These may be signs of liver problems, (This only occurs in a very small number of people.
• Shortness of breath, unexpected weight gain, swollen legs, feeling unusually fatigued, or starting to wake up at night. These may be signs of heart failure. Shortness of breath may also be a sign of fluid in the lungs (this rarely occurs).

Consult your doctor or pharmacist if you notice any of the following side effects:

Frequent (affects less than 1 in 10 patients):

• Stomach pain and feeling sick (nausea).
• Headache.

Rare (affects less than 1 in 100 patients):

• Menstrual problems.
• Sinusitis, nasal discharge, cough, and colds.
• Constipation, diarrhea, gas, being sick (vomiting), indigestion

Rare (affects less than 1 in 1000 patients):

• Increased liver function tests (shown by blood tests).
• Unexpected loss of urine or need to urinate more frequently.
• Visual problems, including blurred vision and double vision.
• Changes in taste.
• Certain blood changes, which may increase the risk of bleeding, pain, or infection
• Tinnitus.
• Permanent hearing loss.
• Severe pain in the upper stomach, often with nausea and vomiting (pancreatitis)
• Swelling due to fluid retention under the skin.
• Unusual hair loss (alopecia).
• Red skin, with itching or peeling
• High levels of triglycerides in the blood (shown by blood tests)
• Sensitivity of the skin to light
• Difficulty with erection

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging after "Cad." The expiration date is the last day of the month indicated.

Do not use this medication if you have visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Itraconazol Normon 100 mg capsules

The active ingredient is itraconazole. Each capsule contains 100 mg of itraconazole.

The other components are:

Content of the capsule: sugar spheres (cornstarch and sucrose), poloxamer 188 and hypromellose.

Capsule coating: indigo carmine (E 132), yellow quinoline (E 104), titanium dioxide (E 171) and gelatin.

Appearance of the product and content of the container

Itraconazol NORMON 100 mg capsules are presented in the form of hard gelatin capsules containing microgranules.

Containers of 4, 6, 7, 14, 15, 16, 18, 28, 30, 32 and 60 capsules. Hospital containers of 100 capsules.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo – 19200 Azuqueca de Henares – Guadalajara (SPAIN)

HEUMANN PHARMA GMBH & CO. GENERICA KG

Südwestpark 50 · 90449 Nürnberg

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Itraconazole Heuman 100 mg Hard Capsules

Bulgaria: Itraconazole Fungizol 100 mg,??????

Spain: Itraconazol Normon 100 mg hard capsules EFG

Hungary: Itraconazole Universal Farma 100 mg hard capsule

Poland: Ipomezumax, 100 mg, hard capsules

Portugal: Itraconazole Fungizol 100 mg capsules

United Kingdom: Itraconazole 100 mg Capsules

Czech Republic: CONISOR 100 MG HARD CAPSULESRepublic of Slovakia: Prokanazol 100 mg

Last review date of this leaflet:May 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es