ITRACONAZOLE NORMON 100 mg HARD CAPSULES

1. What Itraconazol Normon 100 mg hard capsules are and what they are used for

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

Itraconazol Normon 100 mg hard capsules are used to treat infections caused by fungi or yeasts in adults. They are used for:

• Infections of the mouth or vagina that cause “candidiasis”.
• Infections of the skin.
• Infections that affect other parts of the body.

The skin patches may take several weeks to disappear completely after finishing treatment with itraconazole capsules. The fingernails or toenails may take several months to clear up completely. This is because your skin or nail will only look normal after a new skin or nail has grown, even though the medicine has eliminated the fungus that caused the infection.

2. What you need to know before you take Itraconazol Normon

Do not take Itraconazol Normon

• 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 be pregnant unless your doctor has told you to take it (see Pregnancy and Breast-feeding).

Do not take this medicine if any of the above applies to you. If you are not sure, 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 hard capsules if:

• You have ever had kidney problems. Your dose of itraconazole may need to be changed.
• You have ever had liver problems such as yellow skin (jaundice). Your dose of itraconazole may need to be changed. If after taking this medicine you have severe loss of appetite, feel sick (nausea), are sick (vomiting), feel unusually tired, have stomach pain, muscle weakness, yellowing of the skin and the whites of the eyes, dark urine, pale stools or hair loss, stop taking itraconazole capsules and consult your doctor immediately.
• You have ever had heart problems including heart failure (congestive heart failure or CHF). Itraconazole capsules could make it worse. If after taking this medicine:
• you are short of breath,
• 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 properly.
• If you have had an allergic reaction to another antifungal product in the past.
• Itraconazole capsules are not usually given to elderly people. However, your doctor may prescribe them in special cases.

Children and adolescents

Itraconazole capsules are not usually given to children under 12 years of age. 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 with a blood test.

Using Itraconazol Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, do not take these medicines and consult your doctor if you are taking any of the following:

• Medicines for hay fever or allergy, such as terfenadine, astemizole or mizolastine.
• Medicines used to lower cholesterol, such as atorvastatin, lovastatin or simvastatin.
• Medicines used for irregular heartbeats, called quinidine, disopyramide, dronedarone or dofetilide.
• Medicines used to treat angina (chest pain) and high blood pressure, bepridil, felodipine, lercanidipine, ivabradine, ranolazine and nisoldipine.
• Medicines for migraines, dihydroergotamine and ergotamine.
• Medicines for drug abuse treatment, levacetylmethadol and methadone.
• Cisapride, for digestive problems.
• Colchicine (also in patients with kidney and liver problems) – for the treatment of gout.
• Eplerenone – a diuretic
• Ergometrine (ergonovine) and methylergometrine (methylergonovine) used after childbirth.
• Halofantrine - for the treatment of malaria.
• Irinotecan – for cancer
• Dabigatran – a blood thinner
• Ticagrelor - a blood thinner
• Quetiapine - for conditions that affect thoughts, feelings and behavior
• Aliskiren – for high blood pressure
• Dirafenacin- for urge incontinence and/or increased frequency of urination.

• Midazolam (oral) or triazolam, for anxiety or to help you sleep.
• Pimozide, lurasidone and sertindole, medicines for disorders that affect thoughts, feelings and behavior.

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

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

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

• Medicines for cancer treatment such as axitinib, dabrafenib, dasatinib, ibrutinib, lapatinib, nilotinib, sunitinib or trabectedin.
• Colchicine – for the treatment of gout
• Ebastine – for allergy
• Eletriptan – for migraine headaches
• Everolimus – usually given after an organ transplant
• Fentanyl – a strong pain reliever
• Rivaroxaban – a blood thinner
• Salmeterol – for asthma and other respiratory problems
• Tamsulosin – for urinary incontinence in men
• Vardenafil – for erection problems
• Ciclesonide – usually given after an organ transplant
• Temsirolimus – usually given after an organ transplant

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

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

• Medicines for tuberculosis such as rifampicin, rifabutin and isoniazid.
• Medicines for epilepsy such as phenytoin, carbamazepine or phenobarbital.
• Medicines for the treatment of viral infections such as efavirenz or nevirapine.
• St John's Wort (a herbal medicine).

Before taking or if you are already taking any of the above medicines, consult your doctor. They may prevent itraconazole capsules from working properly.

Your doctor may need to change the dose of itraconazole capsules or the other medicines:

• Strong pain relievers such as alfentanil, buprenorphine (by injection or under the tongue) and oxycodone.
• Medicines for indigestion, stomach ulcers or heartburn may affect the production of stomach acid. There must be enough acid in the stomach to ensure that the 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 are taking medicines that stop the production of stomach acid, you should take itraconazole capsules with a non-diet cola drink.

• Medicines for anxiety to help you sleep (tranquilizers), such as buspirone, alprazolam or brotizolam.
• Medicines used in cancer treatment, such as bortezomib, busulfan, docetaxel, erlotinib, ixabepilone, trimetrexate and a group of medicines known as vinca alkaloids.
• Medicines for conditions that affect thoughts, feelings and behavior such as aripiprazole, haloperidol, perospirone, ramelteon and risperidone.
• Medicines to thin the blood (anticoagulants) such as warfarin.
• Medicines for HIV infection, such as ritonavir, darunavir, indinavir, fosamprenavir and saquinavir. (These are called antiviral protease inhibitors). Also maraviroc.
• Medicines for bacterial infections such as ciprofloxacin, clarithromycin and erythromycin.
• Medicines that act on the heart and blood vessels, such as nadolol, digoxin and cilostazol or “calcium channel blockers” such as dihydropyridines or verapamil
• Medicines for inflammation, asthma or allergies (given by mouth or injection), such as methylprednisolone, fluticasone, budesonide or dexamethasone.
• Medicines that are usually given after an organ transplant, such as cyclosporine, tacrolimus and rapamycin (also known as sirolimus).
• Medicines for an overactive bladder – fesoterodine, imidafenacin, solifenacin or tolterodine.
• Alitretinoin (by mouth) – for eczema
• Aprepitant and domperidone – for the treatment of nausea and vomiting
• Atorvastatin – to lower cholesterol
• Cinacalcet – for an overactive parathyroid gland
• Mozavaptan or tolvaptan – for low sodium levels in the blood
• Praziquantel - for the treatment of worms
• Reboxetine, for depression.
• Repaglinide or saxagliptin, for diabetes.
• Meloxicam – to reduce inflammation and pain
• Midazolam, to help you relax or sleep when given by vein.
• Sildenafil and tadalafil – for erection problems

Consult your doctor before taking or if you are already taking any of the above medicines. It may be necessary to adjust the dose of itraconazole capsules or the other medicine.

Taking Itraconazol Normon with food and drinks

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

Pregnancy, breast-feeding and fertility

• Do not take itraconazole capsules if you are pregnant unless your doctor has told you to. You must take adequate contraceptive measures to ensure that you do not become pregnant while taking this medicine.
• Itraconazole capsules remain in your body for some time after stopping treatment. After stopping treatment with itraconazole, you should continue to use a suitable 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 them and consult your doctor immediately.
• Do not breast-feed if you are taking itraconazole capsules, as small amounts of the medicine are excreted in breast milk. Ask your doctor for advice.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Itraconazol Normon 100 mg hard capsules may cause dizziness, double or blurred vision or hearing loss. If you experience these symptoms, do not drive or use machines.

Itraconazol Normon contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Itraconazol Normon 100 mg hard capsules

Follow exactly the instructions of administration of Itraconazol Normon indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Method and route of administration:

• Always take itraconazole capsules immediately after a meal, as this helps the absorption.
• Swallow the capsules whole with a little liquid.

There must be enough acid in the stomach to ensure the absorption of this medicine. Medicines for indigestion, stomach ulcers and heartburn may affect the acidity of the stomach. For this reason, you should wait two hours after taking itraconazole capsules before taking any of these other medicines. If you are taking medicines that regulate the production of stomach acid, take itraconazole capsules with a non-diet cola drink.

Frequency and duration of treatment:

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

Fungal infections of the vagina (candidiasis)

• Take 2 capsules in the morning and 2 capsules 12 hours later on a single 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 to take and for how long depending on your infection.

If you take more Itraconazol Normon than you should:

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service, Telephone 91 562 04 20.

If you forget to take Itraconazol 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 continue with your regular dosing schedule. Do not take a double dose to make up for the missed dose.

If you stop taking Itraconazol Normon

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

4. Possible Adverse Effects

Like all medicines, itraconazole Normon can cause adverse effects, although not all people suffer from them.

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

• Sudden signs of allergy such as hives, severe skin irritation, swelling of the face, lips, tongue, or other parts of the body. This can be a sign of a severe allergic reaction. This only occurs in a very small number of people.
• Severe skin disorders with peeling and/or hives with small blisters (with fever) or blistering of the skin, mouth, eyes, and genitals, with fever, chills, muscle pain, and generally not feeling well (the precise frequency of how these effects may occur is not known).
• Feeling of tingling, numbness, or weakness in the limbs (the precise frequency of how these effects may occur is not known).
• Severe lack of appetite, feeling sick (nausea), being sick (vomiting), feeling unusually tired, with abdominal pain, muscle weakness, yellowing of the skin and whites of the eyes, unusually dark urine, pale stools, or hair loss. These can be signs of a liver problem (this only occurs in a very small number of people).
• Shortness of breath, unexpected weight gain, swollen legs, feeling unusually tired, or waking up at night. These can be signs of heart failure. Shortness of breath can also be a sign of fluid in the lungs (this rarely occurs).

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

Frequent (affects less than 1 in 10 patients):

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

Infrequent (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.
• Vision problems, including blurred vision and double vision.
• Changes in taste.
• Certain blood disorders, which can increase the risk of bleeding, pain, or infection.
• Ringing in the ears.
• Hearing loss (can be permanent).
• Severe pain in the upper abdomen, often with nausea and vomiting (pancreatitis).
• Swelling due to fluid retention under the skin.
• Loss or unusual thinning of hair (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 Adverse Effects

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

5. Storage of Itraconazole Normon 100 mg Capsules

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Do not use this medicine if it shows visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Itraconazole Normon 100 mg Capsules

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

The other ingredients are:

Capsule content: sugar spheres (cornstarch and sucrose), poloxamer 188, and hypromellose.

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

Appearance of the Product and Package Contents

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

Packaging of 4, 6, 7, 14, 15, 16, 18, 28, 30, 32, and 60 capsules. Packaging of 100 capsules for hospitals.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

LABORATORIOS NORMON, S.A.

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

Manufacturer:

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial 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 under the following names:

Germany: Itraconazole Heumann 100 mg hard capsules

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

Spain: Itraconazole Normon 100 mg hard capsules EFG

Hungary: Itraconazole Universal Farma 100 mg hard capsules

Poland: Ipozumax, 100 mg, hard capsules

Portugal: Itraconazole Fungizol 100 mg capsules

United Kingdom: Itraconazole 100 mg Capsules

Czech Republic: CONISOR 100 MG HARD CAPSULES Slovak Republic: Prokanazol 100 mg

Date of the last revision of this leaflet: May 2020

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