Itraconazole Normon 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Itraconazole Normon 100 mg Hard Capsules EFG

Itraconazole

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet Contents

1. What Itraconazole Normon 100 mg capsules are and what they are used for
2. What you need to know before taking Itraconazole Normon 100 mg capsules
3. How to take Itraconazole Normon 100 mg capsules
4. Possible adverse effects
5. How to store Itraconazole Normon 100 mg capsules
6. Contents of the pack and other information

1. What Itraconazol Normon 100 mg capsules is and what it is used for

Itraconazol Normon 100 mg capsules contain the active substance called itraconazole. It belongs to a group of medicines known as "antifungals".

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

• Infections of the mouth or vagina causing "candidiasis".
• Skin infections.
• Infections affecting other parts of the body.

Skin spots may take several weeks to completely disappear after completing your treatment with itraconazole capsules. Fingernails and toenails may take several months to fully clear. This is because your skin or nail will only appear normal once 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 starting to take Itraconazol Normon

Do not take Itraconazol Normon

• If you are allergic (hypersensitive) to itraconazole or to any of the other components of this medicine (listed in section 6)

• If you are pregnant, think you may be pregnant, or could become pregnant unless your doctor has instructed you otherwise (see Pregnancy and Breastfeeding)

• If you have a serious heart condition called heart failure (also known as congestive heart failure or CHF), unless your doctor has instructed you otherwise (see Special caution with itraconazole capsules)

Do not take this medicine if you are in any of the situations listed above. If you are unsure, consult your doctor or pharmacist before starting to take itraconazole capsules.

Inform your doctor if you are taking any medication before taking itraconazole capsules.

Do not use itraconazole capsules if you are taking any of the following medicines or within 2 weeks after stopping itraconazole.

Medicines for heart, blood or circulation problems

• aliskiren, eplerenone, lercanidipine or nisoldipine (for high blood pressure)
• bepridil, ivabradine or ranolazine (for angina – chest pain)
• dabigatran or ticagrelor (for blood clots)
• disopyramide, dofetilide, dronedarone or quinidine (for irregular heartbeat)
• finerenone (for kidney problems in patients with type 2 diabetes)
• lomitapide, lovastatin or simvastatin (to lower cholesterol)
• sildenafil (for pulmonary arterial hypertension)

Medicines for stomach problems or constipation

• cisapride (for stomach disorders)
• domperidone (for nausea and vomiting)
• naloxegol (for constipation caused by opioid painkillers)

Medicines for headaches, sleep or mental health problems

• dihydroergotamine or ergotamine (ergot alkaloids used for migraines)
• midazolam (oral) or triazolam (for sedation or sleep induction)
• lurasidone, pimozide, quetiapine or sertindole (for schizophrenia, bipolar disorder or other mental health disorders)

Medicines for urinary problems

• darifenacin (for urinary incontinence)
• fesoterodine or solifenacin (for overactive bladder) when used in patients with certain kidney or liver problems

Medicines for allergies

• astemizole, mizolastine or terfenadine (for allergies)

Medicines for erection and ejaculation problems

• avanafil (for erectile dysfunction)
• dapoxetine (for premature ejaculation)
• vardenafil (for erectile dysfunction) when used in men over 75 years of age

Other medicines containing:

• colchicine (for gout) when used in patients with kidney or liver problems
• ergometrine (ergonovine) or methylergometrine (methylergonovine) ergot alkaloids used after childbirth
• eliglustat (for Gaucher disease) when used in patients who cannot metabolize certain medicines
• halofantrine (for malaria)
• irinotecan (for cancer)
• isavuconazole (for fungal infections)
• ombitasvir/paritaprevir/ritonavir with or without dasabuvir (for treating hepatitis C)
• venetoclax (for chronic lymphocytic leukemia) when you start taking venetoclax for the first time or when increasing doses at the beginning of treatment

Remember: do not take any of the above medicines within 2 weeks after your last dose of itraconazole capsules.

Warnings and precautions

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

• You have ever had kidney problems. Your itraconazole dose may need to be adjusted.
• You have ever had liver problems such as yellowing of the skin (jaundice). Your itraconazole dose may need to be adjusted. If after taking this medicine you experience severe loss of appetite, feel sick (nausea), are sick (vomiting), feel unusually tired, have abdominal 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 contact your doctor immediately.
• You have ever had heart problems including heart failure (congestive heart failure or CHF). Itraconazole capsules could worsen it. If after taking this medicine:
• you become short of breath,
• gain weight unexpectedly,
• have swollen legs,
• feel unusually fatigued,
• start waking up at night,

stop taking itraconazole capsules and contact your doctor immediately. These may be signs of heart failure.

• You have acquired immunodeficiency syndrome (AIDS) or your immune system is not working properly.
• You have had an allergic reaction to another antifungal medicine in the past.
• Itraconazole capsules are usually not given to elderly people. However, your doctor may prescribe them in special cases.
• You have cystic fibrosis.
• You have hearing problems. In very rare cases, temporary or permanent hearing loss has occurred in patients taking medicines containing itraconazole.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before taking itraconazole capsules.

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.

Elderly

Itraconazole capsules are usually not given to elderly people. However, your doctor may prescribe them in special cases.

Blood tests

If you take itraconazole capsules for more than one month, your doctor may want to monitor your liver function with blood tests.

Taking Itraconazol Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription or herbal remedies. There are medicines you must not take while taking itraconazole. These medicines are listed above under the heading “Do not take itraconazole capsules”.

The use of certain medicines with itraconazole capsules is not recommended. Your doctor may decide that you should not take some medicines at the same time as itraconazole capsules or within 2 weeks after stopping them.

Examples of these medicines are:

Medicines for heart, blood or circulation problems

• apixaban, edoxaban, rivaroxaban or vorapaxar (for blood clots)
• atorvastatin (to lower cholesterol)
• felodipine (for high blood pressure)
• riociguat or tadalafil (for pulmonary hypertension)

Medicines for epilepsy, headaches or mental health problems

• phenytoin, carbamazepine or phenobarbital (antiepileptics)
• eletriptan (for migraines)
• St. John’s wort (Hypericum perforatum) (a herbal medicine used for mental health problems)

Medicines for urinary problems

• tamsulosin (for male urinary incontinence)
• tolterodine (for overactive bladder)

Medicines for cancer

• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedin, trastuzumab emtansine, venetoclax (when you are on a stable dose of venetoclax for chronic lymphocytic leukemia, or at any time during treatment for acute myeloid leukemia) or vinca alkaloids (such as vinflunine, vinorelbine)

Medicines for tuberculosis

• bedaquiline, isoniazid, rifabutin or rifampicin (for tuberculosis)

Medicines for human immunodeficiency virus (HIV) or hepatitis

• efavirenz or nevirapine (for HIV/AIDS)
• elbasvir/grazoprevir, tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) (for HIV or hepatitis)

Medicines used after organ transplant

• everolimus, rapamycin (also known as sirolimus), temsirolimus

Medicines for benign enlargement of the prostate

• alfuzosin, silodosin

Medicines for lung problems or allergies

• ciclesonide (for inflammation, asthma and allergies)
• ebastine (for allergies)
• salmeterol (for asthma or chronic obstructive pulmonary disease, COPD)

Medicines for erection and ejaculation problems

• tadalafil or vardenafil (when used in men aged 75 years or younger) (for erectile dysfunction)

Other medicines containing:

• colchicine (for gout)
• fentanyl (for pain)
• lumacaftor/ivacaftor (for cystic fibrosis)

Remember: do not take any of the above medicines within 2 weeks after your last dose of itraconazole capsules.

This list is not complete, so you must inform your doctor if you are taking or plan to take any of these medicines or any other medicine.

Caution is required when using itraconazole capsules with certain medicines.

You may be more likely to experience side effects, or the dose of itraconazole capsules or the other medicine may need to be adjusted. Examples of these medicines are:

Medicines for heart, blood or circulation problems

• bosentan (for pulmonary hypertension)
• calcium channel blockers such as dihydropyridines, including amlodipine, isradipine, nifedipine, nimodipine or diltiazem (for high blood pressure)
• or verapamil (for high blood pressure)
• cilostazol (for circulatory problems)
• “Coumarins” such as warfarin (for blood clots)
• digoxin (for atrial fibrillation)
• nadolol (for pulmonary hypertension or angina)

Medicines for stomach problems or diarrhoea

• aprepitant or netupitant (for nausea and vomiting during cancer treatment)
• loperamide (for diarrhoea)
• antacids such as aluminium, calcium, magnesium, or sodium bicarbonate; H2-receptor antagonists such as cimetidine, ranitidine and proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (to treat stomach acid problems)

Medicines for sleep or mental health disorders

• alprazolam, brotizolam, buspirone or midazolam (when injected into a vein) (for anxiety or sleep induction)
• zopiclone (for sleep induction)
• reboxetine or venlafaxine (for depression and anxiety)
• aripiprazole, cariprazine, haloperidol or risperidone (for schizophrenia, bipolar disorder or other mental health problems)
• galantamine (for Alzheimer’s disease)
• guanfacine (for attention deficit hyperactivity disorder)

Medicines for urinary problems

• imidafenacina, fesoterodine, oxybutynin, solifenacin (for overactive bladder)

Medicines for cancer

• bortezomib, brentuximab vedotin, busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, pemigatinib, ponatinib, ruxolitinib, sonidegib or tretinoin (oral)

Medicines for infections

• ciprofloxacin, clarithromycin or erythromycin (for bacterial infections)
• delamanid (for tuberculosis)
• artemether-lumefantrine or quinine (for treating malaria)
• praziquantel (for worms and tapeworms)

Medicines for human immunodeficiency virus (HIV) or hepatitis

• cobicistat, elvitegravir boosted with ritonavir, maraviroc, ritonavir, darunavir boosted, fosamprenavir boosted with ritonavir, indinavir or saquinavir boosted with ritonavir (for HIV)
• glecaprevir/pibrentasvir (for hepatitis)

Medicines used after organ transplant

• ciclosporin or tacrolimus

Medicines for benign enlargement of the prostate

• dutasteride

Medicines for lung problems, allergies or inflammatory conditions

• bilastine or rupatadine (for allergy)
• methylprednisolone or dexamethasone (oral or injectable medicines for asthma, allergies or inflammatory conditions)
• budesonide or fluticasone (for asthma, allergies)

Medicines for erection and ejaculation problems

• sildenafil (for erectile dysfunction)

Medicines for pain

• alfentanil, buprenorphine, oxycodone or sufentanil (for pain)
• meloxicam (for inflammation and joint pain)

Other medicines containing:

• alitretinoin (oral) (for eczema)

• cabergoline (for Parkinson’s disease)

• cannabis-based products, including medicines (for nausea and vomiting or muscle spasms in patients with multiple sclerosis)

• cinacalcet (for overactive parathyroid function)

• dienogest or ulipristal (contraceptives)

• eliglustat (for Gaucher disease) when used in patients who cannot metabolize certain medicines

• ivacaftor (for cystic fibrosis)

• methadone (for drug addiction)

• repaglinide or saxagliptin (for diabetes)

• This list is not complete, so you must inform your doctor if you are taking or plan to take any of these medicines, or any other medicine. The dose of itraconazole capsules or your other medicine may need to be adjusted.

Taking Itraconazol Normon with food and drinks

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

Patients with low stomach acid (achlorhydria), some patients with AIDS, or patients taking medicines to reduce gastric acid secretion (e.g., H2 antagonists, proton pump inhibitors) should take Itraconazol Normon capsules with an acidic drink, for example, a non-diet cola drink.

Pregnancy, breastfeeding and fertility

• Do not take itraconazole capsules if you are pregnant unless your doctor instructs you to do so. You must use adequate contraceptive measures to ensure you do not become pregnant while being treated with this medicine.
• Itraconazole capsules remain in the body for some time after stopping treatment. After completing treatment with itraconazole, you should continue using an effective 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 contact your doctor immediately.
• Do not breastfeed while taking itraconazole capsules, as small amounts of the medicine are excreted in breast milk. Seek advice from your doctor.

Consult your doctor or pharmacist before taking any medicine if you are pregnant or breastfeeding.

If you are of childbearing age and could become pregnant, consult your doctor. Use effective contraception to ensure you do not become pregnant while taking this medicine.

Driving and using machines

Itraconazole capsules may occasionally cause dizziness, double/blurred vision or hearing loss. If you experience these symptoms, do not drive or operate machinery.

Itraconazol Normon contains sucrose (sugar)

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

3. How to take Itraconazol Normon 100 mg capsules

Follow exactly the administration instructions for itraconazol Normon provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Method and route of administration:

• Always take itraconazol capsules immediately after meals, as this enhances absorption.
• Swallow the capsules whole with some liquid.
• Sufficient stomach acidity is required to ensure proper absorption of this medicine. Medications for indigestion, stomach ulcers, and heartburn may affect stomach acidity. For this reason, you should wait two hours after taking itraconazol capsules before taking any of these medications.
• If you are taking medicines that regulate stomach acid production, take itraconazol capsules together with a non-diet cola drink.

Your doctor will tell you how many itraconazol capsules you should take and for how long.

The recommended dose in adults is:

Superficial fungal infections
Indications	Dosage	Duration of treatment
Vaginal infection	2 capsules twice daily or 2 capsules once daily	1 day 3 days
Skin fungal infections	2 capsules once daily or 1 capsule once daily	7 days or 2 weeks
Oral candidiasis	100 mg once daily	15 days
Fungal infections of palms and soles	100 mg once daily or 200 mg twice daily	30 days or 7 days
Pityriasis versicolor	2 capsules once daily	7 days
Fungal keratitis	2 capsules once daily	21 days The duration of treatment should be adjusted according to clinical response.

Fungal nail infections
Intermittent pulse treatment (with interruptions)	Dosing regimen and duration of treatment
	The pulse treatment consists of the following administration regimen: 2 hard capsules (equivalent to 400 mg of itraconazole per day) twice daily for one week. Pulse treatments are always separated by three-week intervals without treatment (see table below). Clinical response will become evident with nail growth, after discontinuation of treatment.
Site of fungal nail infection Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails, with or without fingernail involvement First pulse cycle No itraconazole treatment Second pulse cycle No itraconazole treatment Third pulse cycle Fingernails only First pulse cycle No itraconazole treatment Second pulse cycle

Fungal nail infections
Continuous treatment (without interruptions)	Dosage	Duration of treatment
	2 capsules once daily (equivalent to 200 mg per day)	3 months (a shorter duration may be sufficient if only fingernails are affected).

Systemic Mycoses
Indications	Dosage	Duration of treatment1	Observations
Aspergillosis	200 mg once daily	2–5 months	In patients with invasive or disseminated disease, increase dosage to 200 mg twice daily
Candidiasis	100–200 mg once daily	3 weeks–7 months	In case of invasive or disseminated disease, increase to twice daily (morning and evening), 2 hard capsules (equivalent to 400 mg of itraconazole per day)
Non-meningeal cryptococcosis	200 mg once daily	2 months–1 year	Maintenance therapy
Cryptococcal meningitis	200 mg twice daily (morning and evening)	2 months–1 year
Histoplasmosis	200 mg once daily or 200 mg twice daily (morning and evening)	8 months
Blastomycosis	100 mg once daily or 200 mg twice daily	6 months
Extracutaneous sporotrichosis	200 mg twice daily	12 months
Lymphocutaneous and cutaneous sporotrichosis	100 mg or 200 mg once daily (localized lesions) or 200 mg twice daily (morning and evening) (extensive lesions)	3–6 months
Paracoccidioidomycosis	100 mg once daily	6 months	There are no data available on the efficacy of itraconazole capsules at the indicated doses for the treatment of paracoccidioidomycosis in patients with AIDS.
Chromoblastomycosis	100 or 200 mg once daily	6 months

Skin infections:

With skin infections, lesions will disappear a few weeks after completing treatment with itraconazol capsules. This is characteristic of fungal spots: the medication eliminates the fungus itself, but the lesion does not disappear until new skin has grown.

Nail infections:

In the case of nail infections, lesions will disappear 6 to 9 months after completing treatment with itraconazol capsules, since the medication only eliminates the fungus itself. The nail requires time to regrow after the fungus has been eradicated from the infected nail, and this process takes several months. Therefore, do not be concerned if you do not notice improvement during treatment: the medication remains in your nails for several months and fulfills its purpose. Thus, you must stop treatment at the time indicated by your doctor, even if you do not see any improvement.

Internal organ infections:

Higher doses of itraconazol capsules and prolonged treatment duration may be required. Always follow your doctor's instructions, as he or she will adapt the treatment to your individual needs.

Use in children

The use of itraconazol capsules is not recommended in children unless specifically indicated by a physician.

Use in elderly patients

The use of itraconazol capsules is not recommended in elderly patients unless specifically indicated by a physician.

If you take more Itraconazol Normon than you should:

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 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 your 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 interrupt treatment with Itraconazol Normon:

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

4. Possible adverse effects

Like all medicines, itraconazol Normon may produce adverse effects, although not everyone experiences them.

Stop taking itraconazol 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 may be a sign of a severe allergic reaction. This occurs only in a very small number of people.
• Severe skin reactions with peeling and/or hives with small pustules (with fever) or blistering of the skin, mouth, eyes and genitals, accompanied by fever, chills, muscle pain and generally feeling unwell (this rarely occurs). Tingling, numbness or weakness in the limbs (this rarely occurs).
• Severe loss of appetite, feeling sick (nausea), being sick (vomiting), feeling unusually tired, abdominal pain, muscle weakness, yellowing of the skin and whites of the eyes, unusually dark urine, pale stools or hair loss. These may be signs of liver problems. (This occurs only 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 adverse effects:

Frequent (may affect up to 1 in 10 people):

• Stomach pain and feeling sick (nausea)
• Headache

Uncommon (may affect up to 1 in 100 people):

• Sinusitis, upper respiratory tract infection, rhinitis
• Hypersensitivity
• Vomiting, diarrhoea, constipation, indigestion, flatulence
• Abnormal liver function
• Hives, rash, itching
• Menstrual disorders

Rare (may affect up to 1 in 1,000 people):

• Certain blood disorders (leucopenia)
• Serum sickness, painful swelling of the skin and mucous membranes (angioneuritic oedema), hypersensitivity symptoms (anaphylactic reaction)
• Tingling or weakness in hands or feet (paraesthesia), reduced sensation to pain (hypoesthesia), unpleasant taste (dysgeusia)
• Heart failure with signs such as difficulty breathing, unexpected weight gain, swelling of legs or abdomen, unusual fatigue or onset of trouble sleeping through the night (congestive heart failure)
• Difficulty breathing (dyspnoea)
• Severe liver toxicity (hepatotoxicity, including cases of sudden liver failure), elevated bilirubin in blood
• Severe drug-induced allergic skin reactions (such as toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis or leukocytoclastic vasculitis), accompanied by various skin changes, hair loss, photosensitivity
• Frequent urination (polyuria)
• Fluid accumulation in tissues (oedema)
• Increased blood creatine phosphokinase
• Visual disturbances including blurred vision and double vision
• Permanent or transient hearing loss, ringing in the ears (tinnitus)
• Severe pain in the upper abdomen, often accompanied by nausea and vomiting (pancreatitis)
• Increased blood triglycerides (detected by blood tests)
• Erectile dysfunction
• The following side effects have been reported in patients treated with other pharmaceutical forms of itraconazole:
• Certain disorders affecting blood cell production (granulocytopenia, thrombocytopenia)
• Hypersensitivity symptoms (anaphylactoid reaction)
• Increased blood sugar
• Muscle cramps or irregular heartbeat (possible symptoms of high or low potassium levels in blood)
• Muscle cramps or irregular heartbeat (possible symptoms of high or low magnesium levels in blood)
• Confusion
• Peripheral neuropathy, dizziness, drowsiness, tremors
• Heart failure, increased heart rate (tachycardia)
• High blood pressure (hypertension), low blood pressure (hypotension)
• Fluid in the lungs, difficulty speaking, cough
• Gastrointestinal disorders
• Liver failure, inflammation of the liver (hepatitis), yellowing of the skin (jaundice)
• Erythematous rash, excessive sweating
• Muscle pain (myalgia), joint pain (arthralgia)
• Kidney problems, urinary incontinence
• General swelling, facial swelling, chest pain, fever, aches, fatigue, chills
• Abnormal urine and blood tests, elevated levels in liver function tests (increased liver enzymes)

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging following "Exp.". The expiry date refers to the last day of the month indicated.

Do not use this medicine if there are visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused medicines and their packaging, please consult your pharmacist. This will help protect the environment.

6. Package contents and other information

Composition of Itraconazol Normon 100 mg capsules

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

The other components are:

Capsule contents: sugar spheres (corn starch and sucrose), poloxamer 188 and hypromellose.

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

Appearance of the medicine and contents of the pack

Itraconazol NORMON 100 mg capsules are presented as hard gelatin capsules containing microgranules.

Pack sizes of 4, 6, 7, 14, 15, 16, 18, 28, 30, 32 and 60 capsules. Packs of 100 capsules for hospital use.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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)

This medicine is authorised in the European Economic Area member states under the following names:

Portugal Itraconazol Fungizol 100 mg capsules

Bulgaria Itraconazol Fungizol 100 mg ???????, ??????

Czech Republic CONISOR 100 MG TVRDÉ TOBOLKY

Germany Itraconazol Heumann 100 mg Hartkapseln

Spain Itraconazol Normon 100 mg hard capsules

Hungary Itraconazol Medico Uno 100 mg kemény kapszula

Poland Ipozumax, 100 mg, kapsulki twarde

Slovakia Prokanazol 100 mg

United Kingdom (Northern Ireland) Itraconazole 100mg Capsules

Date of the most recent review of this leaflet: October 2025

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