ITRAGERM 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Itragerm 50 mg hard capsules

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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1 What is Itragerm and what is it used for

2 What you need to know before you take Itragerm

3 How to take Itragerm

4 Possible side effects

5 Storing Itragerm

6 Contents of the pack and other information

1. What is Itragerm and what is it used for

Itragerm is part of a group of medicines called systemic antifungal medicinesor also known as antifungal medicines.

Itragerm is used to treat fungal infections, including those caused by yeasts. These infections can affect:

• the skin
• the nails

2. What you need to know before you take Itragerm

Do not takeItragermif:

• If you are allergic(hypersensitive)to itraconazole or any of the other ingredients of this medicine(listed in section 6)
• if you are pregnant, think you may be pregnant or are planning to have a baby (see pregnancy section)
• if you have a condition called heart failure (also called congestive heart failure or CHF) unless your doctor has told you to take it (see "Warnings and precautions" below)

Do not take this medicine if you are in any of the above situations. If you are not sure, consult your doctor before taking Itragerm.

Before taking Itragerm, tell your doctor if you are taking any other medicines.

Do not use Itragerm if you are taking any of the following medicines, or within 2 weeks after stopping Itragerm:

Medicines used to treat heart, blood, or circulation problems

• aliskiren, eplerenone, lercanidipine, or nisoldipine (for hypertension)
• bepridil, ivabradine, or ranolazine (for angina)
• 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 or constipation problems

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

Medicines for headache, sleep, or mental health problems

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

Medicines for urinary problems

• darifenacin (for urinary incontinence)
• fesoterodine or solifenacin (for an irritated urinary 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 old

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's disease) when used in patients who cannot break down certain medicines in the body
• alofantrine (for malaria)
• irinotecan (for cancer)
• isavuconazole (for fungal infections)
• ombitasvir, paritaprevir, ritonavir with or without dasabuvir (for hepatitis C)
• venetoclax (for chronic lymphocytic leukemia) when you first start taking venetoclax or when you take increasing doses at the start of treatment

Remember: do not take any of the above medicines during 2 weeks after your last treatment with Itragerm capsules.

Warnings and precautions

Consult your doctor before starting to take ITRAGERM

• If you have or have had liver problems. If your doctor decides to prescribe you Itragerm, the dose may need to be adjusted. You should also be alert to detect symptoms that may appear during treatment with Itragerm. Read section 4, "Possible side effects"for more information. If you take Itragerm for more than one month continuously, your doctor may ask you to have regular blood tests.
• If you have or have had heart problems. If the doctor decides to prescribe you Itragerm, you should be alert to detect symptoms that may occur during treatment. Read section 4, "Possible side effects"for more information.
• If you have or have had kidney problems. If the doctor decides to prescribe you Itragerm, the dose may need to be adjusted.
• If you are infected with HIV or have AIDS or any disease in which your immune system is not working as well as it should.
• If you have ever had an allergic reactionto any other antifungal treatment.
• If you develop any numbness or weakness in your muscles
• If you have cystic fibrosis, consult your doctor before taking this medicine.

In rare cases, Itragerm can cause hearing loss, which usually improves when you stop taking the medicine, although it can be permanent.

Using Itragerm with other medicines

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines, including those bought without a prescription or based on plants.

Do not take Itragerm if you are taking any of the following medicines:

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 hypertension)
• riociguat or tadalafil (for pulmonary hypertension)

Medicines for epilepsy, headache, or mental health problems

• phenytoin, carbamazepine, or phenobarbital (antiepileptics)
• eletriptan (for migraines)
• St. John's Wort (Hypericum perforatum) (a plant-based medicine used for mental health problems)

Medicines for urinary problems

• tamsulosin (for male urinary incontinence)
• tolterodine (for an irritated urinary bladder)

Medicines for cancer

• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedina, 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 (e.g., vinflunine, vinorelbine)

Medicines for tuberculosis

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

Medicines for 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 transplantation

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

Medicines for benign prostatic hyperplasia

• alfuzosin, silodosin

Medicines for lung problems, allergies, or inflammatory conditions

• ciclesonide (for inflammation, asthma, or 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 75 years old or less) (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 during 2 weeks after your last treatment with.

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

Be careful when using Itragerm with certain medicines.

You may have a higher chance of getting side effects or the dose of Itragerm capsules or the other medicine may need to be changed. Examples of these medicines are:

Medicines for heart, blood, or circulation problems

• bosentan (for pulmonary hypertension)
• calcium channel blockers such as dihydropyridines, e.g., amlodipine, isradipine, nifedipine, nimodipine, or diltiazem (for hypertension)
• verapamil (for hypertension)
• cilostazol (for circulation problems)
• "coumarins" such as warfarin (for blood clots)
• digoxin (for atrial fibrillation)
• nadolol (for pulmonary hypertension or angina)

Medicines for stomach or diarrhea problems

• aprepitant or netupitant (for nausea and vomiting during cancer treatment)
• loperamide (for diarrhea)
• proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (for stomach acid problems)

Medicines for sleep disorders or mental health problems

• alprazolam, brotizolam, buspirone, or midazolam (when injected into a vein) (for anxiety or inducing sleep)
• zopiclone (for inducing sleep)
• 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

• imidafenacin, fesoterodine, oxybutynin, solifenacin (for an irritated urinary 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 malaria)
• praziquantel (for worms and tapeworms)

Medicines for 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 transplantation

• ciclosporin or tacrolimus

Medicines for benign prostatic hyperplasia

• dutasteride

Medicines for lung problems, allergies, or inflammatory conditions

• bilastine or rupatadine (for allergies)
• methylprednisolone or dexamethasone (oral or injectable medicines for asthma, allergies, or inflammatory conditions)
• budesonide or fluticasone (for asthma or 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 excess parathyroid activity)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher's disease) when used in patients who cannot break down certain medicines in the body
• ivacaftor (for cystic fibrosis)
• methadone (for drug addiction)
• repaglinide or saxagliptin (for diabetes)

This list is not complete, so you should tell your doctor if you are taking or plan to take any of these medicines or any other medicine. You may need to adjust the dose of Itragerm capsules or your other medicine.

Pregnancy and breastfeeding

Do not take Itragerm if you are pregnant

Tell your doctorand do not take Itragermif you are pregnant, think you may be pregnant, or are planning to become pregnant.

If you are of childbearing age, use a reliable contraceptive method during your treatment with Itragerm capsules. After finishing the treatment cycle with Itragerm, continue using a reliable contraceptive method until your next menstrual cycle.

If you are breastfeeding

Ask your doctorbefore taking Itragerm. Small amounts of the medicine may pass into breast milk.

Children and elderly patients

Itragerm is not recommended for use in children or elderly patients unless the potential benefits outweigh the risks.

Driving and using machines

Generally, taking Itragermwill not affect your ability to drive or use machines. However, in rare cases, Itragermcan cause dizziness, ringing in the ears (tinnitus), and hearing loss. Do not drive or use machines if you feel unwell.

3. How to take Itragerm

Follow the administration instructions for Itragerm exactly as indicated by your doctor.In case of doubt, ask your doctor or pharmacist again.

Swallow the capsules with water. Itragermcan be taken with or without food.

Amount to be taken

The Itragerm capsules are specially designed to provide higher levels of active ingredient in the blood than other conventional itraconazole capsule formulations. One Itragerm capsule provides your body with a similar amount of medication to a 100 mg conventional itraconazole capsule with the same therapeutic efficacy. Take only the amount of Itragerm capsules prescribed to you and, in case of doubt, consult your doctor or pharmacist.

The usual doseof Itragerm depends on the type of fungal infection you are suffering from:

For nail infections, depending on your personal needs, your doctor may prescribe a pulsed treatment:

It is possible that your doctor may prescribe different doses during different periods, depending on your illness. It is important that you take the entire prescribed treatment cycle.

What to expect from treatment with Itragerm

Do not worry if you do not see an immediate improvement after your treatment.

• With skin infections, the marks or spots (lesions)usually disappear a few weeks after finishing the treatment. The medication eliminates the fungus, but the lesion does not disappear until new skin is formed.
• In the case of nail infections, the marks on the nails may take 6 to 9 months to disappear, as the new nail needs to grow.

Consult your doctor or pharmacistif you are not sure that the treatment is working.

If you take more Itragerm than you should

Contact the emergency service of the nearest hospital or your doctor immediately:

• If you (or someone else) ingest many Itragerm capsules
• If you think a childhas ingested Itragerm capsules

Bring this leaflet, the remaining capsules, and the packagingto the hospital or doctor so that they know what medication has been ingested.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or the Toxicology Information Service immediately, telephone 91 562 04 20, indicating the medication and the amount used.

If you forget to take Itragerm

If you forget to take a dose, take the next one as usual. Then, continue with the treatment until you finish all the capsules.

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Itragerm

If you stop taking Itragerm before finishing all the capsules of the treatment, it is possible that the infection will not be completely treated and will recur. Do not suspend treatment until you have finished it, even if you feel better.

4. Possible side effects

Like all medicines, Itragerm can cause side effects, although not everyone gets them.

If you think any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Adverse reactions were classified according to frequency using the following convention:

• Very common: affects more than 1 in 10 patients
• Common: affects between 1 and 10 in 100 patients
• Uncommon: affects between 1 and 10 in 1,000 patients
• Rare: affects between 1 and 10 in 10,000 patients
• Very rare: affects less than 1 in 10,000 patients
• Frequency not known: cannot be estimated from the available data

Infections and infestations

Uncommon: sinusitis (irritation and swelling of the nasal sinuses), upper respiratory tract infection, rhinitis (inflammation of the nasal mucosa that runs with watery mucus production and frequent sneezing)

Blood and lymphatic system disorders

Rare: leukopenia

Immune system disorders

Uncommon: hypersensitivity and allergic reaction

Rare: anaphylactic reactions (allergic), serum sickness (allergy that appears after the injection of some sera and is characterized by the appearance of urticaria, fluid accumulation, joint pain, fever, and extreme exhaustion), angioedema (swelling due to fluid accumulation that can affect the mouth and upper respiratory tract)

Metabolic and nutritional disorders

Rare: increased triglycerides

Nervous system disorders

Common: headache

Rare: tremor, tingling sensation in the limbs (paresthesia), decreased sensitivity (hypoesthesia), unpleasant taste (bad taste in the mouth)

Eye disorders

Rare: visual disturbances (including blurred vision and double vision)

Ear and labyrinth disorders

Rare: permanent or transient hearing loss, subjective sensation of noises in the ear

Cardiac disorders

Rare: congestive heart failure

Respiratory, thoracic, and mediastinal disorders

Rare: shortness of breath, difficulty breathing (dyspnea)

Gastrointestinal disorders

Common: abdominal pain, nausea

Uncommon: vomiting, discomfort associated with eating, diarrhea, and constipation, gas accumulation in the intestine (flatulence)

Rare: pancreatitis

Hepatobiliary disorders

Uncommon: abnormal liver function

Rare: elevated bilirubin levels in the blood (hyperbilirubinemia), severe hepatotoxicity (including cases of severe acute liver failure)

Skin and subcutaneous tissue disorders

Uncommon: urticaria, rash, itching

Rare: toxic epidermal necrolysis (a serious skin disease characterized by a rash and the appearance of blisters and scales), Stevens-Johnson syndrome (severe erythema of the skin, mucous membranes, and eyes), a severe skin disorder (widespread rash with scaling of the skin and blisters in the mouth, eyes, and genitals, or rash with small pustules or blisters), erythema multiforme (a skin disease characterized by the appearance of vesicles, blisters, etc.), exfoliative dermatitis (a skin disease characterized by scaling), leukocytoclastic vasculitis (inflammation of the blood vessel wall), alopecia (hair loss), photosensitivity (exaggerated skin response to sunlight)

Renal and urinary disorders

Rare: increased frequency of urination

Reproductive system and breast disorders

Uncommon: menstrual disorders

Rare: erectile dysfunction

Investigations

Rare: increased creatine phosphokinase in the blood (a parameter that measures liver function)

Description of certain side effects

The following side effects have been reported in patients taking other conventional itraconazole formulations (oral solution or intravenous)

- Blood and lymphatic system disorders: granulocytopenia, thrombocytopenia (decrease in some blood cells).

- Immune system disorders: anaphylactoid reaction

- Metabolic and nutritional disorders: hyperglycemia (increased sugar in the blood), hyperpotasemia (high potassium levels in the blood), hypopotasemia (low potassium levels in the blood), hypomagnesemia (low magnesium levels in the blood)

- Psychiatric disorders: feeling of confusion or disorientation

- Nervous system disorders: peripheral neuropathy (peripheral nerve damage with a sensation of tingling, numbness, or weakness in the limbs), dizziness, somnolence

- Cardiac disorders: heart failure, left ventricular failure, tachycardia (rapid heart rate)

- Vascular disorders: high blood pressure (hypertension), low blood pressure (hypotension)

- Respiratory, thoracic, and mediastinal disorders: pulmonary edema, hoarseness, cough

- Gastrointestinal disorders: gastrointestinal disorder

- Hepatobiliary disorders: liver failure, hepatitis, jaundice (yellowing of the skin, eyes, mucous membranes, and secretions)

- Skin and subcutaneous tissue disorders: erythematous rash (red skin rash), excessive sweating

- Musculoskeletal and connective tissue disorders: muscle pain or weakness (myalgia), joint pain (arthralgia)

- Renal and urinary disorders: renal failure, urinary incontinence (loss of urine)

- General disorders and administration site conditions: excessive fluid accumulation in the body tissues (generalized edema), fluid accumulation in the face (facial edema), chest pain, fever, pain, fatigue, chills

- Investigations: increased alanine aminotransferase, increased aspartate aminotransferase, increased alkaline phosphatase in the blood, increased lactate dehydrogenase in the blood, increased urea in the blood, increased gamma-glutamyltransferase, increased liver enzymes, abnormal urine analysis.

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect 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 side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Itragerm

Keep Itragerm out of sight and reach of children.

Package sizes

HDPE bottles / Semi-rigid aluminum blister packs:

This medication does not require any special storage temperature.

Keep in the original packaging to protect it from light and moisture.

Triple blister: Do not store above 25°C.

Keep the capsules in the original packaging to protect them from light and moisture.

Do not use Itragerm after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package contents and additional information

Itragerm composition

The active ingredient is itraconazole.

Each hard capsule contains 50 mg of itraconazole.

The other ingredients are hypromellose phthalate, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate.

The capsule is made of gelatin and the colors FD&C Blue FC (E133), titanium dioxide (E171).

The capsule is printed with black ink (SW-9008), consisting of shellac, potassium hydroxide, black iron oxide (E172), and purified water.

Appearance of Itragerm and package contents

Itragerm 50 mg hard capsules are light blue gelatin hard capsules (size 1) with i-50 printed in black ink.

Itragerm is available in blister pack sizes of 4, 6, 7, 8, 14, 15, 18, 28, 30, and 60 capsules.

Itragerm is available in bottle sizes of 15, 30, 60, and 90 capsules.

Marketing authorization holder and manufacturer

ISDIN, S.A. Provençals, 33. 08019 Barcelona

Manufacturer

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

This leaflet was approved in July 2025.

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