Leaflet: Information for the User

Itragerm 50 mg Hard Capsules

Itraconazole

Read this leaflet carefully before you start taking this medicine, because 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 you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1 What Itragerm is and what it is used for

2 What you need to know before you start taking Itragerm

3 How to take Itragerm

4 Possible side effects

5 Storage of Itragerm

6 Contents of the pack and additional information

Itragerm is part of a group of medications calledsystemic antimycoticsor also known asantifungals.

Itragerm is used in the treatment of fungal infections, including those caused by yeasts. These infections can affect:

- the skin

- the nails

Do not takeItragerm:

• If you are allergic(hypersensitive)to itraconazole or to any of the other components of this medication(including those listed in section6)
• If you are pregnant, think you may be pregnant or may become pregnant (see pregnancy section)
• If you have a condition called heart failure (also known as congestive heart failure or CHF) unless your doctor has told you to (see "Warnings and precautions" below)

Do not take this medication if you are in any of the above circumstances. If you are unsure, consult your doctor before starting to take Itragerm.

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

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

Medications used to treat heart, blood or circulation problems

Medications to treat stomach or constipation problems

Medications to treat headache, sleep or mental health problems

Medications to treat urinary problems

Medications to treat allergies

Medications to treat erection and ejaculation problems

Other medications that contain:

Remember: do not take any of the above medications 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 Itragerm, the dose may need to be adjusted. You should also be aware of symptoms that may appear during treatment with Itragerm.See section 4,“Possible side effects”for more information. If you take Itragerm for more than a month continuously, your doctor may ask you to have blood tests periodically.
• If you have or have had heart problems. If your doctor decides to prescribe Itragerm, you should be aware of symptoms that may occur during treatment.See section 4,“Possible side effects”for more information.
• If you have or have had kidney problems. If your doctor decides to prescribe Itragerm, the dose may need to be adjusted.
• If you are infected with HIV or have acquired immunodeficiency syndrome (AIDS) or any condition in which your immune system is not working as well as it should.
• If you have ever had anallergic 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 medication.

In rare cases, Itragerm may cause hearing loss, which usually improves when the medication is stopped, although it may be permanent.

Use of Itragerm with other medications

Inform your doctor or pharmacistif you are taking, have taken recently or need to take any other medication, including those purchased without a prescription or based on plants.

Do not take Itragermif you are taking any of the following medications:

Examples of these medications are:

Medications to treat 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)

Medications to treat epilepsy, headache or mental health problems

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

Medications to treat urinary problems

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

Medications to treat cancer

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

Medications to treat tuberculosis

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

Medications to treat HIV or hepatitis

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

Medications used after organ transplantation

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

Medications to treat benign prostatic hyperplasia

• alfuzosin, silodosin

Medications to treat respiratory or allergy problems

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

Medications to treat erection and ejaculation problems

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

Other medications that contain:

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

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

This list is not exhaustive, so you should inform your doctor if you are taking or plan to take any of these medications or any other medication.

Care should be taken when usingItragermwith certain medications.

You may be more likely to experience side effects or the dose of Itragerm capsules or your other medication may need to be adjusted. Examples of these medications are:

Medications to treat heart, blood or circulation problems

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

Medications to treat 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 (to treat stomach acid problems)

Medications to treat sleep or mental health problems

• 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 conditions)
• galantamine (for Alzheimer's disease)
• guanfacine (for attention deficit hyperactivity disorder)

Medications to treat urinary problems

• imidafenacin, fesoterodine, oxybutynin, solifenacin (for irritated bladder)

Medications to treat cancer

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

Medications to treat infections

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

Medications to treat 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)

Medications used after organ transplantation

• ciclosporin or tacrolimus

Medications to treat benign prostatic hyperplasia

• dutasteride

Medications to treat respiratory, allergy or inflammatory conditions

• bilastine or rupatadine (for allergies)
• prednisolone or dexamethasone (oral or injectable medications for asthma, allergies or inflammatory conditions)
• budesonide or fluticasone (for asthma, allergies)

Medications to treat erection and ejaculation problems

• sildenafil (for erectile dysfunction)

Medications to treat pain

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

Other medications that contain:

• alitretinoin (oral) (for eczema)
• cabergoline (for Parkinson's disease)
• cannabis-based products, including medications (for nausea and vomiting or muscle spasms in patients with multiple sclerosis)
• cinacalcet (for excessive parathyroid activity)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher's disease) when used in patients who cannot break down certain medications in the body
• ivacaftor (for cystic fibrosis)
• methadone (for opioid addiction)
• repaglinide or saxagliptin (for diabetes)

This list is not exhaustive, so you should inform your doctor if you are taking or plan to take any of these medications or any other medication. You may need to adjust the dose of Itragerm capsules or your other medication.

Pregnancy and breastfeeding

Do not take Itragerm if you are pregnant

Inform your doctoranddo not take Itragermif you are pregnant, think you may be pregnant or plan to become pregnant.

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

If you are breastfeeding

Ask your doctorbefore takingItragerm. Small amounts of the medication may pass into breast milk.

Children and elderly patients

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

Driving and operating machinery

Generally, the use ofItragermwill not affect your ability to drive or operate machinery. However, in rare cases,Itragermmay cause dizziness, ringing in the ears (tinnitus) and hearing loss. Do not drive or operate machinery if you feel unwell.

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Follow exactly the administration instructions forItragermprescribed by your doctor.If in doubt, ask your doctor or pharmacist again.

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

Amount to take

The Itragerm capsules are specially designed to provide higher levels of active ingredient in the blood than conventional itraconazole capsules. 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 Itragermcapsules prescribed and, if in doubt, consult your doctor or pharmacist..

Usual doseofItragermdepends on the type of fungal infection you have:

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

Your doctor may prescribe different doses for different periods, depending on your condition.It is essential to complete the entire treatment prescribed by your doctor..

What to expect from Itragerm treatment

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

• Withskin infections, the marks or spots(lesions)usually disappear a few weeks after completing treatment. The medication eliminates the fungus, but the lesion does not disappear until new skin forms.
• In the case ofnail infections, nail marks may take6 to9months to disappear, as the new nail must grow.

Consult your doctor or pharmacistif you are unsure if the treatment is working.

If you take more Itragerm than you should

Call the nearest hospital emergency service or your doctor immediately:

• If you (or someone else) ingest many Itragerm capsules
• If you believe achildhas ingested Itragerm capsules

Take this leaflet, the remaining capsules, and the packaging with you to the hospital or doctor so they know which medication was ingested.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or the Toxicology Information Service, Teléfono 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 have finished all the capsules.

Do not take a double dose to compensate for the missed doses.

If you interrupt Itragerm treatment

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

Like all medicines, Itragermmay cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Adverse reactions were classified by 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 with available data

Infections and infestations

Uncommon: sinusitis (nasal sinus irritation and swelling), upper respiratory tract infection, rhinitis (inflammation of the nasal mucosa with watery discharge and frequent sneezing)

Blood and lymphatic system disorders

Rare: leucopenia

Immune system disorders

Uncommon: hypersensitivity and allergic reactions

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

Metabolism and nutrition disorders

Rare: increased triglycerides

Nervous system disorders

Common: headache

Rare: tremor, numbness in the extremities (paresthesia), decreased sensitivity (hypoaesthesia), unpleasant taste (bad taste)

Eye disorders

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

Ear and labyrinth disorders

Rare: permanent or temporary hearing loss, subjective sensation of ear noises

Cardiac disorders

Rare: congestive heart failure

Respiratory, thoracic and mediastinal disorders

Rare: dyspnea, shortness of breath

Gastrointestinal disorders

Common: abdominal pain, nausea

Uncommon: vomiting, meal-related discomfort, diarrhea, constipation, flatulence

Rare: pancreatitis

Hepatobiliary disorders:

Uncommon: abnormal liver function

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

Skin and subcutaneous tissue disorders

Uncommon: urticaria, rash, pruritus

Rare: toxic epidermal necrolysis (severe skin disease characterized by skin rash and the appearance of blisters and scales), Stevens-Johnson syndrome (severe skin, mucous membrane, and eye inflammation), a severe skin disorder (generalized rash with skin peeling and blisters in the mouth, eyes, and genitals, or generalized rash with small pustules or blisters), multiform erythema (skin disease characterized by the appearance of vesicles, blisters, etc.), exfoliative dermatitis (skin disease characterized by skin peeling), leukocytoclastic vasculitis (inflammation of the blood vessel walls), alopecia (hair loss), photosensitivity (exaggered skin response to sunlight)

Renal and urinary disorders

Rare: increased frequency of urination

Reproductive and breast disorders

Uncommon: menstrual disorders

Rare: erectile dysfunction

Investigations

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

Description of certain side effects

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

-Blood and lymphatic system disorders: granulocytopenia, thrombocytopenia (decreased levels of certain blood cells)

-Immune system disorders: anaphylactoid reaction

-Metabolism and nutrition disorders: hyperglycemia (increased blood sugar levels), hyperkalemia (high potassium levels in blood), hypokalemia (low potassium levels in blood), hypomagnesemia (low magnesium levels in blood)

-Mental disorders: feeling of confusion or disorientation

-Nervous system disorders: peripheral neuropathy (affection of peripheral nerves with numbness, tingling, or weakness in the extremities), dizziness, somnolence

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

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

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

-Gastrointestinal disorders: gastrointestinal disorder

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

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

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

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

-General disorders and administration site conditions: generalized edema, facial edema, chest pain, fever, pain, fatigue, chills

-Investigations: increased alanine aminotransferase, increased aspartate aminotransferase, increased alkaline phosphatase in blood, increased lactate dehydrogenase in blood, increased urea in 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 mentioned in this leaflet. You can also report them directly through the Spanish System of 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.

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Keep Itragerm out of sight and reach of children.

Packaging Sizes

HDPE Bottles/Aluminum Semi-Rigid Blister:

This medication does not require any special storage temperature.

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

Triple Blister: Do not store above 25°C.

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

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

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

Composition of Itragerm

The active ingredient is itraconazole.

Each hard capsule contains 50 mg of itraconazole.

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

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

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

Appearance of the Itragerm product and contents of the packaging

Itragerm 50 mg hard capsules are clear blue hard gelatin 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 responsible manufacturer

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

Manufacturer

MEDICOFARMA, S.A.Tarnobrzeska 13Radom26-613Poland.

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

This leaflet was approved in June 2024.

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