Itragerm 50 mg hard capsules: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Itragerm 50 mg hard capsules

Itraconazole

Read the 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 you should not give it to others, even if they have the same symptoms as you, because it may 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 Itragerm is and what it is used for

2 What you need to know before taking Itragerm

3 How to take Itragerm

4 Possible adverse effects

5 How to store Itragerm

6 Contents of the pack and other information

1. What Itragerm is and what it is used for

Itragerm belongs to a group of medicines called antifungal agents for systemic use, also known as antifungal medicines.

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

the skin
the nails

2. What you need to know before starting to take Itragerm

Do not take Itragerm:

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 might be pregnant, or could 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 specifically instructed you to do so (see "Warnings and precautions" below)

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

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

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 high blood pressure)
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 to treat stomach or constipation problems

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

Medicines to treat 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 to treat urinary problems

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

Medicines to treat allergies

astemizole, mizolastine, or terfenadine (for allergies)

Medicines to treat erectile dysfunction and premature ejaculation

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 break down certain medicines in the body
alofantrine (for malaria)
irinotecan (for cancer)
isavuconazole (for fungal infections)
ombitasvir, paritaprevir, ritonavir with or without dasabuvir (to treat hepatitis C)
venetoclax (for chronic lymphocytic leukemia), when you are starting 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 Itragerm capsules.

Warnings and precautions

Talk to your doctor before starting to take ITRAGERM

If you have or have had liver problems. If your doctor decides to prescribe Itragerm, your dose may need to be adjusted. You should also be alert for symptoms that may occur during treatment with Itragerm. See section 4, “Possible side effects” for more information. If you take Itragerm continuously for more than one month, your doctor may ask you to have periodic blood tests.
If you have or have had heart problems. If your doctor decides to prescribe Itragerm, you should be alert for 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, your 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 an allergic reaction to 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 may cause hearing loss, which usually improves when the medicine is stopped, although it may be permanent.

Using Itragerm 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.

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

Examples of these medicines include:

Medicines to treat 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 to treat 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 to treat urinary problems

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

Medicines to treat 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 (e.g., vinflunine, vinorelbine)

Medicines to treat tuberculosis

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

Medicines to treat 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 to treat benign enlargement of the prostate

alfuzosin, silodosin

Medicines to treat lung problems or allergies

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

Medicines to treat erectile dysfunction

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 .

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 medicines.

Caution is required when using Itragerm with certain medicines.

You may have a higher risk of side effects, or it may be necessary to adjust the dose of Itragerm capsules or the other medicine. Examples of such medicines include:

Medicines to treat 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 circulation problems)
"coumarins" such as warfarin (for blood clots)
digoxin (for atrial fibrillation)
nadolol (for pulmonary hypertension or angina)

Medicines to treat stomach or diarrhoea problems

aprepitant or netupitant (for nausea and vomiting during cancer treatment)
loperamide (for diarrhoea)
proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (to treat acid-related stomach problems)

Medicines to treat 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 to treat urinary problems

imidafenacin, fesoterodine, oxybutynin, solifenacin (for overactive bladder)

Medicines to treat cancer

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

Medicines to treat infections

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

Medicines to treat 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 to treat benign enlargement of the prostate

dutasteride

Medicines to treat 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 to treat erectile dysfunction

sildenafil (for erectile dysfunction)

Medicines to treat 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 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 must inform your doctor if you are taking or plan to take any of these medicines or any other medicines. Your dose of Itragerm capsules or the other medicine may need to be adjusted.

Pregnancy and breastfeeding

Do not take Itragerm if you are pregnant

Inform your doctor and do not take Itragerm if you are pregnant, think you might be pregnant, or plan to become pregnant.

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

If you are breastfeeding

Ask your doctor before 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

In general, taking Itragerm will not affect your ability to drive or operate machinery. However, in very rare cases, Itragerm may cause dizziness, ringing in the ears (tinnitus), and hearing loss. Do not drive or operate machinery if you feel unwell.

3. How to take Itragerm

Follow exactly the administration instructions for Itragerm given to you by your doctor. If in doubt, ask your doctor or pharmacist again.

Swallow the capsules with water. Itragerm may be taken with or without food.

Dosage

Itragerm capsules are specially designed to provide higher levels of active ingredient in the blood compared to other conventional itraconazole capsule formulations. One capsule of Itragerm delivers to your body an amount of medication similar to that of a 100 mg capsule of conventional Itraconazole, with equivalent therapeutic efficacy. Take only the number of Itragerm capsules prescribed for you, and, if in doubt, consult your doctor or pharmacist.

The usual dose of Itragerm depends on the type of fungal infection you have:

Superficial fungal infections (skin, mucous membranes, eyes)
Indication	Dosage of Itragerm 50 mg hard capsules	Duration of treatment
Skin infection, usually on the chest and back (pityriasis versicolor, tinea versicolor)	2 hard capsules once daily	7 days
Genital, arm or leg skin infection (tinea corporis, tinea cruris)	1 hard capsule once daily or 2 hard capsules once daily	2 weeks 7 days
Athlete's foot Hand skin infection (tinea manus, tinea pedis)	1 hard capsule once daily or 2 hard capsules twice daily	4 weeks 7 days
Nail infection (tinea unguium)	Continuous therapy: 2 hard capsules per day	12 weeks
In some immunocompromised patients, e.g., those with neutropenia, AIDS, or transplant recipients, the bioavailability of itraconazole may be reduced. Dose doubling may be indicated.

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

Indication	Dosage	Notes
Fungal infection (onychomycosis) of fingernails	2 pulse treatments	Each pulse treatment should be separated by a three-week period without treatment.
Fungal infection (onychomycosis) of toenails	3 pulse treatments

Type of infection	Week 1	Weeks 2, 3 and 4	Week 5	Weeks 6, 7 and 8	Week 9	Week 10
Fingernails only	2 capsules in the morning 2 capsules in the evening	No itraconazole treatment	2 capsules in the morning 2 capsules in the evening	Suspend treatment
Toenails with or without fingernail infection	2 capsules in the morning 2 capsules in the evening	No itraconazole treatment	2 capsules in the morning 2 capsules in the evening	No itraconazole treatment	2 capsules in the morning 2 capsules in the evening	Suspend treatment

Your doctor may prescribe different doses for different periods, depending on your condition. It is important that you complete the full course of treatment prescribed by your doctor.

What to expect from Itragerm treatment

Do not be concerned if you do not see immediate improvement after your treatment.

With skin infections, skin lesions (marks or spots) usually disappear several weeks after completing treatment. The medicine eliminates the fungus, but the lesion does not clear until new skin has formed.
In the case of nail infections, nail abnormalities may take 6 to 9 months to disappear, as new nail needs to grow out.

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

If you take more Itragerm than you should

Contact the nearest hospital emergency department or your doctor immediately:

If you (or someone else) have swallowed several Itragerm capsules.
If you think a child has swallowed Itragerm capsules.

Take this leaflet, any remaining capsules, and the packaging with you to the hospital or doctor so they can identify the medicine taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist or the Toxicology Information Service immediately, Telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Itragerm

If you miss a dose, take the next one as usual. Then continue your treatment until all capsules are finished.

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

If you stop Itragerm treatment

If you stop taking Itragerm before finishing all the capsules in the prescribed course, the infection may not be completely cured and could return. Do not stop treatment until it is finished, even if you feel better.

4. Possible adverse effects

Like all medicines, Itragerm may cause adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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

Very common: affects more than 1 in 10 people
Common: affects between 1 and 10 in 100 people
Uncommon: affects between 1 and 10 in 1,000 people
Rare: affects between 1 and 10 in 10,000 people
Very rare: affects fewer than 1 in 10,000 people
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 causing watery mucus discharge and frequent sneezing)

Disorders of the blood and lymphatic system

Rare: leucopenia

Immune system disorders

Uncommon: hypersensitivity and allergic reactions

Rare: anaphylactic (allergic) reactions, serum sickness (an allergic reaction occurring after injection of certain sera, characterized by urticaria, fluid accumulation, joint pain, fever, and extreme exhaustion), angioneurotic edema (swelling due to fluid accumulation that may affect the mouth and upper airways)

Metabolism and nutrition disorders

Rare: increased triglycerides

Nervous system disorders

Common: headache

Rare: tremor, tingling sensation in the limbs (paraesthesia), reduced sensitivity (hypoesthesia), unpleasant taste (dysgeusia)

Eye disorders

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

Ear and labyrinth disorders

Rare: permanent or transient hearing loss, subjective sensation of ringing in the ears (tinnitus)

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 meals, diarrhea and constipation, accumulation of gas in the intestine (flatulence)

Rare: inflammation of the pancreas

Hepatobiliary disorders

Uncommon: abnormal liver function

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

Skin and subcutaneous tissue disorders

Uncommon: urticaria, rash, itching

Rare: toxic epidermal necrolysis (a serious skin disease characterized by skin rash and the appearance of blisters and peeling), Stevens-Johnson syndrome (severe erythema of the skin, mucous membranes and eyes), a serious skin disorder (generalized rash with skin peeling 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 peeling), leukocytoclastic vasculitis (inflammation of the walls of blood vessels), 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 blood creatine phosphokinase (a parameter measuring liver function)

Description of certain adverse effects

Below are listed adverse effects reported in patients taking other conventional itraconazole formulations (oral solution or intravenous):

Disorders of the blood and lymphatic system: granulocytopenia, thrombocytopenia (decrease in certain blood cells)
Immune system disorders: anaphylactoid reaction
Metabolism and nutrition disorders: hyperglycaemia (increased blood sugar), hyperkalaemia (high blood potassium levels), hypokalaemia (low blood potassium levels), hypomagnesaemia (low blood magnesium levels)
Psychiatric disorders: feeling of confusion or disorientation
Nervous system disorders: peripheral neuropathy (peripheral nerve damage causing 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: red skin rash (erythematous exanthema), excessive sweating
Musculoskeletal and connective tissue disorders: muscle pain or weakness (myalgia), joint pain (arthralgia)
Renal and urinary disorders: renal failure, urinary incontinence (urine leakage)
General disorders and administration site conditions: excessive accumulation of fluid in 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 blood, increased lactate dehydrogenase in blood, increased blood urea, increased gamma-glutamyl transferase, increased liver enzymes, abnormal urine test results

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Itragerm

Keep Itragerm out of the sight and reach of children.

Pack sizes

HDPE bottles/Aluminum foil semi-rigid blister packs:

This medicine 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.

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

Do not use Itragerm after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Itragerm

The active substance is itraconazole.

Each hard capsule contains 50 mg of itraconazole.

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

The capsule shell is made of gelatin and the colours FD&C Blue No. 1 (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 contents of the pack

Itragerm 50 mg hard capsules are light 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 pack sizes of 15, 30, 60 and 90 capsules.

Marketing Authorization Holder and Manufacturer

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

Manufacturer

Medicofarma, S.A.

Tarnobrzeska 13, Radom, 26613

Poland

LABORATORI FUNDACIÓ DAU

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

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000

Malta

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

Germany:	ITRAISDIN
Spain, Italy:	ITRAGERM
Austria:	MYTRA

This leaflet was approved in July 2025.

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