HONGOSERIL 100 mg CAPSULES

Introduction

Package Leaflet: Information for the User

Hongoseril 100 mg 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.

Contents of the pack

1. What Hongoseril 100 mg Capsules is and what it is used for
2. What you need to know before you take Hongoseril 100 mg Capsules
3. How to take Hongoseril 100 mg Capsules
4. Possible side effects
5. Storage of Hongoseril 100 mg Capsules
6. Contents of the pack and other information

1. What Hongoseril 100 mg Capsules is and what it is used for

Hongoseril belongs to a group of medicines called “antifungals”. It is used to treat infections caused by fungi of the vagina, skin, mouth, eyes, nails, or internal organs.

2. What you need to know before you start taking Hongoseril 100 mg Capsules

Do not take Hongoseril 100 mg Capsules

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

• if you have a disease called heart failure (also called congestive heart failure or CHF). This medicine could make it worse. If your doctor decides that you should take this medicine, contact him immediately if you notice that you are short of breath, gain weight unexpectedly, have swollen legs, feel unusually tired, or start waking up at night.

• if you are pregnant, think you may be pregnant, or are planning to become pregnant (see section on pregnancy).
• if you are of childbearing age, you should take adequate contraceptive measures to avoid becoming pregnant during treatment. Because this medicine can stay in your body for some time, you should continue to use contraceptive measures until your next menstrual period after finishing treatment with this medicine.
• Hongoseril Capsules must not be taken with some medicines. There are many medicines that interact with Hongoseril Capsules. See the section “Using other medicines and Hongoseril Capsules” and the list below.

Tell your doctor if you are taking any other medicines before you start taking Hongoseril Capsules.

Do not take Hongoseril Capsules if you are taking certain medicines, or within 2 weeks after finishing Hongoseril Capsules. The following list includes examples of medicines that you must not take with Hongoseril Capsules or within 2 weeks after finishing Hongoseril Capsules:

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 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 (by mouth) or triazolam (for sedation or inducing sleep)
• 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 an irritated 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 that contain:

• 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
• 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 first start taking venetoclax or when you take increasing doses at the start of treatment
• voclosporin (for treating kidney problems related to lupus)

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

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

Warnings and precautions

Be especially careful with Hongoseril 100 mg Capsules

• if you have heart problems, consult your doctor. Inform your doctor immediately if you experience difficulty breathing, unexpected weight gain, swollen legs, unusual fatigue, or insomnia, as these may be symptoms of heart failure.
• if you have liver problems, it may be necessary to adjust the dose of this medicine. If any of the following symptoms appear during treatment with this medicine, stop taking it and consult your doctor immediately: loss of appetite, nausea, vomiting, tiredness, abdominal pain, yellowing of the skin, eyes, mucous membranes, and secretions, dark urine, or pale stools. If you are taking Hongoseril Capsules, your doctor may regularly perform blood tests, as liver disorders have occurred in very rare cases.
• if you have kidney problems, consult your doctor. It may be necessary to adjust the dose of this medicine.
• consult your doctor or seek immediate medical attention if you experience a severe allergic reaction (characterized by a pronounced skin rash, itching, hives, difficulty breathing, and/or swelling of the face) while taking Hongoseril Capsules.
• stop taking this medicine and consult your doctor immediately if you become too sensitive to sunlight.
• stop taking Hongoseril Capsules and consult your doctor immediately if you experience a severe skin disorder, such as a widespread rash with skin peeling and blisters in the mouth, eyes, and genitals, or a rash with small blisters or bumps.
• contact your doctor if you have neutropenia, AIDS, or have received an organ transplant. The dose of this medicine may need to be adjusted.
• if you have had an allergic reaction to Hongoseril Capsules or another medicine used to treat fungal infections (medicines known as azoles), consult your doctor. A hypersensitivity reaction can be recognized, for example, by the appearance of a skin rash, itching, hives, shortness of breath, or difficulty breathing, and/or swelling of the face. If you experience a severe allergic reaction, consult your doctor immediately.
• if you have cystic fibrosis, consult your doctor before taking Hongoseril Capsules.
• stop taking Hongoseril Capsules and consult your doctor immediately if you experience any sensation of tingling, numbness, decreased sensitivity, or weakness in the limbs or other nerve problems in the arms and legs (neuropathy).
• stop taking this medicine and contact your doctor immediately if you experience any hearing problems. In very rare cases, temporary or permanent hearing loss has occurred.
• tell your doctor if your vision becomes blurred or you see double, if you hear a ringing in your ears, if you lose control of your urine or urinate more than usual.
• this medicine is not recommended for elderly patients. It should only be prescribed by a doctor in exceptional cases.

Other Medications and Hongoseril Capsules

Tell your doctor or pharmacist if you are taking, have recently taken, or are planning to take any other medication, including those purchased without a prescription.

There are medications that should not be takenwhile taking Hongoserilcapsules. These medications are listed above under the heading "Do not take Hongoseril100 mg capsules"

It is not recommended to use certain medications with Hongoseril.

Your doctor may decide that you should not take some medications at the same time as Hongoseril capsules or in the 2 weeks following their completion.

Examples of these medications are:

Medications to treat heart, blood, or circulation problems

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

Medications to treat epilepsy, headaches, or mental health problems

• phenytoin, carbamazepine, or phenobarbital (antiepileptics)
• 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 an irritated urinary 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, 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)

Medications to treat tuberculosis

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

Medications 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)

Medications used after organ transplantation

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

Medications to treat benign prostatic hyperplasia

• alfuzosin, silodosin

Medications to treat lung problems or allergies

• 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 for 2 weeks after your last treatment with Hongoseril capsules.

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

Caution should be exercised when usingHongoserilcapsules with certain medications.

You may be more likely to experience adverse effects or it may be necessary to modify the dose of Hongoseril capsules or the other medication. 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)
• "cumarins" 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)
• antacids such as aluminum, 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)

Medications to treat sleep disorders or mental health problems

• alprazolam, brotizolam, buspirone, or midazolam (when injected into a vein) (for anxiety or help with sleep induction)

Medications to treat urinary problems

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

Medications to treat human immunodeficiency virus (HIV) or hepatitis

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

Medications used after organ transplantation

• cyclosporine or tacrolimus

Medications to treat benign prostatic hyperplasia

• dutasteride

Medications to treat lung problems, allergies, or inflammatory conditions

• bilastine or rupatadine (for allergies)
• methylprednisolone 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 excess parathyroid activity)
• diengest 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 drug addiction)
• repaglinide or saxagliptin (for diabetes)

This list is not complete, so you should inform your doctor if you are taking or plan to take any of these medications or any other medication, so that the necessary measures can be taken.

There should be sufficient stomach acidity to ensure the absorption of Hongoseril capsules. Therefore, medications that neutralize stomach acidity should be used at least 2 hours before taking Hongoseril capsules or after 2 hours of taking this medication. For the same reason, if you are taking medications that regulate stomach acid production, take Hongoseril capsules with a cola drink (see section 3 "How to take Hongoseril 100 mg capsules").

In case of doubt, consult your doctor or pharmacist.

Taking Hongoseril 100 mg capsules with food and drinks

Take this medication immediately after finishing one of the main meals.

If you are taking any medication that regulates stomach acid production, it is recommended to take this medication with a cola drink.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medication.

Hongoseril should not be used in case of pregnancy.

If you are of childbearing age and can become pregnant, consult your doctor. You should use effective contraceptives to ensure you do not become pregnant while taking the medication. Because Hongoseril capsules can remain in the body for some time, you should extend contraceptive measures until the next menstrual period after completing treatment with this medication (see section 2 "Do not take Hongoseril 100 mg capsules").

Breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are breastfeeding, consult your doctor before taking Hongoseril, as small amounts of the medication may appear in breast milk.

Driving and using machines

Hongoseril 100 mg capsules can sometimes cause dizziness, blurred or double vision, or hearing loss. If you experience any of these symptoms, do not drive or operate machinery.

Important information about some of the excipients of Hongoseril 100 mg capsules

This medication contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Hongoseril 100 mg capsules

Follow the administration instructions for Hongoseril capsules exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

Your doctor will indicate the duration of your treatment with this medication. Do not stop treatment before.

If you think the effect of the medication is too strong or too weak, inform your doctor or pharmacist.

You should take Hongoseril capsules immediately after meals, as they are better absorbed. Swallow the capsules whole with a little water. The number of capsules you should take and for how long depends on the type of fungus and the location of the infection. Your doctor will tell you exactly how many Hongoseril capsules to take.

There should be sufficient stomach acidity to ensure the absorption of this medication. Therefore, medications that neutralize stomach acidity should be used after 2 hours of taking this medication or 2 hours before taking Hongoseril 100 mg capsules. For the same reason, if you are taking medications that regulate stomach acid production, take Hongoseril capsules with a cola drink.

The following doses are the most common:

? Nail infections: depending on your personal needs, your doctor will opt for continuous or pulsed treatment.

• Continuous treatment for foot nail infections:

• Pulsed treatment for nails:

It consists of 2 capsules twice a day for 1 week; then stop taking Hongoseril 100 mg capsules for 3 weeks. Then repeat the cycle, once for hand nails and twice for foot nails (with or without nail infection). (See the following table)

In skin infections, the lesions will disappear a few weeks after finishing treatment. This is characteristic of fungal spots: the medication eliminates the fungus itself, but the lesion does not disappear until new skin grows.

Nail lesions will disappear 6 to 9 months after finishing treatment, as the medication only eliminates the fungus itself. The nail has to grow, and this takes several months. Therefore, do not worry if you do not notice improvement during treatment: the medication remains in your nails for several months and fulfills its mission. Therefore, you should stop treatment when your doctor indicates, even if you do not see any improvement.

Internal organ infections:Higher doses and longer treatment periods may be necessary.

Always follow your doctor's instructions, as they will adapt the treatment to your needs.

Use in Children

Hongoseril capsules should not be used in children. Only in exceptional cases can it be prescribed by a doctor.

If you take more Hongoseril 100 mg capsules than you should

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

In case of accidental overdose, your doctor will apply supportive measures. Itraconazole is not eliminated by hemodialysis. No specific antidotes are known.

If you forget to take Hongoseril 100 mg capsules

If you forget to take the medication, take the next dose that corresponds to you and continue treatment as indicated by your doctor. Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Hongoseril 100 mg capsules

Do not interrupt treatment with Hongoseril without consulting your doctor, as symptoms of your disease may reappear or worsen.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Hongoseril 100 mg capsules can cause adverse effects, although not all people suffer from them.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

The following adverse effects are mentioned during the marketing of the medicine and clinical trials.

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

Very frequent: affecting more than 1 in 10 patients

Frequent: affecting between 1 and 10 in 100 patients

Uncommon: affecting between 1 and 10 in 1,000 patients

Rare: affecting between 1 and 10 in 10,000 patients

Very rare: affecting less than 1 in 10,000 patients

Frequency not known: cannot be estimated with 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 occurs with the production of watery mucus and frequent sneezing)

? Blood and lymphatic system disorders

Rare: leucopenia.

• 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).

• Metabolism and nutrition disorders

Rare: increased triglycerides.

• Nervous system disorders

Frequent: 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, decreased heart rate.

• Respiratory, thoracic, and mediastinal disorders

Rare: shortness of breath, difficulty breathing (dyspnea).

• Gastrointestinal disorders

Frequent: abdominal pain, nausea.

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

Rare: pancreatitis.

• Hepatobiliary disorders

Uncommon: abnormal liver function

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

• Skin and subcutaneous tissue disorders

Uncommon: urticaria, rash, itching.

Rare: toxic epidermal necrolysis (severe skin disease characterized by skin 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 skin peeling and blisters in the mouth, eyes, and genitals, or rash with small pustules or blisters), erythema multiforme (skin disease characterized by the appearance of vesicles, blisters, etc.), exfoliative dermatitis (skin disease characterized by peeling), 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.

• General disorders and administration site conditions

Rare: edema (fluid accumulation).

• Investigations

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

Description of certain adverse effects

The following adverse effects associated with itraconazole were reported in clinical trials of itraconazole oral and intravenous solution, excluding the adverse effect "inflammation at the injection site" since this effect is specific to the injection route.

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

Immune system disorders: anaphylactoid reaction

Metabolism and nutrition disorders: hyperglycemia (increased sugar in blood), hyperkalemia (increased potassium in blood), hypokalemia (decreased potassium in blood), hypomagnesemia (decreased magnesium in blood),

Psychiatric disorders: feeling of confusion or disorientation

Nervous system disorders: peripheral neuropathy (peripheral nerve damage with tingling, numbness, or weakness in the limbs), dizziness, somnolence, tremor.

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 (exanthematous 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 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 urea in blood, increased gamma-glutamyltransferase, increased liver enzymes, abnormal urine analysis.

Adverse effects in the pediatric population

Based on clinical trial data in pediatric patients, the most frequently reported adverse effects were: headache, vomiting, abdominal pain, diarrhea, abnormal liver function, low blood pressure, nausea, and urticaria.

In general, the nature of the adverse effects is similar to that observed in adult patients, although the incidence is higher in pediatric patients.

If you experience any of these adverse effects, consult your doctor.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting adverse effects

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

5. Storage of Hongoseril 100 mg capsules

Keep out of sight and reach of children.

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

Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Medicines should not be thrown away through the sewage system or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Hongoseril 100 mg capsules

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

The other components are: sugar spheres (sucrose, cornstarch), hypromellose, and macrogol.

The components of the capsule are titanium dioxide (E171), indigo carmine (E132), erythrosine sodium, and gelatin.

Product appearance and package contents

Hongoseril 100 mg capsules are presented in pink and blue capsules containing 100 milligrams of itraconazole in packages of 7 and 14 capsules.

Marketing authorization holder

Marketing authorization holder:

Isdin SA

Provençals, 33

08019 Barcelona

Spain

Manufacturer

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Date of the last revision of this prospectus: August 2025

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