Hongoseril 100 mg capsulas

Leaflet: information for the user

Hongoseril 100 mg capsules

Itraconazole

Read this leaflet carefully before you start taking the medicine, because it contains important information for you

• Keep this leaflet, as you may need to read it again.
  If you have any questions, consult 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.

1. What isHongoseril 100 mg capsulesand what it is used for

2. What you need to know before takingHongoseril 100 mg capsules

3. How to takeHongoseril 100 mg capsules

4. Possible side effects

5. Storage ofHongoseril 100 mg capsules

6. Contents of the pack and additional information

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

No use Hongoseril 100 mg cápsulas

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

• If you have a condition called heart failure (also known as congestive heart failure or CHF). This medicine may make it worse. If your doctor thinks 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 may become pregnant (see section Pregnancy)
• If you are fertile, you should take adequate contraceptive measures to avoid becoming pregnant during treatment. Because this medicine may stay in the body for a long time, you should prolong contraceptive measures until the next menstrual period after completing treatment with this medicine.
• Do not use Hongoseril capsules with some medicines. There are many medicines that interact with Hongoseril capsules. See section “Use of other medicines and Hongoseril capsules” and the list below.

Inform your doctor if you are taking any other medicine, before taking Hongoseril capsules.

Do not use Hongoseril capsules if you are taking certain medicines, or within 2 weeks after stopping Hongoseril capsules. The following list includes examples of medicines that you should not take with Hongoseril capsules or within 2 weeks after stopping 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)
• Digoxin, dofetilide, dronedarone, or quinidine (for irregular heart rhythm)
• Finerenone (for kidney problems in patients with type 2 diabetes)
• Lomitapide, lovastatin, or simvastatin (to lower cholesterol)
• Sildenafil (for pulmonary hypertension)

Medicines to treat stomach or constipation problems

• Cisapride (for stomach disorders)
• Domperidone (for nausea and vomiting)
• Naloxegol (for constipation caused by taking opioid painkillers)

Medicines to treat headache, sleep, or mental health problems

• Dihydroergotamine or ergotamine (alkaloids of ergot 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 problems)

Medicines to treat urinary problems

• Darifenacin (for urinary incontinence)
• Fesoterodine or solifenacin (for irritated bladder) when used in patients with certain kidney or liver problems

Medicines to treat allergies

• Astemizole, mizolastine, or terfenadine (for allergies)

Medicines to treat 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) alkaloids of ergot 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 hepatitis C)
• Venetoclax (for chronic lymphocytic leukemia) when you start taking venetoclax for the first time or when taking increasing doses at the beginning of treatment
• Voclosporin (for 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; inform 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 notice any of the following symptoms: difficulty breathing, unexpected weight gain, swollen legs, unusual fatigue, or insomnia, as they may be symptoms of heart failure.
• If you have any 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, fatigue, abdominal pain, jaundice (yellowing of the skin, eyes, mucous membranes, and secretions), dark urine, or pale stools. If you continue treatment with Hongoseril capsules, it is very likely that your doctor will ask you to have regular blood tests, as there have been rare cases of liver damage.
• If you have any 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 facial swelling) 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 generalized rash with skin peeling and blisters on the mouth, eyes, and genitals, or a rash with small pustules or blisters.
• Contact your doctor if you have neutropenia, HIV/AIDS, or have received an organ transplant. The dose of this medicine may need to be adjusted.
• Contact your doctor if you have had an allergic reaction due to Hongoseril capsules or another antifungal medicine (known as azoles). 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 facial swelling. 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 numbness, tingling, decreased sensitivity, or weakness in your arms and legs (neuropathy).
• Stop taking this medicine and contact your doctor immediately if you do not hear correctly. In rare cases, there has been temporary or permanent hearing loss.
• Inform your doctor if your vision becomes blurry or you see double, if you hear a buzzing in your ears, if you lose control of your urine or urinate more than usual.
• Do not recommend taking this medicine in elderly patients. It may only be prescribed by your doctor in exceptional cases.

Other medicines and Hongoseril capsules

Inform your doctor or pharmacist if you are taking, have taken recently, or plan to take any other medicine, including those purchased without a prescription.

There are medicines that you should not take while taking Hongoseril capsules. These medicines are listed above under the heading “Do not take Hongoseril 100 mg capsules”

Do not recommend the use of certain medicines with Hongoseril.

Your doctor may decide that you should not take some medicines at the same time as Hongoseril capsules or within 2 weeks after stopping Hongoseril capsules.

Examples of these medicines are:

Medicines used 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, headache, or mental health problems

• Fenitoin, carbamazepine, or phenobarbital (antiepileptic medicines)
• Eletriptan (for migraines)
• St. John's Wort (Hypericum perforatum) (a plant-based medicine used for mental health problems)

Medicines to treat urinary problems

• Tamsulosin (for male urinary incontinence)
• Tolterodine (for irritated 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 of acute myeloid leukemia), or vinca alkaloids (e.g., vinflunine, vinorelbine)

Medicines to treat tuberculosis

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

Medicines to treat HIV/AIDS 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 to treat benign prostatic hyperplasia

• Alfuzosin, silodosin

Medicines to treat respiratory, allergy, or inflammatory problems

• Ciclesonide (for inflammation, asthma, and allergies)
• Ebastine (for allergies)
• Salmeterol (for asthma or chronic obstructive pulmonary disease, COPD)

Medicines to treat erection and ejaculation problems

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

Other medicines that contain:

• 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 Hongoseril capsules.

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

You should be careful when using Hongoseril capsules with certain medicines.

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

Medicines used 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 high blood pressure)
• 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 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, or proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (for stomach acid problems)

Medicines to treat sleep or mental health problems

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

...

Medicamines to treat urinary problems

• Imidafenacin, fesoterodine, oxibutinina, solifenacina (for irritated bladder)

Medicines to treat cancer

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

Medicines to treat infections

• Ciprofloxacin, clarithromycin, or erythromycin (for bacterial infections)
• Delamanid (for tuberculosis)
• Artemether-lumefantrine or quinine (for malaria)
• Praziquantel (for tapeworms and tapeworms)

Medicines to treat HIV/AIDS or hepatitis

• Cobicistat, elvitegravir, maraviroc, ritonavir, darunavir with ritonavir, fosamprenavir with ritonavir, indinavir, or saquinavir (for HIV/AIDS)
• Glecaprevir/pibrentasvir (for hepatitis)

Medicines used after organ transplantation

• Ciclosporin or tacrolimus

Medicines to treat benign prostatic hyperplasia

• Dutasteride

Medicines to treat respiratory, allergy, or inflammatory problems

• Bilastine, or rupatadine (for allergies)
• Methylprednisolone or dexamethasone (medicines administered orally or injectable for asthma, allergies, or inflammatory problems)
• Budesonide or fluticasone (for asthma, allergies)

Medicines to treat erection and ejaculation problems

• Sildenafil (for erectile dysfunction)

Medicines to treat pain

• Alfentanil, buprenorphine, oxycodone, or sufentanil (for pain)
• Meloxicam (for inflammation and joint pain)

Other medicines that contain:

• Alitretinoin (administered orally) (for eczema)
• Cabergoline (for Parkinson's disease)
• Cannabis products, including medicines (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 medicines in the body
• Ivacaftor (for cystic fibrosis)
• Methadone (for opioid 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 medicines, or any other medicine, so that appropriate measures can be taken.

You should have enough acidity in the stomach to ensure the absorption of Hongoseril capsules. Therefore, medicines that neutralize stomach acid should be taken at least 2 hours before taking Hongoseril capsules or 2 hours after taking this medicine. For the same reason, if you are taking medicines that regulate the production of acid in the stomach, take Hongoseril capsules with a cola drink (see section 3 “How to take Hongoseril 100 mg capsules”).

Consult your doctor or pharmacist if you are unsure.

Taking Hongoseril 100 mg capsules with food and drinks

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

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

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Hongoseril will not be used during pregnancy.

If you are fertile and may become pregnant, consult your doctor. You should use effective contraceptive measures to avoid becoming pregnant while taking the medicine. Because Hongoseril capsules may stay in the body for a long time, you should prolong contraceptive measures until the next menstrual period after completing treatment with this medicine (see section 2 “Do not take Hongoseril 100 mg capsules”).

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Driving and operating machinery

Hongoseril 100 mg capsules may cause dizziness, blurry 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 medicine contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

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

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

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

If you estimate that the medication's action is too strong or weak, inform your doctor or pharmacist.

You must take Hongoseril capsules immediately after meals, as this is when they are best 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 you should take.

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

The following doses are the most common:

?Fungal nail infections: Depending on your personal needs, your doctor will choose between continuous or pulsatile treatment.

• Continuous treatment for foot nail infections:

-Pulsatile treatment for nails:

This consists of 2 capsules twice a day for 1 week; then stop taking Hongoseril 100 mg capsules for 3 weeks. The cycle is then repeated, once for the hands and twice for the feet (with or without nail infection on the hands). (See the following table)

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

Nail lesions will disappear from 6 to 9 months after completing treatment, as the medication only eliminates the fungus itself. The nail must grow, which 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 purpose. Therefore, you must discontinue treatment at the time indicated by your doctor, even if you do not see any improvement.

Internal organ infections:Higher doses may be needed and for a long time.

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 may be prescribed by the doctor.

If you take more Hongoseril 100 mg capsules than you should

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.

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 the treatment as indicated by your doctor. Do not take a double dose to compensate for the missed doses.

If you discontinue treatment with Hongoseril 100 mg capsules

Do not discontinue treatment with Hongoseril without consulting your doctor, as the 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.

Like all medications, Hongoseril 100 mg capsules may cause side effects, although not everyone will experience them.

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

The following side effects have been seen during the marketing of the medication and clinical trials.

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)

?Haematological and lymphatic system disorders

Rare: leucopenia.

• Immune system disorders

Uncommon: excessive and allergic hypersensitivity reaction.

Rare: anaphylactic reactions (allergic reactions), serum disease (allergy that appears after the injection of some sera, characterized by the appearance of urticaria, accumulation of fluids, joint pains, fever, and extreme exhaustion), angioneuritic oedema (swelling due to fluid accumulation that can affect the mouth and upper respiratory tract).

• Endocrine disorders

Unknown: symptoms of elevated aldosterone levels (such as high blood pressure or low potassium levels in the blood), although the level in the blood of aldosterone is normal or low

• Metabolic and nutritional disorders

Rare: increased triglycerides.

• Nervous system disorders

Common: headache

Rare: tremor, sensation of numbness in the extremities (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 temporary hearing loss, subjective sensation of noise in the ear.

• Cardiac disorders

Rare: congestive heart failure.

• Respiratory, thoracic and mediastinal disorders

Rare: dyspnoea, difficulty breathing.

• Gastrointestinal disorders

Common: abdominal pain, nausea.

Uncommon: vomiting, discomfort associated with meals, diarrhoea and constipation, accumulation of gases in the intestine (flatulence).

Rare: pancreatitis.

• Hepatobiliary disorders

Uncommon: abnormal liver function

Rare: elevated bilirubin levels in the blood (hyperbilirubinaemia), 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 and mucous membrane inflammation and eye inflammation), a severe skin disorder (generalised rash with skin peeling and blisters in the mouth, eyes, and genitals, or generalised 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), leucocytoclastic 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.

• General disorders and administration site conditions

Rare: oedema (fluid accumulation).

• Laboratory investigations

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

Description of certain side effects

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

Haematological and lymphatic system disorders:granulocytopenia, thrombocytopenia (decrease in certain blood cells).

Immune system disorders:anaphylactoid reaction

Metabolic and nutritional disorders:hyperglycaemia (elevated blood sugar), hyperpotasemia (elevated potassium levels), hypokalaemia (decreased potassium levels), hypomagnesaemia (decreased magnesium levels),

Psychiatric disorders:sensation of confusion or disorientation

Nervous system disorders:peripheral neuropathy (affecting peripheral nerves with sensation of numbness, tingling, or weakness in the extremities), dizziness, somnolence, tremor.

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

Vascular disorders:hypertension, hypotension

Respiratory, thoracic and mediastinal disorders:pulmonary oedema, hoarseness, cough

Gastrointestinal disorders:gastrointestinal disorder

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

Skin and subcutaneous tissue disorders:erythematous rash (exanthema eritematoso), 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:generalised oedema, facial oedema, chest pain, fever, pain, fatigue, chills

Laboratory 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.

Side effects in the paediatric population

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

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

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

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

Reporting of side effects

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 System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

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

Do not store at a temperature above30°C. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

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 capsule components are titanium dioxide (E171), indigotindisulfonate sodium (E132), erythrosine sodium, and gelatin.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization

Holder of the marketing authorization:

Isdin SA

Provençals, 33

08019 Barcelona

Spain

Responsible for manufacturing:

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-9708107

Martorelles (Barcelona)

Spain

Last review date of this leaflet:May 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/.