SPORANOX 100 mg CAPSULES

Introduction

Package Leaflet: Information for the User

Sporanox 100 mg Capsules

Itraconazole

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Package Leaflet Contents

1. What Sporanox 100 mg Capsules are and what they are used for
   1. What you need to know before taking Sporanox 100 mg Capsules
   2. How to take Sporanox 100 mg Capsules
   3. Possible side effects
   4. Storage of Sporanox 100 mg Capsules

1. Package Contents and Additional Information

1. What Sporanox 100 mg Capsules are and what they are used for

Sporanox belongs to the group of medications called “antifungals”.

It is indicated for the treatment of infections caused by fungi of the vagina, skin, mouth, eyes, nails, or internal organs.

2. What you need to know before taking Sporanox 100 mg capsules

Do not take Sporanox 100 mg capsules

• if you are allergic(hypersensitive) to any of the components of this medicine (listed in section 6).
• if you have a disease called heart failure (also called congestive heart failure or CHF). This medicine may worsen it.

If your doctor considers that you should take this medicine, contact them 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 pregnancy section).
• 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 extend contraceptive measures until your next menstrual period after finishing treatment with this medicine.
• Sporanox capsules cannot be used with some medicines. There are many medicines that interact with Sporanox capsules, see the section "Use of other medicines and Sporanox capsules" and the list below.

Do not take Sporanox capsules if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before starting to take this medicine.

Tell your doctor if you are taking any medicine before taking Sporanox capsules.

Medicines that you should not take with Sporanox 100 mg capsules

Do not use Sporanox 100 mg capsulesifyou are taking certain medicines or within 2 weeks after finishing Sporanox capsules.

Examples of these medicines are:

Medicines for heart, blood, or circulation problems

• aliskiren, eplerenone, lercanidipine, or nisoldipine (for hypertension)
• bepridil, ivabradine, or ranolazine (for angina - oppressive chest pain)
• dabigatran or ticagrelor (for blood clots)
• disopyramide, dofetilide, dronedarone, or quinidine (for irregular heartbeat problems)
• finerenone (for kidney problems in patients with type 2 diabetes)
• lomitapide, lovastatin, or simvastatin (to lower cholesterol)
• sildenafil when used to treat pulmonary hypertension (increased blood pressure in the blood vessels of the lungs)

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 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 for urinary problems

• darifenacin (for urinary incontinence)
• fesoterodine or solifenacin (for an irritated urinary bladder) when used in patients with certain kidney or liver problems

Medicines for allergies

• astemizole, mizolastine, or terfenadine (for allergies)

Medicines for erection and ejaculation problems

• avanafil (for erectile dysfunction)
• dapoxetine (for premature ejaculation)
• vardenafil (for erectile dysfunction) when used in men over 75 years old

Other medicines 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 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 kidney problems related to lupus)

Do not take Sporanox capsules if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before starting to take Sporanox capsules.

Remember: do not take any of the above medicines during 2 weeks after your last treatment with Sporanox 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 particularly careful with Sporanox 100 mg capsules

• if you have heart problems, consult your doctor. Inform your doctor immediately if you experience difficulty breathing, unexpected weight gain, leg swelling, unusual fatigue, or insomnia, as these 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 are taking Sporanox capsules, it is likely that your doctor will order regular blood tests, as liver disorders have occurred in very rare cases.

• 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, while taking Sporanox capsules, you have a severe allergic reaction (characterized by a pronounced skin rash, itching, hives, difficulty breathing, and/or swelling of the face).
• stop taking this medicine and consult your doctor immediately if you become too sensitive to sunlight.
• stop taking Sporanox 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 Sporanox capsules or any other 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 Sporanox capsules.
• stop taking Sporanox 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 do not hear correctly. 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 much more than usual.
• it is not recommended to take this medicine in elderly patients. Only in exceptional cases may it be prescribed by the doctor.

Other medicines and Sporanox 100 mg capsules

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those obtained without a prescription.

Medicines that you should not take

There are medicines that you should not takewhile taking Sporanox. These medicines are listed above under the heading "Medicines that you should not take with Sporanox 100 mg capsules"

It is not recommended to use certain medicines with Sporanox 100 mg capsules.

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

Examples of these medicines are:

Medicines for heart, blood, or circulation problems

• apixaban, edoxaban, rivaroxaban, or vorapaxar (for blood clots)
• atorvastatin (to lower cholesterol)
• felodipine (for hypertension)
• riociguat or tadalafil when used to treat pulmonary hypertension (increased blood pressure in the blood vessels of the lungs)

Medicines for epilepsy, headaches, or mental health problems

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

Medicines for urinary problems

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

Medicines for cancer

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

Medicines for tuberculosis

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

Medicines for 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 an organ transplant

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

Medicines for benign prostatic hyperplasia

• alfuzosin, silodosin

Medicines for inflammatory, pulmonary, or allergic disorders

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

Medicines for erection and ejaculation problems

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

Other medicines 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 Sporanox 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.

Caution is required when using Sporanox 100 mg capsules with certain medicines.

You may be more likely to experience side effects or it may be necessary to modify the dose of Sporanox capsules or the other medicine. Examples of these medicines are:

Medicines for heart, blood, or circulation problems

• bosentan when used to treat pulmonary hypertension (increased blood pressure in the blood vessels of the lungs)
• calcium channel blockers such as dihydropyridines, such as amlodipine, isradipine, nifedipine, nimodipine, diltiazem, 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)

Medicines for 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 (for stomach acid problems)

Medicines for sleep disorders or mental health problems

• alprazolam, brotizolam, buspirone, or midazolam (when injected into a vein) (for anxiety or 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 for urinary problems

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

Medicines for cancer

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

Medicines for infections

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

Medicines for 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)

Medicines used after an organ transplant

• cyclosporine or tacrolimus

Medicines for benign prostatic hyperplasia

• dutasteride

Medicines for pulmonary, allergic, or inflammatory disorders

• bilastine or rupatadine (for allergies)
• methylprednisolone or dexamethasone (oral or injectable medicines for asthma, allergies, or inflammatory disorders)
• budesonide or fluticasone (for asthma, allergies)

Medicines for erection and ejaculation problems

• sildenafil (for erectile dysfunction)

Medicines for pain

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

Other medicines that contain:

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

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

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

In case of doubt, consult your doctor or pharmacist.

Taking Sporanox 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 stomach acid production, it is recommended to take this medicine with a cola drink.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Sporanox should not be used during pregnancy.

If you are of childbearing age and may become pregnant, consult your doctor.

• Use effective contraceptives to ensure you do not become pregnant while taking the medicine.
• Also, continue to use some contraceptive method until your next menstrual period after stopping Sporanox capsules. This is because Sporanox capsules can stay in your body for some time after you stop taking it. (See section 2 "Do not take Sporanox 100 mg capsules").

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

3. How to take Sporanox 100 mg capsules

Follow your doctor's instructions for taking this medicine exactly. In case of doubt, consult your doctor or pharmacist again. Remember to take your medicine.

Your doctor will indicate the duration of your treatment with this medicine. Do not stop treatment beforehand. If you think the effect of the medicine is too strong or too weak, tell your doctor or pharmacist.

How to take Sporanox 100 mg capsules

You should take Sporanox 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 Sporanox capsules to take.

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

How much to take

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 Sporanox 100 mg capsules for 3 weeks. The cycle is then repeated, once for hand nails and twice for foot nails (with or without nail infection in the hands). (See the following table)

In skin infections, the lesions will disappear a few weeks after finishing treatment. This is characteristic of fungal spots: the medicine 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 medicine 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 medicine remains in your nails for several months and fulfills its mission. Therefore, you should stop treatment at the time indicated by your doctor, even if you do not see any improvement.

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

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

Use in Children

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

If you take more Sporanox 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 medicine 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 Sporanox 100 mg capsules

If you forget to take the medicine, 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 Sporanox 100 mg capsules

Do not interrupt treatment with Sporanox 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 side effects

Like all medicines, Sporanox 100 mg capsules can cause side effects, although not everyone gets them.

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

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

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

Very common: affects more than 1 in 10 patients

Common: affects between 1 and 10 in 100 patients

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

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

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

Frequency not known: cannot be estimated from available data

? Infections and infestations

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

? Blood and lymphatic system disorders

Rare: leucopenia

• Immune system disorders

Uncommon: hypersensitivity and allergic reactions

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

• Endocrine disorders

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

• Metabolic and nutritional disorders

Rare: increased triglycerides

• Nervous system disorders

Common: headache

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

? Eye disorders

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

? Ear and labyrinth disorders

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

• Cardiac disorders

Rare: congestive heart failure, decreased heart rate

• Respiratory, thoracic, and mediastinal disorders

Rare: shortness of breath, difficulty breathing (dyspnea)

• Gastrointestinal disorders

Common: abdominal pain, nausea

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

Rare: pancreatitis

• Hepatobiliary disorders:

Uncommon: abnormal liver function

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

• Skin and subcutaneous tissue disorders

Uncommon: urticaria, rash, itching

Rare: toxic epidermal necrolysis (a severe skin disease characterized by a rash and the appearance of blisters and scales), Stevens-Johnson syndrome (a severe skin disease characterized by a rash, mucous membrane lesions, and eye lesions), a severe skin disorder (widespread rash with peeling skin and blisters in the mouth, eyes, and genitals, or rash with small pustules or blisters), erythema multiforme (a skin disease characterized by the appearance of vesicles, blisters, etc.), exfoliative dermatitis (a skin disease characterized by peeling), leukocytoclastic vasculitis (inflammation of the blood vessel walls), 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 the blood (a parameter that measures liver function)

Description of certain side effects

The following side effects associated with itraconazole were reported in clinical trials of Sporanox oral and/or intravenous solution, except for the side 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

Metabolic and nutritional disorders: hyperglycemia (increased sugar in the blood), hyperkalemia (increased potassium in the blood), hypokalemia (decreased potassium in the blood), hypomagnesemia (decreased magnesium in the blood),

Psychiatric disorders: feeling of confusion or disorientation

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

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

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

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

Gastrointestinal disorders: gastrointestinal disorder

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

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

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

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

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

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

Side effects in the pediatric population

Based on clinical trial data in pediatric patients, the most frequently reported side effects were: headache, vomiting, abdominal pain, diarrhea, 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 pediatric patients.

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

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

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

5. Storage of Sporanox 100 mg capsules

Keep this medicine out of the sight and reach of children.

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

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in 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 Sporanox 100 mg capsules

• The active ingredient is itraconazole. Each capsule contains 100 mg of itraconazole.
• The other ingredients are: sugar spheres (sucrose, cornstarch), hypromellose, and macrogol. The capsule ingredients are: titanium dioxide (E171), indigo carmine (E132), erythrosine sodium, and gelatin.

Appearance of the product and package contents

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

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Janssen-Cilag, S.A.

Paseo del Club Deportivo 1, Edificio 16

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer:

Janssen-Cilag, SpA

Via C. Janssen

04100 Borgo San Michele

Latina (Italy)

Date of the last revision of this leaflet:June 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/)