Sporanox 100 mg capsules: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sporanox 100 mg capsules

Itraconazole

Read this 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

What Sporanox 100 mg capsules are and what they are used for
What you need to know before taking Sporanox 100 mg capsules
How to take Sporanox 100 mg capsules
Possible side effects
How to store Sporanox 100 mg capsules
Contents of the pack and other information

1. What Sporanox 100 mg capsules is and what it is used for

Sporanox 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.

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 condition called heart failure (also known as congestive heart failure or CHF). This medicine could worsen it.

If your doctor determines that you should take this medicine, contact them immediately if you experience shortness of breath, unexpected weight gain, swollen legs, unusual fatigue, or begin waking up at night.

if you are pregnant, think you might be pregnant, or could become pregnant (see pregnancy section).
if you are of childbearing potential, you must use adequate contraceptive measures to avoid pregnancy during treatment. Because this medicine may remain in the body for some time, you should continue contraceptive measures until your next menstrual period after completing treatment with this medicine.
Sporanox capsules must not be used together with certain medicines. There are many medicines that interact with Sporanox capsules; see 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 unsure, consult your doctor or pharmacist before starting this medicine.

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

Medicines you must not take with Sporanox 100 mg capsules

Do not use Sporanox 100 mg capsules if you are taking certain medicines or within 2 weeks after stopping 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 – chest pain)
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 when used to treat pulmonary hypertension (increased blood pressure in the blood vessels of the lungs)

Medicines for stomach problems or constipation

cisapride (for stomach disorders)
domperidone (for nausea and vomiting)
naloxegol (for constipation caused by 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 overactive bladder) when used in patients with certain kidney or liver problems

Medicines for allergies

astemizole, mizolastine, or terfenadine (for allergies)

Medicines for erectile dysfunction and ejaculation problems

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 metabolize certain medicines
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 start taking venetoclax for the first time or when increasing doses at the beginning 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 unsure, consult your doctor or pharmacist before starting Sporanox capsules.

Remember: do not take any of the above medicines for 2 weeks after your last dose of Sporanox capsules.

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

Warnings and precautions

Take special care with Sporanox 100 mg capsules

if you have heart problems, consult your doctor. Inform your doctor immediately if you develop difficulty breathing, unexpected weight gain, leg swelling, unusual fatigue, or insomnia, as these may be symptoms of heart failure.
if you have liver problems. The dose of this medicine may need to be adjusted. If any of the following symptoms occur during treatment, stop taking the medicine and contact your doctor immediately: loss of appetite, nausea, vomiting, tiredness, abdominal pain, jaundice (yellowing of the skin, eyes, mucous membranes, and secretions), dark urine, or pale stools. If you are on Sporanox capsule treatment, your doctor will likely order regular blood tests, as liver disorders have occurred in very rare cases.
if you have kidney problems, consult your doctor. The dose of this medicine may need to be adjusted.
consult your doctor or seek immediate medical attention if you experience a severe allergic reaction while taking Sporanox capsules (characterized by severe skin rash, itching, hives, difficulty breathing, and/or facial swelling).
stop taking this medicine and contact your doctor immediately if you become overly sensitive to sunlight.
stop taking Sporanox capsules and contact your doctor immediately if you develop a serious skin disorder, such as widespread rash with skin peeling and blisters in the mouth, eyes, or genitals, or a rash with small pustules or blisters.
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 to another antifungal medicine (medicines known as azoles), consult your doctor. A hypersensitivity reaction may include skin rash, itching, hives, shortness of breath, or difficulty breathing, and/or facial swelling. If you experience a severe allergic reaction, contact your doctor immediately.
if you have cystic fibrosis, consult your doctor before taking Sporanox capsules.
stop taking Sporanox capsules and contact your doctor immediately if you experience tingling, numbness, reduced sensation, 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 hearing problems. In very rare cases, temporary or permanent hearing loss has occurred.
inform your doctor if your vision becomes blurred or double, if you hear ringing in your ears, if you lose control of your urine, or if you urinate more than usual.
this medicine is not recommended for elderly patients. It may be prescribed by a doctor only in exceptional cases.

Other medicines and Sporanox 100 mg capsules

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

Medicines you must not take

There are medicines that you must not take while taking Sporanox. These medicines are listed above under the heading “Medicines you must not take with Sporanox 100 mg capsules”.

The use of certain medicines with Sporanox 100 mg capsules is not recommended.

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

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 overactive 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 organ transplant

everolimus, rapamycin (also known as sirolimus), temsirolimus

Medicines for benign enlargement of the prostate

alfuzosin, silodosin

Medicines for inflammation, lung problems, or allergies

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

Medicines for erectile dysfunction and ejaculation problems

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 for 2 weeks after your last dose of Sporanox capsules.

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

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

You may be more likely to experience adverse effects, or the dose of Sporanox capsules or the other medicine may need to be adjusted. 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, including 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 problems or diarrhea

aprepitant or netupitant (for nausea and vomiting during cancer treatment)
loperamide (for diarrhea)
antacids such as aluminium, calcium, magnesium, or sodium bicarbonate; H2-receptor antagonists such as cimetidine, ranitidine; proton pump inhibitors such as lansoprazol, omeprazole, rabeprazole (for treating stomach acid problems)

Medicines for sleep disorders or mental health problems

alprazolam, brotizolam, buspirone, or midazolam (when injected intravenously) (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 disorders)
galantamine (for Alzheimer’s disease)
guanfacine (for attention deficit hyperactivity disorder)

Medicines for urinary problems

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

Medicines for cancer

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

Medicines for infections

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

Medicines for human immunodeficiency virus (HIV) or hepatitis

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

Medicines used after organ transplant

cyclosporine or tacrolimus

Medicines for benign enlargement of the prostate

dutasteride

Medicines for lung problems, allergies, or inflammatory conditions

bilastine or rupatadine (for allergies)
methylprednisolone or dexamethasone (orally administered or injectable medicines for asthma, allergies, or inflammatory conditions)
budesonide or fluticasone (for asthma, allergies)

Medicines for erectile dysfunction 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 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 metabolize certain medicines
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 or other medicines so appropriate measures can be taken.

There must be sufficient stomach acidity to ensure absorption of Sporanox capsules. Therefore, medicines that neutralize stomach acid should be taken at least 2 hours before or at least 2 hours after taking Sporanox capsules. 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”).

If in doubt, consult your doctor or pharmacist.

Taking Sporanox 100 mg capsules with food and drinks

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

If you are taking a 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 will not be used during pregnancy.

If you are of childbearing potential and could become pregnant, consult your doctor.

Use effective contraception to ensure you do not become pregnant while taking this medicine.
In addition, continue using contraception until your next menstrual period after stopping Sporanox capsules. This is because Sporanox capsules may remain in the body for some time after stopping treatment. (See section 2 “Do not take Sporanox 100 mg capsules”).

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are breastfeeding, consult your doctor before taking Sporanox. This is because small amounts of the medicine may pass into breast milk.

Driving and using machines

Sporanox may sometimes cause dizziness, blurred or double vision, or hearing loss. If you experience any of these effects, do not drive or operate machinery or tools.

Important information about some of the components of Sporanox 100 mg capsules

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

3. How to take Sporanox 100 mg capsules

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. Remember to take your medicine.

Your doctor will tell you how long to take this medicine. Do not stop treatment early. If you think the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

How to take Sporanox 100 mg capsules

You should take Sporanox capsules immediately after meals, as this improves absorption. Swallow the capsules whole with a little water. The number of capsules you need to take and for how long depends on the type of fungus and the location of the infection. Your doctor will tell you exactly how much Sporanox capsules to take.

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

How much to take

The following doses are the most common:

TYPE OF INFECTION	CAPSULES PER DAY	DURATION
Vaginal infection	2 capsules twice a day or 2 capsules once a day	1 day 3 days
Skin infection	2 capsules once a day or 1 capsule once a day	7 days 2 weeks
	If palms of hands or soles of feet are affected, 2 capsules twice a day for 7 days or 1 capsule once a day for 1 month may be required.
Oral infections	1 capsule once a day	2 weeks
Eye infections	2 capsules once a day	3 weeks
Internal infections	1 to 4 capsules daily	longer periods

? Nail infections: depending on your individual needs, your doctor will choose between continuous or pulsed treatment.

Continuous treatment for toenail infections:

TYPE OF INFECTION	CAPSULES PER DAY	DURATION
Continuous treatment for nails	2 capsules once daily	3 months

Pulsed therapy for nails:

Consists of two capsules twice a day for 1 week; then stop taking Sporanox 100 mg capsules for 3 weeks. The cycle is then repeated, once for fingernails and twice for toenails (with or without infection in the fingernails). (See the following table)

Week

Toenails with or without fingernail involvement

Take 2 capsules twice daily

No treatment with

Sporanox capsules

Take 2 capsules twice daily

No treatment with

Sporanox capsules

Take 2 capsules twice daily

Interrupt treatment

Fingernails only

Take 2 capsules twice daily

No treatment with

Sporanox capsules

Take 2 capsules twice daily

Interrupt treatment

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

Nail lesions will disappear 6 to 9 months after treatment ends, since the medication only eliminates the fungus itself. The nail must regrow, and this takes several months. Therefore, do not be concerned if you do not notice improvement during treatment: the medication remains in your nails for several months and continues to work. Thus, you must stop treatment at the time indicated by your doctor, even if you do not see any improvement.

Internal organ infections: Higher doses and prolonged treatment may be required.

Always follow your doctor's instructions; he or she will adjust the treatment according to your needs.

Use in Children

Sporanox capsules must not be used in children. It may only be prescribed by a physician in exceptional cases.

If you take more Sporanox 100 mg capsules than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

In case of accidental overdose, your doctor will implement supportive measures. Itraconazole is not removed by hemodialysis. Specific antidotes are not known.

If you forget to take Sporanox 100 mg capsules

If you forget to take the medication, take the next dose as scheduled and continue treatment as directed by your physician. Do not take a double dose to make up for a missed dose.

If you stop taking Sporanox 100 mg capsules

Do not interrupt treatment with Sporanox without consulting your doctor, as symptoms of your illness may recur or worsen.

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

4. Possible adverse effects

Like all medicines, Sporanox 100 mg capsules can cause adverse effects, although not everyone will experience them.

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

The following are adverse effects observed during the drug's marketing and clinical trials.

Adverse reactions are classified by frequency according to 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 fewer 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 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 reactions (allergic), serum sickness (an allergy appearing after injection of certain sera, characterized by hives, fluid accumulation, joint pain, fever, and extreme exhaustion), angioneurotic edema (swelling due to fluid accumulation that may affect the mouth and upper airways)

Endocrine disorders

Frequency not known: symptoms of elevated "aldosterone" hormone levels (such as high blood pressure or low potassium levels in blood), even though blood levels of "aldosterone" are normal or low

Metabolism and nutrition disorders

Rare: increased triglycerides

Nervous system disorders

Common: headache
Rare: tremor, tingling sensation in the limbs (paresthesia), decreased 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 ear (tinnitus)

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 meals, diarrhea and constipation, intestinal gas accumulation (flatulence)
Rare: pancreatitis (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 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

General disorders and administration site conditions

Rare: edema (fluid accumulation)

Investigations

Rare: increased blood creatine phosphokinase (a parameter measuring liver function)

Description of certain adverse effects

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

Disorders of the blood and lymphatic system: granulocytopenia, thrombocytopenia (decrease in certain blood cells).

Immune system disorders: anaphylactoid reaction

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

Psychiatric disorders: feeling confused or disoriented

Nervous system disorders: peripheral neuropathy (peripheral nerve involvement 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 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 blood urea, 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 any of the adverse effects you experience to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

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 via 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 Sporanox 100 mg capsules

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

Do not use Sporanox after the expiry date stated on the container. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point at the pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sporanox 100 mg capsules

The active substance is itraconazole. Each capsule contains 100 mg of itraconazole.
The other components are: sugar spheres (sucrose, maize starch), hypromellose and macrogol. The components of the capsule shell are: titanium dioxide (E171), indigo carmine (E132), sodium erythrosine and gelatin.

Appearance of the product and contents of the pack

Sporanox 100 mg capsules are presented as pink and blue capsules containing 100 milligrams of itraconazole in packs 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 most recent revision of this product information: June 2025.

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