Label: information for the user

SPORANOX 100 mg capsules

Itraconazole

Read this label carefully before starting to take this medicine, as it contains important information for you.

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

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

• This medicine has been prescribed only for you, 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What SPORANOX 100 mg capsules are and for what they are used

1. What you need to know before starting to take SPORANOX 100 mg capsules
2. How to take SPORANOX 100 mg capsules
3. Possible side effects
4. Storage of SPORANOX 100 mg capsules

6. Contents of the pack and additional information

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.

Do not take SPORANOX 100 mg capsules

• if you areallergicto any of the components of SPORANOX capsules (see section 6).
• if you have a condition called heart failure (also known as congestive heart failure or CHF). This medicine may worsen it.

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 pregnancy section).
• if you are of childbearing age, you should take adequate contraceptive measures to avoid becoming pregnant during treatment. Since this medicine may remain in the body for some time, you should prolong the contraceptive measures until the next menstrual period after completing treatment with this medicine.
• do not use SPORANOX capsules 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.

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

Do not use SPORANOX 100 mg capsulesifyou are takingthe following medicines or within 2 weeks of the end of SPORANOX capsules treatment:

Medicines used to treat heart, blood, or circulation problems

Medicines to treat stomach or constipation problems

Medicines to treat headache, sleep, or mental health problems

Medicines to treat urinary problems

Medicines to treat allergies

• astemizole, mizolastine, or terfenadine (for allergies)

Medicines to treat erection and ejaculation problems

Other medicines that contain:

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 especially 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, swollen legs, unusual fatigue, or insomnia, as these may be symptoms of heart failure.
• if you have any liver problems. Your doctor may need 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 have any kidney problems, consult your doctor. Your doctor may need to adjust the dose of this medicine.
• consult your doctor or seek medical attention immediately ifyou experience a severe allergic reaction (characterized by a pronouncedskin eruption,itching,hives,difficulty breathing, and/or facial swelling)while taking SPORANOX capsules.
• 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 generalized skin eruption with peeling of the skin and blisters in the mouth, eyes, and genitals, or a skin eruption 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.

• if you have had an allergic reaction due to SPORANOX capsules or another antifungal medicine (known as azoles), consult your doctor. A hypersensitivity reaction can be recognized, for example, by the appearance of a skin eruption, 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 SPORANOX capsules.
• stop taking SPORANOX 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, temporary or permanent hearing loss has been reported.
• inform your doctor if your vision becomes blurry ordouble,if you hear a buzzing in your ears,if you lose control of your urine or urinate much more than usual.
• do not recommend taking this medicine in elderly patients. It is only prescribed by a doctor in exceptional cases.

Other medicines and SPORANOX 100 mg capsules

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

There are medicines thatshould not be takenwhile taking SPORANOX capsules. These medicines are listed above under the heading “Do not use SPORANOX 100 mg capsules”

Do not use certain medicines with SPORANOX 100 mg capsules.

Your doctor may decide thatyou should not take some medicines at the same time as SPORANOX capsules or within 2 weeks after the end of SPORANOX capsules treatment.

Examples of these medicines are:

Medicines used to treat heart, blood, or circulation problems

Medicines to treat epilepsy, headache, or mental health problems

Medicines to treat urinary problems

Medicines to treat cancer

Medicines to treat tuberculosis

Medicines to treat HIV or hepatitis

Medicines used after organ transplantation

Medicines to treat benign prostatic hyperplasia

Medicines to treat respiratory, allergy, or inflammatory problems

Medicines to treat erection and ejaculation problems

Medicines to treat pain

Other medicines that contain:

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 SPORANOX capsules. Therefore, medicines that neutralize stomach acid should be taken at least 2 hours before taking SPORANOX capsules or 2 hours after taking this medicine. For the same reason, if you are taking medicines that regulateacid production in the stomach, 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 acid production 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.

SPORANOX will not be used during pregnancy.

If you are of childbearing age and may become pregnant, consult your doctor. You should use effective contraceptive measures to avoid becoming pregnant during treatment. Since SPORANOX capsules may remain in the body for some time, you should prolong the contraceptive measures until the next menstrual period after completing treatment with this medicine. (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, as small amounts of the medicine may appear in milk.

Driving and operating machinery

SPORANOX may cause dizziness,blurred vision/double vision, or hearing loss. If you experience any of these symptoms, do not drive or operate machinery.

Important information about some components of SPORANOX 100 mg capsules

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 SPORANOX capsules as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

Your doctor will inform you of the duration of your treatment with this medication..Do not discontinue treatment beforehand. If you estimate that the medication's action is too strong or weak, inform your doctor or pharmacist.

You must take SPORANOX 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 SPORANOX capsules you should take.

There must be sufficient 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 SPORANOX capsules. For the same reason, if you are taking medications that regulate the production of acid in the stomach, take SPORANOX capsules with a cola drink.

The following doses are the most common:

?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 SPORANOX 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 interrupt 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

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

If you take more SPORANOX 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 SPORANOX 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 compensate for the missed doses.

If you interrupt treatment with SPORANOX 100 mg capsules

Do not discontinue treatment with SPORANOX 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 medicines, SPORANOX 100 mg capsules may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are 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 medicine 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 (irritation and swelling of the nasal sinuses), 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: hypersensitivity and allergic reactions

Rare: anaphylactic reactions (allergic reactions), serum sickness (allergy that appears after the injection of some sera and is characterized by the appearance of urticaria, accumulation of fluid, joint pain, 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 of aldosterone in the blood is normal or low

• Metabolic and nutritional disorders

Rare: increased triglycerides

• Nervous system disorders

Common: headache

Rare: tremor, sensation of numbness in the limbs (paresthesia), decreased sensitivity (hypoaesthesia), unpleasant taste (bad taste)

?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, decreased heart rate

• 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 gas 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), a severe skin disorder (generalized 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), leucocytoclastic vasculitis (inflammation of the blood vessel wall), 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 SPORANOX oral and/or intravenous solution, excluding the side effect "inflammation at the injection site" which is specific to the injection route.

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

Immune system disorders:anaphylactoid reaction

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

Psychiatric disorders: feeling of confusion or disorientation

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

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, jaundice (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:generalized 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 that any of the side effects you are experiencing are 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of SPORANOX 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

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

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Janssen-Cilag, S. A.

Pº de las Doce Estrellas, 5-7

28042 Madrid

Responsible for manufacturing:

Janssen-Cilag, SpA

Via C. Janssen

04100 Borgo San Michele

Latina (Italy)

Revision date of this prospectus:February 2025.

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