ITRACONAZOLE STADA 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Itraconazol Stada 100 mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Itraconazol Stada and what is it used for.
2. What you need to know before you take Itraconazol Stada.
3. How to take Itraconazol Stada.
4. Possible side effects.
5. Storing Itraconazol Stada.
6. Contents of the pack and other information.

1. What is Itraconazol Stada and what is it used for

Itraconazol Stada 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 you take Itraconazol Stada

Do not take Itraconazol Stada

• if you are allergic to itraconazole or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”).
• if you have a disease called heart failure (also called congestive heart failure or CHF). This medicine could make it worse.

If your doctor decides that you should take this medicine, contact him immediately if you notice that you are short of breath, gain weight unexpectedly, have swollen legs, feel unusually tired, or start waking up at night.

• if you are pregnant, think you may be pregnant or are planning to have a baby(see section pregnancy) your doctor will decide if you should take this medicine.
• 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 the next menstrual period after finishing treatment with this medicine.
• itraconazole capsules should not be used with some medicines. There are many medicines that interact with itraconazole capsules, see section “Using other medicines and Itraconazol Stada” and the list below.

Before taking itraconazole capsules, inform your doctor if you are taking any other medicine.

Do not use itraconazole 100 mg capsulesif you are taking any of the following medicines, or within 2 weeks after finishing Itraconazol:

M

• aliskiren, eplerenone, lercanidipine, or nisoldipine (for hypertension)
• bepridil, ivabradine, or ranolazine (for angina)
• dabigatran or ticagrelor (for blood clots)
• disopyramide, dofetilide, dronedarone, or quinidine (for irregular heart rhythm)
• lomitapide, lovastatin, or simvastatin (to lower cholesterol)
• sildenafil (for pulmonary arterial hypertension)

M

• cisapride (for stomach disorders)
• domperidone (for nausea and vomiting)
• naloxegol (for constipation caused by taking opioid painkillers)

M

• dihydroergotamine or ergotamine (ergot alkaloids used for migraines)
• midazolam (oral) or triazolam (for sedation or inducing sleep)
• lurasidone, pimozide, quetiapine, or sertindole (for schizophrenia, bipolar disorder, or other mental health disorders)

M

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

M

• astemizole, mizolastine, or terfenadine (for allergies)

M

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

O:

• 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)

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take itraconazole:

• 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. It may be necessary to adjust the dose of this medicine. If any of the following symptoms appear during treatment with this medicine, stop taking it and consult your doctor immediately: loss of appetite, nausea, vomiting, tiredness, abdominal pain, jaundice (yellowing of the skin, eyes, mucous membranes, and secretions), dark urine, or pale stools. If you are taking itraconazole 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 you have a severe allergic reaction while taking itraconazole capsules (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 itraconazole 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 vesicles.
• 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 itraconazole 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 itraconazole capsules.
• stop taking itraconazole capsules and consult your doctor immediately if you experience any sensation of tingling, numbness, decreased sensitivity, or weakness in the limbs or other nerve problems in the arms and legs (neuropathy).
• stop taking this medicine and contact your doctor immediately if you experience any hearing loss. In 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 buzzing in your ears, if you lose control of your urine or urinate 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 Itraconazol Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

There are medicines that you must nottake while taking itraconazole. These medicines are listed above under the heading "Do not use Itraconazol 100 mg capsules"

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

Your doctor may decide that you must nottake some medicines at the same time as itraconazole capsules or in the 2 weeks following their completion.

Examples of these medicines are:

M

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

M

• phenytoin, carbamazepine, or phenobarbital (antiepileptics)
• 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)

M

• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, trabectedin, trastuzumab emtansine, or vinca alkaloids (e.g., vinflunine, vinorelbine)

Medicines for tuberculosis

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

M

• efavirenz or nevirapine (for HIV/AIDS)
• elbasvir/grazoprevir, simeprevir, tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) (for HIV or hepatitis)

M

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

M

• alfuzosin, silodosin

M

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

M

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

O

• 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 itraconazole 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 advised when using itraconazole 100 mg capsules with certain medicines.You may be more likely to experience side effects or it may be necessary to adjust the dose of itraconazole capsules or the other medicine. Examples of these medicines are:

M

• bosentan (for pulmonary hypertension)
• calcium channel blockers such as dihydropyridines, such as amlodipine, isradipine, nifedipine, nimodipine, or diltiazem (for hypertension)
• or verapamil (for hypertension)
• cilostazol (for circulatory problems)
• "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 or mental health disorders

• alprazolam, brotizolam, buspirone, or midazolam (when injected into a vein) (for anxiety or inducing sleep)
• zopiclone (for inducing sleep)
• 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, ponatinib, ruxolitinib, or sonidegib

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)

M

• cyclosporine or tacrolimus

M

• dutasteride

M

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

M

• sildenafil (for erectile dysfunction)

M

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

Other medications that contain:

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

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

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

In case of doubt, consult your doctor or pharmacist.

Taking Itraconazol Stada with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Itraconazole should not be used during pregnancy.

Breastfeeding

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

Fertility

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

Driving and using machines

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

Itraconazol Stada contains sucrose

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

3. How to take Itraconazol Stada

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

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

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

You should take itraconazole capsules immediately after meals, as they are better absorbed that way. 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 much itraconazole to 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 after two hours of taking this medication or two hours before taking itraconazole capsules. For the same reason, if you are taking medications that regulate stomach acid production, take itraconazole capsules with a cola drink.

The following doses are the most common:

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

• Continuous treatment for foot nail infections:

• Pulsatile treatment for nails:

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

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

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

• Internal organ infections: higher doses and longer treatment periods may be necessary. Always follow your doctor's instructions, as they will adapt the treatment to your needs.

Use in children

Itraconazole should not be used in children. It can only be prescribed by a doctor in exceptional cases.

If you take more Itraconazol Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, Phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication's prospectus to the healthcare professional.

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 Itraconazol Stada

Do not take a double dose to make up for forgotten doses.

If you forget to take the medication, take the next dose that corresponds to you and continue treatment as indicated by your doctor.

If you interrupt treatment with Itraconazol Stada

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

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

4. Possible side effects

Like all medications, itraconazole can cause side effects, although not everyone will experience them.

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

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

Very common: may affect more than 1 in 10 people

Common: may affect between 1 and 10 in 100 people

Uncommon: may affect between 1 and 10 in 1,000 people

Rare: may affect between 1 and 10 in 10,000 people

Very rare: may affect less than 1 in 10,000 people

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)

• 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 (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

• 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 blood (hyperbilirubinemia), severe hepatotoxicity (including cases of acute severe 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, and eye involvement), 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), leucocytoclastic 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 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 itraconazole 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

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

Psychiatric disorders: feeling of confusion or disorientation

Nervous system disorders: peripheral neuropathy (peripheral nerve damage with 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), facial edema, chest pain, fever, pain, fatigue, chills

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

Side effects in the pediatric population

Based on data from clinical trials 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 experiencing is serious or if you notice any side effect not mentioned in this prospectus, inform 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Itraconazol Stada

Keep out of sight and reach of children.

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

Do not store at a temperature above 25°C.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and unused medications at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Itraconazol STADA

Itraconazol STADA is presented in the form of hard gelatin capsules containing microgranules.

• The active ingredient is itraconazole. Each capsule contains 100 mg of itraconazole.
• The other components are:

Capsule content: sugar spheres (corn starch and sucrose), poloxamer 188, and hypromellose 6cP.

Capsule shell: indigo carmine (E 132), quinoline yellow (E 104), titanium dioxide (E 171), and gelatin.

Product Appearance and Package Contents

The product is available in blister packs of 6, 7, 14, 18, or 100 capsules, with the larger size intended for hospital use.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the Last Revision of this Prospectus: May 2022

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