Package Insert: Information for the User

Itraconazol Stada 100 mg Hard Capsules EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you 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 package insert. See section 4.

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.

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 condition called heart failure (also known as congestive heart failure or CHF). This medicine may make it worse.

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

• if you are pregnant,think you may be pregnant or are planning to become pregnant(see pregnancy section) your doctor will assess whether you should take this medicine.
• if you are fertile, you should take adequate contraceptive measures to avoid becoming pregnant during treatment. Because 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.
• itraconazole capsules cannot be used with some medicines. There are many medicines that interact with itraconazole capsules, see section “Use of other medicines and Itraconazol Stada” and the list below.

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

Do notuseitraconazol 100 mg capsulesifyou are taking any of the following medicines, or within 2 weeks of finishing Itraconazol:

Medicines used to treat heart, blood or circulation problems

• 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)
• lomotil, lovastatin or simvastatin (to reduce cholesterol)
• sildenafil (for pulmonary hypertension)

Medicines to treat stomach or constipation problems

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

Medicines to treat headache, sleep or mental health problems

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

Medicines to treat urinary problems

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

Medicines to treat allergies

• astemizole, mizolastine or terfenadine (for allergies)

Medicines to treat erection and ejaculation problems

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

Other medicines that contain:

• colchicine (for gout) when used in patients with kidney or liver problems
• ergometrine (ergonovine) or methylergometrine (methylergonovine) alkaloids of ergot used after childbirth
• eliglustat (for Gaucher's disease) when used in patients who cannot break down certain medicines in the body
• halofantrine (for malaria)
• irinotecan (for cancer)
• isavuconazole (for fungal infections)
• ombitasvir, paritaprevir, ritonavir with or without dasabuvir (for hepatitis C)

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 tiredness 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), very dark urine or pale stools. If you continue treatment with itraconazole capsules, it is very likely that your doctor will send you regular blood tests, as there have been rare cases of liver disorders.

• 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 medical attention immediately if while taking itraconazole capsules you experience a severe allergic reaction (characterized by a pronounced skin rash, itching, hives, difficulty breathing and/or facial swelling).
• 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 generalized rash with skin peeling and blisters in the mouth, eyes and genitals, or a rash with small pustules or blisters.
• contact your doctor if you have neutropenia, HIV 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 itraconazole 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 rash, itching, hives, shortness of breath or difficulty breathing, and/or facial swelling. If you suffer 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 numbness, tingling, decreased sensitivity or weakness in the arms or legs (neuropathy).
• stop taking this medicine and contact your doctor immediately if you do not hear correctly. In rare cases, there has been temporary or permanent hearing loss.
• inform your doctor if your vision becomes 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.
• do not recommend taking this medicine in elderly patients. Only in exceptional cases can it be prescribed by the doctor.

Other medicines and itraconazol stada

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

There aremedicinesthatyou should not takewhileyou are takingitraconazol.Thesemedicinesare listedaboveundertheheading“Do not use Itraconazol 100 mg capsules”

Do not recommend the use of certain medicines with Itraconazol 100 mg capsules.

Your doctor may decide thatyou should not take some medicines at the same time as itraconazole capsules or in the 2 weeks following its completion.

Examples of these medicines are:

Medicines used to treat heart, blood or circulation problems

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

Medicines to treat epilepsy, headache or mental health problems

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

Medicines to treat urinary problems

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

Medicines to treat cancer

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

Medicines to treat tuberculosis

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

Medicines to treat HIV or hepatitis

• efavirenz or nevirapine (for HIV/AIDS)
• elbasvir/grazoprevir, simeprevir, 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 to treat benign prostatic hyperplasia

• alfuzosin, silodosin

Medicines to treat respiratory or allergy problems

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

Medicines to treat erection and ejaculation problems

• tadalafil or vardenafil (when used in men under 75 years old) (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 itraconazole capsules.

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

You should be careful when using itraconazole 100 mg capsules with certain medicines.You may be more likely to experience side effects or the dose ofitraconazolcapsules or the other medicine may need to be adjusted. Examples of these medicines are:

Medicines used to treat heart, blood or circulation problems

• bosentan (for pulmonary hypertension)
• calcium channel blockers such as dihydropyridines, such as amlodipine, isradipine, nifedipine, nimodipine or diltiazem (for 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 to treat stomach or diarrhea problems

• 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 and proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (for treating stomach acid problems)

Medicines to treat sleep or mental health problems

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

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

Medicines to treat cancer

• bortezomib, brentuximab vedotin, busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, ponatinib, ruxolitinib or sonidegib

Medicines to treat infections

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

Medicines to treat HIV 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

• cyclosporin or tacrolimus

Medicines to treat benign prostatic hyperplasia

• dutasteride

Medicines to treat respiratory, allergy or inflammatory problems

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

Medicines to treat erection and ejaculation problems

• sildenafil (for erectile dysfunction)

Medicines to treat pain

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

Other medicines that contain:

• alitretinoin (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 excessive parathyroid activity)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher's disease) when used in patients who cannot break down certain medicines in the body
• ivacaftor (for cystic fibrosis)
• methadone (for treating addiction)
• repaglinide or saxagliptin (for diabetes)

This list is not exhaustive, 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 acid in your stomach to ensure the absorption of itraconazole capsules. Therefore, medicines that neutralize stomach acid should be used at least 2 hours before taking itraconazole capsules or 2 hours after taking this medicine. For the same reason, if you are taking medicines that regulate the production of acid in your stomach, 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 medicine immediately after finishing one of the main meals.

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

Pregnancy, breastfeeding and fertility

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

Pregnancy

Itraconazole will not be used in pregnancy.

Breastfeeding

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

Fertility

If you are fertile and can become pregnant, consult your doctor. You should use effective contraceptive measures to avoid becoming pregnant while taking the medicine. Because itraconazole 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 Itraconazol Stada”).

Driving and operating machinery

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

Itraconazol Stada contains sucrose

This medicine contains sucrose. 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 this medication 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 suspend the treatment before.

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

You must take itraconazole capsules immediately after meals, as this is when it is absorbed better. 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 capsules you should take.

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

The following doses are the most frequent:

• Fungal nail infections: Depending on your personal needs, your doctor will choose a 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 itraconazole 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 completing treatment. This is characteristic of fungal spots: 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 mission. 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

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

If you take more Itraconazole Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, Tel: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet 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 forgot to take Itraconazole Stada

Do not take a double dose to compensate for the missed doses.

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

If you interrupt treatment with Itraconazole Stada

Do not interrupt treatment with itraconazole 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 medication, ask your doctor or pharmacist.

Like all medicines, itraconazole may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you experience 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.

The adverse reactions were classified by 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 fewer 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 is accompanied by frequent sneezing)

• Blood 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 fluids, joint pains, fever, and extreme exhaustion), angioneuritic edema (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, sensation of numbness in the extremities (paresthesia), decreased sensitivity (hypoesthesia), 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

• Respiratory, thoracic and mediastinal disorders

Rare: dyspnea, shortness of breath

• Gastrointestinal disorders

Common: abdominal pain, nausea

Uncommon: vomiting, discomfort associated with meals, diarrhea, constipation, flatulence

Rare: pancreatitis

• Hepatobiliary disorders

Uncommon: abnormal liver function

Rare: elevated bilirubin in blood (hyperbilirubinemia), 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, mucous membrane, and eye rash), a severe skin disorder (generalized exfoliative dermatitis with blistering in the mouth, eyes, and genitals, or generalized exfoliative dermatitis with small pustules or blisters), erythema multiforme (skin disease characterized by the appearance of vesicles, blisters, etc.), dermatitis exfoliativa (skin disease characterized by peeling), leukocytoclastic vasculitis (inflammation of the blood vessel walls), alopecia (hair loss), photosensitivity (exaggered skin response to sunlight)

• Renal and urinary disorders

Rare: increased frequency of urination

• Reproductive and breast disorders

Uncommon: menstrual disorders

Rare: erectile dysfunction

• General disorders and administration site conditions

Rare: edema (fluid accumulation)

• Laboratory investigations

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

Description of certain side effects

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

Blood and lymphatic system disorders:granulocytopenia, thrombocytopenia (decreased blood cells)

Immune system disorders:anaphylactoid reaction

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

Mental disorders: feeling of confusion or disorientation

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

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

Vascular disorders:hypertension, hypotension

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

Gastrointestinal disorders: gastrointestinal disorder

Hepatobiliary disorders:liver insufficiency, hepatitis, jaundice (yellow discoloration of the skin, eyes, mucous membranes, and secretions)

Skin and subcutaneous tissue disorders: erythematous rash, 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 edema, facial edema, chest pain, fever, pain, fatigue, chills

Laboratory 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 consider that any of the side effects you experience 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 not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance 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 out of sight and reach of children.

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

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

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:

Caplet content: sugar spheres (cornstarch and sucrose), poloxamer 188, and hypromellose 6cP.

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

Appearance of the product and contents of the packaging

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 packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

Liconsa Laboratories, S.A.

Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet: May 2022

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