Package Leaflet: Information for the User

Itraconazol Sandoz 100 mg Hard Capsules EFG

Read this leaflet carefully before you start taking this medicine because 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2.What you need to know before you start taking Itraconazol Sandoz

3.How to take Itraconazol Sandoz

4.Possible side effects

5Storage of Itraconazol Sandoz

6.Contents of the pack and additional information

Itraconazol Sandoz 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 Sandoz:

• if you are allergic to itraconazole or any of the other ingredients 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 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 might be or could become pregnant(see pregnancy section), your doctor will assess whether you should take this medicine,
• if you are fertile, you should take appropriate contraceptive measures to avoid becoming pregnant during treatment. Because this medicine may remain in the body for a long time, you should prolong contraceptive measures until the next menstrual period after completing treatment with this medicine.
• itraconazole cannot be used with some medicines. There are many medicines that interact with itraconazole, see section “Other medicines and Itraconazol Sandoz” and the list below.

Inform your doctor if you are taking any other medicine before taking itraconazole.

Do not use itraconazole if you are taking any of the following medicines, or within 2 weeks of finishing itraconazole:

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),
• lomitapide, lovastatin or simvastatin (to lower cholesterol),
• sildenafil (for pulmonary hypertension).

Medicines for treating stomach or constipation problems

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

Medicines for treating 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 for treating urinary problems

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

Medicines for treating allergies

• astemizole, mizolastine or terfenadine (for allergies).

Medicines for treating erection and ejaculation problems

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

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 delivery,
• 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 (to treat hepatitis C).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take itraconazole. Be especially careful with itraconazole:

• If you have heart problems, consult your doctor. Inform your doctor immediately if you experience shortness of breath, unexpected weight gain, swollen legs, unusual fatigue or insomnia, as these may be symptoms of heart failure.
• If you have any liver problems. The dose of this medicine may need to be adjusted. 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), very dark urine or pale stools. If you continue treatment with itraconazole, it is very likely that your doctor will send you regular blood tests, as liver damage has occurred in very rare cases.
• If you have any kidney problems, consult your doctor. The dose of this medicine may need to be adjusted.
• Consult your doctor or seek immediate medical attention if while taking itraconazole 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 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/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 itraconazole 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 experience a severe allergic reaction, consult your doctor immediately.
• If you have cystic fibrosis, consult your doctor before taking itraconazole.
• Stop taking itraconazole 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 very rare cases, temporary or permanent hearing loss has occurred.
• Inform your doctor if your vision becomes blurred or double, if you hear a buzzing in your ears, if you lose control of your urine or urinate much more than usual.
• This medicine is not recommended for elderly patients. It is only prescribed by a doctor in exceptional cases.

Other medicines and Itraconazol Sandoz

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

There are medicines that you should not take while taking itraconazole. These medicines are listed above under the heading “Do not take Itraconazol Sandoz”

Some medicines should not be used with itraconazole. Your doctor may decide that you should not take some medicines at the same time as itraconazole or within 2 weeks.

Examples of these medicines are:

Medicines used to treat heart, blood or circulation problems

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

Medicines for treating 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 for treating urinary problems

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

Medicines for treating 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 for treating tuberculosis

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

Medicines for treating 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 for treating benign prostatic hyperplasia

• alfuzosin, silodosin.

Medicines for treating respiratory, allergy or inflammatory problems

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

Medicines for treating erection and ejaculation problems

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

Other medicines that contain:

• colchicine (for gout),
• fentanyl (for pain),
• lumacaftor/ivacaftor (for cystic fibrosis).

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

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 with certain medicines.

You may be more likely to experience side effects or the dose of itraconazole 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 for treating 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 treating 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 problems),
• galantamine (for Alzheimer's disease),
• guanfacine (for attention deficit hyperactivity disorder).

Medicines for treating urinary problems

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

Medicines for treating cancer

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

Medicines for treating infections

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

Medicines for treating HIV or hepatitis

• cobicistat, elvitegravir boosted, maraviroc, ritonavir, darunavir boosted with ritonavir, fosamprenavir boosted with ritonavir, indinavir or saquinavir (for HIV/AIDS),
• glecaprevir/pibrentasvir (for hepatitis).

Medicines used after an organ transplant

• ciclosporin or tacrolimus.

Medicines for treating benign prostatic hyperplasia

• dutasteride.

Medicines for treating respiratory, allergy or inflammatory problems

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

Medicines for treating erection and ejaculation problems

• sildenafil (for erectile dysfunction),

Medicines for treating pain

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

Other medicines that contain:

• etretinate (administered orally) (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 opioid addiction),

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 acidity in the stomach to ensure the absorption of itraconazole. Therefore, medicines that neutralize stomach acid should be taken at least 2 hours before taking itraconazole or 2 hours after taking this medicine. For the same reason, if you are taking medicines that regulate the production of acid in the stomach, take itraconazole with a cola drink (see section 3 “How to take Itraconazol Sandoz”).

If in doubt, consult your doctor or pharmacist.

Taking Itraconazol Sandoz with food and drinks

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

If you are taking any medicine that regulates the production of acid 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.

Itraconazole will not be used during pregnancy.

If you are fertile and may become pregnant, consult your doctor. You should use effective contraceptive measures to avoid becoming pregnant while taking the medicine. Because itraconazole may remain in the body for a long time, you should prolong contraceptive measures until the next menstrual period after completing treatment with this medicine. (See section 2 “Do not take Itraconazol Sandoz”).

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

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 Sandoz contains saccharose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; it is essentially “sodium-free”.

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

You must take itraconazole immediately after meals, as it is absorbed better. Swallow the capsules whole with a little water. The amount 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 you should take.

You must have 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. For the same reason, if you are taking medications that regulate the production of acid in the stomach, take itraconazole 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 100 mg capsules for 3 weeks. Then the cycle is repeated, once for the hands and twice for the feet (with or without infection on the hands).(See the following table)

For skin infections, lesions will disappear a few weeks after treatment is completed. 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 treatment is completed, 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 and Adolescents

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

If you take more Itraconazole Sandoz than you should

If you have taken more itraconazole than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the 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 forget to take Itraconazole Sandoz

If you forget to take the medication, take the next dose that corresponds to you and continue the treatment as indicated by your doctor. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Itraconazole Sandoz

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 product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you consider that any of the side effects you experience are serious 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:

Frequent side effects (can affect more than 1 in 10 people)

Common side effects (can affect up to 1 in 10 people)

Uncommon side effects (can affect up to 1 in 100 people)

Rare side effects (can affect up to 1 in 1,000 people)

Very rare side effects (can affect up to 1 in 10,000 people)

Infections and infestations

Uncommon: sinusitis (nasal sinus irritation and swelling), upper respiratory tract infection, rhinitis (inflammation of the nasal mucosa with watery discharge and 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, 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, numbness in the extremities (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 temporary hearing loss, subjective sensation of noise 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, meal-related discomfort, diarrhea, constipation, flatulence.

Rare: pancreatitis.

Hepatobiliary disorders:

Uncommon: abnormal liver function.

Rare: elevated bilirubin in the 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 rash with skin peeling and blisters in the mouth, eyes, and genitals, or generalized rash 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).

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 oral and intravenous itraconazole, excluding the effect "inflammation at the injection site" which is specific to the intravenous route.

Blood and lymphatic system disorders:granulocytopenia, thrombocytopenia (decreased blood cell count).

Immune system disorders:anaphylactoid reaction.

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

Mental and behavioral disorders:sensation of confusion or disorientation.

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

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

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

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 (red 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 (excessive fluid accumulation in the body tissues), facial edema (fluid accumulation in the face), chest pain, fever, pain, fatigue, chills.

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

Side effects in the pediatric population

Based on clinical trial data in pediatric patients, the most frequently reported side effects were: headache, vomiting, abdominal pain, diarrhea, abnormal liver function, low blood pressure, nausea, and urticaria.

In general, the nature of the side effects is similar to that observed in adult patients, although the incidence is higher in pediatric patients.

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

If you consider that any of the side effects you experience are serious 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 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 this medication after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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

Composition of Itraconazol Sandoz

-The active ingredient is itraconazole. Each capsule contains 100 mg of itraconazole.

-The other components are:

Sugar spheres (constituted by cornstarch and sucrose), poloxamer 188, micronized poloxamer 188, hypromellose.

Durable gelatin capsule: gelatin, indigo carmine (E132), quinoline yellow (E104) (contains sodium) and titanium dioxide (E171).

Appearance of the product and content of the container

Green opaque size Nº 0 capsules containing yellow-beige spherical microgranules packaged in Alu/Alu blister, 7, 14 or 100 (clinical packaging) capsules.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

Liconsa, S.A.

Gran Vía Carlos III, 98, 7th floor

08028 Barcelona

Spain

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Last review date of thisleaflet:January 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/