Leaflet: information for the user

Itraconazole Viatris 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 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 leaflet. See section 4.

1.What Itraconazole Viatris is and what it is used for

2.What you need to know before you start taking Itraconazole Viatris

3.How to take Itraconazole Viatris

4.Possible side effects

5.Storage of Itraconazole Viatris

6.Contents of the pack and additional information

Itraconazol 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 Viatris 100 mg capsules

• if you areallergicto itraconazol or to any of the otheringredients 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 may 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 contraceptive measures until the next menstrual period after completing treatment with this medicine.
• itraconazol cannot be used with some medicines. There are many medicines that interact with itraconazol, see section “Other medicines and Itraconazol Viatris” and the list below.

Before taking Itraconazol, tell your doctor if you are taking any other medicine.

Do not use Itraconazol Viatris ifyou are taking any of the following medicines, or within 2 weeks of stopping Itraconazol:

Medicines used to treat heart, blood, or circulation problems

?aliskiren, eplerenone, lercanidipine, or nisoldipine (for high blood pressure)

?bepridil, ivabradine, or ranolazine (for angina)

?dabigatran or ticagrelor(for blood clots)

?disopyramide, dofetilide, dronedarone, or quinidine (for irregular heart rhythm)

• felodipine (for high blood pressure)

?finerenone (for kidney problems in patients with type 2 diabetes)

?lomitapide, lovastatin, or simvastatin (to lower cholesterol)

?sildenafilo (for high blood pressure in the lungs)

Medicines used to treat stomach or constipation problems

?cisapride (for stomach disorders)

?domperidone (for nausea and vomiting)

?naloxegol (for constipation caused by taking opioid analgesics)

Medicines used 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 problems)

Medicines used 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 used to treat allergies

?astemizole, mizolastine, or terfenadine (for allergies)

Medicines used 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)

• venetoclax (for chronic lymphocytic leukemia) when you start taking venetoclax for the first time or when taking increasing doses at the beginning of treatment

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

Warnings and precautions

Be especially careful with itraconazol Viatris

?if you have heart problems, consult your doctor. Tell 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. 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), dark urine, or pale stools. If you continue treatment with itraconazol capsules, your doctor may regularly send you for blood tests, as rare cases of liver damage have occurred.

?if you have any kidney problems, consult your doctor. The dose of this medicine may need to be adjusted.

?consult your doctor or seek medical attention immediately if 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 itraconazol 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 itraconazol 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 itraconazol.

?stop taking itraconazol and consult your doctor immediately if you experience any numbness, tingling, decreased sensitivity, or weakness in your arms or 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 occurred.

?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. It is only prescribed by a doctor in exceptional cases.

Other medicines and itraconazol 100 mg Viatris

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

There are medicines thatshould not be takenwhile taking itraconazol. These medicines are listed above under the heading “Do not use Itraconazol Viatris”

Do not recommend using certain medicines with Itraconazol Viatris.

Your doctor may decide thatyou should not take some medicines at the same time as itraconazol or within 2 weeks after stopping it.

Examples of these medicines are:

Medicines used to treat heart, blood, or circulation problems

• apixaban, edoxaban, rivaroxaban, or vorapaxar (for blood clots)
• atorvastatin (to lower cholesterol)

?felodipine (for high blood pressure)

?riociguat or tadalafil (for high blood pressure in the lungs)

Medicines used to treat epilepsy, headaches, 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 used to treat urinary problems

?tamsulosin (for male urinary incontinence)

?tolterodine (for irritated bladder)

Medicines used to treat cancer

?axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedin, trastuzumab emtansine, venetoclax (when you are on a stable dose of venetoclax for chronic lymphocytic leukemia, or at any time during treatment of acute myeloid leukemia) or vinca alkaloids (e.g., vinflunine, vinorelbine)

Medicines used to treat tuberculosis

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

Medicines used to treat HIV or hepatitis

?efavirenz or nevirapine (for HIV/AIDS)

?elbasvir/grazoprevir, tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) (for HIV or hepatitis)

Medicines used after an organ transplant

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

Medicines used to treat benign prostatic hyperplasia

?alfuzosin, silodosin

Medicines used 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 used 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 itraconazol 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 Itraconazol Viatris with certain medicines.

You may be more likely to experience side effects or the dose of itraconazol 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 high blood pressure in the lungs)

?calcium channel blockers such as dihydropyridines, such as amlodipine, isradipine, nifedipine, nimodipine, or diltiazem (for high blood pressure)

• verapamil (for high blood pressure)

?cilostazol (for circulation problems)

?“coumarins” such as warfarin (for blood clots)

?digoxin (for atrial fibrillation)

?nadolol (for high blood pressure in the lungs or angina)

Medicines used to treat 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, or proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (for stomach acid problems)

Medicines used 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 problems)

?galantamine (for Alzheimer's disease)

?guanfacine (for attention deficit hyperactivity disorder)

Medicines used to treat urinary problems

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

Medicines used to treat cancer

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

Medicines used to treat infections

?ciprofloxacin, clarithromycin, or erythromycin (for bacterial infections)

?delamanid (for tuberculosis)

?artemether-lumefantrine or quinine (for malaria)

?praziquantel (for tapeworms and tenias)

Medicines used 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

?ciclosporin or tacrolimus

Medicines used to treat benign prostatic hyperplasia

?dutasteride

Medicines used 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 used to treat erection and ejaculation problems

?sildenafil (for erectile dysfunction)

Medicines used 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 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 acidity in the stomach to ensure the absorption of itraconazol capsules. Therefore, medicines that neutralize stomach acid should be used at least 2 hours before taking itraconazol 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 itraconazol capsules with a cola drink (see section 3 “How to take Itraconazol Viatris”).

In case of doubt, consult your doctor or pharmacist.

Taking itraconazol Viatris 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

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

Pregnancy

Itraconazol will not be used during pregnancy.

If you are fertile and may become pregnant, consult your doctor. You should use effective contraceptive measures to ensure you do not become pregnant while taking the medicine.

Because itraconazol may remain in the body for some time, you should prolong contraceptive measures until the next menstrual period after completing treatment with this medicine. (See section 2 “Do not take Itraconazol Viatris”).

Breastfeeding

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

Driving and operating machinery

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

This medicine contains saccharose

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 as indicated by your doctor. 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 too weak, inform your doctor or pharmacist.

You must take Itraconazol immediately after meals, as 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 Itraconazol 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 Itraconazol. For the same reason, if you are taking medications that regulate the production of acid in the stomach, take Itraconazol with a cola drink.

The following doses are the most frequent:

?Fingernail infections: depending on your personal needs, your doctor will opt for a continuous or intermittent treatment.

-Continuous treatment for foot nail infections:

-Intermittent treatment for nails:

This consists of 2 capsules twice a day for 1 week; then stop taking Itraconazol for 3 weeks. Then, the cycle is repeated, once for the hands and twice for the feet (with or without infection in the hands) (see the following table).

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 personal needs.

Use in Children

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

If you take more Itraconazol Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount used.

In case of accidental overdose, your doctor will apply supportive measures. Itraconazol is not eliminated by hemodialysis. No specific antidotes are known.

If you forgot to take Itraconazol Viatris:

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. Resume taking the medication as soon as possible.

If you interrupt the treatment with Itraconazol Viatris

Do not interrupt the treatment with itraconazol 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 are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Below, the side effects seen during the marketing of the medicine and clinical trials are listed.

The 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 that is accompanied by the production of watery mucus and sneezingcommon)

?Haematological and lymphatic system disorders

Rare: leucopenia

?Immune system disorders

Uncommon: excessive and allergic hypersensitivity reaction

Rare: anaphylactic reactions (allergic), serum disease (allergy that appears after the injection of some sera and is characterized by the appearance of urticaria, accumulation of fluids, joint pain, fever, and extreme exhaustion), angioneuritic oedema (swelling due to fluid accumulation that can affect the mouth and upper respiratory tract).

?Metabolic and nutritional disorders

Rare: increased triglycerides

?Nervous system disorders

Common: headache

Rare: tremor, sensation of numbness in the limbs (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: dyspnoea, difficulty breathing

?Gastrointestinal disorders

Common: abdominal pain, nausea

Uncommon: vomiting, meal-related discomfort, diarrhoea and constipation, accumulation of gas in the intestine (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 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)

?Investigations

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

Description of certain side effects

Below, the side effects associated with itraconazole notified in itraconazole oral and/or intravenous clinical trials, excluding the side effect "inflammation at the injection site" since this side effect 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 (increased blood sugar), hyperkalaemia (increased potassium in blood), hypokalaemia (decreased potassium in blood), hypomagnesaemia (decreased magnesium in blood),

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, coughGastrointestinal 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 (exanthema), 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

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 clinical trial data in pediatric patients, the most frequently reported side effects were: headache, vomiting, abdominal pain, diarrhoea, abnormal liver function, hypotension, 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 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 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 this medication out of the sight and reach of children

Do not use Itraconazol Viatris 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 above30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and themedicines that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Itraconazol Viatris

• The active ingredient is itraconazole. Each capsule contains 100 mg of itraconazole
• The other components (excipients) are: sugar spheres (made of cornstarch and sucrose), poloxamer 188, and hypromellose. The capsule is composed of indigo carmine (E-132), quinoline yellow (E-104), titanium dioxide (E-171), and gelatin.

Appearance of the product and content of the packaging

Itraconazol Viatris 100 mg hard capsules are available in blisters of 7, 14, or 100 (clinical pack) hard capsules and in perforated single-dose blisters of 7 and 14 hard capsules of Aluminum/Aluminum.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization :

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing:

Liconsa, S.A.

Avda. Miralcampo, nº 7

Pol. Ind. Miralcampo

19200 – Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet: April 2024

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/