Itraconazole Viatris 100 mg capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Itraconazole Viatris 100 mg hard capsules EFG

Read the entire package 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 questions, ask your doctor or pharmacist.

? This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.

? If you experience any adverse reactions, consult your doctor or pharmacist, even if they are reactions not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What Itraconazole Viatris is and what it is used for
2. What you need to know before taking Itraconazole Viatris
3. How to take Itraconazole Viatris
4. Possible adverse effects
5. How to store Itraconazole Viatris
6. Contents of the pack and other information

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

Itraconazole belongs to a group of medicines called "antifungals".

It is indicated for the treatment of fungal infections affecting the vagina, skin, mouth, eyes, nails, or internal organs.

2. What you need to know before taking Itraconazol Viatris

Do not take Itraconazol Viatris

• If you are allergic (hypersensitive) to itraconazole or to any of the other ingredients of this medicine listed in section 6 “Contents of the pack and further information”.

• If you have a condition called heart failure (also known as congestive heart failure or CHF). This medicine could worsen your condition. If your doctor decides you should take this medicine, contact them immediately if you experience shortness of breath, unexpected weight gain, swollen legs, unusual fatigue, or begin waking up at night.

• If you are pregnant, think you might be pregnant, or could become pregnant (see pregnancy section), your doctor will assess whether you should take this medicine.

• If you are of childbearing age, you must use adequate contraceptive measures to avoid becoming pregnant during treatment. Because this medicine may remain in the body for some time, you should continue contraceptive measures until your next menstrual period after stopping treatment with this medicine.

• Itraconazole must not be used together with certain medicines. Many medicines interact with itraconazole; see section “Other medicines and Itraconazol Viatris” and the list below.

Do not take itraconazole if you are in any of the situations listed above. If you are unsure, consult your doctor or pharmacist before starting this medicine.

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

Do not use Itraconazol Viatris if you are taking certain medicines, or within 2 weeks after stopping itraconazole.

Examples of these medicines are:

Medicines used to treat heart, blood, or circulation problems

? aliskiren, eplerenone, lercanidipine, or nisoldipine (for hypertension)

? bepridil, ivabradine, or ranolazine (for angina – chest pain)

? dabigatran or ticagrelor (for blood clots)

? disopyramide, dofetilide, dronedarone, or quinidine (for irregular heartbeat)

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

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

? sildenafil when used to treat pulmonary arterial hypertension (increased blood pressure in the lung blood vessels)

Medicines to treat stomach problems or constipation

? cisapride (for stomach disorders)

? domperidone (for nausea and vomiting)

? naloxegol (for constipation caused by opioid painkillers)

Medicines to treat headaches, sleep, or mental health problems

? dihydroergotamine or ergotamine (ergot alkaloids 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 overactive bladder) when used in patients with certain kidney or liver problems

Medicines to treat allergies

• astemizole, mizolastine, or terfenadine (for allergies)

Medicines to treat erectile dysfunction and ejaculation problems

? avanafil (for erectile dysfunction)

? dapoxetine (for premature ejaculation)

? vardenafil (for erectile dysfunction) when used in men over 75 years of age

Other medicines containing:

? 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 metabolize certain medicines

? halofantrine (for malaria)

? irinotecan (for cancer)

? isavuconazole (for fungal infections)

? ombitasvir, paritaprevir, ritonavir with or without dasabuvir (to treat hepatitis C)

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

• voclosporin (to treat lupus-related kidney problems)

Do not take itraconazole if you are in any of the situations listed above. If you are unsure, consult your doctor or pharmacist before starting itraconazole.

Remember: do not take any of the above medicines within 2 weeks after your last dose of itraconazole.

This is not a complete list; inform your doctor if you are taking or plan to take any of these medicines or any other medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting itraconazole:

? If you have heart problems, consult your doctor. Inform your doctor immediately if you develop difficulty breathing, unexpected weight gain, leg swelling, unusual fatigue, or insomnia, as these may be symptoms of heart failure.

? If you have liver problems. The dose of this medicine may need to be adjusted. If any of the following symptoms occur during treatment, stop taking the medicine and contact 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 are taking itraconazole capsules, your doctor may order regular blood tests, as liver disorders, although very rare, have been reported.

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

? Consult your doctor or seek immediate medical attention if you experience a severe allergic reaction while taking itraconazole (characterized by severe skin rash, itching, hives, difficulty breathing, and/or facial swelling).

? Stop taking this medicine and contact your doctor immediately if you become overly sensitive to sunlight.

? Stop taking itraconazole and contact your doctor immediately if you develop a serious skin disorder, such as a widespread rash with skin peeling and blisters in the mouth, eyes, or genitals, or a rash with small pustules or blisters.

? 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 or to another medicine used to treat fungal infections (medicines known as azoles), consult your doctor. A hypersensitivity reaction may include skin rash, itching, hives, shortness of breath, or difficulty breathing, and/or facial swelling. If you experience a severe allergic reaction, contact your doctor immediately.

? If you have cystic fibrosis, consult your doctor before taking itraconazole.

? Stop taking itraconazole and contact your doctor immediately if you experience tingling, numbness, reduced sensation, 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 hearing problems. In very rare cases, temporary or permanent hearing loss has occurred.

? Inform your doctor if your vision becomes blurred or double, if you hear ringing in the ears, if you lose control of your urine, or if you urinate more than usual.

? This medicine is not recommended for elderly patients. It may only be prescribed by a doctor in exceptional cases.

Other medicines and Itraconazol Viatris

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

There are medicines that must not be taken while you are taking itraconazole. These medicines are listed above under the heading “Do not take Itraconazol Viatres”.

The use of certain medicines with itraconazole is not recommended.

Your doctor may decide that you should not take certain medicines at the same time as itraconazole or within 2 weeks after stopping itraconazole.

Examples of these medicines are:

Medicines to treat heart, blood, or circulation problems

• apixaban, edoxaban, rivaroxaban, or vorapaxar (for blood clots)

• atorvastatin (to lower cholesterol)

? felodipine (for hypertension)

? riociguat or tadalafil when used to treat pulmonary hypertension (increased blood pressure in the lung blood vessels)

Medicines to treat epilepsy, headaches, or mental health problems

? phenytoin, carbamazepine, or phenobarbital (antiepileptics)

? eletriptan (for migraines)

? St. John’s Wort (Hypericum perforatum) (a herbal medicine used for mental health problems)

Medicines to treat urinary problems

? tamsulosin (for male urinary incontinence)

? tolterodine (for overactive bladder)

Medicines 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 for acute myeloid leukemia), or vinca alkaloids (e.g., vinflunine, vinorelbine)

Medicines to treat tuberculosis

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

Medicines to treat human immunodeficiency virus (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 organ transplantation

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

Medicines to treat benign prostatic hyperplasia

? alfuzosin, silodosin

Medicines to treat lung problems or allergies

? ciclesonide (for inflammation, asthma, and allergies)

? ebastine (for allergies)

? salmeterol (for asthma or chronic obstructive pulmonary disease, COPD)

Medicines to treat erectile dysfunction and ejaculation problems

? tadalafil or vardenafil (when used in men aged 75 years or younger) (for erectile dysfunction)

Other medicines containing:

? colchicine (for gout)

? fentanyl (for pain)

? lumacaftor/ivacaftor (for cystic fibrosis)

Remember: do not take any of the above medicines within 2 weeks after your last dose of itraconazole capsules.

This list is not complete; inform your doctor if you are taking or plan to take any of these medicines or any other medicine.

Caution is required when using itraconazole with certain medicines.

You may be more likely to experience adverse effects, or the dose of itraconazole or the other medicine may need to be adjusted. Examples of these medicines are:

Medicines to treat heart, blood, or circulation problems

? bosentan when used to treat pulmonary hypertension (increased blood pressure in the lung blood vessels)

? calcium channel blockers such as dihydropyridines, including amlodipine, isradipine, nifedipine, nimodipine, or diltiazem (for hypertension)

• 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 problems or diarrhoea

? aprepitant or netupitant (for nausea and vomiting during cancer treatment)

? loperamide (for diarrhoea)

? 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 (to treat stomach acid problems)

Medicines to treat sleep or mental health disorders

? alprazolam, brotizolam, buspirone, or midazolam (when injected intravenously) (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

? imidafenacina, fesoterodine, oxybutynin, solifenacin (for overactive bladder)

Medicines to treat cancer

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

Medicines to treat infections

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

? delamanid (for tuberculosis)

? artemether-lumefantrine or quinine (for treating malaria)

? praziquantel (for worms and tapeworms)

Medicines to treat human immunodeficiency virus (HIV) or hepatitis

? cobicistat, boosted elvitegravir, maraviroc, ritonavir, darunavir boosted with ritonavir, fosamprenavir boosted with ritonavir, indinavir, or saquinavir (for HIV)

? glecaprevir/pibrentasvir (for hepatitis)

Medicines used after organ transplantation

? cyclosporine or tacrolimus

Medicines to treat benign prostatic hyperplasia

? dutasteride

Medicines to treat lung problems, allergies, or inflammatory conditions

? bilastine or rupatadine (for allergies)

? methylprednisolone or dexamethasone (oral or injectable medicines for asthma, allergies, or inflammatory conditions)

? budesonide or fluticasone (for asthma, allergies)

Medicines to treat erectile dysfunction 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 containing:

? 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 overactive parathyroid function)

? dienogest or ulipristal (contraceptives)

? eliglustat (for Gaucher’s disease) when used in patients who cannot metabolize certain medicines

? ivacaftor (for cystic fibrosis)

? methadone (for drug addiction)

? repaglinide or saxagliptin (for diabetes)

This list is not complete; inform your doctor if you are taking or plan to take any of these medicines or any other medicine, so appropriate measures can be taken.

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

If in doubt, consult your doctor or pharmacist.

Taking Itraconazol Viatris with food and drinks

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 during pregnancy.

If you are of childbearing age and could become pregnant, consult your doctor. You must use effective contraception to ensure you do not become pregnant while taking this medicine.

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

Breastfeeding

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

Driving and using machines

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

This medicine contains sucrose

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

3. How to take Itraconazol Viatris

Follow exactly the instructions for use of this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how long to take this medicine. Do not stop treatment prematurely. If you think the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

You should take itraconazol immediately after meals, as it is better absorbed this 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 itraconazol you should take.

There must be sufficient acidity in the stomach to ensure proper absorption of this medicine. Therefore, medicines that neutralize stomach acidity should be taken either two hours after taking this medicine or two hours before taking itraconazol. For the same reason, if you are taking medicines that regulate acid production in the stomach, take itraconazol with a cola drink.

The following doses are the most common:

TYPE OF INFECTION	CAPSULES PER DAY	DURATION
Vaginal infection	2 capsules twice a day or 2 capsules once a day	1 day 3 days
Skin infection	2 capsules once a day or 1 capsule once a day	7 days 2 weeks
	If palms of hands or soles of feet are affected, 2 capsules twice a day for 7 days or 1 capsule once a day for 1 month may be required
Oral infections	1 capsule once a day	2 weeks
Eye infections	2 capsules once a day	3 weeks
Internal infections	1 to 4 capsules daily	longer periods

? Nail infections: depending on your individual needs, your doctor will choose either continuous or intermittent treatment.

• Continuous treatment for toenail infections:

TYPE OF INFECTION	CAPSULES PER DAY	DURATION
Continuous treatment for nails	2 capsules once daily	3 months

• Intermittent treatment for nails:

Consists of two capsules twice daily for 1 week; then stop taking itraconazole for 3 weeks. Subsequently, repeat the cycle once for fingernails and twice for toenails (with or without fingernail infection) (see the following table).

	Week 1	Week 2	Week 3	Week 4	Week 5	Week 6	Week 7	Week 8	Week 9	Week 10
Toenails with or without fingernail involvement	Take 2 capsules twice daily	No treatment with itraconazole	Take 2 capsules twice daily	No treatment with itraconazole	Take 2 capsules twice daily	Interrupt treatment
Fingernails only	Take 2 capsules twice daily	No treatment with itraconazole	Take 2 capsules twice daily	Interrupt treatment

In skin infections, 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 has grown.

Nail lesions will disappear 6 to 9 months after completing treatment, as the medication only eliminates the fungus itself. The nail must regrow, which takes several months. Therefore, do not be concerned if you do not notice improvement during treatment: the medication remains in your nails for several months and fulfills its purpose. Thus, you must stop treatment at the time indicated by your doctor, even if you do not see any improvement.

Internal organ infections: higher doses and prolonged treatment may be required.

Always follow your doctor's instructions; he or she will adapt the treatment to your individual needs.

Use in Children

Itraconazol capsules should not be used in children. Only in exceptional cases may it be prescribed by a physician.

If you take more Itraconazol Viatris than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

In case of accidental overdose, your doctor will implement supportive measures. Itraconazol is not removed by hemodialysis. Specific antidotes are not known.

If you forget to take Itraconazol Viatris:

If you forget to take the medication, take the next scheduled dose and continue treatment as directed by your doctor. Do not take a double dose to make up for missed doses. Resume taking the medication as soon as possible.

If you stop treatment with Itraconazol Viatris

Do not stop treatment with itraconazol without consulting your doctor, as symptoms of your condition may reappear or worsen.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Below are the adverse effects observed during clinical trials and post-marketing experience with the medicine.

Adverse reactions are classified according to 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 fewer than 1 in 10,000 patients
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 causing watery mucus discharge and frequent sneezing)

? Blood and lymphatic system disorders

Rare: leukopenia

? Immune system disorders

Uncommon: hypersensitivity and allergic reactions
Rare: anaphylactic (allergic) reactions, serum sickness (an allergic reaction occurring after injection of certain sera, characterized by hives, fluid accumulation, joint pain, fever, and extreme exhaustion), angioneurotic edema (swelling due to fluid accumulation that may affect the mouth and upper airways)

? Endocrine disorders

Frequency not known: symptoms of elevated "aldosterone" hormone levels (such as high blood pressure or low blood potassium levels), even when blood levels of "aldosterone" are normal or low

? 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 (dysgeusia)

? Eye disorders

Rare: visual disturbances (including blurred vision and double vision)

? Ear and labyrinth disorders

Rare: permanent or temporary hearing loss, subjective sensation of ringing in the ears (tinnitus)

? Cardiac disorders

Rare: congestive heart failure, decreased heart rate

? Respiratory, thoracic and mediastinal disorders

Rare: shortness of breath, difficulty breathing (dyspnea)

? Gastrointestinal disorders

Common: abdominal pain, nausea
Uncommon: vomiting, discomfort associated with meals, diarrhea and constipation, intestinal gas accumulation (flatulence)
Rare: inflammation of the pancreas (pancreatitis)

? Hepatobiliary disorders

Uncommon: abnormal liver function
Rare: elevated blood bilirubin levels (hyperbilirubinemia), severe hepatotoxicity (including cases of very severe acute liver failure)

? Skin and subcutaneous tissue disorders

Uncommon: urticaria, rash, itching
Rare: toxic epidermal necrolysis (a severe skin disease characterized by rash, blisters, and skin peeling), Stevens-Johnson syndrome (severe erythema of the skin, mucous membranes, and eyes), a serious skin disorder (generalized rash with skin peeling and blisters in the mouth, eyes, and genitals, or rash with small pustules or blisters), erythema multiforme (a skin disease characterized by vesicles, blisters, etc.), exfoliative dermatitis (a skin disease characterized by skin peeling), leukocytoclastic vasculitis (inflammation of blood vessel walls), alopecia (hair loss), photosensitivity (exaggerated skin reaction 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 blood creatine phosphokinase (a parameter measuring liver function)

Description of certain adverse effects

Below are the adverse effects associated with itraconazole reported in clinical trials of oral and/or intravenous itraconazole solution, excluding the adverse effect "injection site reaction," as this effect is specific to the injectable route of administration.

Blood and lymphatic system disorders: granulocytopenia, thrombocytopenia (decrease in certain blood cells)

Immune system disorders: anaphylactoid reaction

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

Psychiatric disorders: feeling of confusion or disorientation

Nervous system disorders: peripheral neuropathy (peripheral nerve damage causing 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: red skin rash (erythematous exanthema), excessive sweating

Musculoskeletal and connective tissue disorders: muscle pain or weakness (myalgia), joint pain (arthralgia)

Renal and urinary disorders: renal failure, urinary incontinence (urine leakage)

General disorders and administration site conditions: excessive fluid accumulation in body tissues (generalized edema), fluid accumulation in the face (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 blood urea, increased gamma-glutamyl transferase, increased liver enzymes, abnormal urine test

Adverse effects in the pediatric population

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

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

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Itraconazole Viatris

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

Do not use Itraconazole Viatris after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Itraconazole Viatris

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

Appearance of the product and contents of the container

Itraconazole Viatris consists of hard capsules with an opaque green cap and body.

Itraconazole Viatris is available in blisters of 7, 14 or 100 capsules (hospital pack) and in single-dose perforated blisters of 7 and 14 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Liconsa, S.A.

Avda. Miralcampo, nº 7

Pol. Ind. Miralcampo

19200 – Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent revision of this summary: January 2026

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