Orungal

Patient Information Leaflet: Information for the Patient

Orungal, 100 mg, Capsules

Itraconazole

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Orungal and what is it used for
• 2. Important information before taking Orungal
• 3. How to take Orungal
• 4. Possible side effects
• 5. How to store Orungal
• 6. Contents of the pack and other information

1. What is Orungal and what is it used for

Orungal contains the active substance itraconazole, which belongs to the group of thiazole derivatives and is a broad-spectrum antifungal agent.
Orungal is indicated for the treatment of:

• genital infections: vaginal candidiasis and vulvovaginal candidiasis;
• skin, mucous membrane, or eye infections: skin candidiasis, pityriasis versicolor, oral candidiasis, fungal keratitis;
• fungal nail infections caused by dermatophytes and/or yeasts;
• systemic fungal infections (fungal infections of various organs and tissues): systemic aspergillosis and systemic candidiasis, cryptococcosis, including cryptococcal meningitis, in patients with cryptococcosis and impaired immunity, and in all patients with cryptococcal central nervous system infection (Orungal is indicated only when first-line treatment is ineffective), histoplasmosis, blastomycosis, sporotrichosis (including lymphatic-cutaneous/skin and extracutaneous), paracoccidioidomycosis, and chromoblastomycosis.

2. Important information before taking Orungal

When not to take Orungal capsules

• If the patient is allergic (hypersensitive) to any of the ingredients of this medication (listed in section 6).
• If the patient has or has had heart problems, such as congestive heart failure, unless it is a life-threatening infection or other severe infection. Symptoms of congestive heart failure include shortness of breath, unexpected weight gain, swelling of limbs or abdomen, severe fatigue, or waking up at night with shortness of breath.
• If the patient is pregnant, thinks they may be pregnant, or may become pregnant (see section 2 "Pregnancy and breastfeeding").

Do not take Orungal if any of the above situations apply to the patient. In case of doubts, consult a doctor or pharmacist before taking Orungal.
Before starting to take Orungal, inform the doctor about taking any other medications.

Medications that should not be taken with Orungal

Do not take Orungal capsules ifthe patient is taking certain medications (and also do not take them within 2 weeks of stopping Orungal).
Examples of these medications are:

Medications for heart, blood, or circulation problems

• aliskiren, eplerenone, lercanidipine, or nizoldipine (used for hypertension)
• bepridil, ivabradine, or ranolazine - (used for angina pectoris - chest pain)
• dabigatran or ticagrelor (used for blood clots)
• disopyramide, dofetilide, dronedarone, or quinidine (used for heart rhythm disorders )
• finerenone (used to treat kidney problems in patients with type 2 diabetes)
• lomitapide, lovastatin, or simvastatin (used to lower cholesterol levels)
• sildenafil, when used to treat pulmonary hypertension (high blood pressure in the blood vessels of the lungs)

Medications for stomach or constipation problems

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

Medications for headaches, sleep disorders, or mental problems

• dihydroergotamine or ergotamine (ergot alkaloids used for migraine headaches)
• midazolam (taken orally) or triazolam (used for sedation or to help fall asleep)
• lurasidone, pimozide, quetiapine, or sertindole (used for schizophrenia, bipolar disorder, or other mental problems)

Medications for urinary problems

• darifenacin (used for urinary incontinence)
• fezoterodine or solifenacin (used for overactive bladder) - in patients with certain kidney or liver problems

Medications for allergies

• astemizole, mizolastine, or terfenadine (used for allergies)

Medications for erection and ejaculation problems

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

Other medications containing:

• colchicine (used to treat gout) - in patients with kidney or liver problems
• ergometrine or methylergometrine (ergot alkaloids used after childbirth)
• eliglustat (used to treat Gaucher's disease), when used in patients who cannot break down certain medications in the body
• halofantrine (used to treat malaria)
• irinotecan (used to treat cancer)
• isavuconazole (used to treat fungal infections)
• ombitasvir, paritaprevir, ritonavir with or without dasabuvir (used to treat hepatitis C)
• venetoclax (used to treat chronic lymphocytic leukemia) when starting venetoclax or increasing the dose at the start of treatment
• voclosporin (used to treat kidney diseases related to lupus)

Do not take Orungal capsules if any of the above situations apply to the patient. In case of doubts, consult a doctor before taking Orungal capsules.
Remember not to take any of the above medications for 2 weeks after stopping Orungal capsules.

It is not a complete list, so inform the doctor if the patient is taking or plans to take any of these medications or any other medications.

Warnings and precautions

If the patient has any of the following conditions, they should discuss it with their doctor or pharmacist before
starting to take Orungal.

• The patient has kidney problems. The dose of this medication may need to be adjusted.
• The patient has liver problems. The dose of this medication may need to be adjusted. The doctor may recommend monitoring liver function in patients taking Orungal, as this medication can very rarely cause severe liver damage.
• The patient has heart problems.
• The patient has had an allergic reaction to another antifungal medication.
• The patient has impaired immunity, e.g., due to neutropenia, AIDS, or organ transplantation. The dose of this medication may need to be adjusted.
• The patient is taking other medications.

If the patient experiences any of the following symptoms while taking Orungal, they should tell their doctor.

• Symptoms of liver inflammation: loss of appetite, nausea, vomiting, fatigue, abdominal pain, yellowing of the skin or eyes, pale stools, or dark urine
• stop taking the medication and see a doctor immediately.
• Symptoms of congestive heart failure: shortness of breath, unexplained weight gain, swelling of legs or abdomen, severe fatigue, or waking up at night with shortness of breath - stop taking the medication and see a doctor immediately.
• Symptoms of a severe allergic reaction: rash, itching, hives, difficulty breathing, and/or swelling of the face - stop taking the medication and see a doctor immediately.
• Sensitivity to light.
• Severe skin reactions, such as generalized rash with peeling and blisters in the mouth, eyes, and genitals, or rash with small blisters or vesicles - stop taking the medication and see a doctor immediately.
• Symptoms of neuropathy (nerve damage), such as: tingling, numbness, decreased sensation, weakness in the limbs, headache, dizziness - stop taking the medication and see a doctor immediately.
• Symptoms of hearing loss.
• Blurred or double vision, ringing in the ears, incontinence, or frequent urination.

Orungal and other medications

Tell the doctor about all medications the patient is currently taking or has recently taken, as well as any medications they plan to take.

Medications that should not be taken

There are medications that should not be takenwhile taking Orungal. They are listed above in the section “Medications that should not be taken with Orungal”.

Some medications are not recommended to be taken with Orungal capsules.

The doctor may decide which medications the patient should not take at the same time or
within 2 weeks of stopping Orungal.
Examples of these medications are:

Medications for heart, blood, or circulation problems

• apixaban, edoxaban, rivaroxaban, or vorapaxar (used for blood clots)
• atorvastatin (used to lower cholesterol levels)
• felodipine (used for high blood pressure)
• riociguat or tadalafil, when used to treat pulmonary hypertension (high blood pressure in the blood vessels of the lungs)

Medications for epilepsy, headaches, or mental problems

• phenytoin, carbamazepine, or phenobarbital (used for epilepsy)
• eletriptan (used for migraine headaches)
• St. John's wort ( Hypericum perforatum) (a herbal remedy used to treat mental problems)

Medications for urinary problems

• tamsulosin (used for urinary incontinence in men)
• tolterodine (used for overactive bladder)

Medications for 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 the patient is on a stable dose of venetoclax in chronic lymphocytic leukemia or at any time during treatment for acute lymphoblastic leukemia) or vinca alkaloids (such as vinflunine, vinorelbine)

Medications for tuberculosis

• bedaquiline, isoniazid, rifabutin, or rifampicin (anti-tuberculosis medications)

Medications for HIV infection or hepatitis

• efavirenz or nevirapine (used for HIV/AIDS) elbasvir/grazoprevir, fumaric acid tenofovir alafenamide (TAF), fumaric acid tenofovir disoproxil (TDF) (used for HIV or hepatitis)

Medications used after organ transplantation

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

Medications for benign prostatic hyperplasia

• alfuzosin, silodosin

Medications for inflammatory, lung, or allergic disorders

• ciclesonide (used for inflammatory, asthma, or allergic disorders)
• ebastine (used for allergies)
• salmeterol (used to treat asthma or chronic obstructive pulmonary disease - COPD)

Medications for erection and ejaculation problems

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

Other medications containing:

• colchicine (used to treat gout)
• fentanyl (a pain medication)
• lumacaftor/ivacaftor (used to treat cystic fibrosis)

Remember not to take any of the above medications for 2 weeks after stopping Orungal.

It is not a complete list, so inform the doctor if the patient is taking or plans to take any of these medications or any other medications.

Caution is required when taking Orungal with certain other medications.

The risk of side effects may be higher, and the dose of Orungal or the other medication may need to be changed.
Examples of these medications are:

Medications for heart, blood, or circulation problems

• bozentan, when used to treat pulmonary hypertension (high blood pressure in the blood vessels of the lungs)
• calcium channel blockers, such as dihydropyridines: amlodipine, isradipine, nifedipine, nimodipine, diltiazem, or verapamil (used for high blood pressure)
• cylostazol (used for circulation problems)
• "coumarins", such as warfarin (used for blood clots)
• digoxin (used for atrial fibrillation)
• nadolol (used for pulmonary hypertension or angina pectoris)

Medications for stomach or diarrhea problems

• aprepitant or netupitant (for nausea and vomiting during cancer treatment)
• loperamide (used for diarrhea)
• antacids, such as aluminum, calcium, magnesium, or sodium hydroxide; H2 receptor antagonists, such as cimetidine, ranitidine, and proton pump inhibitors, such as lansoprazole, omeprazole, rabeprazole (used to treat symptoms of acid reflux)

Medications for sleep or mental problems

• alprazolam, brotizolam, buspirone, or midazolam (given intravenously) (used for anxiety or to help fall asleep)
• zopiclone (a sleep medication)
• reboxetine or venlafaxine (used to treat depression and anxiety)
• aripiprazole, cariprazine, haloperidol, or risperidone (used for schizophrenia, bipolar disorder, or other mental problems)
• galantamine (used to treat Alzheimer's disease)
• guanfacine (used to treat ADHD)

Medications for urinary problems

• imidafenacin, fezoterodine, oxybutynin, solifenacin (used for overactive bladder)

Medications for cancer

• bortezomib, brentuximab, vedotin, busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, pemigatinib, ponatinib, rucoximab, sonidegib, or tretinoin (given orally)

Medications for infections

• ciprofloxacin, clarithromycin, or erythromycin (used for bacterial infections)
• delamanid (used to treat tuberculosis)
• artemether-lumefantrine or quinine (used to treat malaria)
• praziquantel (used to treat worm infections - hookworm and tapeworm)

Medications for HIV infection or hepatitis

• cobicistat, boosted elvitegravir, maraviroc, ritonavir, darunavir boosted with ritonavir, fosamprenavir boosted with ritonavir, indinavir, or saquinavir (used to treat HIV)
• glecaprevir/pibrentasvir (used to treat hepatitis)

Medications used after organ transplantation

• cyclosporine or tacrolimus

Medications for benign prostatic hyperplasia

• dutasteride

Medications for lung, allergic, or inflammatory disorders

• bilastine or rupatadine (used for allergies)
• methylprednisolone or dexamethasone (oral or injectable medications for asthma, allergies, or inflammatory disorders)
• budesonide or fluticasone (used to treat asthma, allergies)

Medications for erection and ejaculation problems

• sildenafil (used for erectile dysfunction)

Medications for pain

• alfentanil, buprenorphine, oxycodone, or sufentanil (used to treat pain)
• meloxicam (used to treat joint inflammation and pain)

Other medications containing:

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

It is not a complete list, so inform the doctor if the patient is taking or plans to take any of these medications or any other medications.

Medications that affect itraconazole absorption

Medications that reduce stomach acid can disrupt the absorption of itraconazole released from Orungal capsules. Therefore, antacids can be taken at least 1 hour before or at least 2 hours after taking Orungal.
For the same reason, if the patient is taking medications that reduce stomach acid secretion, they should take Orungal with a non-diet cola drink.
In case of doubts, consult a doctor or pharmacist.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before taking this medication.

Pregnancy

Orungal should not be taken during pregnancy, unless it is a life-threatening situation, in which case the expected benefits of taking the medication outweigh the potential risks to the fetus.
If the woman is of childbearing age and may become pregnant, she should discuss it with her doctor.

• She should use effective contraception to ensure she does not become pregnant while taking this medication.
• Effective contraception should be used until the next menstrual period after stopping Orungal. This is because Orungal remains in the body for some time after stopping the medication.

Breastfeeding

Itraconazole passes into breast milk in very small amounts. The doctor will decide whether the expected benefits of taking Orungal during breastfeeding outweigh the risks to the baby. In case of doubts, the patient should not breastfeed.

Driving and using machines

Orungal may occasionally cause dizziness, blurred or double vision, or hearing loss. If the patient experiences these symptoms, they should not drive vehicles or operate machines or use tools.

Orungal contains sucrose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.

3. How to take Orungal

Take this medication always as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

How to take Orungal capsules

Orungal should be taken immediately after a full meal. The capsules should be swallowed whole.

How much to take

Dosage for adults

Fungal nail infections caused by dermatophytes and/or yeasts

Pulse therapy

It involves taking two capsules of the medication twice a day (200 mg twice a day) for one week. In the treatment of fungal nail infections of the hands, two cycles are used. In the treatment of fungal nail infections of the feet, three cycles are used. The periods of taking the medication (cycles) are separated by a three-week break, during which the medication is not taken. The response to treatment becomes visible after the end of treatment and after the nails have grown out.

The elimination of itraconazole from the skin and nails is slower than from the blood. Optimal treatment results in terms of clinical symptoms and microbiological results are achieved within 2 to 4 weeks after the end of treatment for skin infections and within 6 to 9 months after the end of treatment for nail infections.

Use in children

Orungal may be used in children only if the doctor decides that the expected benefits outweigh the potential risks.

Taking more than the recommended dose of Orungal

In case of taking more than the recommended dose of Orungal, consult a doctor as soon as possible.

Missing a dose of Orungal

Do not take a double dose to make up for a missed dose.

Stopping Orungal treatment

Continue taking Orungal for as long as the doctor recommends. Do not stop treatment on your own, even if the patient feels better.
In case of any further doubts about taking this medication, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Orungal can cause side effects, although not everybody gets them.
In clinical trials involving 8499 patients taking Orungal, the following side effects occurred in at least 1 in 100 patients: headache, nausea, and abdominal pain.
In these clinical trials, the following side effects occurred in less than 1 in 100 patients taking Orungal: nasal inflammation, sinusitis, upper respiratory tract infections, low white blood cell count, hypersensitivity, taste disorders, numbness, paresthesia (sensory disturbances, tingling, numbness, burning on the skin), tinnitus, constipation, diarrhea, dyspepsia, vomiting, abnormal liver function, high bilirubin levels in the blood, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, and edema.
The following side effects have been reported for the first time after the medication was approved for all pharmaceutical forms of Orungal:

Very rare side effects (may occur in less than 1 in 10,000 patients):

• serum sickness-like reaction (a type of systemic allergic reaction), angioedema (swelling that occurs most often in the face or throat, which can make breathing difficult), anaphylactic reaction (allergic reaction);
• tremor;
• hypertriglyceridemia (high levels of triglycerides in the blood);
• visual disturbances (including double and blurred vision);
• transient or permanent hearing loss;
• congestive heart failure (including symptoms such as shortness of breath, unexpected weight gain, swelling of limbs or abdomen, severe fatigue, or waking up at night with shortness of breath);
• decreased heart rate;
• shortness of breath;
• pancreatitis;
• severe hepatotoxicity (severe liver damage, including several cases of death due to acute liver failure);
• severe, exfoliative skin reactions (toxic epidermal necrolysis [Lyell's syndrome], Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis), acute generalized exanthematous pustulosis, leukocytoclastic vasculitis (inflammation of small blood vessels in the skin), alopecia, photosensitivity;
• increased levels of creatine phosphokinase in the blood;
• symptoms of increased levels of a hormone called "aldosterone" (such as high blood pressure or low potassium levels in the blood), even if the aldosterone level in the blood is normal or low.

Additional side effects in children and adolescents

In clinical trials of Orungal in children and adolescents (aged 1 to 17), the following side effects occurred in more than 1 in 100 patients: headache, vomiting, abdominal pain, diarrhea, abnormal liver function, hypotension, nausea, and urticaria.

Reporting side effects

If side effects occur, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Orungal

Keep the medication out of sight and reach of children.
Store at a temperature below 30°C.
Do not use this medication after the expiration date stated on the outer packaging and blister after: "EXP". The expiration date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Orungal contains

• The active substance of Orungal is itraconazole. One capsule contains 100 mg of itraconazole.
• Other ingredients are: sugar spheres 25-30 mesh (cornstarch, hydrolyzed starch syrup, sucrose), hypromellose, polyoxyethylene glycol, sodium salt of indigo carmine (E 132), titanium dioxide (E 171), gelatin, sodium salt of erythrosine (E 127).

What Orungal looks like and contents of the pack

Orungal is a capsule consisting of a blue and pink part.
The pack contains: 4, 15, or 28 capsules, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder:

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer:

Janssen-Cilag SpA
Via C. Janssen
04010 Borgo San Michele, Latina
Italy
To obtain more detailed information about this medication, contact the local representative of the marketing authorization holder:
Janssen-Cilag Polska Sp. z o.o.
Iłżecka Street 24
02-135 Warsaw
Phone: +48 22 237 60 00

Date of last revision of the leaflet: 06/2025