Trioxal

Package Leaflet: Information for the Patient

Trioxal, 100 mg, Hard Capsules

Itraconazole

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Trioxal and what is it used for

Trioxal contains the active substance itraconazole, which belongs to the group of thiazole derivatives, and is a broad-spectrum antifungal agent.

Trioxal is indicated for the treatment of:

• genital infections: vaginal candidiasis and vulvovaginal candidiasis;
• skin, mucous membrane, or eye infections: skin candidiasis, pityriasis versicolor, severe or recurrent seborrheic dermatitis, 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 (Trioxal is indicated only when first-line treatment is ineffective), histoplasmosis, blastomycosis, sporotrichosis, paracoccidioidomycosis, and other rare systemic or tropical fungal infections.

2. Important information before taking Trioxal

When not to take Trioxal:

in the event of taking a higher dose of Trioxal than recommended, you should immediately consult a doctor.

While taking Trioxal, it is contraindicated to take certain other medications (see "Trioxal and other medications").

Warnings and precautions

Before starting Trioxal, you should discuss with your doctor if any of the following situations apply to you.

• You have kidney problems. It may be necessary to adjust the dose of this medication.
• You have liver problems. It may be necessary to adjust the dose of this medication. Your doctor may recommend monitoring liver function in patients taking Trioxal, as this medication can very rarely cause severe liver damage.
• You have heart problems.
• You have had an allergic reaction to another antifungal medication.
• You have impaired immunity, e.g., due to neutropenia, AIDS, or organ transplantation. It may be necessary to adjust the dose of this medication.
• You are taking other medications.

If you experience any of the following symptoms while taking Trioxal, you should inform your doctor.

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

Trioxal and other medications

You should inform your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Medications that should not be taken with Trioxal:

• certain medications used for allergies: terfenadine, astemizole, mizolastine;
• certain medications used for angina pectoris (coronary artery disease) or high blood pressure: bepridil, felodipine, nizoldipine, lerkanidipine, ivabradine, ranolazine, eplerenone;
• cisapride, a medication used for gastrointestinal motility disorders;
• certain medications used to lower cholesterol: simvastatin, lovastatin;
• certain sedatives: midazolam (oral), triazolam;
• certain medications used for psychotic disorders: lurasidone, pimozide, sertindole;
• colchicine, a medication used for gout, when given to patients with renal or hepatic impairment;
• certain medications used for severe pain or addiction: levomethadyl (i.e., levomethadone), methadone;
• halofantrine, a medication used for malaria;
• irinotecan, an anticancer medication;
• ergot alkaloids used for migraine headaches: dihydroergotamine or ergotamine;
• ergot alkaloids used to control bleeding and maintain uterine contraction after childbirth: ergometrine (i.e., ergonovine) or methylergometrine (i.e., methylergonovine);
• certain medications used for arrhythmias: disopyramide, dronedarone, quinidine, dofetilide.

If you are taking any of these medications, it is contraindicated to take Trioxal. If you are taking Trioxal, you should not start taking these medications until at least 2 weeks after stopping Trioxal.
Medications whose use with Trioxal is not recommended, unless your doctor considers it necessary:

• certain medications used for cancer: dasatinib, nilotinib, trabectedin;
• aliskiren, a medication used for high blood pressure;
• rifabutin, an antitubercular medication;
• carbamazepine, an antiepileptic medication;
• colchicine, a medication used for gout;
• everolimus, a medication given after organ transplantation;
• fentanyl, a strong pain reliever;
• rivaroxaban, an anticoagulant medication;
• salmeterol, a medication used for asthma;
• tamsulosin, a medication used for urinary incontinence in men;
• vardenafil, a medication used for erectile dysfunction. You can start taking these medications at least 2 weeks after stopping Trioxal.

Other medications that interact with Trioxal:

• certain antibiotics: ciprofloxacin, clarithromycin, erythromycin;
• certain medications that affect the heart or blood vessels: digoxin, nadolol, certain calcium channel blockers, including verapamil;
• anticoagulant medications: coumarins, cilostazol, dabigatran;
• methylprednisolone, budesonide, ciclesonide, fluticasone, or dexamethasone, given orally, by injection, or inhaled for the treatment of inflammatory conditions, asthma, and allergies;
• cyclosporine, tacrolimus, temsirolimus, sirolimus (i.e., rapamycin), usually given after organ transplantation;
• certain medications used for HIV infection (AIDS): maraviroc, protease inhibitors, including indinavir, ritonavir, darunavir, fosamprenavir, saquinavir;
• certain medications used for cancer: bortezomib, busulfan, docetaxel, erlotinib, ixabepilone, lapatinib, trimetrexate, vinca alkaloids;
• certain medications used for anxiety or sedation: buspirone, perospirone, ramelteon, midazolam (given intravenously), alprazolam, brotizolam;
• certain strong pain relievers: alfentanil, buprenorphine, oxycodone;
• certain medications used for diabetes: repaglinide, saxagliptin;
• certain medications used for psychosis: aripiprazole, haloperidol, quetiapine, risperidone;
• certain medications used for nausea and vomiting: aprepitant, domperidone;
• certain medications used for urinary tract infections: fesoterodine, imidafenacin, solifenacin, tolterodine;
• certain medications used for erectile dysfunction: sildenafil, tadalafil;
• praziquantel, an antiparasitic medication;
• ebastine, an antihistamine medication;
• reboxetine, an antidepressant medication;
• atorvastatin, a cholesterol-lowering medication;
• meloxicam, a medication used for arthritis and pain;
• cinacalcet, a medication used for hyperparathyroidism;
• certain medications used for low sodium levels in the blood: tolvaptan, mozavaptan;
• alitretinoin (given orally), a medication used for eczema;
• eletriptan, a medication used for migraine headaches.

If you are taking any of these medications, it may be necessary to adjust the dose of these medications or Trioxal.
Medications that affect the absorption of itraconazole
Medications that reduce stomach acid can disrupt the absorption of itraconazole released from Trioxal capsules. Therefore, antacids can be taken at least 1 hour before or at least 2 hours after taking Trioxal. For the same reason, if you are taking medications that reduce gastric acid secretion, you should take Trioxal with a "cola"-type drink (non-diet).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medication.
Trioxal should not be taken during pregnancy, except in life-threatening situations where the potential benefits of treatment outweigh the potential risks to the fetus.
Women of childbearing age taking Trioxal should use effective contraceptive methods until the first menstrual period after stopping Trioxal.
Itraconazole passes into breast milk in very small amounts. Your doctor will decide whether the expected benefits of taking Trioxal during breastfeeding outweigh the risks to the baby. If in doubt, you should not breastfeed.

Driving and using machines

Trioxal can sometimes cause dizziness, blurred or double vision, or hearing loss. If you experience these symptoms, you should not drive or operate machinery.

Trioxal contains sucrose

One hard capsule contains 265.3 mg of sucrose in granules, containing 80.0-91.5% sucrose. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medication.

3. How to take Trioxal

This medication should always be taken as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Trioxal is taken orally, immediately after a full meal. The capsules should be swallowed whole.
Dosage for adults

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 test 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

Trioxal can be used in children only if the doctor decides that the expected benefits outweigh the risks.

Taking a higher dose of Trioxal than recommended

In the event of taking a higher dose of Trioxal than recommended, you should immediately consult a doctor.

Missing a dose of Trioxal

You should not take a double dose to make up for a missed dose.

Stopping Trioxal treatment

You should continue taking Trioxal for as long as your doctor recommends. You should not stop treatment on your own, even if you feel better.
If you have any further questions about taking this medication, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Trioxal can cause side effects, although not everybody gets them.
In clinical trials involving 8499 patients taking itraconazole, 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 less frequently than in 1 in 100 patients taking itraconazole: nasal passage inflammation, sinusitis, upper respiratory tract infections, low white blood cell count, hypersensitivity, taste disturbances, numbness, paresthesia (sensory disturbances, tingling, numbness, burning sensation on the skin), tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, abnormal liver function, high bilirubin levels in the blood, itching, rash, hives, polyuria, erectile dysfunction, menstrual disorders, and edema.

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 commonly in the face or throat, which can make breathing difficult), anaphylactic reaction (allergic reaction);
• 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 the legs or abdomen, severe fatigue or waking up at night with shortness of breath);
• 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, 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.

Additional side effects in children and adolescents

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website:
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Trioxal

Medications should be kept out of the sight and reach of children.
Store in a temperature below 30°C.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medications should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Trioxal contains

• The active substance of Trioxal is itraconazole. Each capsule contains 100 mg of itraconazole.
• The other ingredients are: sucrose granules (sucrose, cornstarch, purified water), poloxamer 188, hypromellose, poloxamer 188 (micronized); capsule shell: indigo carmine (E132), quinoline yellow (E104), titanium dioxide (E171), gelatin, purified water.

What Trioxal looks like and contents of the pack

Trioxal is a hard gelatin capsule (size 0), filled with yellow-beige spherical microgranules. The cap and body are opaque, green in color.
Aluminum/Aluminum blisters, in a cardboard box.
The pack contains 4, 14, 15, 28, or 84 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
LICONSA SA
Avda. Miralcampo, No 7, E-19200 Azuqueca de Henares (Guadalajara)
Spain

Date of last revision of the leaflet: