TRIASPORIN 100 mg Hard Capsules

Зміст інструкції

1. TRIASPORIN 10 mg/ml oral solution
   1. WHAT IS TRIASPORIN AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING TRIASPORIN
   3. HOW TO TAKE TRIASPORIN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TRIASPORIN
   6. PACK CONTENTS AND OTHER INFORMATION
2. Triasporin 100 mg hard capsules
   1. What Triasporin is and what it is used for
   2. Cosa deve sapere prima di prendere Triasporin
   3. How to use Triasporin
   4. Possible side effects
   5. How to store Triasporin
   6. Contents of the pack and other information

TRIASPORIN 10 mg/ml oral solution

Itraconazole
Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet:

• 1. What TRIASPORIN is and what it is used for
• 2. What you need to know before you use TRIASPORIN
• 3. How to use TRIASPORIN
• 4. Possible side effects
• 5. How to store TRIASPORIN
• 6. Contents of the pack and other information

1. WHAT IS TRIASPORIN AND WHAT IS IT USED FOR

TRIASPORIN contains itraconazole which belongs to a group of medicines called
“systemic antifungal agents” and is indicated for:

• Treating candidiasis (candida infections) of the mouth and/or esophagus (the food channel from the throat to the stomach) in cases of HIV or a compromised immune system.
• Preventing some fungal infections (caused by fungi) in cases of blood cancers or bone marrow transplantation.

2. WHAT YOU NEED TO KNOW BEFORE USING TRIASPORIN

Do not use TRIASPORIN:

• if you are allergic to itraconazole or any of the other ingredients of this medicine (listed in section 6);
• if you have heart problems, for example if you suffer from congestive heart failure (a condition in which the heart is unable to pump blood efficiently) unless your doctor assesses the need to treat life-threatening infections or other serious infections. TRIASPORIN should not be used during pregnancy except in conditions that are life-threatening. Tell your doctor if you are taking other medicines before taking TRIASPORIN.

The following medicines must not be used during treatment with TRIASPORIN and for
two weeks after completion of treatment.

Medicines used to treat heart, blood or circulation problems

• aliskiren, eplerenone, lercanidipine or nisoldipine (for high blood pressure)
• bepridil ivabradine or ranolazine (for angina , a heart condition that causes chest pain)
• dabigatran or ticagrelor (to prevent blood clot formation)
• disopyramide, dofetilide, dronedarone or quinidine (for irregular heartbeat)
• finerenone, for kidney problems in patients with diabetes, a condition that causes increased blood sugar (sugar levels in the blood)
• lomitapide, lovastatin or simvastatin (to lower cholesterol)
• sildenafil (for high blood pressure in the pulmonary arteries) Medicines to treat stomach or intestinal problems
• cisapride (for stomach disorders)
• domperidone (for nausea and vomiting)
• naloxegol (for constipation caused by taking opioid pain relievers) Medicines to treat headaches, sleep problems or mental health
• dihydroergotamine or ergotamine (for headaches)
• midazolam or triazolam (for anxiety and to induce sleep)
• lurasidone, pimozide, quetiapine or sertindole (for mental disorders) Medicines to treat urinary problems
• darifenacin (for urinary incontinence)
• fesoterodine or solifenacin (for overactive bladder that causes the need to urinate frequently and urgently) and have kidney or liver problems Medicines to treat allergies
• astemizole, mizolastine or terfenadine. Medicines to treat erectile and ejaculatory problems
• avanafil (for erectile dysfunction)
• dapoxetine (for premature ejaculation)
• vardenafil (for erectile dysfunction) and are over 75 years old Other medicines containing:
• colchicine (for gout, a condition that causes pain, swelling and redness of the joints) and have kidney or liver problems
• ergometrine and methylergometrine, (to treat vaginal bleeding after childbirth)
• eliglustat (for Gaucher's disease, an inherited disease that causes weakness, infections and frequent bleeding)
• alofantrine (for malaria, an infection of red blood cells)
• irinotecan (for tumors )
• isavuconazole (for fungal infections)
• ombitasvir, paritaprevir, ritonavir with or without dasabuvir (to treat hepatitis C)
• venetoclax (for chronic lymphocytic leukemia, a blood cancer) when starting treatment or when taking increasing doses at the beginning of treatment
• voclosporin (to treat kidney problems associated with lupus, an autoimmune disease that affects various organs) Note:do not take any of the medicines listed above during and for 2 weeks after treatment with TRIASPORIN.

Warnings and precautions
Talk to your doctor or pharmacist before taking TRIASPORIN.
Contact your doctor immediately if the following should occur:

• anorexia (loss or lack of appetite)
• nausea
• vomiting
• asthenia (weakness)
• abdominal pain
• dark urine In this case, treatment with TRIASPORIN should be discontinued. If your doctor deems it necessary to take TRIASPORIN, they will prescribe you regular blood tests to identify any liver problems early on.

Contact your doctor if you experience hearing loss.
Tell your doctor if you suffer from achlorhydria (a condition that causes a reduction in stomach acid) or if you are taking medicines that reduce stomach acid, in these cases it is advisable
to take TRIASPORIN with a cola-containing beverage.
Contact your doctor immediately in case of:

• shortness of breath
• unexpected weight gain
• swelling of the ankles
• fatigue
• difficulty breathing when lying down These may be due to the onset of heart failure (the heart's inability to provide an adequate amount of blood to the lungs), in which case treatment should be discontinued.

Contact your doctor in case of:

• tingling
• numbness
• weakness in the limbs
• pain in the arms or legs
• blurred vision or double vision
• ringing in the ears (perception of noises not present in the external environment)
• difficulty holding or passing urine. These may be signs of neuropathy (nerve disease), in which case treatment should be discontinued. Tell your doctor if you have or have had:
• liver problems
• heart problems
• kidney problems
• cystic fibrosis (an inherited disease characterized by obstruction of the bronchi due to the secretion of a very dense and viscous mucus)
• neutropenia (reduction in the number of white blood cells)
• AIDS
• an organ transplant. In these cases, your doctor may need to adjust the dose of TRIASPORIN or may consider alternative therapy. The doctor will prescribe TRIASPORIN to elderly, children and adolescents only after a careful assessment of the risks and benefits.

Other medicines and TRIASPORIN
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicine.
For medicines that you must not takeif you are being treated with TRIASPORIN see “ Do not use
TRIASPORIN”.
The use of some medicines is not recommended with TRIASPORIN.
Your doctor will tell you if you should not take some medicines at the same time as
TRIASPORIN and for up to 2 weeks after stopping it.
Examples of these medicines are:

Medicines to treat heart, blood or circulation problems

• apixaban, edoxaban, rivaroxaban or vorapaxar (to prevent blood clot formation)
• atorvastatin (to lower cholesterol)
• felodipine (for high blood pressure)
• riociguat or tadalafil (for high blood pressure in the pulmonary arteries) Medicines to treat epilepsy, headaches or mental health problems
• phenytoin, carbamazepine or phenobarbital (for epilepsy, a condition that causes loss of consciousness and violent involuntary muscle contractions)
• eletriptan (for headache)
• Hypericum perforatum(St. John's wort for depression)

Medicines to treat urinary problems

• tolterodine (for overactive bladder that causes the need to urinate frequently and urgently) Medicines to treat tumors
• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedine, trastuzumab emtansine
• venetoclax, if you are taking a fixed dose for chronic lymphocytic leukemia, or at any time during treatment for acute myeloid leukemia
• vinflunine, vinorelbine Medicines to treat tuberculosis (an infectious disease that affects the lungs andbones)
• bedaquiline, isoniazid, rifabutin or rifampicin Medicines to treat viral infections
• efavirenz or nevirapine (for HIV/AIDS)
• elbasvir/grazoprevir, tenofovir alafenamide fumarate, tenofovir disoproxil fumarate (for HIV or hepatitis) Medicines used for organ transplantation and for diseases that affect theimmune system
• everolimus, sirolimus, temsirolimus Medicines to treat benign prostatic hyperplasia (a condition that causes anincrease in the size of the prostate that causes an urgent urge to urinateboth day and night)
• tamsulosin, alfuzosin, silodosin Medicinesto treat lung or allergy problems
• ciclesonide for bronchial asthma (a disease that causes narrowing and inflammation of the bronchi)
• ebastine (for allergies)
• salmeterol (for asthma and chronic obstructive pulmonary disease, a disease that makes it difficult to empty air from the lungs) Medicines to treat erectile problems
• tadalafil
• vardenafil (contraindicated if you are over 75 years old, otherwise not recommended) Other medicines containing:
• colchicine (for gout, a condition that causes pain, swelling and redness of the joints)
• fentanyl (to induce sedation, reduce pain sensitivity and muscle relaxation)
• lumacaftor/ivacaftor (for cystic fibrosis, an inherited disease characterized by obstruction of the bronchi due to the secretion of a very dense and viscous mucus) Caution is necessary when taking TRIASPORIN with some medicines. If TRIASPORIN is used with other medicines, there may be a greater likelihood of side effects or dosage adjustments may be necessary. Examples of these medicines are: Medicines to treat heart or circulation problems
• bosentan (for high blood pressure in the pulmonary arteries)
• amlodipine, isradipine, nifedipine, nimodipine, diltiazem and verapamil (for high blood pressure)
• cilostazol (for blood circulation)
• coumarins such as warfarin (to prevent blood clot formation)
• digoxin for heart failure (a condition in which the heart is unable to pump blood efficiently) and for atrial fibrillation (a heart rhythm disorder)
• nadolol, for high blood pressure in the pulmonary arteries and for angina (a heart condition that causes chest pain) Medicines to treat stomach problems or diarrhea
• aprepitant or netupitant (for nausea and vomiting induced by chemotherapy)
• loperamide (for diarrhea)
• aluminum, calcium, magnesium or sodium bicarbonate salts, cimetidine, ranitidine, lansoprazole, omeprazole, rabeprazole (to treat stomach acidity problems) Medicines to treat sleep or mental health problems
• alprazolam, brotizolam, buspirone or midazolam (when injected intravenously), for anxiety or to induce sleep
• zopiclone (to treat insomnia)
• reboxetine, venlafaxine (for depression and anxiety)
• aripiprazole, cariprazine, haloperidol or risperidone (for mental disorders)
• galantamine (for Alzheimer's disease that causes dementia)
• guanfacine (for hyperactivity and attention deficit problems) Medicines to treat urinary problems
• imidafenacin, fesoterodine, oxybutynin, solifenacin (for overactive bladder that causes the need to urinate frequently and urgently) Medicines to treat tumors
• bortezomib, brentuximab vedotin busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, pemigatinib, ponatinib, ruxolitinib, sonidegib, tretinoin (taken orally)

Medicines to treat infections

• ciprofloxacin, clarithromycin or erythromycin (antibiotics used for infections caused by bacteria
• delamanid (for tuberculosis, an infectious disease that affects the lungs and bones)
• artemether-lumefantrine or quinine (to treat malaria, an infection of red blood cells)
• praziquantel, for parasitic infections (trematodes and tapeworm) Medicines to treat infections caused by viruses
• cobicistat, boosted elvitegravir, maraviroc, ritonavir, darunavir boosted with ritonavir, fosamprenavir boosted with ritonavir, indinavir or saquinavir (for HIV)
• glecaprevir/pibrentasvir (for hepatitis) Medicines used for organ transplants and diseases affecting theimmune system
• cyclosporine or tacrolimus Medicines to treat benign prostatic hyperplasia (a disease that causes anincrease in the size of the prostate which causes an urgent urge to urinateboth during the day and at night)
• dutasteride Medicines to treat lung problems, allergies or inflammatory conditions
• bilastine or rupatadine (for allergies)
• methylprednisolone or desamethasone budesonide, fluticasone (whether administered orally or by injection) for allergies, inflammation and for bronchial asthma (a disease that causes narrowing and inflammation of the bronchi) Medicines to treat erectile dysfunction
• sildenafil Medicines to treat pain
• alfentanil, buprenorphine, oxycodone, sufentanil, meloxicam Other medicines containing:
• alitretinoin (administered orally), for eczema (a skin rash)
• cabergoline (for Parkinson's disease, a disease that causes rigidity and tremor)
• products based on cannabis(for nausea, vomiting or for muscle spasms in patients with multiple sclerosis, a disease that causes an alteration in the fluidity of movements)
• cinacalcet (to reduce the amount of calcium in the blood)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher's disease, a hereditary disease that causes weakness, infections and frequent bleeding)
• ivacaftor (for cystic fibrosis, a hereditary disease characterized by obstruction of the bronchi due to the secretion of a very dense and viscous mucus)
• methadone (to treat severe pain or to reduce withdrawal symptoms in cases of drug dependence)
• repaglinide or saxagliptin, for diabetes, a disease that causes an increase in blood sugar (amount of sugar in the blood) The simultaneous intake of some medicines with TRIASPORIN may be harmful or may alter the activity of TRIASPORIN. The absorption of TRIASPORIN into the body occurs in the presence of sufficient acidity in the stomach. For this reason, antacids (medicines that neutralize acid in the stomach) must be taken at least 1 hour before or at least 2 hours after TRIASPORIN.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Pregnancy
TRIASPORIN is contraindicated in pregnancy unless the doctor assesses the need to
treat potentially life-threatening infections, where the expected benefit for the mother
is greater than the potential risk to the fetus (see “Do not use Triasporin”).

Breastfeeding
A small amount of TRIASPORIN passes into breast milk, therefore treatment with
TRIASPORIN is not recommended.
The doctor will prescribe TRIASPORIN only if absolutely necessary.

Fertility
If you are a woman of childbearing potential, talk to your doctor because you must use effective
contraceptive measures during treatment with TRIASPORIN and until the next menstruation after the end
of therapy with TRIASPORIN.

Driving and operating machinery
TRIASPORIN can cause dizziness, visual disturbances and hearing loss (see “Possible
side effects”).
TRIASPORIN may impair the ability to drive vehicles or operate machinery.
Do not drive or operate machinery.

TRIASPORIN contains sorbitol
This medicine contains 7,920 mg of sorbitol in a dose of 40 mL equivalent to 198 mg
in each mL.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant
to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease
in which patients cannot transform fructose, talk to your doctor before
you (or the child) take this medicine. It can cause gastrointestinal problems and have
a mild laxative effect.

TRIASPORIN contains propylene glycol
This medicine contains 4.2 g of propylene glycol per 40 mL dose
equivalent to 104 mg/mL.
If the child is less than 5 years of age, talk to your doctor or pharmacist before
administering this medicine, especially if the child is taking other medicines
containing propylene glycol or alcohol.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks during therapy.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks during therapy.

TRIASPORINcontains cyclodextrin
This medicine contains 16,000 mg of cyclodextrins per 40 mL, which is equivalent to
400 mg/mL.
Do not use in children under 2 years of age unless otherwise recommended by your doctor.
Cyclodextrin can cause gastrointestinal problems such as diarrhea.

TRIASPORIN contains alcohol (ethanol)
This medicine contains 0.2 mg of alcohol (ethanol) in each 40 mL dose, which is equivalent
to 0.005 mg/mL. The amount in 40 mL of this medicine is equivalent to less than 1 mL of beer
or wine. The small amount of alcohol in this medicine will not produce significant effects.

TRIASPORINcontains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 40 mL dose, i.e.
essentially “sodium-free”.

3. HOW TO TAKE TRIASPORIN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

• Treatment of oral and/or esophageal candidiasisThe recommended dose is 200 mg (corresponding to 20 ml, equal to -2 measuring spoons,) per day, preferably in two administrations or in a single administration for one week. If after one week of treatment with TRIASPORIN the infection is not resolved, the treatment must be continued for another week.
• Treatment of oral and/or esophageal candidiasis resistant to fluconazole (anotherantifungal)
• The recommended dose is 100 mg - 200 mg (corresponding to 10 - 20 ml, equal to 1-2 measuring spoons, respectively) twice a day for two weeks. The treatment must be continued for another two weeks if the infection does not resolve in the initial two weeks of treatment. For patients who take a dose of 400 mg (corresponding to 40 ml, equal to 4 measuring spoons) per day, the treatment must be limited to 14 days, if there is no evidence of improvement during this period. Do not exceed the recommended maximum daily dose.
• Prevention of fungal infectionsThe dose is calculated based on your body weight. The recommended dose is 5 mg per kg of weight divided into two administrations per day. The dose to be taken varies depending on your health conditions. Taking the medicine on an empty stomach ensures optimal absorption of the medicine. Avoid eating food for at least 1 hour after administration. It is recommended to hold TRIASPORIN in your mouth for about 20 seconds before swallowing it. Do not rinse your mouth after taking the oral solution. Use the graduated measuring spoon.

Instructions for opening the bottle and using the measuring cup
The bottle is equipped with a child-resistant cap, which must be opened as indicated:
press the cap down and, at the same time, rotate it counterclockwise.
A graduated 10 ml polypropylene measuring cup is attached to the package.
Before using the measuring cup, verify that the direction of the arrow is facing
upwards: the graduated part is the one to be filled.

If you take more TRIASPORIN than you should
If more TRIASPORIN is used than prescribed, contact your doctor or
the nearest hospital immediately.
TRIASPORIN is not removed by hemodialysis (an extracorporeal blood purification technique that removes the medicine) and there is no antidote (a substance that
neutralizes the medicine taken in excess) available, therefore the treatment will be symptomatic
(the undesirable effects that will manifest will be treated).

If you forget to take TRIASPORIN
If you forget to take the medicine, take the next dose as usual and continue to
take the medicine as directed by your doctor. Do not take a double dose to compensate
for forgetting the dose.
If you have any doubts about the use of TRIASPORIN, ask your doctor or pharmacist for advice.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects are:

• severe allergic reactions
• heart failure/congestive heart failure (a condition in which the heart is unable to pump blood efficiently)
• pulmonary edema (fluid accumulation in the lungs)
• pancreatitis (inflammation of the pancreas)
• severe hepatotoxicity (serious liver damage), including some cases of fatal acute liver failure (liver problems that can cause death) Other side effects detected during clinical studies are listed below: Common side effects (may affect up to 1 in 10 people) include:
• dizziness (a sensation of movement, spinning, and loss of balance)
• headache
• dysgeusia (altered taste)
• dyspnea (difficulty breathing)
• cough
• abdominal pain
• diarrhea
• vomiting
• nausea
• vomiting
• dyspepsia (difficult digestion)
• skin rash
• fever Uncommon side effects (may affect up to 1 in 100 people) include:
• leukopenia (decreased number of white blood cells)
• thrombocytopenia (decreased number of platelets)
• hypersensitivity (allergy)
• hypokalemia (decreased potassium in the blood)
• peripheral neuropathy (a disease of the nerves that causes pain, numbness, tingling, and weakness)*
• paresthesia (altered sensation in the limbs or other parts of the body)
• hypoesthesia (decreased sensation)
• visual disturbances, including diplopia (double vision) and blurred vision
• tinnitus (persistent perception of noises in the ear)
• heart failure (a condition in which the heart is unable to pump blood efficiently)
• constipation
• liver failure (liver problems)*
• hyperbilirubinemia (increased bilirubin in the blood, which can cause jaundice)
• urticaria (appearance of raised, red, itchy wheals)
• pruritus (itching)
• myalgia (muscle pain)
• arthralgia (joint pain)
• menstrual disorders
• edema (swelling)
• edema (swelling) Side effects with unknown frequency (frequency cannot be estimated based on available data) include:
• serum sickness (allergic reaction)
• angioedema (swelling of the skin and mucous membranes)
• anaphylactic reactions (severe allergic reaction)
• pseudoaldosteronism (fluid retention, high blood pressure, and weakness as if there were an increase in the hormone aldosterone, even if its level in the blood is normal or low).
• Hypertriglyceridemia (increased triglycerides (fats) in the blood)
• transient or permanent hearing loss*
• congestive heart failure (a condition in which the heart is unable to pump blood efficiently)*
• pancreatitis (inflammation of the pancreas)
• severe hepatotoxicity (serious liver damage), including some cases of fatal acute liver failure (liver problems that can cause death)
• toxic epidermal necrolysis and Stevens-Johnson syndrome (severe skin rashes with redness, blistering, and exfoliation, ulcerations of the mouth, lips, and skin)
• acute generalized exanthematous pustulosis (severe form of drug reaction, characterized by erythema and swelling with the formation of pustules)
• erythema multiforme (formation of skin lesions that may be smooth, raised, or sunken, red or blistering, with scaling, especially on legs, arms, hands, and feet, which may spread to the face, lips, and mucous membranes, occasionally accompanied by fever)
• exfoliative dermatitis (severe and widespread irritation that causes skin peeling)
• leucocytoclastic vasculitis (inflammation of small blood vessels)
• alopecia (hair loss)
• photosensitivity (abnormal and excessive reactivity of the skin to sunlight or artificial irradiation)
• increased blood creatine phosphokinase (a substance present in the blood) *see “Warnings and precautions” The following is a list of side effects that have been reported in clinical studies with itraconazole oral solution and/or itraconazole administered intravenously:
• sinusitis (inflammation of the mucous membrane lining the cavities around the nose and eyes)
• upper respiratory tract infection
• rhinitis (inflammation of the nasal mucosa)
• granulocytopenia (decreased number of a type of white blood cells)
• anaphylactoid reaction (severe allergic reaction)
• hyperglycemia (increased blood sugar)
• hyperkalemia (increased potassium in the blood)
• hypomagnesemia (decreased magnesium in the blood)
• confusion
• somnolence (drowsiness)
• tremor
• left ventricular failure (conditions in which the heart is unable to pump blood efficiently)
• tachycardia (increased heart rate)
• hypertension (high blood pressure)
• hypotension (low blood pressure)
• pulmonary edema (fluid accumulation in the lungs)
• dysphonia (altered voice)
• gastrointestinal disorders
• flatulence (gas in the intestines)
• hepatitis (inflammation of the liver)
• jaundice (yellowing of the skin or whites of the eyes)
• altered liver function (liver problems)
• erythematous rash (skin rash)
• hyperhidrosis (increased sweating)
• renal impairment
• pollakiuria (frequent urination of small amounts of urine)
• urinary incontinence (difficulty holding urine)
• erectile dysfunction
• generalized edema (generalized swelling)
• facial edema (swollen face)
• chest pain
• pain
• fatigue
• chills
• Alterations in blood tests (increased alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, urea, gamma-glutamyltransferase)
• abnormal urine analysis.

Paediatric population
Based on safety data from clinical studies, the most
commonly reported side effects in children and adolescents are:

• vomiting
• fever
• diarrhea
• mucosal inflammation
• rash (skin rash)
• abdominal pain
• nausea
• hypertension (high blood pressure)
• cough The side effects reported in pediatric patients are similar to those observed in adults, but the frequency is higher in pediatric patients.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. HOW TO STORE TRIASPORIN

Keep this medicine out of the sight and reach of children.
Store TRIASPORIN oral solution at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The
expiry date refers to the last day of that month.
The oral solution should not be used for more than 1 month from the first opening of the bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What TRIASPORIN contains

• The active ingredient is itraconazole (10 mg of itraconazole per ml)
• The other ingredients are: hydroxypropyl-β (cyclodextrin) E420, sorbitol (non-crystallizing liquid), propylene glycol E1520, hydrochloric acid, cherry flavour 1 and 2 (contains ethanol), caramel flavour, sodium saccharin, sodium hydroxide and water.

Description of the appearance of TRIASPORIN and package contents
Clear solution, with a colour ranging from yellow to slightly amber in a 150 ml glass bottle with
child-resistant closure and with a 10 ml graduated polypropylene measuring cup.

Marketing Authorisation Holder
ITALFARMACO S.p.A. - Viale Fulvio Testi, 330 – 20126 MILANO
Manufactured under license from JANSSEN PHARMACEUTICA-N.V. – Beerse (Belgium)

Manufacturer:
Janssen Pharmaceutica N.V.
Turnhoutseweg, 30
B-2340 Beerse
Belgium

Triasporin 100 mg hard capsules

Itraconazole
Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Triasporin is and what it is used for

Triasporin contains itraconazole which belongs to a group of medicines called
“systemic antimycotics” and is indicated for the following fungal infections:

• Superficial mycoses:
• vulvovaginal candidiasis (infection of the female genital tract)
• pityriasis versicolor (skin infection characterized by light and dark spots)
• dermatophytosis (superficial skin infection)
• oral candidiasis (mouth infection)
• fungal keratitis (inflammation of the cornea on the front of the eye)
• onychomycosis (nail infections) caused by fungi and/or yeasts.
• Systemic mycoses(infections caused by fungi that spread throughout the body):
• aspergillosis (infection caused by Aspergillus)
• candidiasis (infection caused by Candida)
• cryptococcosis (infection caused by Cryptococcus), including cryptococcal meningitis (inflammation of the meninges): in immunocompromised patients with cryptococcosis and in all patients with central nervous system cryptococcosis, Triasporin is indicated only when first-line treatment is considered inappropriate or has proven ineffective;
• histoplasmosis (infection caused by Histoplasma)
• sporotrichosis, including lymphocutaneous and cutaneous sporotrichosis (infection caused by Sporothrix)
• paracoccidioidomycosis (infection caused by Paracoccidioides Brasiliensis)
• blastomycosis (infection caused by Blastomyces Dermatitidis)
• other rare systemic mycoses.

2. Cosa deve sapere prima di prendere Triasporin

Non usi Triasporin:

• se è allergico all’itraconazolo o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6);
• Se ha problemi al cuore, per esempio se soffre di insufficienza cardiaca congestizia (malattia in cui il cuore non è in grado di pompare sangue in maniera efficiente) a meno che il medico non valuti la necessità di trattare infezioni potenzialmente pericolose per la vita o altre gravi infezioni. Triasporin non deve essere usato in gravidanza ad eccezione di condizioni che rappresentano pericolo di vita. Informi il medico se sta assumendo altri medicinali prima di prendere Triasporin. I seguenti medicinali non devono essere usati durante il trattamento con Triasporine perdue settimane successive al completamento del trattamento.Medicinali usati per trattare problemi del cuore, del sangue o della circolazione
• aliskiren, eplerenone, lercanidipina o nisoldipina (per la pressione alta)
• bepridil ivabradina o ranolazina (per l’angina ,una malattia del cuore che causadolori al petto)
• dabigatran o tricagrelor (per evitare la formazione di coaguli di sangue)
• disopiramide, dofetilide, dronedarone o chinidina (per il battito cardiaco irregolare)
• finerenone, per problemi renali in pazienti con diabete, una malattia che causa un aumento della glicemia (quantità di zuccheri nel sangue)
• lomitapide, lovastatina o simvastatina (per abbassare il colesterolo)
• sildenafil (per la pressione alta delle arterie dei polmoni) Medicinali per trattare problemi di stomaco o intestino
• cisapride (per i disturbi di stomaco)
• domperidone (per nausea e vomito)
• naloxegol (per la stitichezza causata dall’assunzione di antidolorifici oppioidi) Medicinali per trattare mal di testa, problemi del sonno o della salute mentale
• diidroergotamina o ergotamina (per i mal di testa)
• midazolam o triazolam (per l’ansia e per indurre il sonno)
• lurasidone, pimozide, quetiapina o sertindolo (per i disturbi della mente) Medicinali per trattare i problemi urinari
• darifenacina (per l’incontinenza urinaria)
• fesoterodina o solifenacina (per la vescica iperattiva che causa la necessità di urinare frequentemente e con urgenza) e ha problemi ai reni o al fegato Medicinali per trattare le allergie
• astemizolo, mizolastina o terfenadina Medicinali per trattare i problemi di erezione ed eiaculazione
• avanafil (per la disfunzione erettile)
• dapoxetina (per l’eiaculazione precoce)
• vardenafil (per la disfunzione erettile) e ha più di 75 anni Altri medicinali contenenti:
• colchicina (per la gotta, una malattia che causa dolore, gonfiore e rossore delle articolazioni) e ha problemi ai reni o al fegato
• ergometrina e metilergometrina, (per trattare le perdite di sangue vaginali dopo il parto)
• eliglustat (per la malattia di Gaucher, una malattia ereditaria che provoca debolezza, infezioni e sanguinamenti frequenti)
• alofantrina (per la malaria, un’infezione dei globuli rossi)
• irinotecan (per i tumor i)
• isavuconazolo (per infezioni causate dai funghi)
• ombitasvir, paritaprevir, ritonavir con o senza dasabuvir (per trattare l’epatite C)
• venetoclax (per la leucemia linfocitica cronica, un tumore del sangue) quando inizia il trattamento o quando assume dosi crescenti all’inizio del trattamento
• voclosporina (per trattare problemi renali associati a lupus, una malattia autoimmune che colpisce diversi organi)

Nota:non prenda nessuno dei medicinali sopra riportati durante e nelle 2 settimane
successive al trattamento con Triasporin.

Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di prendere Triasporin.
Consulti immediatamente il medico qualora dovessero insorgere:

• anoressia (riduzione o mancanza dell’appetito)
• nausea
• vomito
• astenia (debolezza)
• dolori addominali
• urine scure In tal caso il trattamento con Triasporin dovrà essere interrotto. Se il medico dovesse ritenere necessaria l’assunzione di Triasporin, le prescriverà regolarmente esami del sangue per identificare precocemente eventuali problemi al fegato.

Contatti il medico se avverte la perdita dell’udito.
Informi il medico se soffre di acloridria (una malattia che causa una riduzione dell’acidità dello
stomaco) o se assume medicinali che riducono l’acidità di stomaco, in questi casi è opportuno
prendere Triasporin con una bevanda contenente cola.
Contatti immediatamente il medico in caso di:

• mancanza di respiro
• inatteso aumento di peso
• gonfiore alle caviglie
• stanchezza
• difficoltà a respirare da sdraiati. Questi possono essere dovuti all’insorgenza di uno scompenso cardiaco (incapacità del cuore di fornire un’adeguata quantità di sangue ai polmoni), in tal caso il trattamento deve essere sospeso.

Contatti il medico in caso di:

• formicolio
• intorpidimento
• debolezza agli arti
• dolore alle braccia o alle gambe
• visione sfocata o vista doppia
• ronzio alle orecchie (percezione di rumori non presenti nell’ambiente esterno
• difficoltà a trattenere o emettere le urine. Questi possono essere segnali di una neuropatia (malattia dei nervi), in tal caso il trattamento dovrà essere sospeso.

Informi il medico se ha o ha avuto:

• problemi al fegato
• problemi al cuore;
• problemi ai reni;
• fibrosi cistica (una malattia ereditaria caratterizzata da ostruzione dei bronchi a causa della secrezione di un muco molto denso e viscoso);
• neutropenia (riduzione del numero di globuli bianchi);
• AIDS
• un trapianto d’organo.

In questi casi il medico può ritenere necessario un aggiustamento del dosaggio di Triasporin o
può prendere in considerazione una terapia alternativa.
Il medico prescriverà Triasporin ad anziani, bambini e adolescenti soltanto dopo un attento
bilancio dei rischi e benefici.

Altri medicinali e Triasporin
Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe
assumere qualsiasi altro medicinale.
Per i medicinali che non deve prenderese è in trattamento con Triasporin veda “ Non usi
Triasporin”.
L’uso di alcuni medicinali non è raccomandato con Triasporin.
Il medico le indicherà se non deve prendere alcuni medicinali contemporaneamente a
Triasporin e fino a 2 settimane dalla sua interruzione.
Esempi di questi medicinali sono:

Medicinali per trattare problemi cardiaci, del sangue o della circolazione

• apixaban, edoxaban, rivaroxaban o vorapaxar (per evitare la formazione di coaguli di sangue)
• atorvastatina (per ridurre il colesterolo)
• felodipina (per la pressione alta)
• riociguat o tadalafil (per la pressione alta delle arterie dei polmoni) Medicinali per trattare epilessia, mal di testa o problemi di salute mentale
• fenitoina, carbamazepina o fenobarbital (per l’epilessia, una malattia che causa perdita di coscienza e violente contrazioni involontarie dei muscoli)
• eletriptan (per il mal di testa)
• Hypericum perforatum(erba di San Giovanni per la depressione) Medicinali per trattare i problemi urinari
• tolterodina (per la vescica iperattiva che causa la necessità di urinare frequentemente e con urgenza)

Medicinali per trattare i tumori

• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedina, trastuzumab emtansina
• venetoclax, se sta assumendo una dose fissa per la leucemia linfocitica cronica, o in qualsiasi momento del trattamento della leucemia mieloide acuta)
• vinflunina, vinorelbina Medicinali per trattare la tubercolosi (una malattia infettiva che colpisce i polmoni ele ossa)
• bedaquilina, isoniazid, rifabutina o rifampicina Medicinali per trattare infezioni causate da virus
• efavirenz o nevirapina (per HIV/AIDS),
• elbasvir/grazoprevir, tenofovir alafenamide fumarato, tenofovir disoproxil fumarato (per HIV o epatite) Medicinali usati per il trapianto di organi e per malattie che colpiscono il sistemaimmunitario
• everolimus, sirolimus, temsirolimus Medicinali per trattare l’ipertrofia prostatica benigna (una malattia che provoca unaumento delle dimensioni della prostata che causa uno stimolo impellente a urinaresia di giorno che di notte)
• tamsulosina, alfuzosina, silodosina Medicinaliper trattare i problemi polmonari o le allergie
• ciclesonide per l’asma bronchiale (una malattia che causa il restringimento e infiammazione dei bronchi)
• ebastina (per le allergie)
• salmeterolo (per l’asma e la broncopneumopatia cronica ostruttiva, una malattia che rende difficile svuotare l’aria dai polmoni) Medicinali per trattare i problemi di erezione
• tadalafil vardenafil (controindicato se ha più di 75 anni, altrimenti non raccomandato) Altrimedicinali contenenti:
• colchicina (per la gotta, una malattia che causa dolore, gonfiore e rossore delle articolazioni)
• fentanil (per indurre sedazione, ridurre sensibilità al dolore e rilassamento muscolare)
• lumacaftor/ivacaftor (per la fibrosi cistica, una malattia ereditaria caratterizzata da ostruzione dei bronchi a causa della secrezione di un muco molto denso e viscoso)

È necessario usare cautela quando si assume Triasporin con alcuni medicinali.
In caso di uso di Triasporin con altri medicinali può esserci una maggiore probabilità di avere
effetti indesiderati oppure può essere necessario modificare i dosaggi. Esempi di questi
medicinali sono:

Medicinali per trattare problemi del cuore, o della circolazione

• bosentan (per la pressione alta delle arterie dei polmoni)
• amlodipina, isradipina, nifedipina, nimodipina, diltiazem e verapamil (per la pressione alta)
• cilostazolo (per la circolazione del sangue)
• coumarinici come warfarin (per evitare la formazione di coaguli di sangue)
• digossina per l’insufficienza cardiaca (una condizione in cui il cuore non è in grado di pompare sangue in maniera efficiente) e per la fibrillazione atriale (un disturbo del ritmo del cuore) Medicinali per trattare problemi di stomaco o diarrea
• aprepitant o netupitant (per la nausea e il vomito indotti dalla chemioterapia)
• loperamide (per la diarrea)
• sali di alluminio, calcio, magnesio o bicarbonato di sodio, cimetidina, ranitidina, lansoprazolo, omeprazolo, rabeprazolo (per trattare i problemi di acidità di stomaco) Medicinali per trattare i problemi del sonno o della salute mentale
• alprazolam, brotizolam, buspirone o midazolam (quando iniettato in vena), per l’ansia o per indurre il sonno
• zopiclone (per trattare l’insonnia)
• reboxetina, venlafaxina (per depressione e ansia)
• ariprazolo, cariprazina, aloperidolo o risperidone (per i disturbi della mente)
• galantamina (per la malattia di Alzheimer che provoca demenza)
• guanfacina (per problemi di iperattività e deficit di attenzione) Medicinali per trattare i problemi urinari
• imidafenacina, fesoterodina, ossibutinina, solifenacina (per la vescica iperattiva che causa la necessità di urinare frequentemente e con urgenza) Medicinali per trattare i tumori
• bortezomib, brentuximab vedotin busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, pemigatinib, ponatinib, ruxolitinib, sonidegib , tretinoina (assunto per bocca) Medicinali per trattare le infezioni
• ciprofloxacina, claritromicina o eritromicina (antibiotici che si usano per le infezioni provocate da batteri)
• delamanid (per la tubercolosi, una malattia infettiva che colpisce i polmoni e le ossa)
• artemetere-lumefantrina o chinina (per trattare la malaria, un’infezione dei globuli rossi)
• praziquantel, per infezioni da parassiti (trematodi e tenia) Medicinali per trattare le infezioni causate da viruscobicistat, elvitegravir potenziato, maraviroc, ritonavir, darunavir potenziato con ritonavir, fosamprenavir potenziato con ritonavir, indinavir o saquinavir (per l’HIV)
• glecaprevir/pibrentasvir (per l’epatite) Medicinali usati per i trapianti di organi e malattie che colpiscono il sistemaimmunitario
• ciclosporina o tacrolimus

Medicines to treat benign prostatic hyperplasia (a disease that causes an
increase in the size of the prostate which causes an urgent urge to urinate
both during the day and at night)

• dutasteride Medicines to treat lung problems, allergies or inflammatory conditions
• bilastine or rupatadine (for allergies)
• methylprednisolone or dexamethasone budesonide, fluticasone (whether administered orally or by injection) for allergies, inflammation and for bronchial asthma (a disease that causes narrowing and inflammation of the bronchi) Medicines to treat erectile dysfunctionsildenafil Medicines to treat pain
• alfentanil, buprenorphine, oxycodone, sufentanil, meloxicam Other medicines containing:
• alitretinoin (administered orally), for eczema (a skin rash)
• cabergoline (for Parkinson's disease, a disease that causes stiffness and tremor)
• products based on cannabis(for nausea, vomiting or for muscle spasms in patients with multiple sclerosis, a disease that causes an alteration in the fluidity of movements)
• cinacalcet (to reduce the amount of calcium in the blood)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher's disease, a hereditary disease that causes weakness, infections and frequent bleeding)
• ivacaftor (for cystic fibrosis, a hereditary disease characterized by obstruction of the bronchi due to the secretion of very dense and viscous mucus)
• methadone (to treat severe pain or to reduce withdrawal symptoms in cases of drug dependence)
• repaglinide or saxagliptin, for diabetes, a disease that causes an increase in blood sugar (amount of sugar in the blood) The simultaneous intake of some medicines with Triasporin may be harmful or may alter the activity of Triasporin. The absorption of Triasporin into the body occurs in the presence of sufficient acidity in the stomach. For this reason, antacids (medicines that neutralize acid in the stomach) must be taken at least 1 hour before or at least 2 hours after Triasporin.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Pregnancy
Triasporin is contraindicated in pregnancy unless the doctor assesses the need to
treat infections potentially dangerous to life, where the expected benefit for the mother
is greater than the potential risk to the fetus (see “Do not use Triasporin”).

Breastfeeding
A small amount of Triasporin passes into breast milk, therefore treatment with
Triasporin is not recommended.
The doctor will prescribe Triasporin only if absolutely necessary.

Fertility
If you are a woman of childbearing potential, talk to your doctor because you must use effective
contraceptive measures during treatment with Triasporin and until the next menstruation after the end of
therapy with Triasporin.

Driving and operating machinery
Triasporin can cause dizziness, visual disturbances and hearing loss (see “Possible
side effects”).
Triasporin may impair the ability to drive vehicles or operate machinery.
Do not drive or operate machinery.

Triasporin contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

3. How to use Triasporin

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The dose to be taken varies depending on the infection to be treated.
Always carefully follow your doctor's instructions, who may adjust the treatment to your needs from time to time.

Treatment of superficial fungal infections

In skin infections, lesions disappear completely only 2-4 weeks after the
end of treatment.
In onychomycosis (nail infections) it is necessary to wait for the regrowth of the nails which
occurs 6 to 9 months after the end of treatment.

Treatment of systemic fungal infections (infections of internal organs)

Take Triasporin immediately after one of the main meals, to ensure
optimal absorption.
The capsules must not be opened and must be swallowed whole.

If you take more Triasporin than you should
In case of accidental ingestion/intake of an excessive dose of Triasporin, immediately inform
your doctor or go to the nearest hospital.
Triasporin is not removed by hemodialysis (extracorporeal blood purification technique
that removes the medicine) and there is no antidote (a substance that neutralizes
the medicine taken in excess), therefore the treatment will be symptomatic (the
manifesting side effects will be treated).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most serious side effects are:

• Severe allergic reactions
• Heart failure and congestive heart failure (a condition in which the heart is unable to pump blood efficiently)
• Pulmonary edema (accumulation of fluid in the lungs)
• Pancreatitis (inflammation of the pancreas)
• Severe hepatotoxicity (severe liver damage), including some cases of acute fatal hepatic failure (liver problems that can cause death).
• Severe skin reactions. Other side effects detected during clinical studies are listed below: Common side effects (may affect up to 1 in 10 people) include:
• Headache
• Abdominal pain
• Nausea Uncommon side effects (may affect up to 1 in 100 people) include:
• Sinusitis (inflammation of the mucous membrane lining the cavities around the nose and eyes)
• Upper respiratory tract infection
• Rhinitis (inflammation of the nasal mucosa)
• Hypersensitivity (allergy)*
• Dysgeusia (altered taste)
• Paresthesia (altered sensitivity of the limbs or other parts of the body)
• Confusion
• Diarrhea
• Vomiting
• Constipation
• Dyspepsia (indigestion)

• Flatulence (gas in the intestines)
• Abnormal liver function (including some cases of acute fatal hepatic failure)*
• Hyperbilirubinemia (increased bilirubin in the blood which can cause jaundice)
• Urticaria (appearance of raised, red, itchy wheals)
• Rash
• Pruritus (itching)
• Alopecia (hair loss)
• Menstrual disorders
• Edema (swelling) Rare side effects (may affect up to 1 in 1,000 people) include:
• Leukopenia (reduction in white blood cells)
• Serum sickness (allergic reaction)
• Angioedema (swelling of the skin and mucous membranes)
• Anaphylactic reaction (severe allergic reaction)
• Hypertriglyceridemia (increased triglycerides in the blood)
• Tremor
• Hypoesthesia (reduced sensitivity)
• Visual disturbances, including diplopia (double vision) and blurred vision
• Transient or permanent hearing loss*
• Tinnitus (persistent ringing in the ears)
• Congestive heart failure (a condition in which the heart is unable to pump blood efficiently)*
• Dyspnea (difficulty breathing)
• Pancreatitis (inflammation of the pancreas)
• Severe hepatotoxicity (severe liver damage), including some cases of acute fatal hepatic failure (liver problems that can cause death)*
• Stevens-Johnson syndrome and toxic epidermal necrolysis (severe skin rashes with redness, blistering and exfoliation, ulcerations of the mouth, lips and skin)
• Acute generalized exanthematous pustulosis (severe form of drug reaction, characterized by erythema and swelling with the formation of pustules)
• Erythema multiforme (formation of skin lesions that may be smooth, raised or sunken, red or widespread blisters with scaling, especially on legs, arms, hands and feet, which may extend to the face, lips and mucous membranes, occasionally accompanied by fever)
• Exfoliative dermatitis (severe and widespread irritation that causes skin peeling)
• Leucocytoclastic vasculitis (inflammation of small blood vessels)
• Photosensitivity (abnormal and excessive reactivity of the skin to sunlight or artificial radiation)
• Pollakiuria (frequent urination of small amounts of urine)
• Erectile dysfunction
• Fever
• Increased blood creatine phosphokinase (a substance present in the blood)

Side effects with unknown frequency (frequency cannot be estimated based on available data) include:

• Pseudoaldosteronism (fluid retention, high blood pressure and weakness as if there was an increase in the hormone aldosterone, even if its level in the blood is normal or low). *see “Warnings and precautions”

The following is a list of side effects that have been reported in clinical studies with oral itraconazole solution and/or itraconazole administered intravenously:

• Granulocytopenia (reduction in the number of a type of white blood cells)
• Thrombocytopenia (reduction in the number of platelets)
• Anaphylactoid reaction (severe allergic reaction)
• Hyperglycemia (increased blood sugar)
• Hyperkalemia (increased potassium in the blood)
• Hypokalemia (decreased potassium in the blood)
• Hypomagnesemia (decreased magnesium in the blood)
• Confusional state
• Peripheral neuropathy (a disease of the nerves that causes pain, numbness, tingling and weakness)*
• Dizziness
• Somnolence (sleepiness)
• Heart failure and left ventricular failure (conditions in which the heart is unable to pump blood efficiently)
• Tachycardia (increased heart rate)
• Hypertension (high blood pressure)
• Hypotension (low blood pressure)
• Pulmonary edema (accumulation of fluid in the lungs)
• Dysphonia (altered voice)
• Cough
• Chest pain
• Gastrointestinal disorders
• Hepatic failure*
• Hepatitis (inflammation of the liver)
• Jaundice (yellowing of the skin or whites of the eyes)
• Erythematous rash (skin rash)
• Hyperhidrosis (increased sweating)
• Myalgia (muscle pain)
• Arthralgia (joint pain)
• Renal failure
• Urinary incontinence (difficulty holding urine)
• Generalized edema (widespread swelling)
• Facial edema (swollen face)
• Pyrexia (fever)
• Pain
• Fatigue
• Chills
• Alteration of blood tests (increase in alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, urea, gamma-glutamyltransferase)
• Abnormal urine analysis.

Pediatric population
Based on safety data from clinical studies, the most commonly reported side effects in children and adolescents are:

• Headache
• Vomiting
• Abdominal pain
• Diarrhea
• Altered liver function
• Hypotension (low blood pressure)
• Nausea
• Urticaria (appearance of raised, red, itchy wheals)

The side effects reported in pediatric patients are similar to those observed in adult subjects, but the frequency is higher in pediatric patients.
Some cases of cardiac arrest (cessation of heart activity) have also been reported.

Side effects detected during post-marketing of Triasporin, whose frequency is unknown

• Serum sickness (allergic reaction)
• Angioedema (swelling of the skin and mucous membranes)
• Anaphylactic reaction (severe allergic reaction)
• Hypertriglyceridemia (increased triglycerides in the blood)
• Visual disturbances, including diplopia (double vision) and blurred vision
• Transient or permanent hearing loss
• Congestive heart failure (a condition in which the heart is unable to pump blood efficiently))
• Dyspnea (difficulty breathing)
• Pancreatitis (inflammation of the pancreas)
• Severe hepatotoxicity including some cases of acute fatal hepatic failure (severe liver damage that can cause death)
• Stevens-Johnson syndrome and toxic epidermal necrolysis (severe skin rashes with redness, blistering and exfoliation, ulcerations of the mouth, lips and skin)
• Acute generalized exanthematous pustulosis (severe form of drug reaction, characterized by erythema and swelling with the formation of pustules)
• Erythema multiforme (formation of skin lesions that may be smooth, raised or sunken, red or widespread blisters with scaling, especially on legs, arms, hands and feet, which may extend to the face, lips and mucous membranes, occasionally accompanied by fever)
• Exfoliative dermatitis (severe and widespread irritation that causes skin peeling)
• Leucocytoclastic vasculitis (inflammation of small blood vessels)
• Alopecia (hair loss)
• Photosensitivity (abnormal and excessive reactivity of the skin to sunlight or artificial radiation)
• Increased blood creatine phosphokinase (a substance present in the blood)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Triasporin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after the
word Exp. The expiry date refers to the last day of that month. The expiry date
refers to the product in intact packaging, correctly stored.
Store at a temperature below 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Triasporin contains

• The active ingredient is itraconazole. One capsule contains 100 mg of itraconazole.
• The other ingredients are sugary granules as a support (composed of corn starch, purified water and sucrose), hypromellose, macrogol. Capsule constituents: gelatin, titanium dioxide (E171), erythrosine (E127), indigotine (E132).

Description of the appearance of Triasporin and contents of the pack
8 hard capsules in PVC/PE/PVDC/Al blisters.

Marketing authorisation holder and manufacturer
Italfarmaco S.p.A.
Viale Fulvio Testi, 330
20126 Milano
Producted under license from JANSSEN PHARMACEUTICA – N.V. Beerse (Belgium)