Triasporin

Package leaflet: Information for the patient

Triasporin 100 mg hard capsules

Itraconazole
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 taking 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 antifungals", 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 patches)
• dermatophytosis (superficial skin infection)
• oral candidiasis (mouth infection)
• fungal keratitis (inflammation of the cornea on the front part of the eye)
• onychomycosis (nail infections) caused by fungi and/or yeasts.

Systemic mycoses (infections caused by fungi spreading 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. What you should know before taking Triasporin

Do not use Triasporin:

• if you are allergic to itraconazole or to 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 determines that treatment for potentially life-threatening infections or other serious infections is necessary. Triasporin must not be used during pregnancy except in life-threatening conditions. Inform your doctor if you are taking any other medicines before taking Triasporin.

The following medicines must not be used during treatment with Triasporin and for two weeks after treatment has ended:
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 disease causing chest pain)
• dabigatran or ticagrelor (to prevent blood clots)
• disopyramide, dofetilide, dronedarone, or quinidine (for irregular heartbeat)
• finerenone, for kidney problems in patients with diabetes, a disease causing elevated blood glucose (sugar levels in the blood)
• lomitapide, lovastatin, or simvastatin (to lower cholesterol)
• sildenafil (for high blood pressure in the lung arteries)
  Medicines to treat stomach or intestinal problems
• cisapride (for stomach disorders)
• domperidone (for nausea and vomiting)
• naloxegol (for constipation caused by opioid painkillers)
  Medicines to treat headaches, sleep problems, or mental health conditions
• 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 causing frequent and urgent need to urinate), especially if you have kidney or liver problems
  Medicines to treat allergies
• astemizole, mizolastine, or terfenadine
  Medicines to treat erectile and ejaculation problems
• avanafil (for erectile dysfunction)
• dapoxetine (for premature ejaculation)
• vardenafil (for erectile dysfunction) if you are over 75 years old
  Other medicines containing:
• colchicine (for gout, a disease causing joint pain, swelling, and redness), especially if you have kidney or liver problems
• ergometrine and methylergometrine (to treat vaginal bleeding after childbirth)
• eliglustat (for Gaucher’s disease, a hereditary condition causing weakness, frequent infections, and bleeding)
• halofantrine (for malaria, an infection of red blood cells)
• irinotecan (for cancers)
• isavuconazole (for fungal infections)
• ombitasvir, paritaprevir, ritonavir with or without dasabuvir (for treating hepatitis C)
• venetoclax (for chronic lymphocytic leukemia, a blood cancer), especially when starting treatment or during dose escalation at the beginning of treatment
• voclosporin (to treat kidney problems associated with lupus, an autoimmune disease affecting multiple organs)

Note: Do not take any of the above-mentioned medicines during and within 2 weeks after treatment with Triasporin.
Warnings and precautions
Talk to your doctor or pharmacist before taking Triasporin.
Contact your doctor immediately if you experience:

• anorexia (reduced or absent appetite)
• nausea
• vomiting
• asthenia (weakness)
• abdominal pain
• dark urine
  If any of these occur, treatment with Triasporin should be stopped. If your doctor considers continued use of Triasporin necessary, they will prescribe regular blood tests to detect early signs of liver problems.

Contact your doctor if you experience hearing loss.
Inform your doctor if you suffer from achlorhydria (a condition causing reduced stomach acidity) or if you are taking medicines that reduce stomach acidity. In such cases, it is advisable to take Triasporin with a cola-containing drink.
Contact your doctor immediately if you experience:

• shortness of breath
• unexpected weight gain
• ankle swelling
• fatigue
• difficulty breathing when lying down
  These symptoms may indicate the onset of heart failure (the heart’s inability to supply adequate blood to the lungs), in which case treatment must be discontinued.

Contact your doctor if you experience:

• tingling
• numbness
• limb weakness
• pain in arms or legs
• blurred or double vision
• tinnitus (perception of noises not present in the external environment)
• difficulty in retaining or passing urine
  These may be signs of neuropathy (nerve disease), and treatment should be stopped.

Inform your doctor if you have or have had:

• liver problems
• heart problems
• kidney problems
• cystic fibrosis (a hereditary disease characterized by bronchial obstruction due to secretion of thick, viscous mucus)
• neutropenia (reduced number of white blood cells)
• AIDS
• an organ transplant

In such cases, your doctor may consider dose adjustment of Triasporin or an alternative therapy.
Your doctor will prescribe Triasporin to elderly patients, children, and adolescents only after carefully weighing the risks and benefits.
Other medicines and Triasporin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
For medicines you must not take while on Triasporin, see “Do not use Triasporin.”
The use of certain medicines is not recommended with Triasporin.
Your doctor will advise you whether you should avoid taking certain medicines together with Triasporin and for up to 2 weeks after stopping it.
Examples of such medicines include:
Medicines to treat heart, blood, or circulation problems

• apixaban, edoxaban, rivaroxaban, or vorapaxar (to prevent blood clots)
• atorvastatin (to lower cholesterol)
• felodipine (for high blood pressure)
• riociguat or tadalafil (for high blood pressure in the lung arteries)
  Medicines to treat epilepsy, headaches, or mental health problems
• phenytoin, carbamazepine, or phenobarbital (for epilepsy, a disease causing loss of consciousness and violent involuntary muscle contractions)
• eletriptan (for headaches)
• Hypericum perforatum (St. John’s wort for depression)
  Medicines to treat urinary problems
• tolterodine (for overactive bladder causing frequent and urgent need to urinate)
  Medicines to treat cancers
• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedin, 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 affecting the lungs and bones)
• 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 transplants and immune system disorders
• everolimus, sirolimus, temsirolimus
  Medicines to treat benign prostatic hyperplasia (a condition causing enlarged prostate leading to urgent need to urinate both day and night)
• tamsulosin, alfuzosin, silodosin
  Medicines to treat lung problems or allergies
• ciclesonide for bronchial asthma (a disease causing narrowing and inflammation of the bronchi)
• ebastine (for allergies)
• salmeterol (for asthma and chronic obstructive pulmonary disease, a condition making it difficult to empty air from the lungs)
  Medicines to treat erectile dysfunction
• tadalafil
• vardenafil (contraindicated if over 75 years old; otherwise not recommended)
  Other medicines containing:
• colchicine (for gout, a disease causing joint pain, swelling, and redness)
• fentanyl (to induce sedation, reduce pain sensitivity, and cause muscle relaxation)
• lumacaftor/ivacaftor (for cystic fibrosis, a hereditary disease characterized by bronchial obstruction due to secretion of thick, viscous mucus)

Caution is required when taking Triasporin with certain medicines.
When using Triasporin with other medicines, there may be an increased risk of side effects, or dosage adjustments may be needed. Examples include:
Medicines to treat heart or circulation problems

• bosentan (for high blood pressure in the lung arteries)
• amlodipine, isradipine, nifedipine, nimodipine, diltiazem, and verapamil (for high blood pressure)
• cilostazol (for blood circulation)
• coumarins such as warfarin (to prevent blood clots)
• digoxin (for heart failure, a condition in which the heart cannot pump blood efficiently, and for atrial fibrillation, a heart rhythm disorder)
• nadolol (for high blood pressure in the lung arteries and for angina, a heart disease causing chest pain)
  Medicines to treat stomach problems or diarrhea
• aprepitant or netupitant (for chemotherapy-induced nausea and vomiting)
• loperamide (for diarrhea)
• aluminum, calcium, or magnesium salts, sodium bicarbonate, cimetidine, ranitidine, lansoprazole, omeprazole, rabeprazole (for stomach acidity problems)
  Medicines to treat sleep or mental health problems
• alprazolam, brotizolam, buspirone, or midazolam (when administered intravenously) for anxiety or to induce sleep
• zopiclone (for insomnia)
• reboxetine, venlafaxine (for depression and anxiety)
• aripiprazole, cariprazine, haloperidol, or risperidone (for mental disorders)
• galantamine (for Alzheimer’s disease causing dementia)
• guanfacine (for hyperactivity and attention deficit disorders)
  Medicines to treat urinary problems
• imidafenacine, fesoterodine, oxybutynin, solifenacin (for overactive bladder causing frequent and urgent need to urinate)
  Medicines to treat cancers
• bortezomib, brentuximab vedotin, busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, pemigatinib, ponatinib, ruxolitinib, sonidegib, tretinoin (oral)
  Medicines to treat infections
• ciprofloxacin, clarithromycin, or erythromycin (antibiotics used for bacterial infections)
• delamanid (for tuberculosis, an infectious disease affecting the lungs and bones)
• artemether-lumefantrine or quinine (for treating malaria, an infection of red blood cells)
• praziquantel (for parasitic infections: trematodes and tapeworms)
  Medicines to treat viral infections
• cobicistat, boosted elvitegravir, maraviroc, ritonavir, boosted darunavir, boosted fosamprenavir, indinavir, or saquinavir (for HIV)
• glecaprevir/pibrentasvir (for hepatitis)
  Medicines used for organ transplants and immune system disorders
• cyclosporine or tacrolimus
  Medicines to treat benign prostatic hyperplasia
• dutasteride
  Medicines to treat lung problems, allergies, or inflammatory conditions
• bilastine or rupatadine (for allergies)
• methylprednisolone or dexamethasone, budesonide, fluticasone (whether administered orally or by injection) for allergies, inflammation, and bronchial asthma (a disease causing 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 (oral), for eczema (a skin rash)
• cabergoline (for Parkinson’s disease, a condition causing stiffness and tremors)
• cannabis-based products (for nausea, vomiting, or muscle spasms in patients with multiple sclerosis, a disease causing impaired movement)
• cinacalcet (to reduce blood calcium levels)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher’s disease, a hereditary condition causing weakness, frequent infections, and bleeding)
• ivacaftor (for cystic fibrosis, a hereditary disease characterized by bronchial obstruction due to thick, viscous mucus)
• methadone (to treat severe pain or reduce withdrawal symptoms in opioid dependence)
• repaglinide or saxagliptin (for diabetes, a disease causing elevated blood glucose levels)

Concomitant use of certain medicines with Triasporin may be harmful or may alter the activity of Triasporin. Triasporin is absorbed in the body under conditions of sufficient stomach acidity. Therefore, antacids (medicines that neutralize stomach acid) should be taken at least 1 hour before or at least 2 hours after Triasporin.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Triasporin is contraindicated during pregnancy unless your doctor determines that treatment for potentially life-threatening infections is necessary, where the expected benefit to the mother outweighs 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.
Your doctor will prescribe Triasporin only if clearly needed.
Fertility
If you are a woman of childbearing potential, discuss with your doctor, as you must use effective contraception during treatment with Triasporin and until your next menstrual period after the end of therapy.
Driving and use of machines
Triasporin may cause dizziness, visual disturbances, and hearing loss (see “Possible side effects”).
Triasporin may impair your ability to drive 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 them before taking this medicine.

3. How to use Triasporin

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose to be taken varies depending on the infection being treated.
Always follow your doctor's instructions carefully, as they may adjust the treatment according to your
needs.
Treatment of superficial fungal (fungal) infections

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

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/overdose of Triasporin, inform your doctor immediately or go to the nearest hospital.
Triasporin is not removed by haemodialysis (a technique for extracorporeal blood purification that removes the medicine) and no antidote (a substance that neutralizes the excess medicine) is available; therefore, treatment will be symptomatic (undesirable effects that occur will be treated).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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 (fluid accumulation in the lungs)
• Pancreatitis (inflammation of the pancreas)
• Severe hepatotoxicity (severe liver damage), including some cases of fatal acute liver failure (liver problems that may lead to death)
• Severe skin reactions.

Other side effects observed 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 sensation in limbs or other body parts)
• Confusion
• Diarrhea
• Vomiting
• Constipation
• Dyspepsia (indigestion)
• Flatulence (gas in the intestine)
• Abnormal liver function (including some cases of fatal acute liver failure)*
• Hyperbilirubinemia (increased bilirubin in the blood, which may cause yellowing of the skin)
• Urticaria (raised, red, itchy skin rash)
• Rash (skin eruption)
• Pruritus (itching)
• Alopecia (hair loss)
• Menstrual disorders
• Edema (swelling)

Rare side effects (may affect up to 1 in 1,000 people) include:

• Leukopenia (reduced white blood cells)
• Serum sickness (allergic reaction)
• Angioneurotic edema (swelling of the skin and mucous membranes)
• Anaphylactic reaction (severe allergic reaction)
• Hypertriglyceridemia (increased triglycerides in the blood)
• Tremor
• Hypoesthesia (reduced sensation)
• Visual disturbances, including diplopia (double vision) and blurred vision
• Temporary or permanent hearing loss*
• Tinnitus (persistent perception of noise in the ear)
• Congestive heart failure (a condition in which the heart is unable to pump blood efficiently)*
• Reduced heart rate
• Dyspnea (difficulty breathing)
• Pancreatitis (inflammation of the pancreas)
• Severe hepatotoxicity (severe liver damage), including some cases of fatal acute liver failure (liver problems that may lead to death)*
• Stevens-Johnson syndrome and toxic epidermal necrolysis (serious skin rashes with redness, blistering, peeling, and ulceration of the mouth, lips, and skin)
• Generalized acute exanthematous pustulosis (a severe drug reaction characterized by erythema, swelling, and pustule formation)
• Erythema multiforme (skin lesions that may be smooth, raised, or depressed, red or blistering, with peeling, particularly on legs, arms, hands, and feet, possibly spreading to the face, lips, and mucous membranes, occasionally accompanied by fever)
• Exfoliative dermatitis (widespread, severe irritation causing skin peeling)
• Leukocytoclastic vasculitis (inflammation of small blood vessels)
• Photosensitivity (abnormal and excessive skin reaction to sunlight or artificial light)
• Pollakiuria (frequent passage of small amounts of urine)
• Erectile dysfunction
• Fever
• Increased blood creatine phosphokinase (a substance present in the blood)

Side effects not known (frequency cannot be established from available data) include:

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

Listed below are side effects reported in clinical studies with oral itraconazole solution and/or intravenous itraconazole:

• Granulocytopenia (reduced number of a type of white blood cells)
• Thrombocytopenia (reduced number of platelets)
• Anaphylactoid reaction (severe allergic reaction)
• Hyperglycemia (increased blood glucose)
• Hyperkalemia (increased potassium in the blood)
• Hypokalemia (reduced potassium in the blood)
• Hypomagnesemia (reduced magnesium in the blood)
• Confusional state
• Peripheral neuropathy (a nerve disease causing pain, numbness, tingling, and weakness)*
• Dizziness
• Somnolence
• 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 (fluid accumulation in the lungs)
• Dysphonia (voice alteration)
• Cough
• Chest pain
• Gastrointestinal disorders
• Liver failure*
• Hepatitis (inflammation of the liver)
• Jaundice (yellowing of the skin or whites of the eyes)
• Erythematous skin rash (skin eruption)
• Hyperhidrosis (increased sweating)
• Myalgia (muscle pain)
• Arthralgia (joint pain)
• Renal failure
• Urinary incontinence (difficulty holding urine)
• Generalized edema (generalized swelling)
• Facial edema (swollen face)
• Pyrexia (fever)
• Pain
• Fatigue
• Chills
• Blood test abnormalities (increased alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, urea, gamma-glutamyltransferase)
• Abnormal urine tests

Paediatric 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 (raised, red, itchy skin rash)

The side effects reported in paediatric patients are similar to those observed in adults, but the frequency is higher in paediatric patients.
There have also been reports of cardiac arrest (cessation of heart activity).

Side effects identified during post-marketing surveillance of Triasporin, for which frequency is unknown

• Serum sickness (allergic reaction)
• Angioneurotic edema (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
• Temporary 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 fatal acute liver failure (severe liver damage that may lead to death)
• Stevens-Johnson syndrome and toxic epidermal necrolysis (serious skin rashes with redness, blistering, peeling, and ulceration of the mouth, lips, and skin)
• Generalized acute exanthematous pustulosis (a severe drug reaction characterized by erythema and swelling with pustule formation)
• Erythema multiforme (skin lesions that may be smooth, raised, or depressed, red or blistering, with peeling, particularly on legs, arms, hands, and feet, possibly spreading to the face, lips, and mucous membranes, occasionally accompanied by fever)
• Exfoliative dermatitis (widespread, severe irritation causing skin peeling)
• Leukocytoclastic vasculitis (inflammation of small blood vessels)
• Alopecia (hair loss)
• Photosensitivity (abnormal and excessive skin reaction to sunlight or artificial light)
• Increased blood creatine phosphokinase (a substance present in the blood)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website
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.
Do not use this medicine after the expiry date stated on the packaging after the word "Exp."
The expiry date refers to the last day of that month. The expiry date applies to the product in its original, undamaged packaging, properly stored.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Triasporin contains

• The active substance is itraconazole. One capsule contains 100 mg of itraconazole.
• The other components are sugar-based granules (composed of corn starch, purified water and sucrose), hypromellose, macrogol. Capsule constituents: gelatin, titanium dioxide (E171), erythrosine (E127), indigo carmine (E132).

Description of the appearance of Triasporin and contents of the pack
8 hard capsules in PVC/PE/PVDC/Al blisters.
Marketing Authorization Holder and Manufacturer
Italfarmaco S.p.A.
Viale Fulvio Testi, 330
20126 Milan
Manufactured under license from JANSSEN PHARMACEUTICA – N.V., Beerse (Belgium)

PATIENT INFORMATION LEAFLET

TRIASPORIN 10 mg/ml oral solution

Itraconazole
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 using 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 TRIASPORIN IS AND WHAT IT IS USED FOR

TRIASPORIN contains itraconazole, which belongs to a group of medicines known as
"systemic antifungals", and is indicated for:

• Treating candidiasis (candida infections) of the mouth and/or oesophagus (the food passage from the throat to the stomach) in patients with HIV or with a weakened immune system.
• Preventing certain fungal infections in patients with blood cancers or who have undergone bone marrow transplantation.

2. WHAT YOU SHOULD KNOW BEFORE USING TRIASPORIN

Do not use TRIASPORIN:

• if you are allergic to itraconazole or to 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 considers treatment for life-threatening infections or other serious infections necessary. TRIASPORIN must not be used during pregnancy except in life-threatening conditions.

Inform 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 disease causing chest pain)
• dabigatran or ticagrelor (to prevent blood clots)
• disopyramide, dofetilide, dronedarone or quinidine (for irregular heartbeat)
• finerenone, for kidney problems in patients with diabetes, a disease causing increased blood glucose (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 opioid painkillers) Medicines to treat headaches, sleep or mental health problems
• 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 causing frequent and urgent need to urinate) and you have kidney or liver problems Medicines to treat allergies
• astemizole, mizolastine or terfenadine Medicines to treat erectile and ejaculation problems
• avanafil (for erectile dysfunction)
• dapoxetine (for premature ejaculation)
• vardenafil (for erectile dysfunction) and you are over 75 years old Other medicines containing:
• colchicine (for gout, a disease causing pain, swelling and redness in joints) and you have kidney or liver problems
• ergometrine and methylergometrine (to treat vaginal bleeding after childbirth)
• eliglustat (for Gaucher disease, a hereditary disease causing weakness, frequent infections and bleeding)
• halofantrine (for malaria, an infection of red blood cells)
• irinotecan (for cancer)
• 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 affecting multiple organs)
  Note: Do not take any of the above-mentioned medicines during and within 2 weeks after treatment with TRIASPORIN.

Warnings and precautions
Talk to your doctor or pharmacist before taking TRIASPORIN.
Contact your doctor immediately if you experience:

• anorexia (reduced or absent appetite)
• nausea
• vomiting
• asthenia (weakness)
• abdominal pain
• dark urine In such cases, treatment with TRIASPORIN should be stopped. If your doctor considers it necessary to continue TRIASPORIN, they will regularly prescribe blood tests to detect potential liver problems early.

Contact your doctor if you experience hearing loss.
Inform your doctor if you suffer from achlorhydria (a condition causing reduced stomach acidity)
or if you are taking medicines that reduce stomach acidity; in these cases, it is advisable to take
TRIASPORIN with a cola-containing beverage.
Contact your doctor immediately if you experience:

• shortness of breath
• unexpected weight gain
• swelling in the ankles
• fatigue
• difficulty breathing when lying down These may be due to the onset of heart failure (the heart’s inability to supply adequate blood to the lungs); in such cases, treatment must be stopped.

Contact your doctor if you experience:

• tingling
• numbness
• weakness in limbs
• pain in arms or legs
• blurred vision or double vision
• tinnitus (perception of noises not present in the external environment)
• difficulty in holding or passing urine. These may be signs of neuropathy (nerve disease), in which case treatment should be stopped. Inform your doctor if you have or have had:
• liver problems
• heart problems
• kidney problems
• cystic fibrosis (a hereditary disease characterized by bronchial obstruction due to secretion of thick, sticky mucus)
• neutropenia (reduced number of white blood cells)
• AIDS
• organ transplant. In these cases, your doctor may consider it necessary to adjust the dosage of TRIASPORIN or may consider alternative therapy. Your doctor will prescribe TRIASPORIN to elderly patients, children and adolescents only after carefully weighing the risks and benefits.

Other medicines and TRIASPORIN
Inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
For medicines you must not take while being treated with TRIASPORIN, see “Do not use
TRIASPORIN”.
The use of certain medicines is not recommended with TRIASPORIN.
Your doctor will advise you whether you should not take certain medicines together with TRIASPORIN and
up to 2 weeks after stopping it.
Examples of such medicines are:
Medicines to treat heart, blood or circulation problems

• apixaban, edoxaban, rivaroxaban or vorapaxar (to prevent blood clots)
• atorvastatin (to reduce 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 disease causing loss of consciousness and violent involuntary muscle contractions)
• eletriptan (for headaches)
• Hypericum perforatum (St. John’s wort for depression) Medicines to treat urinary problems
• tolterodine (for overactive bladder causing frequent and urgent need to urinate) Medicines to treat cancers
• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedin, 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 affecting lungs and bones)
• bedaquiline, isoniazid, rifabutin or rifampicin Medicines to treat virus-induced infections
• efavirenz or nevirapine (for HIV/AIDS)
• elbasvir/grazoprevir, tenofovir alafenamide fumarate, tenofovir disoproxil fumarate (for HIV or hepatitis) Medicines used for organ transplants and immune system disorders
• everolimus, sirolimus, temsirolimus Medicines to treat benign prostatic hyperplasia (a condition causing increased prostate size leading to urgent need to urinate both day and night)
• tamsulosin, alfuzosin, silodosin Medicines to treat lung problems or allergies
• ciclesonide for bronchial asthma (a disease causing narrowing and inflammation of the bronchi)
• ebastine (for allergies)
• salmeterol (for asthma and chronic obstructive pulmonary disease, a condition making it difficult to empty air from the lungs) Medicines to treat erectile problems
• tadalafil
• vardenafil (contraindicated if over 75 years old, otherwise not recommended) Other medicines containing:
• colchicine (for gout, a disease causing pain, swelling and redness in joints)
• fentanyl (to induce sedation, reduce pain sensitivity and muscle relaxation)
• lumacaftor/ivacaftor (for cystic fibrosis, a hereditary disease characterized by bronchial obstruction due to secretion of thick, sticky mucus). Caution is required when taking TRIASPORIN with certain medicines. Taking TRIASPORIN with other medicines may increase the risk of adverse effects or may require dosage adjustments. Examples of such 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 clots)
• digoxin for heart failure (a condition in which the heart cannot 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 disease causing 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 salts or sodium bicarbonate, 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 causing dementia)
• guanfacine (for hyperactivity and attention deficit disorders) Medicines to treat urinary problems
• imidafenacine, fesoterodine, oxybutynin, solifenacin (for overactive bladder causing frequent and urgent need to urinate) Medicines to treat cancers
• 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 bacterial infections)
• delamanid (for tuberculosis, an infectious disease affecting lungs and bones)
• artemether-lumefantrine or quinine (to treat malaria, an infection of red blood cells)
• praziquantel, for parasitic infections (trematodes and tapeworms) Medicines to treat virus-induced infections
• 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 immune system disorders
• cyclosporine or tacrolimus

Medicines to treat benign prostatic hyperplasia (a condition causing increased prostate size leading to urgent need to urinate both day and 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 bronchial asthma (a disease causing narrowing and inflammation of the bronchi) Medicines to treat erectile problems
• sildenafil Medicines to treat pain
• alfentanil, buprenorphine, oxycodone, sufentanil, meloxicam Other medicines containing:
• alitretinoin (taken orally), for eczema (a skin rash)
• cabergoline (for Parkinson’s disease, a disease causing stiffness and tremors)
• cannabis-based products (for nausea, vomiting or muscle spasms in patients with multiple sclerosis, a disease causing impaired movement fluidity)
• cinacalcet (to reduce calcium levels in the blood)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher disease, a hereditary disease causing weakness, frequent infections and bleeding)
• ivacaftor (for cystic fibrosis, a hereditary disease characterized by bronchial obstruction due to secretion of thick, sticky mucus)
• methadone (to treat severe pain or to reduce withdrawal symptoms in drug addiction)
• repaglinide or saxagliptin, for diabetes, a disease causing increased blood glucose (sugar levels in the blood)
  Taking certain medicines together with TRIASPORIN may be harmful or may alter the activity of TRIASPORIN. Absorption of TRIASPORIN into the body occurs in the presence of sufficient stomach acidity. For this reason, antacids (medicines that neutralize stomach acid) should be taken at least 1 hour before or at least 2 hours after TRIASPORIN.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your
doctor or pharmacist before taking this medicine.
Pregnancy
TRIASPORIN is contraindicated during pregnancy unless your doctor considers treatment of potentially life-threatening infections necessary, where the expected benefit to the mother outweighs 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.
Your doctor will prescribe TRIASPORIN only if strictly necessary.
Fertility
If you are a woman of childbearing age, discuss with your doctor, as you must use effective contraceptive measures during treatment with TRIASPORIN and until the next menstruation following the end of therapy with
TRIASPORIN.
Driving and using machines
TRIASPORIN may cause dizziness, visual disturbances and hearing loss (see “Possible side effects”).
TRIASPORIN may impair your ability to drive or use machinery.
Do not drive or operate machinery.
TRIASPORIN contains sorbitol
This medicine contains 7,920 mg of sorbitol in a 40 mL dose, equivalent to 198 mg per mL.
Sorbitol is a source of fructose. If your doctor has informed you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, speak with your doctor before (you or the child) take this medicine. It may cause gastrointestinal problems and has 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 under 5 years of age, speak with 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. Your doctor may perform additional monitoring during therapy.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during therapy.
TRIASPORIN contains cyclodextrin
This medicine contains 16,000 mg of cyclodextrins per 40 mL, equivalent to 400 mg/mL.
Do not use in children under 2 years of age unless otherwise recommended by your doctor.
Cyclodextrin may cause gastrointestinal problems such as diarrhea.
TRIASPORIN contains alcohol (ethanol)
This medicine contains 0.2 mg of alcohol (ethanol) per 40 mL dose, 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.
TRIASPORIN contains 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 exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Treatment of oral and/or oesophageal candidiasis
The recommended dose is 200 mg (corresponding to 20 ml, equal to -2 measuring spoons) daily, preferably
divided into two administrations or taken as a single dose for one week.
If after one week of treatment with TRIASPORIN the infection has not resolved, treatment should be
continued for another week.
Treatment of fluconazole-resistant oral and/or oesophageal candidiasis (fluconazole is another antifungal)
The recommended dose is 100 mg - 200 mg (corresponding to 10 - 20 ml, equal to 1-2 measuring spoons,
respectively) twice daily for two weeks. Treatment should be continued for an additional two
weeks if the infection does not resolve during the initial two weeks of treatment. For patients receiving
a dose of 400 mg (corresponding to 40 ml, equal to 4 measuring spoons) daily, treatment should 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 infections
The dose is calculated based on your body weight.
The recommended dose is 5 mg per kg of body weight, divided into two daily administrations.
The dose required varies according to your health condition.
Taking the medicine on an empty stomach ensures optimal absorption.
Avoid eating for at least 1 hour after administration.
It is recommended to hold TRIASPORIN in the mouth for approximately 20 seconds before swallowing. Do not rinse
the mouth after taking the oral solution.
Use the graduated measuring spoon.
Instructions for opening the bottle and using the dosing cup
The bottle is equipped with a child-resistant cap, which must be opened as follows: press the cap
downwards and, at the same time, turn it counterclockwise.
The package includes a graduated 10 ml dosing cup made of polypropylene.
Before using the dosing cup, ensure that the arrow points upward: the part to be filled is the graduated section.
If you take more TRIASPORIN than you should
If more TRIASPORIN is taken than prescribed, contact your doctor or the nearest hospital
immediately.
TRIASPORIN is not removed by haemodialysis (an extracorporeal blood purification technique that
removes medicines) and no antidote (a substance that neutralizes an overdose of medicine) is available; therefore, treatment will be symptomatic (symptoms and adverse effects will be managed as they occur).
If you forget to take TRIASPORIN
If you forget to take your dose, take the next dose at the usual time and continue taking the
medicine as directed by your doctor. Do not take a double dose to make up for the missed dose.
If you have any questions about the use of TRIASPORIN, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The most serious adverse reactions 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 (severe liver damage), including some cases of fatal acute liver failure (liver problems that may lead to death)

Other adverse reactions observed in clinical studies are listed below:

Common adverse reactions (may affect up to 1 in 10 people) include:

• dizziness (sensation of movement, spinning, and loss of balance)
• headache
• dysgeusia (altered taste)
• dyspnea (difficulty breathing)
• cough
• abdominal pain
• diarrhea
• vomiting
• nausea
• vomiting
• dyspepsia (indigestion)
• rash
• fever

Uncommon adverse reactions (may affect up to 1 in 100 people) include:

• leucopenia (reduction in the number of white blood cells)
• thrombocytopenia (reduction in the number of platelets)
• hypersensitivity (allergy)
• hypokalemia (reduced potassium levels in the blood)
• peripheral neuropathy (a nerve disorder causing pain, numbness, tingling, and weakness)*
• paresthesia (altered sensation in limbs or other body parts)
• hypoesthesia (reduced sensation)
• visual disturbances, including diplopia (double vision) and blurred vision
• tinnitus (persistent perception of noise 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 may cause yellowing of the skin)
• urticaria (appearance of raised, red, itchy welts)
• pruritus (itching)
• myalgia (muscle pain)
• arthralgia (joint pain)
• menstrual disorders
• edema (swelling)
• edema (swelling)

Adverse reactions with unknown frequency (cannot be estimated from available data) include:

• serum sickness (allergic reaction)
• angioneurotic edema (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 aldosterone hormone, even though its blood level is normal or low)
• decreased heart rate
• 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 (severe liver damage), including some cases of fatal acute liver failure (liver problems that may lead to death)
• toxic epidermal necrolysis and Stevens-Johnson syndrome (severe skin rashes with redness, blistering, peeling, mouth and lip ulcers, and skin detachment)
• generalized acute exanthematous pustulosis (a severe drug reaction characterized by erythema and swelling with pustule formation)
• erythema multiforme (formation of skin lesions that may be smooth, raised, or depressed, red or blistering, with peeling, particularly on legs, arms, hands, and feet, which may extend to the face, lips, and mucous membranes, occasionally accompanied by fever)
• exfoliative dermatitis (widespread, severe irritation causing skin peeling)
• leukocytoclastic vasculitis (inflammation of small blood vessels)
• alopecia (hair loss)
• photosensitivity (abnormal and excessive skin reaction to sunlight or artificial light)
• increased blood creatine phosphokinase (a substance present in the blood).

*See "Warnings and precautions"

Listed below are adverse reactions reported in clinical studies with oral itraconazole solution and/or intravenous itraconazole:

• 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 (reduction in the number of a type of white blood cells)
• anaphylactoid reaction (severe allergic reaction)
• hyperglycemia (increased blood sugar)
• hyperkalemia (increased potassium in the blood)
• hypomagnesemia (reduced magnesium in the blood)

• confusion
• somnolence
• 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 (voice alteration)
• gastrointestinal disorders
• flatulence (intestinal gas)
• hepatitis (liver inflammation)
• jaundice (yellowing of the skin or whites of the eyes)
• impaired liver function (liver problems)
• erythematous rash (skin rash)
• hyperhidrosis (increased sweating)
• renal impairment

• pollakiuria (frequent passage of small amounts of urine)

• urinary incontinence (difficulty retaining urine)
• erectile dysfunction
• generalized edema (generalized swelling)
• facial edema (swollen face)
• chest pain
• pain
• fatigue
• chills
• Blood test abnormalities (increased alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, urea, gamma-glutamyltransferase)
• abnormal urine test results.

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

• vomiting
• fever
• diarrhea
• mucosal inflammation
• rash (skin rash)
• abdominal pain
• nausea
• hypertension (high blood pressure)
• cough

Adverse reactions reported in paediatric patients are similar to those observed in adults, but occur more frequently in paediatric patients.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, 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.
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 must not be used for more than 1 month after first opening the bottle.
Medicines must 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. PACKAGING CONTENTS AND OTHER INFORMATION

What TRIASPORIN contains

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

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

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

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