TRAZER 100 mg Hard Capsule

Содержание инструкции

1. TRAZER 100 mg hard capsules
   1. What is TRAZER and what it is used for
   2. Cosa deve sapere prima di prendere TRAZER
   3. How to take TRAZER
   4. Possible side effects
   5. How to store TRAZER
   6. Contents of the pack and other Information

TRAZER 100 mg hard capsules

Itraconazole
Generic medicine

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

1. What is TRAZER and what it is used for

TRAZER belongs to a group of medicines called “antifungals” used to treat fungal infections. This
medicine can be taken to treat the following infections:

• yeast infection (Candidiasis) of the mouth, throat or vagina.
• Skin infections (e.g. athlete's foot, tinea and skin infection called pityriasis versicolor) or nails caused by bacteria and/or fungi.
• Infection of the cornea, the front part of the eye (keratitis), caused by bacteria and/or fungi.
• Subcutaneous infection caused by a fungus with the appearance of nodules in the lymphatic vessels (Lymphocutaneous/cutaneous sporotrichosis). General infection caused by a fungus that can manifest as pneumonia (paracoccidioidomycosis), general infection caused by a fungus that manifests in the lungs (blastomycosis and histoplasmosis) in patients with normal immune defenses. Respiratory tract infection caused by the fungus Aspergillus (invasive aspergillosis) in patients who are intolerant or unresponsive to amphotericin B.

2. Cosa deve sapere prima di prendere TRAZER

Non prenda TRAZER:

• se è allergico all’itraconazolo o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6).
• Se è incinta o pensa di esserlo (vedere paragrafo Gravidanza, allattamento e fertilità).
• Se soffre di problemi al cuore (disfunzione ventricolare) per esempio se il cuore non riesce a pompare sangue (insufficienza cardiaca congestizia), a meno che il medico non valuti la necessità di trattare infezioni potenzialmente pericolose per la vita o altre gravi infezioni.
• Se sta già assumendo altri medicinali poiché potrebbero verificarsi situazioni potenzialmente gravi (vedere paragrafo Altri medicinali e TRAZER ).

Informi il medico se sta assumendo dei medicinali prima di prendere TRAZER.

• Non prenda TRAZER se sta assumendo uno qualsiasi dei seguenti medicinali o entro 2 settimane dall’interruzione di TRAZER:

Medicinali usati per trattare problemi cardiaci, del sangue o della circolazione

• aliskiren, eplerenone, lercanidipina o nisoldipina (per la pressione sanguigna alta)
• bepridil, ivabradina o ranolazina (per l’angina)
• dabigataran o tricagrelor (per i coaguli di sangue)
• disopiramide, dofetilide, dronedarone o chinidina (per il battito cardiaco irregolare)
• lomitapide, lovastatina o simvastatina (per abbassare il colesterolo)
• sildenafil (per l’ipertensione arteriosa polmonare).

Medicinali per trattare problemi di stomaco e costipazione

• cisapride (per i disturbi di stomaco)
• domperidone (per nausea e vomito)
• naloxegol (per la costipazione causata dall’assunzione di antidolorifici oppiacei).

Medicinali per trattare mal di testa, problemi di sonno o di salute mentale

• diidroergotamina o ergotamina (alcaloidi dell’ergot usati per il mal di testa da emicrania
• midazolam (per bocca) o triazolam (per sedazione o per aiutarla a dormire)
• lurasidone, pimozide, quetiapina o sertindolo (per schizofrenia, disturbi bipolari o altri problemi di salute mentale).

Medicinali per trattare i problemi urinari

• darifenacina (per l’incontinenza urinaria)
• fesoterodina o solifenacina (per l’irritazione della vescica urinaria) quando utilizzata in pazienti con alcuni problemi renali o epatici.

Medicinali per trattare le allergie

• astemizolo, mizolastina o terfenadina (per le allergie).

Medicinali per trattare i problemi di erezione ed eiaculazione

• avanafil (per la disfunzione erettile)
• dapoxetina (per l’eiaculazione precoce)
• vardenafil (per la disfunzione erettile) quando usato in uomini di età superiore a 75 anni.

Altri medicinali contenenti:

• colchicina (per la gotta) quando usata in pazienti con problemi renali o epatici
• ergometrina (ergonovina) o metilergometrina (metilergonovina), alcaloidi dell’ergot usati dopo il parto
• eliglustat (per la malattia di Gaucher) quando usato in pazienti che non possono scomporre alcuni farmaci nell’organismo
• alofantrina (per la malaria)
• irinotecan (per il tumore)
• isavuconazolo (per infezioni fungine)
• ombitasvir, paritaprevir, ritonavir con o senza dasabuvir (per trattare l’epatite C) Nota: non prenda nessuno dei farmaci riportati sopra per 2 settimane dopo il Suo ultimotrattamento con TRAZER.

Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di prendere TRAZER.
Interrompa il trattamento con TRAZER e consulti immediatamente il suo medico qualora dovessero insorgere sintomi
quali:

• rifiuto del cibo (anoressia) nausea e vomito, stanchezza, dolore all’addome e urine scure. Se lo riterrà necessario, il medico può interrompere il trattamento e sottoporla ad analisi del sangue per controllare il funzionamento del fegato.
• Se soffre di acloridria (una malattia che causa una riduzione dell’acidità dello stomaco). Se soffre di una patologia che riduce l’acidità dello stomaco (ad esempio acloridria) o assume farmaci adatti a questo scopo. In questo caso il medico le dirà di assumere TRAZER con una bevanda acida (ad es cola) e la terrà sotto controllo aumentando la dose se necessario. Il medico le dirà di assumere farmaci per trattare l’acidità di stomaco dopo 2 ore dall’assunzione di TRAZER.
• Se soffre di disturbi cardiaci; contatti immediatamente il medico nel caso comparissero sintomi quali respiro corto, inatteso aumento di peso, gonfiore alle gambe o all'addome, stanchezza insolita, difficoltà a respirare di notte. In questo caso il medico la terrà sotto controllo e, se necessario, le dirà di sospendere TRAZER.
• Se sviluppa sintomi quali formicolio, intorpidimento e debolezza agli arti, altri problemi con i nervi delle braccia o delle gambe, visione sfocata o vista doppia, in caso di ronzio alle orecchie, in caso di perdita di controllo della minzione, questi potrebbero essere sintomi di una malattia nervosa (neuropatia), in tal caso il trattamento deve essere sospeso.

Informi il medico se ha o ha avuto:

• problemi al fegato: potrebbe rendersi necessario un aggiustamento del dosaggio di TRAZER;
• problemi al cuore;
• problemi ai reni. In questo caso il medico la terrà sotto controllo e, se necessario, modificherà il dosaggio di TRAZER;
• fibrosi cistica (una malattia genetica);
• problemi al sistema nervoso periferico (neuropatia);
• se il suo sistema immunitario non funziona correttamente (ad es il numero dei globuli bianchi nel sangue è basso (neutropenia), se soffre di AIDS o se è stato sottoposto a trapianto di organo), potrebbe rendersi necessario un aggiustamento del dosaggio di TRAZER.

Con l’utilizzo di TRAZER è stata riportata perdita dell’udito che solitamente si risolve con la sospensione del
trattamento.
Se soffre di AIDS il medico potrebbe sottoporla ad una terapia di mantenimento.
Se si trova in pericolo di vita, il medico non le prescriverà TRAZER.
Se è affetto da infezioni della pelle (come ad esempio pityriasis versicolor, dermatofitosi) lievi e poco estese, il
medico potrebbe prescriverle un trattamento con un prodotto per uso topico prima di iniziare la terapia con TRAZER.

Pazienti anziani
TRAZER non deve essere utilizzato nei pazienti anziani, salvo diversa prescrizione medica.

Bambini e adolescenti
L’uso di TRAZER nei bambini non è raccomandato.

Altri medicinali e TRAZER
Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere qualsiasi altro
medicinale.
Vi sono alcuni medicinali che non deve prenderese sta assumendo TRAZER. Sono elencate sopra al paragrafo “Non
prenda TRAZER”:

L’uso di alcuni medicinali non è raccomandato con TRAZER.
Il medico deciderà se Lei non deve prendere alcuni medicinali contemporaneamente a TRAZER o entro 2 settimane
dall’interruzione di TRAZER.
Esempi di questi medicinali sono:

Medicinali per trattare problemi cardiaci, del sangue o della circolazione

• apixaban, rivaroxaban o vorapaxar (per i coaguli di sangue)
• atorvastatina (per abbassare il colesterolo)
• felodipina (per la pressione sanguigna alta)
• riociguat o tadalafil (per l’ipertensione polmonare).

Medicinali per trattare epilessia, mal di testa o problemi di salute mentale

• fenitoina, carbamazepina o fenobarbital (anti-epilettici)
• eletriptan (per il mal di testa da emicrania)
• erba di San Giovanni ( Hypericum perforatum) (un medicinale a base di erbe usato per problemi di salute mentale).

Medicinali per trattare i problemi urinari

• tamsulosina (per l’incontinenza urinaria negli uomini)
• tolterodina (per l’irritazione della vescica urinaria).

Medicinali per trattare il tumore

• axitinib, bosutinib, cabazitaxel, cabozatinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, icrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, trabectedina, trastuzumab emtansina o alcaloidi della vinca (ad es. vinflunina, vinorelbina).

Medicinali per trattare la tubercolosi

• bedaquilina, isoniazide, rifabutina o rifampicina (per la tubercolosi).

Medicinali per trattare il virus da immunodeficienza umana (HIV) o l’epatite

• efavirenz o nevirapina (per HIV/AIDS), elbasvir/grazoprevir, simeprevir, tenofovir alafenamide fumarato (TAF), tenofovir disoproxil fumarato (TDF) (per HIV o epatite).

Medicinali usati dopo il trapianto di organi

• everolimus, rapamicina (nota anche come sirolimus), temsirolimus.

Medicinali per trattare l’ipertrofia prostatica benigna

• alfuzosina, silodosina.

Medicinali per trattare i problemi polmonari o le allergie

• ciclesonide (per infiammazione, asma e allergie)
• ebastina (per le allergie)
• salmeterolo (per asma o broncopneumopatia cronica ostruttiva - BPCO).

Medicinali per trattare i problemi di erezione ed eiaculazione

• tadalafil o vardenafil (quando usato negli uomini di età pari o inferiore a 75 anni) (per la disfunzione erettile).

Altri medicinali contenenti:

• colchicina (per la gotta)
• fentanile (per il dolore)
• lumacaftor/ivacaftor (per la fibrosi cistica). Aspetti almeno 2 settimane dopo l’interruzione del trattamento con TRAZER prima di assumere uno qualsiasi di questi medicinali.

Non si tratta di un elenco completo, quindi informi il Suo medico se sta assumendo o prevede di assumere uno di
questi medicinali o qualsiasi altro medicinale.

Quando si assume TRAZER con certi altri medicinali è necessario usare cautela
Lei potrebbe essere più incline ad incorrere in effetti indesiderati oppure potrebbe essere necessario modificare la dose
di TRAZER o dell’altro medicinale. Esempi di questi medicinali sono:

Medicinali per trattare problemi cardiaci, del sangue o della circolazione

• bosentan (per l’ipertensione polmonare)
• bloccanti del canale del calcio come diidropiridine, ad es. amlodipina, isradipina, nifedipina, nimodipina o diltiazem (per l’ipertensione)
• verapamil (per la pressione sanguigna alta)
• cilostazolo (per problemi circolatori)
• cumarinici come warfarin (per i coaguli di sangue)
• digossina (per la fibrillazione atriale)
• nadololo (per l’ipertensione polmonare o l’angina).

Medicinali per trattare problemi di stomaco o diarrea

• aprepitant o netupitant (per nausea e vomito durante il trattamento oncologico)
• loperamide (per la diarrea)
• antiacidi come alluminio, calcio, magnesio o bicarbonato di sodio, antagonisti del recettore H come cimetidina, ranitidina e inibitori della pompa protonica come lansoprazolo, omeprazolo, rabeprazolo (per trattare i problemi di acidità di stomaco).

Medicinali per trattare i problemi di sonno o di salute mentale

• alprazolam, brotizolam, buspirone o midazolam (quando iniettato in vena) (per l’ansia o favorire il sonno)
• zopiclone (per favorire il sonno)
• reboxetina o venlafaxina (per depressione e ansia)
• ariprazolo, cariprazina, aloperidolo o risperidone (per schizofrenia, disturbo bipolare o altri problemi di salute mentale)
• galantamina (per la malattia di Alzheimer)
• guanfacina (per problemi di iperattività e deficit di attenzione).

Medicinali per trattare i problemi urinari

• imidafenacina, fesoterodina, ossibutinina, solifenacina (per l’irritazione della vescica urinaria).

Medicinali per trattare i tumori

• bortezomib, brentuximab vedotin busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, ponatinib, ruxolitinib o sonidegib.

Medicinali per trattare le infezioni

• ciprofloxacina, claritromicina o eritromicina (per infezioni batteriche)
• delamanid (per tubercolosi)
• artemeter-lumefantrina o chinina (per trattare la malaria)
• praziquantel (per trematodi e tenia).

Medicinali per trattare il virus da immunodeficienza umana (HIV) o l’epatite

• cobicistat, 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 dopo il trapianto di organi

• ciclosporina o tacrolimus.

Medicinali per trattare l’ipertrofia prostatica benigna

• dutasteride.

Medicinali per trattare problemi polmonari, allergie o condizioni infiammatorie

• bilastina o rupatadina (per le allergie)
• metilprednisolone o desametasone (medicinali somministrati per bocca o iniezioni per asma, allergie o condizioni infiammatorie)
• budesonide o fluticasone (per asma, allergie).

Medicinali per trattare i problemi di erezione ed eiaculazione

• sildenafil (per la disfunzione erettile).

Medicinali per trattare il dolore

• alfentanil, buprenorfina, ossicodone o sufentanil (per il dolore)
• meloxicam (per l’infiammazione delle articolazioni e il dolore).

Other medicines containing:

• alitretinoin (taken by mouth) (for eczema)
• cabergoline (for Parkinson's disease)
• cannabis-based products, including medicines (such as those for nausea and vomiting or for muscle spasms in patients with multiple sclerosis)
• cinacalcet (for hyperparathyroidism)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher's disease) when used in patients who are unable to break down certain medicines in the body
• ivacaftor (for cystic fibrosis)
• methadone (to treat drug addiction)
• repaglinide or saxagliptin (for diabetes). This is not a complete list, so tell your doctor if you are taking or plan to take any of these medicines or any other medicine.

Taking some medicines at the same time as TRAZER could be harmful or could change
the activity of TRAZER.
TRAZER is absorbed into the body in the presence of sufficient acidity in the stomach. For
this reason, medicines that neutralize stomach acid (antacids) must be taken at least 1
hour before taking TRAZER or must not be taken for at least 2 hours after taking TRAZER.
For the same reason, if you are using medicines that inhibit the production of acid in the stomach, it is
advisable to take TRAZER with a cola-containing beverage.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.
Pregnancy
TRAZER is contraindicated in pregnancy unless your doctor assesses the need to treat infections
that are potentially life-threatening, where the expected benefit for the mother outweighs the potential risk to the
fetus.
Breastfeeding
Breastfeeding during treatment with TRAZER is not recommended, as small amounts of the drug
may pass into breast milk, unless your doctor assesses the potential risk in relation to the expected benefit.
Fertility
If you are of childbearing potential, your doctor will tell you to use suitable contraceptive measures during treatment with TRAZER and to
continue using them until the next cycle after the end of treatment.
Consult your doctor if you have started therapy with TRAZER without taking adequate contraceptive measures.

Driving and using machines
Use caution before driving vehicles or using machines as dizziness,
vision disturbances and hearing loss may occur (See section Possible side effects).

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

3. How to take TRAZER

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your
doctor or pharmacist.
Swallow the capsules whole with a glass of water immediately after a meal. Do not open the capsules.
Unless otherwise prescribed by your doctor, the recommended dose is:

• skin infections (Pityriasis versicolor, dermatophytoses): 2 capsules 1 time a day for 7 days.
• Nail infections (onychomycosis): 1 cycle corresponds to 2 capsules 2 times a day for one week followed by 3 weeks of interruption. For nail infections of the hands, 2 cycles are recommended; for nail infections of the feet, 3 cycles of treatment are recommended.
• Vaginal infections (vulvovaginal candidiasis): 1 capsule 2 times a day for 3 days, or alternatively, 2 capsules 2 times a day for 1 day.
• Mouth infections (oral candidiasis): 1 capsule 1 time a day for 15 days.
• Infection of the front part of the eye (cornea): (2 capsules) 1 time a day for 21 days.
• Treatment of particularly keratinized areas, such as in the plantar forms of tinea pedis and palmar forms of tinea manus: 2 capsules 2 times a day for 7 days.

In skin infections, lesions disappear completely only 2-4 weeks after the end of treatment.
In onychomycosis (nail infections) you must wait for the regrowth of the nails, which occurs 6 to 9 months after
the end of treatment.
In case of fungal infections of internal organs (systemic infections), the usual recommended dose is as follows:

• Aspergillosis: 2 capsules 1 time a day for a period of 2 to 5 months; in case of invasive or disseminated Aspergillosis, it is recommended to take 2 capsules 2 times a day.
• Candidiasis: 1-2 capsules 1 time a day for a period of 3 weeks to 7 months; in case of invasive or disseminated candidiasis, take 2 capsules 2 times a day.
• Non-meningeal cryptococcosis: 2 capsules 1 time a day for a period of 2 months to 1 year; maintenance therapy provides 2 capsules 1 time a day.
• Cryptococcal meningitis: 4 capsules 1 time a day for a period of 2 months to 1 year; maintenance therapy provides 2 capsules 1 time a day.
• Histoplasmosis: from 1 capsule 1 time a day to 2 capsules 2 times a day for 8 months.
• Sporotrichosis: 1 capsule 1 time a day for 3 months.
• Paracoccidioidomycosis: 1 capsule 1 time a day for 6 months. Chromomycosis: 1-2 capsules 1 time a day for 6 months.
• Blastomycosis: from 1 capsule 1 time a day to 2 capsules 2 times a day for 6 months.

If you take more TRAZER than you should
If you take an excessive dose of TRAZER, contact your doctor immediately or go to the nearest emergency
room. Emergency measures that can only be carried out in hospital, such as gastric lavage, may be necessary.

If you forget to take TRAZER
Do not take a double dose to make up for a missed dose. Take the forgotten dose as soon as you remember unless it is already time to take the next dose.

If you stop taking TRAZER
Contact your doctor if you decide to stop taking TRAZER. Even if you feel better, it is important that
you continue to take the capsules for the entire duration of the treatment prescribed by your doctor. If you stop treatment early,
the infection may recur.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of these side effects gets serious, or if you notice any side effect not listed here, please tell your doctor or pharmacist.

The most commonly reported adverse reactions are:

• headache.
• Abdominal pain.
• Nausea.

The more serious side effects are:

• severe allergic reactions.
• Heart problems (heart failure and congestive heart failure).
• Fluid accumulation in the lungs causing swelling (pulmonary edema).
• Inflammation of the pancreas (pancreatitis).
• Liver problems (liver toxicity and acute fatal hepatic failure).
• Severe skin reactions.

Below are other side effects detected during clinical studies.

Common Undesirable Effects(may affect up to 1 in 100 people)

• Headache.
• Abdominal pain.
• Nausea.

Uncommon Undesirable Effects(may affect up to 1 in 1000 people)

• Inflammation of the paranasal sinuses (sinusitis).
• Upper respiratory tract infection.
• Nasal congestion (rhinitis).
• Allergic reaction (hypersensitivity).
• Alteration of taste (dysgeusia).
• Alteration of sensitivity of the limbs or other parts of the body (paresthesia).
• Confusion.
• Diarrhea.
• Vomiting.
• Constipation.
• Difficult digestion (dyspepsia).
• Presence of gas in the stomach or intestines (flatulence).
• Abnormal liver function.
• Increased bilirubin in the blood which can cause yellowing of the skin (hyperbilirubinemia).
• Hives (skin rash).
• Rash (skin rash).
• Itching.
• Hair loss (alopecia).
• Menstrual disorders.
• Swelling due to fluid retention (edema).

Rare Undesirable Effects(may affect up to 1 in 10,000 people)

• Reduced white blood cells (leukopenia).
• Allergy-like reaction (serum sickness).
• Swelling of the face, mouth, lips and/or tongue (angioedema).
• Anaphylactic reaction (severe allergic reaction).
• High levels of triglycerides in the blood (hypertriglyceridemia).
• Tremor.
• Reduced sensation and response to a certain stimulus (hypoesthesia).
• Visual disturbances including double vision (diplopia) and blurred vision.
• Temporary or permanent hearing loss*.
• Ringing in the ear (tinnitus).
• Heart problems (congestive heart failure)*.
• Difficulty breathing (dyspnea).
• Inflammation of the pancreas (pancreatitis).
• Severe hepatotoxicity (harmful effect to the liver), including some cases of acute fatal hepatic failure*.
• Severe reaction of the skin and/or mucous membranes induced by the drug (Stevens-Johnson Syndrome/toxic epidermal necrolysis).
• Sudden skin rash that manifests with the presence of pustules (acute generalized exanthematous pustulosis).
• Inflammation of blood vessels causing an allergic reaction (erythema multiforme).
• Severe and widespread skin irritation causing skin shedding (exfoliative dermatitis).
• Inflammation of small blood vessels (leucocytoclastic vasculitis).
• Abnormal and excessive reactivity of the skin to solar or artificial irradiation (photosensitivity).
• Frequent emission of small amounts of urine (pollakiuria).
• Problems getting/maintaining an erection (erectile dysfunction).
• Fever.
• Increase of an enzyme present in the blood (blood creatine phosphokinase). *See section “Warnings and precautions”.

The following list of ADRs associated with itraconazole that have been reported in clinical studies with itraconazole
oral solution and/or itraconazole ev, excluding the term “Inflammation at the injection site”, which is specific
to the intravenous route of administration.

Hematopoietic system disorders:reduced number of a particular type of white blood cells (granulocytopenia),
reduced number of platelets (thrombocytopenia).

Immune system disorders:severe allergic reactions (anaphylactoid reaction).

Metabolism and nutrition disorders:increased blood sugars (hyperglycemia), increased
potassium in the blood (hyperkalemia), decreased potassium in the blood (hypokalemia), decreased magnesium in the
blood (hypomagnesemia).

Psychiatric disorders:confused state.

Nervous system disorders:nerve disorders (peripheral neuropathy*), dizziness, drowsiness.

Cardiac disorders:heart problems (heart failure, left ventricular failure), rapid heartbeat
(tachycardia).

Vascular disorders:increased blood pressure (hypertension), decreased blood pressure
(hypotension).

Respiratory, thoracic and mediastinal disorders:fluid accumulation in the lungs (pulmonary edema), voice disorders (dysphonia), cough, chest pain.

Gastrointestinal disorders:gastrointestinal disorders.

Hepatobiliary disorders:liver problems (hepatic failure*, hepatitis), yellowing of the skin or the white
of the eye (jaundice).

Skin and subcutaneous tissue disorders:skin rash due to erythema (erythematous),
excessive sweating (hyperhidrosis).

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

Renal and urinary disorders:kidney problems (renal failure), problems holding urine
(urinary incontinence).

Systemic disorders and administration site conditions:fluid accumulation resulting in
general and/or facial swelling (generalized edema, facial edema), fever (pyrexia), pain, fatigue, chills.

Diagnostic tests:increased levels of blood values related to the liver (alanine aminotransferase, aspartate
aminotransferase, alkaline phosphatase, gamma-glutamyltransferase, and other liver enzymes), increased
a protein index of tissue damage (increased levels of lactate dehydrogenase in the blood), increased levels of
urea in the blood (blood urea).
*See section “Warnings and precautions”.

Paediatric population
Based on safety data from clinical studies, the most commonly reported side effects in
paediatric patients are:

• headache.
• Vomiting.
• Abdominal pain.
• Diarrhea.
• Abnormal liver function.
• Low blood pressure (hypotension).
• Nausea.
• Skin rash (urticaria).

In general, the side effects reported in paediatric patients are similar to those observed in adults,
but the frequency is higher in paediatric patients.
Some cases of cardiac arrest have also been reported.

Undesirable effects detected during post-marketing of itraconazole, with unknown frequency

• Allergy-like reaction (serum sickness).
• Swelling of the face, mouth, lips and/or tongue (angioedema).
• Severe allergic reaction (anaphylactic reaction).
• Increased triglycerides in the blood (hypertriglyceridemia).
• Visual disturbances, including double vision (diplopia) and blurred vision.
• Temporary or permanent hearing loss.
• Heart problems (congestive heart failure).
• Difficulty breathing (dyspnea).
• Inflammation of the pancreas (pancreatitis) harmful effect to the liver, including some cases of acute fatal hepatic failure (severe hepatotoxicity).
• Severe reaction of the skin and/or mucous membranes induced by the drug (Stevens-Johnson Syndrome/toxic epidermal necrolysis (SJS/TEN)).
• Sudden skin rash that manifests with the presence of pustules (acute generalized exanthematous pustulosis(AGEP)).
• Inflammation of blood vessels causing an allergic reaction (erythema multiforme).
• Severe and widespread skin irritation causing skin shedding (exfoliative dermatitis).
• Inflammation of small blood vessels (leucocytoclastic vasculitis).
• Hair loss (alopecia).
• Abnormal and excessive reactivity of the skin to solar or artificial irradiation (photosensitivity).
• An enzyme present in the blood (increased blood creatine phosphokinase). *See section “Warnings and precautions”.

Reporting of side effects
If you get any side effects, even 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-avvers.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store TRAZER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package or blister after Exp. The expiry
date refers to the last day of the month.
Do not store at a temperature above 30°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 TRAZER contains
The active ingredient is itraconazole 100 mg.
The other ingredients are saccharated granules as a support, hypromellose, poloxamer 188.
Capsule constituents: gelatin, titanium dioxide (E171), quinoline yellow (E104), indigotine (E132).

Description of the appearance of TRAZER and contents of the pack
Pack of 8 capsules

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
S.F. Group S.r.l., Via Tiburtina 1143, 00156 Roma

Manufacturer
Laboratorios Liconsa S.A. Av.da Miralcampo 7 – Poligono Industrial Miralcampo – 19200 Azuqueca de Henares -
GUADALAJARA (Spain)