Trazer

Package leaflet: Information for the patient

TRAZER 100 mg hard capsules

Itraconazole
Generic medicine
Please read all of this leaflet carefully before you start 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 other people, 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, talk to 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 taking 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 TRAZER is and what it is used for

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

• yeast infection (Candidiasis) of the mouth, throat, or vagina.
• Skin infections (e.g. athlete's foot, tinea, and a skin infection called pityriasis versicolor) or nail infections 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 appearance of nodules along the lymphatic vessels (lymphocutaneous/cutaneous sporotrichosis). Systemic fungal infection that may present as pneumonia (paracoccidioidomycosis), systemic fungal infection manifesting 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 of or do not respond to amphotericin B.

2. What you should know before taking TRAZER

Do not take TRAZER:

• if you are allergic to itraconazole or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or think you might be pregnant (see section Pregnancy, breastfeeding and fertility).
• if you have heart problems (ventricular dysfunction), for example if your heart cannot pump blood effectively (congestive heart failure), unless your doctor considers treatment necessary for potentially life-threatening infections or other serious infections.
• if you are already taking other medicines, as potentially serious situations may occur (see section Other medicines and TRAZER).

Inform your doctor if you are taking any medicines before taking TRAZER.

• Do not take TRAZER if you are taking any of the following medicines, or within 2 weeks after stopping TRAZER:

Medicines used to treat heart, blood or circulation problems

• aliskiren, eplerenone, lercanidipine or nisoldipine (for high blood pressure)
• bepridil, ivabradine or ranolazine (for angina)
• dabigatran or ticagrelor (for blood clots)
• disopyramide, dofetilide, dronedarone or quinidine (for irregular heartbeat)
• lomitapide, lovastatin or simvastatin (to lower cholesterol)
• sildenafil (for pulmonary arterial hypertension).

Medicines to treat stomach problems or constipation

• cisapride (for stomach disorders)
• domperidone (for nausea and vomiting)
• naloxegol (for constipation caused by opioid painkillers).

Medicines to treat headache, sleep or mental health problems

• dihydroergotamine or ergotamine (ergot alkaloids used for migraine headache)
• midazolam (oral) or triazolam (for sedation or to help you sleep)
• lurasidone, pimozide, quetiapine or sertindole (for schizophrenia, bipolar disorder or other mental health problems).

Medicines to treat urinary problems

• darifenacin (for urinary incontinence)
• fesoterodine or solifenacin (for bladder irritation) when used in patients with certain kidney or liver problems.

Medicines to treat allergies

• astemizole, mizolastine or terfenadine (for allergies).

Medicines to treat erectile or ejaculation problems

• avanafil (for erectile dysfunction)
• dapoxetine (for premature ejaculation)
• vardenafil (for erectile dysfunction) when used in men over 75 years of age.

Other medicines containing:

• colchicine (for gout) when used in patients with kidney or liver problems
• ergometrine (ergonovine) or methylergometrine (methylergonovine), ergot alkaloids used after childbirth
• eliglustat (for Gaucher disease) when used in patients who cannot metabolize certain drugs
• halofantrine (for malaria)
• irinotecan (for cancer)
• isavuconazole (for fungal infections)
• ombitasvir, paritaprevir, ritonavir with or without dasabuvir (for treating hepatitis C) Note: do not take any of the above medicines for 2 weeks after your last treatment with TRAZER.

Warnings and precautions
Talk to your doctor or pharmacist before taking TRAZER.
Stop treatment with TRAZER and contact your doctor immediately if you develop symptoms such as:

• loss of appetite, nausea and vomiting, fatigue, abdominal pain and dark urine. If necessary, your doctor may stop treatment and perform blood tests to check liver function.
• If you suffer from achlorhydria (a condition causing reduced stomach acidity). If you have a disease that reduces stomach acidity (e.g. achlorhydria) or are taking medicines for this purpose. In this case, your doctor will instruct you to take TRAZER with an acidic drink (e.g. cola) and will monitor you, increasing the dose if necessary. Your doctor will also advise you to take medicines for stomach acidity at least 2 hours after taking TRAZER.
• If you have heart problems; contact your doctor immediately if symptoms such as shortness of breath, unexpected weight gain, swelling in legs or abdomen, unusual fatigue, or difficulty breathing at night occur. In this case, your doctor will monitor you and, if necessary, may instruct you to stop TRAZER.
• If you develop symptoms such as tingling, numbness and weakness in limbs, other nerve problems in arms or legs, blurred or double vision, ringing in the ears, or loss of bladder control, these could be signs of a nerve disorder (neuropathy), and treatment should be stopped.

Inform your doctor if you have or have had:

• liver problems: dose adjustment of TRAZER may be necessary;
• heart problems;
• kidney problems. In this case, your doctor will monitor you and, if necessary, adjust the dose of TRAZER;
• cystic fibrosis (a genetic disease);
• peripheral nervous system disorders (neuropathy);
• if your immune system is not working properly (e.g. low white blood cell count (neutropenia), if you have AIDS or have undergone organ transplantation), dose adjustment of TRAZER may be necessary.

Hearing loss has been reported with the use of TRAZER, which usually resolves upon discontinuation of treatment.
If you have AIDS, your doctor may consider maintenance therapy.
If you are in a life-threatening condition, your doctor will not prescribe TRAZER.
If you have mild and limited skin infections (such as pityriasis versicolor, dermatophytosis), your doctor may prescribe a topical treatment before starting therapy with TRAZER.
Elderly patients
TRAZER should not be used in elderly patients, unless otherwise prescribed by a doctor.
Children and adolescents
The use of TRAZER in children is not recommended.
Other medicines and TRAZER
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
There are some medicines that you must not take while taking TRAZER. These are listed above in the section “Do not
take TRAZER”:
The use of certain medicines is not recommended with TRAZER.
Your doctor will decide whether you should not take certain medicines together with TRAZER or within 2 weeks after stopping TRAZER.
Examples of these medicines are:
Medicines to treat heart, blood or circulation problems

• apixaban, rivaroxaban or vorapaxar (for blood clots)
• atorvastatin (to lower cholesterol)
• felodipine (for high blood pressure)
• riociguat or tadalafil (for pulmonary hypertension).

Medicines to treat epilepsy, headache or mental health problems

• phenytoin, carbamazepine or phenobarbital (antiepileptics)
• eletriptan (for migraine headache)
• St. John’s wort (Hypericum perforatum) (a herbal medicine used for mental health problems).

Medicines to treat urinary problems

• tamsulosin (for urinary incontinence in men)
• tolterodine (for bladder irritation).

Medicines to treat cancer

• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, trabectedin, trastuzumab emtansine or vinca alkaloids (e.g. vinflunine, vinorelbine).

Medicines to treat tuberculosis

• bedaquiline, isoniazid, rifabutin or rifampicin (for tuberculosis).

Medicines to treat human immunodeficiency virus (HIV) or hepatitis

• efavirenz or nevirapine (for HIV/AIDS), elbasvir/grazoprevir, simeprevir, tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) (for HIV or hepatitis).

Medicines used after organ transplantation

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

Medicines to treat benign prostatic hyperplasia

• alfuzosin, silodosin.

Medicines to treat lung problems or allergies

• ciclesonide (for inflammation, asthma and allergies)
• ebastine (for allergies)
• salmeterol (for asthma or chronic obstructive pulmonary disease - COPD).

Medicines to treat erectile dysfunction or ejaculation problems

• tadalafil or vardenafil (when used in men aged 75 years or younger) (for erectile dysfunction).

Other medicines containing:

• colchicine (for gout)
• fentanyl (for pain)
• lumacaftor/ivacaftor (for cystic fibrosis). Wait at least 2 weeks after stopping treatment with TRAZER before taking any of these medicines.

This is not a complete list, so inform your doctor if you are taking or plan to take any of these medicines or any other medicine.
Caution is required when taking TRAZER with certain other medicines
You may be more likely to experience adverse effects, or it may be necessary to adjust the dose of TRAZER or the other medicine. Examples of these medicines are:
Medicines to treat heart, blood or circulation problems

• bosentan (for pulmonary hypertension)
• calcium channel blockers such as dihydropyridines, e.g. amlodipine, isradipine, nifedipine, nimodipine or diltiazem (for hypertension)
• verapamil (for high blood pressure)
• cilostazol (for circulatory problems)
• coumarins such as warfarin (for blood clots)
• digoxin (for atrial fibrillation)
• nadolol (for pulmonary hypertension or angina).

Medicines to treat stomach problems or diarrhoea

• aprepitant or netupitant (for nausea and vomiting during cancer treatment)
• loperamide (for diarrhoea)
• antacids such as aluminium, calcium, magnesium or sodium bicarbonate, H2-receptor antagonists such as cimetidine, ranitidine, and proton pump inhibitors such as 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 promote sleep)
• zopiclone (to promote sleep)
• reboxetine or venlafaxine (for depression and anxiety)
• aripiprazole, cariprazine, haloperidol or risperidone (for schizophrenia, bipolar disorder or other mental health problems)
• galantamine (for Alzheimer’s disease)
• guanfacine (for attention deficit hyperactivity disorder).

Medicines to treat urinary problems

• imidafenacin, fesoterodine, oxybutynin, solifenacin (for bladder irritation).

Medicines to treat cancer

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

Medicines to treat infections

• ciprofloxacin, clarithromycin or erythromycin (for bacterial infections)
• delamanid (for tuberculosis)
• artemether-lumefantrine or quinine (to treat malaria)
• praziquantel (for trematodes and tapeworms).

Medicines to treat human immunodeficiency virus (HIV) or hepatitis

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

Medicines used after organ transplantation

• ciclosporin 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 (oral or injectable medicines for asthma, allergies or inflammatory conditions)
• budesonide or fluticasone (for asthma, allergies).

Medicines to treat erectile dysfunction or ejaculation problems

• sildenafil (for erectile dysfunction).

Medicines to treat pain

• alfentanil, buprenorphine, oxycodone or sufentanil (for pain)
• meloxicam (for joint inflammation and pain).

Other medicines containing:

• alitretinoin (oral) (for eczema)
• cabergoline (for Parkinson’s disease)
• cannabis-based products, including medicines (such as those for nausea and vomiting or muscle spasms in patients with multiple sclerosis)
• cinacalcet (for hyperparathyroidism)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher disease) when used in patients unable to metabolize certain drugs
• ivacaftor (for cystic fibrosis)
• methadone (for treating drug addiction)
• repaglinide or saxagliptine (for diabetes). This is not a complete list, so inform your doctor if you are taking or plan to take any of these medicines or any other medicine.

Taking certain medicines together with TRAZER may be harmful or may alter the activity of TRAZER.
Absorption of TRAZER into the body requires sufficient gastric acidity. For this reason, medicines that neutralize stomach acidity (antacids) must be taken at least 1 hour before or not within 2 hours after taking TRAZER.
For the same reason, if you are using medicines that inhibit acid production in the stomach, it is advisable to take TRAZER with a cola-containing drink.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
TRAZER is contraindicated during pregnancy unless your doctor considers treatment necessary for potentially life-threatening infections, where the expected benefit to 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 considers the potential risk in relation to the expected benefit.
Fertility
If you are of childbearing age, your doctor will advise you to use adequate contraceptive measures during treatment with TRAZER and to continue them until the next menstrual cycle after the end of treatment.
Consult your doctor if you started TRAZER therapy without adequate contraceptive measures.
Driving and using machines
Exercise caution before driving or operating machinery, as dizziness, visual 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 him before taking this medicine.

3. How to take TRAZER

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult 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, dermatomycoses): 2 capsules once daily for 7 days.
• Nail infections (onychomycosis): 1 treatment cycle consists of 2 capsules twice daily for one week, followed by a 3-week break. For fingernail infections, 2 cycles are recommended; for toenail infections, 3 treatment cycles are recommended.
• Vaginal infections (vulvovaginal candidiasis): 1 capsule twice daily for 3 days, or alternatively, 2 capsules twice daily for 1 day.
• Mouth infections (oral candidiasis): 1 capsule once daily for 15 days.
• Infection of the front part of the eye (cornea): (2 capsules) once daily for 21 days.
• Treatment of particularly keratinized areas, such as plantar forms of tinea pedis and palmar forms of tinea manus: 2 capsules twice daily for 7 days.

In skin infections, lesions disappear completely only 2–4 weeks after the end of treatment.
In onychomycoses (nail infections), it is necessary to wait for the nails to regrow, which occurs 6 to 9 months after the end of treatment.
For fungal infections of internal organs (systemic infections), the usual recommended dose is as follows:

• Aspergillosis: 2 capsules once daily for a period of 2 to 5 months; in case of invasive or disseminated aspergillosis, it is recommended to take 2 capsules twice daily.
• Candidiasis: 1–2 capsules once daily for a period of 3 weeks to 7 months; in case of invasive or disseminated candidiasis, take 2 capsules twice daily.
• Non-meningeal cryptococcosis: 2 capsules once daily for a period of 2 months to 1 year; maintenance therapy consists of 2 capsules once daily.
• Cryptococcal meningitis: 4 capsules once daily for a period of 2 months to 1 year; maintenance therapy consists of 2 capsules once daily.
• Histoplasmosis: from 1 capsule once daily to 2 capsules twice daily for 8 months.
• Sporotrichosis: 1 capsule once daily for 3 months.
• Paracoccidioidomycosis: 1 capsule once daily for 6 months. Chromomycosis: 1–2 capsules once daily for 6 months.
• Blastomycosis: from 1 capsule once daily to 2 capsules twice daily 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 department. Urgency measures, such as gastric lavage, may be required, which should only be performed in a hospital setting.
If you forget to take TRAZER
Do not take a double dose to make up for a forgotten dose. Take the missed dose as soon as you remember, unless it is almost time for your next dose.
If you stop taking TRAZER
Contact your doctor if you decide to stop treatment with TRAZER. Even if you feel better, it is important to continue taking the capsules for the full duration prescribed by your doctor. If you stop treatment early, the infection may recur.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor (or pharmacist).
Following the instructions contained in this leaflet reduces the risk of side effects.
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 liver failure).
• Severe skin reactions.

The following are other side effects observed during clinical studies.
Common side effects (may affect up to 1 in 100 people)

• Headache.
• Abdominal pain.
• Nausea.

Uncommon side effects (may affect up to 1 in 1,000 people)

• Inflammation of the paranasal mucosa (sinusitis).
• Infection of the upper respiratory tract.
• Nasal congestion (rhinitis).
• Allergic reaction (hypersensitivity).
• Altered taste (dysgeusia).
• Altered sensation in limbs or other body parts (paraesthesia).
• Confusion.
• Diarrhoea.
• Vomiting.
• Constipation.
• Indigestion (dyspepsia).
• Presence of gas in the stomach or intestines (flatulence).
• Abnormal liver function.
• Increased bilirubin in the blood which may cause yellowing of the skin (hyperbilirubinaemia).
• Urticaria (skin rash).
• Rash (skin eruption).
• Itching (pruritus).
• Hair loss (alopecia).
• Menstrual disorders.
• Swelling due to fluid accumulation (oedema).

Rare side effects (may affect up to 1 in 10,000 people)

• Reduction in white blood cells (leucopenia).
• 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 (hypertriglyceridaemia).
• Tremor.
• Reduced sensitivity and response to a given stimulus (hypoesthesia).
• Vision disorders including double vision (diplopia) and blurred vision.
• Temporary or permanent hearing loss*.
• Ringing in the ear (tinnitus).
• Heart problems (congestive heart failure)*.
• Difficulty breathing (dyspnoea).
• Inflammation of the pancreas (pancreatitis).
• Severe hepatotoxicity (liver damage), including some cases of acute fatal liver failure*.
• Severe skin and/or mucosal reaction induced by the drug (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• Sudden skin eruption appearing as pustules (acute generalized exanthematous pustulosis).
• Inflammation of blood vessels causing an allergic reaction (erythema multiforme).
• Severe and widespread skin irritation causing skin peeling (exfoliative dermatitis).
• Inflammation of small blood vessels (leucocytoclastic vasculitis).
• Abnormal and excessive skin reaction to sunlight or artificial light (photosensitivity).
• Frequent passage of small amounts of urine (pollakiuria).
• Problems achieving/maintaining an erection (erectile dysfunction).
• Fever.
• Increase in a blood enzyme (elevated serum creatine phosphokinase). *See section “Warnings and precautions”.

The following list includes ADRs associated with itraconazole reported in clinical studies with oral itraconazole solution and/or intravenous itraconazole, excluding the term “injection site inflammation”, which is specific to the injectable route of administration.
Haematopoietic and lymphatic system disorders: reduced number of a particular type of white blood cells (granulocytopenia), reduced platelet count (thrombocytopenia).
Immune system disorders: severe allergic reactions (anaphylactoid reaction).
Metabolism and nutrition disorders: increased blood sugar (hyperglycaemia), increased potassium in blood (hyperkalaemia), decreased potassium in blood (hypokalaemia), decreased magnesium in blood (hypomagnesaemia).
Psychiatric disorders: confusion.
Nervous system disorders: nerve disorders (peripheral neuropathy*), dizziness, somnolence.
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 oedema), voice disorders (dysphonia), cough, chest pain.
Gastrointestinal disorders: gastrointestinal disorders.
Hepatobiliary disorders: liver problems (liver failure*, hepatitis), yellowing of the skin or whites of the eyes (jaundice).
Skin and subcutaneous tissue disorders: skin rash due to erythema (erythematous rash), excessive sweating (hyperhidrosis).
Musculoskeletal and connective tissue disorders: muscle pain (myalgia), joint pain (arthralgia).
Renal and urinary disorders: kidney problems (renal failure), difficulty retaining urine (urinary incontinence).
Systemic disorders and administration site conditions: fluid accumulation leading to general and/or facial swelling (generalised oedema, facial oedema), fever (pyrexia), pain, fatigue, chills.
Investigations: increased blood levels of liver-related parameters (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, and other liver enzymes), increased levels of a protein indicating tissue damage (increased serum lactate dehydrogenase), increased blood urea levels (blood urea), abnormal urine analysis.
*See section “Warnings and precautions”.
Paediatric population
Based on safety data from clinical trials, the most commonly reported adverse effects in paediatric patients are:

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

In general, the adverse effects reported in paediatric patients are similar to those observed in adults, but occur more frequently in paediatric patients.
Cardiac arrest has also been reported in some cases.
Side effects identified during post-marketing surveillance of itraconazole, frequency not known

• 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 (hypertriglyceridaemia).
• Visual disturbances, including double vision (diplopia) and blurred vision.
• Temporary or permanent hearing loss.
• Heart problems (congestive heart failure).
• Difficulty breathing (dyspnoea).
• Inflammation of the pancreas (pancreatitis), liver damage, including some cases of acute fatal liver failure (severe hepatotoxicity).
• Severe skin and/or mucosal reaction induced by the drug (Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN)).
• Sudden skin eruption with pustules (acute generalized exanthematous pustulosis (AGEP)).
• Inflammation of blood vessels causing an allergic reaction (erythema multiforme).
• Severe and widespread skin irritation causing skin peeling (exfoliative dermatitis).
• Inflammation of small blood vessels (leucocytoclastic vasculitis).
• Hair loss (alopecia).
• Abnormal and excessive skin reaction to sunlight or artificial light (photosensitivity).
• A blood enzyme (increased serum creatine phosphokinase).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects 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 stated on the carton or blister after Exp. The expiry date refers to the last day of the month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What TRAZER contains
The active substance is itraconazole 100 mg.
The other components are sugar spheres, hypromellose, poloxamer 188.
Capsule constituents: gelatin, titanium dioxide (E171), quinoline yellow (E104), indigo carmine (E132).

Description of the appearance of TRAZER and the contents of the pack
Box containing 8 capsules

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group S.r.l., Via Tiburtina 1143, 00156 Rome, Italy

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