Itraconazole Sandoz: detailed information

Package leaflet: Information for the patient

Itraconazole Sandoz 100 mg hard capsules

Generic medicine
Please read this entire 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Itraconazole Sandoz is and what it is used for
What you need to know before taking Itraconazole Sandoz
How to take Itraconazole Sandoz
Possible side effects
How to store Itraconazole Sandoz
Contents of the pack and other information

1. What Itraconazolo Sandoz is and what it is used for

Itraconazolo Sandoz contains the active substance itraconazole, which belongs to a group of medicines called antifungals, used to treat infections caused by fungi and yeasts.
Itraconazolo Sandoz is indicated for the treatment of:

Superficial fungal infections:
- 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 fungal infections (infections caused by fungi that spread throughout the body):
- aspergillosis (infection caused by Aspergillus)
- candidiasis (infection caused by Candida)
- cryptococcosis (infection caused by Cryptococcus), including cryptococcal meningitis (inflammation of the meninges): in immunocompromised patients with cryptococcosis and in all patients with central nervous system cryptococcosis, Itraconazolo Sandoz 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 fungal infections.

2. What you need to know before taking Itraconazole Sandoz

Do not use Itraconazole Sandoz

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant, suspect you may be pregnant, or are planning a pregnancy (see section “Pregnancy”), or if you have heart problems (ventricular dysfunction), for example if the heart is unable to pump blood effectively (congestive heart failure), unless your doctor considers it necessary to treat potentially life-threatening infections or other serious infections. Inform your doctor if you are taking any medicines before starting Itraconazole Sandoz capsules.
- Do not take Itraconazole Sandoz if you are taking any of the following medicines, or within 2 weeks after stopping Itraconazole Sandoz capsules. The list below includes examples of medicines that must not be taken with Itraconazole Sandoz, nor within 2 weeks of stopping Itraconazole Sandoz:

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)
finerenone (for kidney problems in patients with type 2 diabetes)
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 headaches, sleep or mental health problems

dihydroergotamine or ergotamine (ergot alkaloids used for migraine headaches)
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 overactive bladder) 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 in the body
halofantrine (for malaria)
irinotecan (for cancer)
isavuconazole (for fungal infections)
ombitasvir, paritaprevir, ritonavir with or without dasabuvir (for treating hepatitis C)
venetoclax (for chronic lymphocytic leukemia) when starting treatment or when increasing the dose at the beginning of treatment
voclosporin (for kidney problems associated with lupus)

Note: do not take any of the medicines listed above for 2 weeks after your last dose of
Itraconazole Sandoz capsules.
This is not a complete list; therefore, inform your doctor if you are taking or plan to take
any of these or other medicines.
Warnings and precautions
Talk to your doctor or pharmacist before taking Itraconazole Sandoz:
Stop treatment with Itraconazole Sandoz capsules and contact your doctor immediately if you experience any of the following symptoms:

loss of appetite (anorexia)
nausea
vomiting
weakness (asthenia)
abdominal pain
dark urine

If your doctor considers treatment with Itraconazole Sandoz capsules necessary, they may recommend regular blood tests to detect any potential liver problems early.
Contact your doctor if you experience hearing loss or if you have achlorhydria (a condition causing reduced stomach acidity).
Contact your doctor immediately if you experience:

shortness of breath
unexpected weight gain
swelling in the legs or abdomen
unusual tiredness
difficulty breathing at night

These could be symptoms of heart failure; in such cases, treatment must be stopped.

tingling
numbness
weakness in limbs
other problems with nerves in arms or legs
blurred vision or double vision, ringing in the ears, or loss of bladder control

These could be symptoms of a nerve disorder (neuropathy), in which case treatment must be stopped.
Inform your doctor if you have or have had:

liver problems: a dose adjustment of Itraconazole Sandoz capsules may be necessary;
heart problems;
kidney problems: a dose adjustment of Itraconazole Sandoz capsules may be necessary;
cystic fibrosis (a genetic disease);
peripheral nervous system problems (neuropathy);
neutropenia (low white blood cell count), AIDS, or if you have had an organ transplant. A dose adjustment of Itraconazole Sandoz capsules may be necessary.

Elderly
Itraconazole Sandoz should not be used in elderly patients unless the doctor considers it absolutely necessary.
Other medicines and Itraconazole Sandoz
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 using Itraconazole Sandoz capsules. These are listed above under the section “Do not use Itraconazole Sandoz capsules if:”
The use of certain medicines is not recommended with Itraconazole Sandoz capsules.
Your doctor will decide whether you should avoid taking certain medicines together with Itraconazole Sandoz
capsules or within 2 weeks after stopping Itraconazole Sandoz capsules.
Examples of these medicines are:
Medicines to treat heart, blood or circulation problems

apixaban, edoxaban, 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, headaches or mental health problems

phenytoin, carbamazepine or phenobarbital (antiepileptics)
eletriptan (for migraine headaches)
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 overactive bladder)

Medicines to treat cancer

axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedin, trastuzumab emtansine, venetoclax (when taking a stable dose of venetoclax for chronic lymphocytic leukemia, or at any time during treatment for acute myeloid leukemia) 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, 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

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)

Note: do not take any of the medicines listed above for 2 weeks after your last dose of
Itraconazole Sandoz capsules.
This is not a complete list, so inform your doctor if you are taking or plan to take any of these or other medicines.
Caution is required when taking Itraconazole Sandoz capsules with certain other medicines
You may be more likely to experience side effects, or it may be necessary to adjust the dose of Itraconazole Sandoz capsules or the other medicine. Examples of such 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)
or 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 acid problems)

Medicines to treat sleep or mental health problems

alprazolam, brotizolam, buspirone or midazolam (when administered 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 overactive bladder)

Medicines to treat cancer

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

Medicines to treat infections

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

Medicines to treat human immunodeficiency virus (HIV) or hepatitis

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

Medicines used after organ transplantation

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 (oral medicines or injections for asthma, allergies or inflammatory conditions)
budesonide or fluticasone (for asthma, allergies)

Medicines to treat erectile dysfunction

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 medicinal products (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 in the body
ivacaftor (for cystic fibrosis)
methadone (for treating opioid dependence)
repaglinide or saxagliptin (for diabetes)

This is not a complete list; therefore, inform your doctor if you are taking or plan to take any of these or other medicines.
Taking certain medicines together with Itraconazole Sandoz capsules may be harmful or may alter the activity of Itraconazole Sandoz capsules.
Itraconazole Sandoz capsules are absorbed into the body only in the presence of sufficient gastric acidity. For this reason, medicines that neutralize stomach acid (antacids) should be taken at least 1 hour before or not within 2 hours after taking Itraconazole Sandoz capsules. For the same reason, if you are using medicines that inhibit stomach acid production, it is advisable to take Itraconazole Sandoz capsules with a cola drink.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Itraconazole Sandoz capsules are contraindicated during pregnancy unless your doctor considers it necessary to treat potentially life-threatening infections, where the expected benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
Avoid breastfeeding during treatment with Itraconazole Sandoz capsules, as small amounts of the medicine may pass into breast milk, unless your doctor considers the potential risk in relation to the expected benefit.
Fertility
If you are a woman of childbearing potential and could become pregnant, speak with your doctor. You must use effective contraception to ensure you do not become pregnant during treatment with this medicine.
Consult your doctor if you started treatment with Itraconazole Sandoz capsules without using adequate contraceptive measures.
Driving and using machines
When driving vehicles or operating machinery, consider the possibility that Itraconazole Sandoz may cause dizziness, visual disturbances and hearing loss (see section “Possible side effects”).
Itraconazole Sandoz contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to use Itraconazole Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take Itraconazole Sandoz immediately after one of the main meals.
Please note the following:

The capsule must not be opened and must be swallowed whole.
The dose required depends on the type of infection being treated. Always follow your doctor's instructions carefully, as they may adjust the treatment according to your individual needs.
Treatment of superficial fungal infections

INDICATION RECOMMENDED DOSE DURATION
Pityriasis versicolor 2 capsules once daily 7 days
Dermatophytosis (skin 2 capsules once daily 7 days
infection)
Treatment of particularly 2 capsules twice daily 7 days
keratinized areas, such as
plantar forms of tinea pedis
and palmar forms of tinea manus
Onychomycosis (fungal 1 cycle = 2 capsules twice 2 cycles
nail infection) of the hands daily for one week Each cycle must be followed
by 3 weeks without treatment.
Onychomycosis (fungal 1 cycle = 2 capsules twice 3 cycles
nail infection) of the feet daily for one week Each cycle must be followed
by 3 weeks without treatment.
Vulvovaginal candidiasis 2 capsules once daily 3 days
(fungal infection of the or 1 day
female genital tract) 2 capsules twice daily
Oral candidiasis (oral 1 capsule once daily 15 days
fungal infection)
Fungal keratitis (fungal 2 capsules once daily 21 days
eye infection)

With skin infections, lesions disappear completely only 2–4 weeks after the end of treatment.
With onychomycosis (nail infections), you must wait for the nails to regrow completely, which takes 6 to 9 months after the end of treatment.

Treatment of systemic fungal infections (internal organ infections)

INDICATION RECOMMENDED DOSE AVERAGE DURATION REMARKS
Aspergillosis 2 capsules once daily 2–5 months In case of invasive or disseminated infections: 2 capsules twice daily
Candidiasis 1–2 capsules once daily 3 weeks – 7 months In case of invasive or disseminated infections: 2 capsules twice daily
Non-meningeal 2 capsules once daily 2 months – 1 year /
cryptococcosis
Cryptococcal meningitis 2 capsules twice daily 2 months – 1 year /
Histoplasmosis 2 capsules once daily 8 months /
or 2 capsules twice daily
Sporotrichosis 1 capsule or 2 capsules 3–6 months /
lymphocutaneous and once daily (localized lesions)
cutaneous or
2 capsules twice daily
(extensive lesions)
Paracoccidioido- 1 capsule once daily 6 months /
mycosis
Chromomycosis 1–2 capsules once daily 6 months /
Blastomycosis 1 capsule once daily 6 months /
or
2 capsules twice daily

If you take more Itraconazole Sandoz than you should
If you accidentally take too much Itraconazole Sandoz, contact your doctor immediately or go to the nearest hospital.
In case of overdose, you may experience the adverse effects described in section 4.
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4. Possible side effects

Like all medicines, Itraconazolo Sandoz capsules can cause side effects, although not everybody gets them.
The most commonly reported side effects during treatment with Itraconazolo Sandoz capsules are:

Headache
Abdominal pain
Nausea

The most serious side effects are:

Severe allergic reactions
Heart failure and congestive heart failure (heart problems)
Pulmonary edema (swelling due to fluid retention in the lungs)
Pancreatitis (inflammation of the pancreas)
Severe hepatotoxicity (liver damage), including some cases of fatal acute liver failure (liver problems)
Severe skin reactions

Other side effects observed in 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 paranasal mucosa)
Upper respiratory tract infection
Rhinitis (nasal congestion)
Hypersensitivity (allergy)*
Dysgeusia (altered taste)
Paresthesia (altered sensation in limbs or other body parts)
Confusion
Diarrhea
Vomiting
Constipation
Dyspepsia (indigestion)
Flatulence (presence of gas in the stomach or intestines)
Abnormal liver function
Hyperbilirubinemia (increased blood bilirubin levels, which may cause yellowing of the skin)
Urticaria (hives)
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 (allergy-like reaction)
Angioneurotic edema (swelling of the face, mouth, lips and/or tongue)
Anaphylactic reaction (severe allergic reaction)
Hypertriglyceridemia (elevated blood triglyceride levels)
Tremor
Hypoesthesia (reduced sensitivity and response to stimuli)
Visual disturbances, including diplopia (double vision) and blurred vision
Transient or permanent hearing loss*
Tinnitus (ringing in the ear)
Congestive heart failure (heart problems)*
Dyspnea (difficulty breathing)
Pancreatitis (inflammation of the pancreas)
Severe hepatotoxicity (liver damage), including some cases of fatal acute liver failure*
Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (severe drug-induced skin and/or mucosal reaction)
Acute generalized exanthematous pustulosis (AGEP) (sudden skin eruption with pustules)
Erythema multiforme (blood vessel inflammation causing allergic reaction)
Exfoliative dermatitis (severe and widespread skin 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 (an enzyme present in the blood)

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

Symptoms of elevated aldosterone hormone levels (such as increased blood pressure or low potassium levels in blood), even when blood aldosterone levels are normal or low.

*See section “Warnings and precautions”

The following list of adverse drug reactions (ADRs) associated with itraconazole has been reported in clinical studies with ITRACONAZOLO SANDOZ oral solution and ITRACONAZOLO SANDOZ iv, excluding the term “injection site reaction”, which is specific to the injectable route of administration.

Blood and lymphatic system disorders: granulocytopenia, thrombocytopenia
Immune system disorders: anaphylactoid reaction
Metabolism and nutrition disorders: hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia
Psychiatric disorders: confusion
Nervous system disorders: peripheral neuropathy*, dizziness, somnolence
Cardiac disorders: heart failure, left ventricular failure, tachycardia
Vascular disorders: hypertension, hypotension
Respiratory, thoracic and mediastinal disorders: pulmonary edema, dysphonia, cough, chest pain
Gastrointestinal disorders: gastrointestinal disorders
Hepatobiliary disorders: liver failure*, hepatitis, jaundice
Skin and subcutaneous tissue disorders: erythematous rash, hyperhidrosis
Musculoskeletal and connective tissue disorders: myalgia, arthralgia
Renal and urinary disorders: renal failure, urinary incontinence
Systemic disorders and administration site conditions: generalized edema, facial edema, pyrexia, pain, fatigue, chills
Investigations: increased alanine aminotransferase levels, increased aspartate aminotransferase levels, increased alkaline phosphatase levels, increased lactate dehydrogenase levels, increased blood urea levels, increased gamma-glutamyltransferase levels, increased liver enzymes, abnormal urine analysis

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

Headache
Vomiting
Abdominal pain
Diarrhea
Abnormal liver function
Hypotension (low blood pressure)
Nausea
Urticaria (hives)

In general, the side 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 Itraconazolo Sandoz, frequency not known

Serum sickness (allergy-like reaction)
Angioneurotic edema (swelling of face, mouth, lips and/or tongue)
Anaphylactic reaction (severe allergic reaction)
Hypertriglyceridemia (increased blood triglyceride levels)
Visual disturbances, including diplopia (double vision) and blurred vision
Transient or permanent hearing loss
Congestive heart failure (heart problems)
Dyspnea (difficulty breathing)
Pancreatitis (inflammation of the pancreas)
Severe hepatotoxicity (liver damage), including some cases of fatal acute liver failure
Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (severe drug-induced skin and/or mucosal reaction)
Acute generalized exanthematous pustulosis (AGEP) (sudden skin eruption with pustules)
Erythema multiforme (blood vessel inflammation causing allergic reaction)
Exfoliative dermatitis (severe and widespread skin 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 (an enzyme present in the blood)

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

5. How to store Itraconazolo Sandoz

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 "Exp.".
The expiry date refers to the last day of that month.
Store below 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 Itraconazolo Sandoz contains

The active substance is: itraconazole. Each tablet contains 100 mg of itraconazole.
The other components are: sugar-based granules (composed of maize starch, purified water and sucrose), hypromellose, poloxamer 188; capsule composition: gelatin, titanium dioxide (E171), quinoline yellow (E 104), indigotine (E 132).

Description of the appearance of Itraconazolo Sandoz and package contents
The package contains 8 capsules in blister packs.
Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy
Manufacturer

Liconsa SA Av.da Miralcampo 7 - Poligono Industrial Miralcampo - 19200 Azuqueca de Henares -Guadalajara (Spain).
Salutas Pharma GmbH - Otto-von-Guericke-Allee 1 - 39179 Barleben (Germany).