Itraconazole Sandoz 100 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Itraconazol Sandoz 100 mg hard capsules EFG

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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may harm them.
If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Itraconazol Sandoz contains a medicine called itraconazole. It belongs to a group of medicines known as "antifungals".

Itraconazol Sandoz is used to treat infections caused by fungi or yeasts. It is used for:

infections of the mouth or vagina causing "candidiasis",
skin and nail infections.

After completing treatment with Itraconazol Sandoz, skin spots or lesions may take several weeks to disappear completely. Fingernails and toenails may take several months to fully recover. This is because the skin or nail only regain a normal appearance when new tissue has grown, even though the medicine has already eliminated the fungus that caused the infection.

2. What you need to know before taking Itraconazol Sandoz

Do not take Itraconazol Sandoz:

if you are allergic to itraconazole or to any of the other ingredients of this medicine (listed in section 6),
if you show signs of severe heart failure (ventricular dysfunction, heart failure) or have previously had heart failure, except when treating life-threatening or serious fungal infections,
if you are pregnant, think you might be pregnant, or plan to become pregnant (see section “Pregnancy and breastfeeding”).
if you are of childbearing age, you must use adequate contraceptive measures to avoid pregnancy during treatment. Because this medicine may remain in the body for some time, you should continue contraceptive measures until your next menstrual period after completing treatment with this medicine.

Before taking Itraconazol Sandoz, inform your doctor if you are taking other medicines.

You must not take Itraconazol Sandoz if you are taking certain medicines. Some medicines should only be taken or used two weeks after stopping Itraconazol Sandoz. Examples of medicines you must not take or use together with Itraconazol Sandoz, or that you may only take/use two weeks after stopping treatment with Itraconazol Sandoz, include:

Medicines used to treat heart, blood, or circulation problems

aliskiren, eplerenone, lercanidipine, or nisoldipine (for hypertension),
bepridil, ivabradine, or ranolazine (for angina),
dabigatran or ticagrelor (for blood clots),
disopyramide, dofetilide, dronedarone, or quinidine (for irregular heart rhythm),
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 analgesics).

Medicines to treat headaches, sleep problems, or mental health conditions

dihydroergotamine or ergotamine (ergot alkaloids used for migraines),
midazolam (oral) or triazolam (for sedation or sleep induction),
lurasidone, pimozide, quetiapine, or sertindole (for schizophrenia, bipolar disorder, or other mental health disorders).

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 dysfunction and 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 medicines,
halofantrine (for malaria),
irinotecan (for cancer),
isavuconazole (for fungal infections),
ombitasvir, paritaprevir, ritonavir with or without dasabuvir (for hepatitis C),
venetoclax (for chronic lymphocytic leukemia) when you start taking venetoclax for the first time or when increasing doses at the beginning of treatment,
voclosporin (for kidney problems related to lupus).

Remember: do not take any of the above medicines within 2 weeks after your last dose of itraconazole.

This is not a complete list; inform your doctor if you are taking or planning to take any of these medicines or any other medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting itraconazole.

Stop taking Itraconazol Sandoz capsules and contact your doctor immediately if during treatment you experience any of the following symptoms of serious liver problems:

severe loss of appetite, nausea, vomiting, unusual tiredness, abdominal pain, dark-colored urine, pale stools

Contact your doctor immediately:

if you experience unusual sensations in your hands or feet, such as tingling, numbness, or weakness, while taking Itraconazol Sandoz.
if you notice symptoms of hearing loss. In very rare cases, patients taking itraconazole have reported temporary or permanent hearing loss.

Talk to your doctor if you have any of the following conditions:

If you have ever had an allergic reaction to another antifungal medicine.
If you have any heart problems, including heart dysfunction (also known as heart failure).
Itraconazol Sandoz may worsen heart dysfunction. If your doctor decides to prescribe this medicine, you should be informed about symptoms to watch for. If you experience any of the following, stop taking the medicine and contact your doctor immediately. These symptoms may indicate heart dysfunction:
- difficulty breathing
- unexpected weight gain
- swelling in the legs or abdomen
- unusual tiredness
- waking up at night due to breathing difficulties
If you have liver problems, such as jaundice (yellowing of the skin), as your itraconazole dose may need adjustment. Your doctor will inform you about symptoms to monitor: loss of appetite, nausea, vomiting, unusual tiredness, abdominal pain, dark urine. If you need to take Itraconazol Sandoz continuously for more than one month, your doctor may order blood tests to check liver function. You may not be able to take certain medicines.
If you have impaired kidney function, as your dose may need adjustment. You may also be unable to take certain medicines.
If you have a weakened immune system, e.g., due to neutropenia (low white blood cell count), AIDS, or organ transplantation. A higher dose of Itraconazol Sandoz may be needed.
If you have a fungal infection affecting internal organs (such as sporotrichosis, blastomycosis, histoplasmosis, cryptococcosis [with or without meningitis]), your doctor will assess whether maintenance treatment is needed.
If you have low stomach acidity, this may reduce absorption of itraconazole from the capsules. If you need to take acid-neutralizing medicines (e.g., aluminum hydroxide), take them at least one hour before or at least two hours after taking itraconazole. Patients with achlorhydria, some AIDS patients, or those taking medicines to reduce acid secretion (such as H2 antagonists or proton pump inhibitors) should take the capsules with a non-diet cola drink.
Your doctor may assess whether an increased itraconazole dose is necessary.

Children and adolescents

Because experience with itraconazole in children and adolescents is limited, its use is not recommended in this age group unless potential benefits outweigh potential risks.

Other medicines and Itraconazol Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

There are medicines you must not take while taking itraconazole. These are listed above under “Do not take Itraconazol Sandoz.”

The use of certain medicines with itraconazole is not recommended. Your doctor may decide that you should not take some medicines at the same time as itraconazole or within 2 weeks after stopping it.

Examples of these medicines include:

Medicines to treat heart, blood, or circulation problems

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

Medicines to treat epilepsy, headaches, or mental health problems

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

Medicines to treat urinary problems

tamsulosin (for male urinary incontinence),
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 you are on 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, simeprevir, tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) (for HIV or hepatitis).

Medicines used after organ transplantation

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

Medicines to treat benign enlargement of the prostate

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 and 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).

Remember: do not take any of the above medicines within 2 weeks after your last dose of itraconazole.

This list is not complete, so inform your doctor if you are taking or planning to take any of these medicines or any other medicine.

Caution is required when using itraconazole with certain medicines.

You may have an increased risk of adverse effects, or dose adjustments of itraconazole or the other medicine may be needed. Examples of such medicines include:

Medicines to treat heart, blood, or circulation problems

bosentan (for pulmonary hypertension),
calcium channel blockers such as dihydropyridines, including amlodipine, isradipine, nifedipine, nimodipine, or diltiazem (for hypertension), or verapamil (for hypertension),
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 diarrhea

aprepitant or netupitant (for nausea and vomiting during cancer treatment),
loperamide (for diarrhea),
antacids such as aluminum, calcium, magnesium, or sodium bicarbonate; H2-receptor antagonists such as cimetidine, ranitidine; and proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (for stomach acid problems).

Medicines to treat sleep disorders or mental health conditions

alprazolam, brotizolam, buspirone, or midazolam (when injected intravenously) (for anxiety or sleep induction),
zopiclone (for sleep induction),
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

imidafenacine, fesoterodine, oxybutynin, solifenacine (for overactive bladder).

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 (for treating malaria),
praziquantel (for worms and tapeworms).

Medicines to treat human immunodeficiency virus (HIV) or hepatitis

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

Medicines used after organ transplantation

cyclosporine or tacrolimus.

Medicines to treat benign enlargement of the prostate

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 and ejaculation problems

sildenafil (for erectile dysfunction).

Medicines to treat pain

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

Other medicines containing:

alitretinoin (oral) (for eczema),
cabergoline (for Parkinson’s disease),
cannabis-based products, including medicines (for nausea and vomiting or muscle spasms in multiple sclerosis patients),
cinacalcet (for overactive parathyroid function),
dienogest or ulipristal (contraceptives),
eliglustat (for Gaucher disease) when used in patients who cannot metabolize certain medicines,
ivacaftor (for cystic fibrosis),
methadone (for drug addiction),
repaglinide or saxagliptine (for diabetes).

This list is not complete, so inform your doctor if you are taking or planning to take any of these medicines or any other medicine, so appropriate measures can be taken.

Sufficient stomach acidity is required to ensure itraconazole absorption. Therefore, medicines that neutralize stomach acidity should be taken at least 2 hours before or at least 2 hours after taking itraconazole. For the same reason, if you are taking medicines that regulate stomach acid production, take itraconazole with a cola drink (see section 3 “How to take Itraconazol Sandoz”).

If in doubt, consult your doctor or pharmacist.

Taking Itraconazol Sandoz with food and drinks

Patients with lack of gastric acid (achlorhydria), some patients with AIDS, or those taking medicines to reduce stomach acid secretion (e.g., H2 antagonists or proton pump inhibitors) should take Itraconazol Sandoz with an acidic drink, such as a non-diet cola.

Children and elderly patients

Itraconazole is generally not administered to children or elderly patients. However, your doctor may prescribe it in special cases.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Do not take Itraconazol Sandoz if you are pregnant, unless your doctor has specifically instructed you to do so because you require life-saving treatment and the potential benefits outweigh the potential risks.

Talk to your doctor if you are of childbearing age and could become pregnant.

You must use an effective contraceptive method to ensure you do not become pregnant while taking this medicine.

Since the active ingredient in Itraconazol Sandoz remains in the body for some time after treatment ends, you should continue using contraception until your next menstrual period after completing treatment.

If you discover you are pregnant after starting treatment with Itraconazol Sandoz, stop taking the medicine and inform your doctor immediately.

Available information on the use of capsules containing itraconazole during pregnancy is limited.

Congenital malformations have been reported in post-marketing experience, including skeletal, genitourinary, cardiovascular, ocular, and chromosomal abnormalities, as well as multiple malformations. To date, a causal relationship with itraconazole has not been established.

Epidemiological data on itraconazole use during the first trimester of pregnancy, usually in short-term treatments, did not show an increased risk of malformations.

Breastfeeding

Do not take itraconazole if you are breastfeeding, as small amounts of the medicine may pass into breast milk.

Driving and using machines

Itraconazole may sometimes cause dizziness, blurred/double vision, or hearing loss. If you experience any of these symptoms, do not drive or operate machinery.

Itraconazol Sandoz contains sucrose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; i.e., essentially “sodium-free”.

3. How to take Itraconazol Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again. Remember to take your medicine.

Your doctor will tell you how long to take this medicine. Do not stop treatment early.

If you think the effect of the medicine is too strong or too weak, inform your doctor or pharmacist.

You should take itraconazole immediately after food, as it is better absorbed this way. Swallow the capsules whole with some water. The number of capsules to take and the duration of treatment depend on the type of fungus and the location of the infection. Your doctor will tell you exactly how many itraconazol capsules you should take.

There must be sufficient acidity in the stomach to ensure proper absorption of this medicine. Therefore, medicines that neutralize stomach acidity should be taken either two hours after taking this medicine or two hours before taking itraconazole. For the same reason, if you are taking medicines that regulate acid production in the stomach, take itraconazole with a cola drink.

The recommended dose is:

TYPE OF INFECTION	CAPSULES PER DAY	DURATION
Vaginal infection	2 capsules twice a day or 2 capsules once a day	1 day 3 days
Skin infection	2 capsules once a day or 1 capsule once a day	7 days 2 weeks
If palms of hands or soles of feet are affected, 2 capsules twice a day for 7 days or 1 capsule once a day for 1 month may be required.
Oral infections	1 capsule once a day	2 weeks
Eye infections	2 capsules once a day	3 weeks
Internal infections	1 to 4 capsules daily	longer periods

Nail infections: depending on your individual needs, your doctor will choose between continuous or pulsed treatment.
Continuous treatment for toenail infections:

TYPE OF INFECTION	CAPSULES PER DAY	DURATION
Continuous treatment for nails	2 capsules once daily	3 months

Pulsed therapy for nails:

Consists of two capsules twice daily for 1 week; then stop taking itraconazole 100 mg capsules for 3 weeks. The cycle is then repeated—once for fingernails and twice for toenails (with or without fingernail infection) (see the following table).

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Week 8

Week

Toenails, with or without fingernail involvement

Take 2 capsules twice daily

No treatment with itraconazole capsules

Take 2 capsules twice daily

No treatment with itraconazole capsules

Take 2 capsules twice daily

Interrupt treatment

Fingernails only

Take 2 capsules twice daily

No treatment with itraconazole capsules

Take 2 capsules twice daily

Interrupt treatment

In skin infections, lesions will disappear a few weeks after completion of treatment. This is characteristic of fungal spots: the medicine eliminates the fungus itself, but the lesion does not disappear until new skin has grown.

Nail lesions will disappear 6 to 9 months after completion of treatment, since the medicine only eliminates the fungus itself. The nail must regrow, which takes several months. Therefore, do not be concerned if you do not notice improvement during treatment: the medicine remains in your nails for several months and performs its function. Thus, you must stop treatment at the time indicated by your doctor, even if you do not see any improvement.

Infections of internal organs: higher doses and prolonged treatment may be required.

Always follow your doctor's instructions; he or she will adapt the treatment to your individual needs.

Use in Children and Adolescents

Itraconazol should not be used in children. It may be prescribed by a physician only in exceptional cases.

If you take more Itraconazol Sandoz than you should

If you have taken more itraconazole than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount taken. It is recommended to bring the package and the leaflet to the healthcare professional.

Currently, there are no data available on overdosage. Supportive measures should be applied. If necessary, activated charcoal may be administered. Itraconazole cannot be removed by dialysis. Specific antidotes are not known.

If you forget to take Itraconazol Sandoz

If you forget to take your dose, take the next scheduled dose as usual. Do not take a double dose to make up for the missed dose and continue treatment as directed by your doctor.

If you stop treatment with Itraconazol Sandoz

If you interrupt or prematurely discontinue treatment with itraconazole, the skin may not eliminate all fungal elements. Under these circumstances, complete cure may not be possible.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Medicines that may cause severe allergic reactions. Stop using Itraconazol Sandoz and contact your doctor immediately if you notice or suspect any of the following symptoms:

sudden difficulty breathing, facial swelling, skin rash, itching (especially if affecting the whole body), or severe skin reactions (widespread rash with skin peeling and blisters in the mouth, eyes, and genitals, or rash with small pustules or blisters).
severe loss of appetite, nausea, vomiting, unusual tiredness, abdominal pain, dark urine, or pale stools. These may be signs of serious liver problems.

Also inform your doctor immediately if you experience any of the following adverse effects:

symptoms resembling heart failure, such as: difficulty breathing, unexpected weight gain, leg swelling, unusual tiredness, or repeatedly waking up at night due to breathing difficulties.
tingling, light sensitivity, numbness, or weakness in arms or legs.
blurred or double vision, ringing in the ears, loss of bladder control, or increased urgency to urinate. If you notice symptoms of hearing loss.
severe pain in the upper abdomen, usually accompanied by nausea and vomiting, which may be due to inflammation of the pancreas (pancreatitis).

Other adverse effects include:

Frequent adverse effects (may affect up to 1 in 10 people)

abdominal pain
feeling unwell (nausea)
headache

Uncommon adverse effects (may affect up to 1 in 100 people)

sinusitis, runny nose, cough, colds
hypersensitivity
diarrhea, vomiting, constipation, indigestion (dyspepsia), gas (flatulence)
increased liver function test values (detected by blood test)
hives, skin rash, itching
menstrual cycle disturbances

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

decrease in white blood cell count, which may increase the risk of infections (leukopenia)
serum sickness, swelling due to fluid accumulation under the skin (angioneurotic edema), hypersensitivity symptoms (anaphylactic reaction)
increased blood fat levels, such as triglycerides (detected by blood test)
tingling or weakness in hands or feet (paresthesia), reduced sensitivity to pain (hypoesthesia), altered sense of taste (dysgeusia)
visual disturbances, including blurred or double vision
hearing loss (may be temporary or permanent), ringing in the ears (tinnitus)
heart failure, with symptoms such as difficulty breathing, unexpected weight gain, leg or abdominal swelling, unusual tiredness, or sleep disturbances (congestive heart failure)
difficulty breathing or shortness of breath (dyspnea)
severe pain in the upper abdomen, often accompanied by nausea and vomiting (pancreatitis)
severe liver damage (hepatotoxicity, including fulminant liver failure), increased blood bilirubin levels
severe drug-induced allergic skin reactions, such as: toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, accompanied by various skin changes, hair loss, light sensitivity, or increased need to urinate (polyuria)
erectile dysfunction in men
fluid retention in tissues (edema)
increased creatine kinase (CPK) levels in blood

Frequency not known: cannot be estimated from available data

Symptoms of elevated aldosterone (e.g., high blood pressure or low potassium levels), even when aldosterone levels are normal or low.

The following adverse effects have been reported in patients who have taken other pharmaceutical forms containing itraconazole:

certain hematological disorders (granulocytopenia, thrombocytopenia)
hypersensitivity symptoms (anaphylactoid reaction)
increased blood sugar levels
muscle cramps or irregular heartbeat (possible symptoms of high or low potassium levels in blood)
muscle cramps or irregular heartbeat (possible symptoms of high or low magnesium levels in blood)
confusion
peripheral neuropathy, dizziness, drowsiness, tremors
heart failure, increased heart rate (tachycardia)
high or low blood pressure
fluid accumulation in the lungs, difficulty speaking, cough
gastrointestinal disorders
liver failure, liver inflammation (hepatitis), yellowing of the skin (jaundice)
erythematous rash, excessive sweating
muscle pain (myalgia), joint pain (arthralgia)
kidney problems, urinary incontinence
generalized swelling, facial swelling, chest pain, fever, pain, tiredness, chills
abnormal urine or blood tests, increased liver function tests (elevated liver enzyme values)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Itraconazole 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 CAD/EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Itraconazole Sandoz

The active substance is itraconazole. Each capsule contains 100 mg of itraconazole.
The other components are:

Sugar spheres (composed of corn starch and sucrose), poloxamer 188, micronized poloxamer 188, hypromellose.

Hard gelatin capsule: gelatin, indigo carmine (E132), quinoline yellow (E104) (contains sodium), and titanium dioxide (E171).

Appearance of the product and contents of the pack

Size No. 0 opaque green hard capsules containing yellowish-beige spherical microgranules, packed in Alu/Alu blisters of 7, 14 or 100 (hospital pack) capsules.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Liconsa, S.A.

Gran Vía Carlos III, 98, 7th floor

08028 Barcelona

Spain

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Date of the most recent review of this package leaflet: November 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/