Itraconazole Teva: detailed information

Package leaflet: Information for the patient

Itraconazole Teva 100 mg hard capsules

Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Itraconazole Teva is and what it is used for

Itraconazole Teva contains itraconazole, a substance with antifungal properties that works by inhibiting the growth of fungi and yeasts (organisms capable of causing disease).
Therefore, Itraconazole Teva is used in the treatment of superficial infections at the:

vulvovaginal level (candidiasis);
oral cavity (candidiasis);
skin (pityriasis versicolor, dermatophytosis);
cornea (fungal keratitis);
nails (onychomycosis due to dermatophytes and yeasts).

Furthermore, Itraconazole Teva is used in the treatment of certain systemic (generalized) infections of 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, Itraconazole Teva is indicated only when first-line treatment is considered inappropriate or has proven ineffective;
histoplasmosis (infection caused by Histoplasma);
paracoccidioidomycosis (infection caused by Paracoccidioides brasiliensis);
blastomycosis (infection caused by Blastomyces dermatitidis);
sporotrichosis, including lymphocutaneous and cutaneous sporotrichosis (infection caused by Sporothrix);
other rare systemic mycoses.

Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Itraconazole Teva

Do not take Itraconazole Teva

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have or have had heart problems such as ventricular dysfunction, for example if you have congestive heart failure, unless your doctor considers it strictly necessary to treat severe or potentially life-threatening infections;
if you are pregnant or suspect you may be pregnant, unless your doctor considers it strictly necessary to treat potentially life-threatening infections;
if you are being treated with other medicines; see section “Other medicines and Itraconazole Teva” for a list of medicines that must not be taken together with Itraconazole Teva.

Warnings and precautions
Talk to your doctor or pharmacist before taking Itraconazole Teva.
Reduced gastric acidity decreases the absorption of Itraconazole Teva and consequently reduces the onset of its therapeutic effect.
Therefore, if you are being treated with antacid medicines that neutralize gastric acidity (e.g. aluminium hydroxide), you should take them at least two hours after administration of this medicine.
For the same reason, if you are a patient with a digestive disorder characterized by the absence of hydrochloric acid in gastric juice (achlorhydria), if you are taking antisecretory medicines or have other conditions that reduce gastric acidity (as may occur in some cases of AIDS), it is recommended to take Itraconazole Teva with an acidic, non-diet cola-containing beverage (see section 3 “How to take Itraconazole Teva”).
Exercise particular caution and consult your doctor before taking Itraconazole Teva if:

you have a history of heart problems (congestive heart failure, valvular heart disease, or cardiac ischemia);
you suffer from a chronic lung disease (chronic obstructive pulmonary disease);
you tend to retain excess fluid leading to swelling, particularly in the hands, feet, or around the eyes (edematous disorders);
you have or have had liver problems, e.g. impaired liver function (hepatic insufficiency, cirrhosis), elevated liver enzymes, or have previously experienced symptoms of liver toxicity during treatment with other medicines;
your kidney function is impaired (renal insufficiency);
you have weakened immune defenses due to various conditions (low white blood cell count, AIDS, organ transplantation);
you suffer from cystic fibrosis (a genetic disease);
you are already being treated with the medicines listed in section “Other medicines and Itraconazole Teva”;
you previously experienced an allergic reaction after treatment with another antifungal medicine;
you are elderly; generally, itraconazole should not be used in elderly patients.

Additionally, you must pay special attention, stop treatment immediately and contact your doctor if you experience (also see section 4 “Possible side effects”):

difficulty breathing (shortness of breath), unexpected weight gain, swelling of the legs or abdomen, unusual fatigue, or if you start waking up at night, as these could be symptoms of impaired heart function (congestive heart failure);
loss of appetite, nausea, vomiting, fatigue, abdominal pain, and dark urine, as these could be symptoms of impaired liver function (hepatitis);
tingling, numbness, or weakness in the hands or feet, other nerve problems in the arms or legs, blurred or double vision, ringing in the ears, or loss of bladder control, as these could be symptoms of impaired nervous system function (neuropathy);
hearing loss.

Laboratory tests

Depending on your health status before taking itraconazole and your response to the medicine, your doctor may prescribe certain monitoring tests and blood examinations to check the function of your heart, liver, and kidneys.
For mild and limited skin infections (e.g. pityriasis versicolor, dermatophytosis), your doctor may recommend using a topical product before starting oral treatment.
Children
Itraconazole Teva should only be administered when strictly necessary and if the paediatrician considers it essential.
Other medicines and Itraconazole Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Taking certain medicines together with itraconazole may be harmful or may alter the activity of this active substance.
Do not take the following medicines during treatment with Itraconazole Teva or within 2 weeks after stopping
treatment with Itraconazole Teva:

medicines for the treatment of allergies: terfenadine, astemizole, mizolastine;
medicines for the treatment of heart, blood, or circulation problems:
- angina (crushing chest pain): bepridil, ivabradine, ranolazine;
- high blood pressure: aliskiren, eplerenone, lercanidipine, nisoldipine;
- irregular heartbeat: dronedarone, quinidine, disopyramide, dofetilide;
- blood clots: dabigatran, ticagrelor;
- high cholesterol: lomitapide, simvastatin, lovastatin;
- pulmonary arterial hypertension: sildenafil;
medicines for the treatment of stomach problems or constipation:
- stomach disorders: cisapride;
- nausea and vomiting: domperidone;
- constipation caused by opioid painkillers: naloxegol;
medicines for the treatment of headaches, sleep problems, or mental health conditions:
- migraine (headache): dihydroergotamine, ergotamine (ergot alkaloids);
- insomnia or sedation: midazolam (oral), triazolam;
- schizophrenia, bipolar disorder, or other mental health problems: lurasidone, pimozide, sertindole, quetiapine;
medicines for the treatment of urinary problems:
- urinary incontinence: darifenacin, fesoterodine (when used in patients with moderate or severe kidney or liver problems), solifenacin (when used in patients with severe kidney problems or moderate to severe liver problems);
medicines for the treatment of erectile or ejaculation problems:
- erectile dysfunction: avanafil;
- premature ejaculation: dapoxetine;
- erectile dysfunction when used in men over 75 years of age: vardenafil;
other medicines containing:
- colchicine for gout (joint inflammation causing pain and swelling), when used in patients with kidney or liver problems;
- ergometrine (ergonovine), methylergometrine (methylergonovine), ergot alkaloids used after childbirth;
- eliglustat for Gaucher’s disease, when used in patients unable to metabolize certain drugs;
- halofantrine for malaria;
- irinotecan for cancer;
- isavuconazole for fungal infections;
- ombitasvir, paritaprevir, ritonavir with or without dasabuvir for hepatitis C.

Note: Do not take any of the medicines listed above for 2 weeks after your last treatment with Itraconazole Teva.
The use of certain medicines is not recommended with Itraconazole Teva. Your doctor will decide whether you
should not take certain medicines together with Itraconazole Teva or within 2 weeks after stopping
Itraconazole Teva.
Examples of these medicines are:

medicines for the treatment of heart, blood, or circulation problems:
- blood clots: apixaban, rivaroxaban or vorapaxar;
- high cholesterol: atorvastatin;
- high blood pressure: felodipine;
- pulmonary arterial hypertension: riociguat, tadalafil;
medicines for the treatment of epilepsy, migraine, or mental health problems:
- epilepsy: carbamazepine, phenytoin, phenobarbital;
- migraine (headache): eletriptan;
- mental health problems, e.g. depression: St John’s wort (Hypericum perforatum);
medicines for the treatment of urinary problems:
- urinary incontinence in men due to benign prostatic hyperplasia: tamsulosin;
- bladder irritation: tolterodine;
medicines for the treatment of 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 for the treatment of tuberculosis: rifampicin, rifabutin, isoniazid, bedaquiline;
medicines for the treatment of HIV/AIDS or hepatitis:
- HIV/AIDS: efavirenz, nevirapine;
- HIV or hepatitis: elbasvir/grazoprevir, simeprevir, tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF);
medicines used after organ transplantation: everolimus, rapamycin (also known as sirolimus), temsirolimus;
medicines for the treatment of benign prostatic hyperplasia: alfuzosin, silodosin;
medicines for the treatment of lung problems or allergies:
- inflammation, asthma and allergies: ciclesonide;
- allergies: ebastine;
- asthma or chronic obstructive pulmonary disease - COPD: salmeterol;
medicines for the treatment of erectile and ejaculation problems:
- erectile dysfunction and benign prostatic hyperplasia: tadalafil;
- erectile dysfunction: vardenafil (when used in men aged 75 years or younger);
other medicines containing:
- colchicine for gout (joint inflammation causing pain and swelling);
- fentanyl for pain;
- lumacaftor/ivacaftor for cystic fibrosis.

Note: Do not take any of the medicines listed above for the 2 weeks following your last treatment with Itraconazole Teva.
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.
When taking Itraconazole Teva with certain medicines, caution is required. You may be more prone to experience adverse effects, or it may be necessary to adjust the dose of Itraconazole Teva or the other medicine.
Examples of these medicines are:

medicines for the treatment of infections:
- bacterial infections: ciprofloxacin, clarithromycin, erythromycin;
- tuberculosis: delamanid;
- malaria: artemether-lumefantrine, quinine;
- trematodes and tapeworms: praziquantel;
medicines for the treatment of stomach problems or diarrhoea:
- nausea and vomiting during cancer treatment: aprepitant, netupitant;
- diarrhoea: loperamide;
- stomach acidity: antacids such as aluminium, calcium, magnesium or sodium bicarbonate; H₂ receptor antagonists such as cimetidine, ranitidine; proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole;
medicines for the treatment of heart, blood or circulation problems:
- pulmonary hypertension: bosentan;
- high blood pressure: calcium channel blockers such as verapamil and dihydropyridines, e.g. amlodipine, isradipine, nifedipine, nimodipine, diltiazem;
- circulatory problems: cilostazol;
- blood clots: coumarins such as warfarin;
- atrial fibrillation: digoxin;
- pulmonary hypertension or angina: nadolol;
medicines for the treatment of lung problems, allergies or inflammatory conditions:
- allergies: bilastine, rupatadine;
- asthma, allergies or inflammatory conditions: methylprednisolone, dexamethasone (oral or injection);
- asthma and allergies: budesonide, fluticasone;
medicines for the treatment of urinary problems:
- bladder irritation: fesoterodine, imidafenacine, oxybutynin, solifenacin;
medicines used after organ transplantation: cyclosporine, tacrolimus;
medicines for the treatment of HIV/AIDS or hepatitis:
- HIV/AIDS: cobicistat, elvitegravir boosted with ritonavir, maraviroc, ritonavir, darunavir boosted with ritonavir, fosamprenavir boosted with ritonavir, indinavir, saquinavir);
- hepatitis: glecaprevir/pibrentasvir;
medicines for the treatment of cancer: bortezomib, brentuximab vedotin, busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, ponatinib, ruxolitinib or sonidegib);
medicines for the treatment of sleep and mental health problems:
- anxiety and insomnia: alprazolam, brotizolam, buspirone or midazolam (intravenous);
- insomnia: zopiclone;
- depression and anxiety: reboxetine, venlafaxine;
- schizophrenia, bipolar disorder or other mental health problems: aripiprazole, cariprazine, haloperidol, risperidone);
Alzheimer’s disease: galantamine;
attention deficit hyperactivity disorder: guanfacine;
medicines for the treatment of pain:
- pain: alfentanil, buprenorphine (intravenous and sublingual), oxycodone, sufentanil;
- joint inflammation and pain: meloxicam;
medicines for the treatment of benign prostatic hyperplasia: dutasteride;
medicines for the treatment of erectile and ejaculation problems:
- erectile dysfunction: sildenafil;
other medicines containing:
- repaglinide, saxagliptin for diabetes;
- cinacalcet for the treatment of hyperparathyroidism (overactivity of the parathyroid glands);
- alitretinoin (oral) for the treatment of eczema (an inflammatory, itchy, non-contagious skin reaction);
- 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;
- dienogest or ulipristal, contraceptive medicines;
- eliglustat for Gaucher’s disease, when used in patients unable to metabolize certain drugs;
- ivacaftor for cystic fibrosis;
- methadone for treating opioid dependence.

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.
Itraconazole is absorbed into the body in the presence of sufficient gastric acidity. For this reason, medicines that neutralize gastric acidity (antacid medicines) should be taken at least 1 hour before taking itraconazole or not taken for at least 2 hours after taking itraconazole.
For the same reason, if you are using medicines that inhibit stomach acid production, it is advisable to take Itraconazole Teva with a cola-containing beverage.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Itraconazole Teva must not be used during pregnancy, unless your doctor considers it strictly necessary to treat potentially life-threatening infections.
Breastfeeding
Since a small amount of itraconazole passes into breast milk, avoid breastfeeding during treatment with Itraconazole Teva, unless your doctor evaluates the potential risk against the expected benefit.
Fertility
If you are a woman of childbearing age and could become pregnant, speak with your doctor. During treatment with this medicine, you must use adequate contraceptive measures to avoid pregnancy and continue using highly effective contraception until the onset of your next menstrual period after stopping treatment with Itraconazole Teva.
Driving and using machines
When driving vehicles or operating machinery, consider the possibility that itraconazole may cause dizziness, visual disturbances, and hearing loss (see section “Possible side effects”). If this occurs, refrain from driving and using machinery.
Itraconazole Teva contains sucrose (sugar spheres)
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Itraconazole Teva

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Method of administration
Take the medicine immediately after one of the main meals.
The capsule must not be opened and must be swallowed whole.
Dosage for the treatment of superficial fungal infections
Vulvovaginal infections (vulvovaginal candidiasis):
The recommended dose is 2 capsules of 100 mg once daily for 3 days, or 2 capsules of 100 mg twice daily for 1 day, depending on the type of fungal infection.
Oral infections (oral candidiasis)
The recommended dose is 1 capsule of 100 mg once daily for 15 days.
Skin infections (pityriasis versicolor, dermatomycoses)
The recommended dose is 2 capsules of 100 mg once daily for 7 days.
For the treatment of infections in particularly keratinized areas of the palms and soles, the recommended dose is 2 capsules of 100 mg twice daily for 7 days.
Corneal infections (fungal keratitis)
The recommended dose is 2 capsules of 100 mg once daily for 21 days.
Nail infections (onychomycosis)
The recommended dosage for one treatment cycle is 2 capsules of 100 mg twice daily for 1 week.
Two treatment cycles are required for nail infections of the hands and three cycles for those of the feet. A break of 3 weeks is required between each treatment cycle.
Your nails will regrow 6–9 months after completion of treatment.
If for any reason your immune defenses are reduced, your doctor may prescribe a double dose compared to that recommended for the type of infection being treated, as the drug's effectiveness may be reduced in such cases. Your doctor will determine the most appropriate dose for your condition.
Therapeutic results are usually achieved 2–4 weeks after the end of treatment.
Dosage for the treatment of systemic infections
Aspergillosis
The recommended dose is 2 capsules of 100 mg once daily for 2–5 months.
If the infection is widespread and particularly severe, your doctor may decide to double your dose; in this case, you should take 2 capsules of 100 mg twice daily for 2–5 months.
Candidiasis
The recommended dose is 1–2 capsules of 100 mg once daily for a duration ranging from 3 weeks to 7 months.
If the infection is widespread and particularly severe, your doctor may decide to double your dose; in this case, you should take 2 capsules of 100 mg twice daily for 2–5 months.
Non-meningeal cryptococcosis
The recommended dose is 2 capsules of 100 mg once daily for a duration ranging from 2 months to 1 year. You will also need to follow a maintenance treatment consisting of taking 2 capsules of 100 mg daily.
Cryptococcal meningitis
The recommended dose is 2 capsules of 100 mg twice daily for a duration ranging from 2 months to 1 year. You will also need to follow a maintenance treatment consisting of taking 2 capsules of 100 mg daily.
Histoplasmosis
The recommended dose is 2 capsules of 100 mg once daily, or 2 capsules of 100 mg twice daily, for 8 months, depending on the type of infection.
Lymphocutaneous and cutaneous sporotrichosis
The recommended dose is 1–2 capsules of 100 mg once daily (for localized lesions) or 2 capsules of 100 mg twice daily (for extensive lesions) for 3–6 months.
Paracoccidioidomycosis
The recommended dose is 1 capsule of 100 mg once daily for 6 months.
Chromomycosis
The recommended dose is 1–2 capsules of 100 mg once daily for 6 months.
Blastomycosis
The recommended dose is 1 capsule of 100 mg once daily or 2 capsules of 100 mg twice daily for 6 months.
Use in children
The use of Itraconazole Teva in children is not recommended unless the pediatrician considers it strictly necessary.
If you take more Itraconazole Teva than you should
If you take more Itraconazole Teva than prescribed, inform your doctor immediately or go to the nearest hospital.
In case of overdose, you may experience the adverse effects described in section 4.
If you forget to take Itraconazole Teva
Do not take a double dose to make up for the missed dose.
If you stop taking Itraconazole Teva
Consult your doctor if you intend to stop treatment.
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.
Stop treatment and contact your doctor immediately if you experience even just one of the following symptoms:

skin rash and itching, difficulty breathing (bronchospasm) or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema). These may be signs of severe allergic reactions (anaphylactic shock);
shortness of breath, unexpected weight gain, swelling of the legs or abdomen, unusual tiredness, or if you start waking up at night, as these could be symptoms of impaired heart function (congestive heart failure);
loss of appetite, nausea, vomiting, fatigue, abdominal pain, and dark urine, as these could be symptoms of impaired liver function (hepatitis);
tingling, numbness, or weakness in the hands or feet, other nerve problems in the arms or legs, blurred or double vision, ringing in the ears, loss of bladder control, as these could be symptoms of impaired nervous system function (neuropathy);
hearing loss.

The possible side effects are listed below:
Common side effects (may affect up to 1 in 10 people):

headache;
abdominal pain;
nausea;

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

sinusitis (inflammation of the paranasal mucosa);
upper respiratory tract infection;
rhinitis (nasal congestion);
allergy (hypersensitivity)*;
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 bilirubin in the blood, which may cause yellowing of the skin);
urticaria;
skin rash;
pruritus (itching);
alopecia (hair loss);
edema (swelling);
menstrual disorder.

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

leucopenia (reduced white blood cells);
serum sickness (allergy-like reaction);
anaphylactic reaction (severe allergic reaction);
hypertriglyceridemia (elevated triglyceride levels in the blood);
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 ears);
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) (serious skin and/or mucous membrane reaction caused by the medicine);
acute generalized exanthematous pustulosis (AGEP) (sudden skin eruption characterized by pustules);
erythema multiforme (inflammation of blood vessels causing an 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);
swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema);
pollakiuria (frequent urination of small volumes);
erectile dysfunction;
fever;
increased blood creatine phosphokinase (an enzyme present in the blood); *see section “Warnings and precautions”.

Very rare side effects (may affect up to 1 in 10,000 people):

anaphylactoid reaction.

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

decrease in certain types of white blood cells in the blood (granulocytopenia);
decrease in the number of platelets in the blood (thrombocytopenia);
increased blood sugar (hyperglycemia);
increase or decrease in blood potassium (hyperkalemia, hypokalemia);
decrease in blood magnesium (hypomagnesemia);
peripheral neuropathy* (peripheral nervous system disorder);
dizziness;
drowsiness;
heart failure, left ventricular failure, tachycardia;
hypertension, hypotension (blood pressure changes);
pulmonary edema;
voice disorder (dysphonia);
cough;
chest pain;
gastrointestinal disorders;
liver failure*, hepatitis, yellowing of the skin (jaundice);
erythematous skin rash;
excessive sweating (hyperhidrosis);
muscle pain (myalgia), joint pain (arthralgia);
renal failure;
urinary incontinence;
pain;
fatigue;
chills;
increased levels of certain liver enzymes (alanine aminotransferase, aspartate aminotransferase);
increased levels of certain blood enzymes (alkaline phosphatase, lactate dehydrogenase, gamma-glutamyl transferase);
increased blood urea levels;
abnormal urine test results.

Additional side effects in children
Based on safety data from clinical studies, the most commonly reported side effects in pediatric patients are:

headache;
vomiting;
abdominal pain;
diarrhea;
abnormal liver function;
hypotension (low blood pressure);
nausea;
urticaria.

In general, the side effects reported in pediatric patients are similar to those observed in adults, but occur more frequently in pediatric patients. Cases of cardiac arrest have also been reported.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Itraconazole Teva

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
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 Teva contains

The active substance is itraconazole. Each hard capsule contains 100 mg of itraconazole.
The other components are: inside the capsule: sugar spheres, hypromellose and poloxamers. Capsule shell: gelatin, titanium dioxide (E171), quinoline yellow (E104) and indigo carmine (E132).

Description of the appearance of Itraconazolo Teva and the contents of the pack
Itraconazolo Teva is presented in a cardboard box containing 8 hard capsules in blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturer
Laboratorios Liconsa S.A., Av.da Miralcampo 7 - Poligono Industrial Miralcampo - 19200 Azuqueca de Henares -
Guadalajara (Spain)