ITRACONAZOLO 100 mg Hard Capsule

Зміст інструкції

1. Itraconazole Sandoz 100 mg hard capsules
   1. What is Itraconazolo Sandoz and what it is used for
   2. What you need to know before taking Itraconazole Sandoz
   3. How to take Itraconazolo Sandoz
   4. Possible side effects
   5. How to store Itraconazolo Sandoz
   6. Contents of the pack and other information

Itraconazole Sandoz 100 mg hard capsules

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Itraconazole Sandoz is and what it is used for
• 2. What you need to know before you take Itraconazole Sandoz
• 3. How to take Itraconazole Sandoz
• 4. Possible side effects
• 5. How to store Itraconazole Sandoz
• 6. Contents of the pack and other information

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

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

• superficial fungal infections caused by fungi and yeasts such as infections of the mouth or vagina (oral candidiasis, vulvovaginal candidiasis), skin infections (pityriasis versicolor, dermatophytosis), nail infections (onychomycosis caused by dermatophytes and/or yeasts), eye infections (fungal keratitis);
• serious fungal infections that affect internal organs (aspergillosis and candidiasis, including cryptococcosis, histoplasmosis, sporotrichosis, paracoccidioidomycosis, blastomycosis and other rare systemic mycoses).

2. What you need to know before taking Itraconazole Sandoz

Do not take Itraconazole Sandoz

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or suspect you may be pregnant (see section “Pregnancy and breastfeeding”), unless your doctor considers it absolutely necessary;
• if you suffer from or have suffered from heart problems (ventricular dysfunction or congestive heart failure) unless you have life-threatening infections (see section “Warnings and precautions”);
• if you are taking medicines that can increase or decrease the levels of Itraconazole Sandoz in the blood (see section “Other medicines and Itraconazole Sandoz”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Itraconazole Sandoz:

• if you experience a severe allergic reaction (widespread rash, itching, hives, difficulty breathing and/or swelling of the face);
• if you have had an allergic reaction after taking other medicines used to treat fungal infections in the past, because you may also be allergic to this medicine;
• if you suffer from liver problems (hepatic insufficiency), because your doctor may need to adjust the dose. In these cases, periodic liver checks are necessary. If you experience symptoms such as nausea, vomiting, weight loss and loss of appetite (anorexia), fatigue, abdominal pain, yellowing of the skin or eyes, pale stools, or dark urine, tell your doctor immediately and stop taking this medicine;
• if you suffer from or have suffered from heart or lung problems;
• if symptoms of a heart problem such as shortness of breath, unexpected weight gain, swelling of the legs or abdomen, unusual fatigue or a tendency to wake up during the night occur, tell your doctor immediately;
• if you suffer from or have suffered from kidney problems, because your doctor may need to adjust the dose;
• if symptoms such as tingling, numbness, weakness of the hands or feet occur, tell your doctor immediately;
• if you have a weakened immune system, for example if you have a low level of white blood cells (neutropenia), if you suffer from AIDS or if you have undergone an organ transplant, because your doctor may need to adjust the dose;
• if you suffer from AIDS and have previously had fungal infections that have spread throughout the body (sporotrichosis, blastomycosis, histoplasmosis or cryptococcosis);
• if you experience problems with your hearing (hearing loss or ringing) during treatment with this medicine
• if you experience excessive sensitivity to light;
• if you experience nerve problems (neuropathy). In this case, stop taking this medicine and tell your doctor immediately. If you need to take antacids (used to treat heartburn, see section "Other medicines and Itraconazole Sandoz"), take them at least two hours after taking Itraconazole Sandoz, as they can interfere with the absorption of this medicine. In these cases, you can facilitate the absorption of Itraconazole Sandoz by taking the capsule with a beverage containing cola.

Avoid taking this medicine if you have a high level of liver enzymes, if you suffer from a liver disease
or if you have suffered from liver problems after taking medicines in the past, except in cases of absolute necessity. In
these cases, periodic liver checks are necessary.

Children and adolescents
Itraconazole Sandoz should not be used in children or adolescents unless your doctor considers it
absolutely necessary.

Elderly
Itraconazole Sandoz should not be used in the elderly unless your doctor considers it absolutely necessary.

Other medicines and Itraconazole Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not take Itraconazole Sandoz if you are taking any of the following medicines:

• some medicines used to treat allergies such as astemizole, mizolastine and terfenadine;
• medicines used to treat some heart problems (angina), such as bepridil, ivabradine, ranolazine;
• cisapride, a medicine used to treat some stomach problems;
• some medicines used to treat irregular heartbeats, such as dofetilide, disopyramide, dronedarone or quinidine;
• levacetylmethadol (levomethadyl), a medicine used to treat opioid abuse;
• pimozide, lurasidone, quetiapine or sertindole, used for some mental disorders;
• some medicines used to lower cholesterol in the blood such as atorvastatin, lovastatin and simvastatin;
• some medicines used to treat insomnia such as triazolam and midazolam (oral);
• ergot alkaloids such as dihydroergotamine and ergotamine, used to treat migraine, ergotamine (ergonovine) and methylergometrine (methylergonovine) used after childbirth;
• eletriptan, a medicine used to treat migraine;
• medicines used to treat high blood pressure, such as nisoldipine, lercanidipine, felodipine, eplerenone, aliskiren;
• methadone, used to treat pain or in detoxification therapies;
• halofantrine, a medicine used to treat malaria;
• irinotecan, a medicine used to treat some types of cancer;
• a medicine used to treat high levels of uric acid in the blood (colchicine), if you suffer from kidney or liver problems.

Do not take this medicine and tell your doctor if you are taking, have recently taken or might
take any of the following medicines, as you need to wait two weeks after the end of treatment
before starting to take Itraconazole Sandoz:

• rifabutin, rifampicin, and isoniazid, antibiotics used to treat some infections caused by bacteria (tuberculosis);
• tamsulosin, a medicine used to treat a prostate disorder (benign prostatic hyperplasia);
• fentanyl, a medicine used as a pain reliever;
• rivaroxaban, a medicine used to prevent blood clots;
• carbamazepine, phenobarbital and phenytoin, medicines used to treat epilepsy;
• medicines used to treat some cancers (dasatinib, nilotinib, trabectedine, everolimus);
• salmeterol, a medicine used to treat some breathing disorders;
• vardenafil, a medicine used to treat impotence;
• colchicine, a medicine used to treat high levels of uric acid in the blood;
• St John's wort (Hypericum perforatum), used to treat depression;
• efavirenz, nevirapine, medicines used to treat HIV/AIDS. Take Itraconazole Sandoz with caution if you are taking the following medicines:
• medicines used to treat high stomach acidity (aluminum hydroxide, H receptor antagonists and proton pump inhibitors); if you are taking medicines that neutralize stomach acid (e.g. aluminum hydroxide), take them 1 hour before or 2 hours after taking Itraconazole Sandoz;
• medicines used as pain relievers (alfentanil, buprenorphine administered intravenously or sublingually, oxycodone);
• some medicines used to treat heart or blood vessel problems, such as digoxin, cilostazol, dabigatran, calcium channel blockers (dihydropyridines) including verapamil;
• some medicines used to treat bacterial infections (clarithromycin, ciprofloxacin and erythromycin);
• medicines used to thin the blood (coumarin medicines);
• praziquantel, a medicine used to treat some parasitic infections;
• nadolol, a medicine used to treat some heart rhythm disorders (cardiac arrhythmias);
• domperidone, a medicine used to treat vomiting;
• some medicines used to treat AIDS, such as ritonavir, indinavir, darunavir in combination with ritonavir, fosamprenavir in combination with ritonavir, saquinavir and maraviroc;
• some medicines used to treat cancer (vinca alkaloids, busulfan, docetaxel, trimetrexate, bortezomib, erlotinib, ixabepilone, lapatinib);
• budesonide, ciclesonide, dexamethasone, fluticasone and methylprednisolone, medicines used to treat inflammation, asthma and allergies;
• cyclosporine, tacrolimus, temsirolimus and rapamycin (also known as sirolimus), medicines used after organ transplants;
• medicines used to treat diabetes (repaglinide, saxagliptin);
• some medicines used to treat anxiety or as tranquilizers (buspirone, alprazolam, brotizolam, ramelteon, midazolam administered intravenously);
• some medicines used to treat some mental disorders (aripiprazole, haloperidol, perospirone, risperidone);
• ebastine, a medicine used to treat allergies;
• reboxetine, a medicine used to treat depression;
• medicines used to treat some bladder disorders (fesoterodine, imidafenacin, solifenacin, tolterodine);
• medicines used to treat sexual disorders in men (sildenafil, tadalafil);
• alitretinoin, a medicine used to treat some skin disorders;
• cinacalcet, a medicine used to treat some parathyroid gland disorders;
• medicines used to treat a hormonal disorder called inappropriate secretion of antidiuretic hormone (mozavaptan, tolvaptan);
• aprepitant, a medicine used to reduce nausea and vomiting. Take Itraconazole Sandoz with caution and under the supervision of your doctor if you are taking meloxicam, a medicine used to treat inflammation.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this
medicine.
Do not take this medicine during pregnancy, unless in cases of absolute necessity, in which your doctor may
prescribe this medicine if you have very serious infections that put your life at risk.
If you are a woman of childbearing potential, adopt adequate contraceptive measures to prevent pregnancy during
treatment with Itraconazole Sandoz and continue them until the next menstrual period after the end of treatment with
this medicine. Consult your doctor if you have started therapy with Itraconazole Sandoz without adopting
adequate contraceptive measures.
Breastfeeding
If you are breastfeeding, ask your doctor for advice as a small amount of this medicine is
excreted in breast milk.

Driving and using machines
There is no data available to establish the effect of this medicine on the ability to drive and operate
machinery. However, if you experience side effects such as dizziness, visual disturbances and hearing loss, avoid
driving or using machinery.

Itraconazole Sandoz contains sucrose
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking this
medicine.

3. How to take Itraconazolo Sandoz

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Take Itraconazolo Sandoz immediately after one of the main meals (breakfast, lunch or dinner).
Do not open the capsule, swallow it whole.
The recommended dose and duration of therapy depend on the type of infection and are indicated below:

• Treatment of skin, nail and eye infections (superficial infections)

Skin infections (Pityriasis versicolor, Dermatomycosis)
The recommended dose is 2 capsules, once a day for 7 days.

Mouth infection (Oral Candidiasis)
The recommended dose is 1 capsule, once a day for 15 days.
The doctor may double the dose if you have problems with your immune defenses (immunodepression).

Vaginal infection (Vulvovaginal Candidiasis)
The recommended dose is 2 capsules, once a day for 3 days or 2 capsules, twice a day for 1
day.
The doctor may double the dose if you have problems with your immune defenses (immunodepression).

Nail infections (Onychomycosis)
Treatment of nail infections requires treatment cycles
A treatment cycle consists of taking 2 capsules, twice a day for 1 week. Each treatment cycle must be followed by 3 weeks of treatment suspension.
If you have a nail infection on your hands, you must complete 2 treatment cycles. If you have a nail infection on your
feet, you must complete 3 treatment cycles.
The doctor may double the dose if you have problems with your immune defenses (immunodepression).

Eye infection (Fungal Keratitis)
The recommended dose is 2 capsules, once a day for 21 days.
Regarding skin infections, lesions disappear completely only a few weeks after
the end of treatment, simultaneously with the regeneration of healthy skin. In onychomycosis, you must wait
for the regrowth of the nails.

• Treatment of infections spread throughout the body (systemic infections)

The recommended dose and duration of therapy depend on the type of infection and are indicated below:

• Aspergillosis:2 capsules, once a day for 2-5 months; in case of severe infections, the doctor may increase the dose to 2 capsules twice a day;
• Candidiasis:1-2 capsules, once a day. The duration of treatment varies from 3 weeks to 7 months. In case of severe infections, the doctor may increase the dose to 2 capsules twice a day;
• Non-meningeal Cryptococcosis:2 capsules, once a day. The duration of treatment varies from 2 months to 1 year. The recommended dose for maintenance therapy is 2 capsules, once a day;
• Cryptococcal Meningitis:4 capsules, once a day. The duration of treatment varies from 2 months to 1 year. The recommended dose for maintenance therapy is 2 capsules, once a day;
• Histoplasmosis:the recommended dose may vary from 2 capsules once a day to 2 capsules twice a day for 8 months;
• Sporotrichosis:1 capsule, once a day for 3 months;
• Paracoccidioidomycosis:1 capsule, once a day for 6 months;
• Chromomycosis:1-2 capsules, once a day for 6 months;
• Blastomycosis:the recommended dose may vary from 1 capsule once a day to 2 capsules twice a day for 6 months.

If you take more Itraconazolo Sandoz than you should
The symptoms of an overdose may correspond to the undesirable effects that may occur following
taking Itraconazolo Sandoz at the recommended doses.
In case of accidental intake of an excessive dose of this medicine, immediately inform your doctor or
go to the nearest hospital.

If you forget to take Itraconazolo Sandoz
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Common(may affect up to 1 in 10 people):

• stomach pain (abdominal pain), nausea;
• headache.

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

• inflammation of the nasal cavities (sinusitis), respiratory tract infections, irritation and inflammation of the nasal mucosa (rhinitis);
• allergic reactions (hypersensitivity);
• confusion, altered sensation in the arms and legs (paresthesia);
• vomiting, diarrhea, constipation, digestive problems (dyspepsia), altered taste (dysgeusia), flatulence;
• increased amount of certain substances in the blood (hyperbilirubinemia, increased alanine aminotransferase, increased aspartate aminotransferase);
• skin irritation (urticaria, rash), hair loss (alopecia), itching;
• menstrual disorders;
• swelling due to fluid retention (edema);
• impaired liver function.

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

• decrease in the levels of white blood cells (leukopenia);
• allergic reactions, including severe ones (anaphylactic reaction, anaphylactoid reaction, serum sickness), swelling of the face and eyes due to fluid retention (angioedema);
• increased levels of fats in the blood (hypertriglyceridemia);
• decreased sensitivity and response to stimuli (hypoesthesia);
• vision disorders (diplopia, blurred vision);
• perception of ringing in the ear (tinnitus);
• heart problems (congestive heart failure);
• difficulty breathing (dyspnea);
• inflammation of the pancreas (pancreatitis);
• severe liver problems
• severe skin disorders characterized by the appearance of lesions (toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leucocytoclastic vasculitis);
• skin sensitivity to light (photosensitivity);
• frequent urination (pollakiuria);
• fever;
• impotence (erectile dysfunction);
• altered levels of a substance in the blood (blood creatine phosphokinase);
• permanent or temporary hearing loss.

Frequency not known(the frequency cannot be estimated from the available data):

• decrease in the levels of white blood cells (granulocytopenia) and platelets (thrombocytopenia);
• allergic reaction, including severe (anaphylaxis);
• reduction of potassium and magnesium levels in the blood (hypokalaemia, hypomagnesaemia);
• reduction of sugar levels in the blood (hyperglycaemia);
• confusion;
• nerve disorders (peripheral neuropathy);
• dizziness;
• drowsiness:
• tremor;
• heart problems (heart failure, left ventricular failure, tachycardia);
• increase or decrease in blood pressure (hypertension, hypotension);
• blurred vision, double vision (diplopia);
• fluid accumulation in the lungs (pulmonary edema);
• cough, chest pain, voice disorders (dysphonia);
• stomach and intestinal disorders;
• liver problems (acute hepatic failure, jaundice), liver inflammation (hepatitis);
• increased sweating (hyperhidrosis);
• skin irritation (erythematous rash);
• muscle pain (myalgia), joint pain (arthralgia);
• urine leakage (urinary incontinence);
• kidney problems (renal failure);
• generalized swelling due to fluid retention (edema), facial swelling (facial edema);
• fever, pain, fatigue and chills;
• altered levels of certain substances present in the blood (increased levels of alanine aminotransferase, increased levels of aspartate aminotransferase, increased levels of alkaline phosphatase, increased levels of lactic acid dehydrogenase, increased levels of blood urea, increased levels of gamma-glutamyltransferase, increased liver enzymes);
• abnormal urine tests.

Additional side effects in children and adolescents
Frequency not known(the frequency cannot be estimated from the available data):

• headache;
• vomiting;
• abdominal pain;
• diarrhea;
• impaired liver function;
• decreased blood pressure;
• nausea;
• skin irritation (urticaria);
• heart problems (cardiac arrest).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
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 at a temperature below 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Itraconazolo Sandoz contains

• The active ingredient is: itraconazole. Each capsule contains 100 mg of Itraconazolo.
• The other ingredients are: saccharated granules (composed of corn 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 contents of the pack
The pack contains 8 capsules in blisters.

Marketing Authorisation Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA) Italy

Manufacturer

• Liconsa SA Av.da Miralcampo 7 - Poligono Industrial Miralcampo - 19200 Azuqueca de Henares - Guadalajara (Spain).
• Salutas Pharma GmbH - Dieselstrasse 5 - 70839 Gerlingen (Germany).