ITRACONAZOLO 100 mg Kapsułka Twarda

Treść ulotki

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

ITRACONAZOLO DOC Generici 100 mg hard capsules

Generic medicine

Read this leaflet carefully before 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 ITRACONAZOLO DOC Generici is and what it is used for
• 2. What you need to know before you take ITRACONAZOLO DOC Generici
• 3. How to take ITRACONAZOLO DOC Generici
• 4. Possible side effects
• 5. How to store ITRACONAZOLO DOC Generici
• 6. Contents of the pack and other information

1. What ITRACONAZOLO DOC Generici is and what it is used for

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

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

2. What you need to know before taking ITRACONAZOLO DOC Generici

Do not take ITRACONAZOLO DOC Generici

• if you are allergic to itraconazole or any of the other ingredients of this medicine (listed in section 6); if you are pregnant or suspect you may be pregnant unless your doctor has assessed the need to treat a potentially life-threatening infection (see section “Pregnancy and breastfeeding”);
• if you have liver problems (moderate or severe hepatic insufficiency);
• if you suffer from or have suffered from heart problems (ventricular dysfunction or congestive heart failure) unless your doctor has assessed the need to treat an infection

potentially dangerous to life or other serious infections .(see section “Warnings and
precautions”);

• if you are taking the following medicines (see section “Other medicines and ITRACONAZOLO DOC Generici”)
• some medicines used to treat allergies such as astemizole, mizolastine and terfenadine;
• bepridil, a medicine used to treat some heart problems (angina);
• cisapride, a medicine used for the treatment of some stomach problems;
• some medicines used to treat irregular heartbeats, such as dofetilide or quinidine;
• levacetylmethadol (levomethadyl), a medicine used for the treatment of opioid abuse;
• pimozide or sertindole, used for some mental disorders;
• some medicines used to reduce cholesterol in the blood such as atorvastatin, lovastatin and simvastatin;
• some medicines used for insomnia such as triazolam and midazolam orally;
• ergot alkaloids such as dihydroergotamine and ergotamine, used for the treatment of migraine, ergometrine (ergonovine) and methylergometrine (methylergonovine) used after childbirth;
• eletriptan, a medicine used to treat migraine;
• nisoldipine, a medicine used to treat high blood pressure.

Warnings and precautions
Talk to your doctor or pharmacist before taking ITRACONAZOLO DOC Generici:
tell your doctor if:

• in the past you have had an allergic reaction after taking other medicines used to treat fungal and yeast infections, because you may also be allergic to this medicine;
• you suffer from liver problems, because your doctor may need to adjust the dose. If symptoms of a liver problem such as loss of appetite (anorexia), nausea, vomiting, fatigue, abdominal pain or dark urine occur, stop taking this medicine and inform your doctor immediately. If your doctor deems it necessary during treatment with this medicine, he/she will advise you to undergo regular blood tests, in order to detect any liver problems early.
• you suffer from kidney problems, because your doctor may need to adjust the dose. If symptoms of a kidney problem such as tingling, numbness, weakness of the hands or feet occur, inform your doctor immediately;
• you notice hearing problems. Hearing loss usually resolves when treatment is stopped, but may persist in some patients.
• your immune defenses are low, 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;
• you suffer from AIDS and have previously had widespread fungal infections throughout the body (sporotrichosis, blastomycosis, histoplasmosis or cryptococcosis), because your doctor must assess the need for maintenance therapy
• 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, inform
your doctor immediately;

• you experience nerve problems (neuropathy). In this case, stop taking this medicine.

If you need to take medicines to treat heartburn (antacids) (e.g. aluminum hydroxide), take them at least two hours after taking ITRACONAZOLO DOC Generici, as they may interfere with the absorption of this
medicine.
In some cases your stomach may not produce the normal amount of acid (achlorhydria)
necessary for the correct absorption of the medicine. This can happen if you suffer from AIDS or if you are
taking medicines to treat stomach ulcers (e.g.: H-antagonists, proton pump inhibitors)
In this case, take the capsules of ITRACONAZOLO DOC Generici with a beverage containing cola
In case of systemic candidiasis (systemic candidiasis), the doctor will assess whether therapy with
itraconazole is suitable for the type of infection.

Children and adolescents
ITRACONAZOLO DOC Generici should not be used in children or adolescents, unless
the doctor considers it absolutely necessary as he/she has assessed that the benefits outweigh
the risks.

Elderly
ITRACONAZOLO DOC Generici should not be used in the elderly, unless the doctor considers it
absolutely necessary as he/she has assessed that the benefits outweigh the risks.

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

• some medicines used to treat allergies such as astemizole, mizolastine and terfenadine;
• bepridil, a medicine used to treat some heart problems (angina);
• cisapride, a medicine used for the treatment of some stomach problems;
• some medicines used to treat irregular heartbeats, such as dofetilide or quinidine;
• levacetylmethadol (levomethadyl), a medicine used for the treatment of opioid abuse;
• pimozide or sertindole, used for some mental disorders;
• some medicines used to reduce cholesterol in the blood such as atorvastatin, lovastatin and simvastatin;
• some medicines used for insomnia such as triazolam and midazolam orally;
• ergot alkaloids such as dihydroergotamine and ergotamine, used for the treatment of migraine, ergometrine (ergonovine) and methylergometrine (methylergonovine) used after childbirth;
• eletriptan, a medicine used to treat migraine;
• nisoldipine, a medicine used to treat high blood pressure.

Do not take ITRACONAZOLO DOC Generici if you are taking any of the following medicines and
inform your doctor if you have taken them recently, as it is necessary to wait two weeks from
the end of treatment before starting to take ITRACONAZOLO DOC Generici:

• rifampicin, rifabutin and isoniazid, antibiotics used to treat some bacterial infections;
• phenobarbital, phenytoin and carbamazepine, medicines used to treat epilepsy;
• St John's wort (Hypericum perforatum), used to treat depression.

Tell your doctor if you are taking the following medicines because the dose may need to be adjusted:

• some medicines used to treat heart or blood vessel problems, such as digoxin, disopyramide, cilostazol, calcium channel blockers (e.g. dihydropyridines and verapamil);
• some medicines used to treat bacterial infections (clarithromycin and erythromycin);
• medicines used to thin the blood;
• some medicines used to treat AIDS, such as ritonavir, indinavir and saquinavir;
• some medicines used to treat cancer, such as vinca alkaloids, busulfan, docetaxel and trimetrexate;
• some medicines used to reduce cholesterol levels in the blood, such as atorvastatin;
• budesonide, dexamethasone, fluticasone and methylprednisolone, medicines used to treat inflammation, asthma and allergies;
• cyclosporine, tacrolimus and rapamycin (also known as sirolimus), medicines used after organ transplants;
• halofantrine, a medicine used to treat malaria;
• repaglinide, a medicine used to treat diabetes;
• some medicines used for the treatment of anxiety or as tranquilizers, such as buspirone, alprazolam or brotizolam;
• alfentanil and fentanyl, medicines used as painkillers;
• ebastine, a medicine used to treat allergies;
• reboxetine, a medicine used to treat depression.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy.
The doctor may prescribe this medicine in cases of absolute necessity, if you have very
serious infections that put your life at risk.
Breastfeeding
If you are breastfeeding, ask your doctor for advice as a small amount of this
medicine passes into breast milk. The doctor will assess the potential risk to your baby
depending on the expected benefit.
Fertility
If you are a woman of childbearing potential, take adequate contraceptive measures to prevent
pregnancy during treatment with ITRACONAZOLO DOC Generici and maintain them until the next
menstruation after the end of treatment with this medicine. Consult your doctor if you have
started therapy with ITRACONAZOLO DOC Generici without taking adequate contraceptive
measures.

Driving and using machines
This medicine can sometimes cause dizziness, visual disturbances or hearing loss. If
you experience these symptoms, do not drive vehicles and do not use machines.

ITRACONAZOLO DOC Generici contains sucrose
This medicine contains sucrose, a type of sugar. If you have been diagnosed with an
intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take ITRACONAZOLO DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Take ITRACONAZOLO DOC Generici 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 and Dermatomycosis)
The recommended dose is 2 capsules, once a day for 7 days; if the infection affects the
palm of the hand or the sole of the foot, the recommended dose is 2 capsules, twice a day
for 7 days.

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

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

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.
Your doctor may double the dose if you have problems with your immune defenses
(immunodeficiency).

Eye infection (Fungal Keratitis)
The recommended dose is 2 capsules, once a day for 21 days.
In skin infections, treatment will show its maximum effectiveness 2-4 weeks after
its conclusion. In nail infections, treatment will show its maximum effectiveness 6-9
months after its conclusion. This is because Itraconazolo Doc Generici remains in the skin and
nails for a long time after the end of treatment.

• 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 1 capsule 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 2 capsules once a day to 2 capsules twice a day for 6 months.

If you take more ITRACONAZOLO DOC Generici than you should
In case of accidental intake of an excessive dose of ITRACONAZOLO DOC Generici, immediately warn
your doctor or go to the nearest hospital.

If you forget to take ITRACONAZOLO DOC Generici
Do not take a double dose to make up for the 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;
• skin rash.
• inflammation of the nasal mucous membranes (sinusitis)
• upper respiratory tract infection
• nasal congestion (rhinitis)

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

• allergic reactions (hypersensitivity);
• headache, dizziness, altered sensitivity 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), hair loss (alopecia), itching;
• menstrual disorders;
• swelling due to fluid retention (edema).

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

• lowering of the levels of white blood cells (leukopenia);
• decreased sensitivity and response to stimuli (hypoesthesia);
• vision disturbances;
• perception of ringing in the ear (tinnitus);
• inflammation of the pancreas (pancreatitis);
• increased levels of enzymes produced by the liver;
• frequent emission of small amounts of urine (pollakiuria);
• fever (pyrexia).

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

• lowering of the levels of white blood cells (neutropenia) and platelets (thrombocytopenia);
• allergic reactions, including severe ones (anaphylactic reaction, anaphylactoid reaction, serum sickness), swelling of the face and eyes due to fluid retention (angioedema);
• reduction of potassium levels in the blood (hypokalaemia), increased levels of fats in the blood (hypertriglyceridaemia);
• nerve disorders (peripheral neuropathy);
• blurred vision, double vision (diplopia);
• permanent or temporary hearing loss;
• heart problems (congestive heart failure);
• fluid accumulation in the lungs (pulmonary edema);
• liver problems (acute hepatic failure), liver inflammation (hepatitis), liver toxicity (hepatotoxicity);
• severe skin disorders characterized by the appearance of lesions (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, leucocytoclastic vasculitis);
• skin sensitivity to light (photosensitivity);
• muscle pain (myalgia), joint pain (arthralgia);
• urine leakage (urinary incontinence);
• impotence (erectile dysfunction).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 waste water 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 DOC Generici contains

• The active substance is itraconazole. Each capsule contains 100 mg of itraconazole.
• The other ingredients are: saccharated granules as a support, hypromellose, poloxamer 188; capsule composition: gelatin, titanium dioxide (E171), quinoline yellow (E 104), indigotine (E 132).

Description of the appearance of ITRACONAZOLO DOC Generici and contents of the pack
The pack contains 8 capsules in blisters.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano – Italy.

Manufacturer

• Liconsa SA Av.da Miralcampo 7 - Poligono Industrial Miralcampo - 19200 Azuqueca de Henares - Guadalajara - Spain.
• Lamp San Prospero S.p.A. - Via della pace 25/A - 41030 San Prospero (Modena) - Italy.