Itraconazole Doc Generici

Package leaflet: information for the patient

ITRACONAZOLE DOC Generics 100 mg hard capsules

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

Contents of this leaflet:

1. What ITRACONAZOLE DOC Generics is and what it is used for
2. What you need to know before taking ITRACONAZOLE DOC Generics
3. How to take ITRACONAZOLE DOC Generics
4. Possible side effects
5. How to store ITRACONAZOLE DOC Generics
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 substance itraconazole, which belongs to a group of medicines called antifungals. Antifungals are used to treat 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 infections of the mouth (oral candidiasis) or of the vagina and vulva (vulvovaginal candidiasis), skin infections (pityriasis versicolor, dermatophytosis), nail infections (onychomycosis due to dermatophytes and/or yeasts), eye infections (fungal keratitis);
• infections caused by fungi and yeasts that spread throughout the body (systemic mycoses) (aspergillosis and candidiasis, cryptococcosis including cryptococcal meningitis, histoplasmosis, sporotrichosis, paracoccidioidomycosis, blastomycosis, and other rare systemic mycoses).

2. What you should know before taking ITRACONAZOLE DOC Generics

Do not take ITRACONAZOLE DOC Generics

• if you are allergic to itraconazole or to 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 determined that treatment for a potentially life-threatening infection is necessary (see section “Pregnancy and breastfeeding”);
• if you have liver problems (moderate or severe hepatic impairment);
• if you currently have or have previously had heart problems (ventricular dysfunction or congestive heart failure), unless your doctor has determined that treatment for a potentially life-threatening infection or other serious infections is necessary (see section “Warnings and precautions”);
• if you are taking any of the following medicines (see section “Other medicines and ITRACONAZOLE DOC Generics”):
  • certain medicines used to treat allergies such as astemizole, mizolastine and terfenadine;
  • bepridil, a medicine used to treat certain heart conditions (angina);
  • cisapride, a medicine used to treat certain stomach problems;
  • certain medicines used to treat irregular heartbeats, such as dofetilide or quinidine;
  • levacetylmethadol (levomethadyl), a medicine used to treat opioid dependence;
  • pimozide or sertindole, used for certain mental disorders;
  • certain medicines used to lower blood cholesterol such as atorvastatin, lovastatin and simvastatin;
  • certain medicines used for insomnia such as oral triazolam and midazolam;
  • ergot alkaloids such as dihydroergotamine and ergotamine, used to treat migraine, and 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 ITRACONAZOLE DOC Generics if:

• you have previously had an allergic reaction to other medicines used to treat fungal or yeast infections, as you may also be allergic to this medicine;
• you have liver problems, because your doctor may need to adjust your dose. If symptoms of liver problems occur, such as loss of appetite, nausea, vomiting, fatigue, abdominal pain or dark urine, stop taking this medicine immediately and contact your doctor without delay. If necessary, your doctor may recommend regular blood tests during treatment to detect any liver problems early;
• you have kidney problems, because your doctor may need to adjust your dose. If symptoms of kidney problems occur, such as tingling, numbness, or weakness in hands or feet, contact your doctor immediately;
• you experience hearing problems. Hearing loss usually resolves after stopping treatment, but may persist in some patients;
• you have a weakened immune system, for example if you have low white blood cell counts (neutropenia), if you have AIDS, or if you have had an organ transplant, because your doctor may need to adjust your dose;
• you have AIDS and have previously had systemic fungal infections (e.g. sporotrichosis, blastomycosis, histoplasmosis or cryptococcosis), because your doctor needs to consider whether maintenance therapy is appropriate;
• you have or have previously had heart or lung problems. If symptoms of heart problems occur, such as shortness of breath, unexpected weight gain, swelling in the legs or abdomen, unusual fatigue, or waking up frequently at night, contact your doctor immediately;
• you develop nerve problems (neuropathy). In this case, stop taking this medicine.

If you need to take medicines for heartburn (antacids) (e.g. aluminium hydroxide), take them at least two hours after taking ITRACONAZOLE DOC Generics, as they may interfere with the absorption of this medicine.
In some cases, your stomach may not produce the normal amount of acid (achlorhydria) required for proper absorption of the medicine. This may occur if you have AIDS or if you are taking medicines for stomach ulcers (e.g. H₂-antagonists, proton pump inhibitors).
In such cases, take ITRACONAZOLE DOC Generics capsules with a cola-containing drink.
For systemic candida infections (systemic candidiasis), your doctor will assess whether itraconazole therapy is appropriate for the type of infection.

Children and adolescents
ITRACONAZOLE DOC Generics must not be used in children or adolescents unless your doctor considers it absolutely necessary and has determined that the benefits outweigh the risks.

Elderly
ITRACONAZOLE DOC Generics must not be used in elderly patients unless your doctor considers it absolutely necessary and has determined that the benefits outweigh the risks.

Other medicines and ITRACONAZOLE DOC Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take ITRACONAZOLE DOC Generics if you are taking any of the following medicines:

• certain medicines used to treat allergies such as astemizole, mizolastine and terfenadine;
• bepridil, a medicine used to treat certain heart conditions (angina);
• cisapride, a medicine used to treat certain stomach problems;
• certain medicines used to treat irregular heartbeats, such as dofetilide or quinidine;
• levacetylmethadol (levomethadyl), a medicine used to treat opioid dependence;
• pimozide or sertindole, used for certain mental disorders;
• certain medicines used to lower blood cholesterol such as atorvastatin, lovastatin and simvastatin;
• certain medicines used for insomnia such as oral triazolam and midazolam;
• ergot alkaloids such as dihydroergotamine and ergotamine, used to treat migraine, and 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 ITRACONAZOLE DOC Generics if you are taking any of the following medicines, and inform your doctor if you have recently taken them, as you must wait two weeks after stopping treatment before starting ITRACONAZOLE DOC Generics:

• rifampicin, rifabutin and isoniazid, antibiotics used to treat certain 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 any of the following medicines, as your dose may need to be adjusted:

• certain medicines used to treat heart or blood vessel conditions, such as digoxin, disopyramide, cilostazol, calcium channel blockers (e.g. dihydropyridines and verapamil);
• certain antibiotics used to treat bacterial infections, such as clarithromycin and erythromycin;
• medicines used to thin the blood;
• certain medicines used to treat AIDS, such as ritonavir, indinavir and saquinavir;
• certain medicines used to treat cancer, such as vinca alkaloids, busulfan, docetaxel and trimetrexate;
• certain medicines used to reduce blood cholesterol levels, such as atorvastatin;
• budesonide, desamethasone, fluticasone and methylprednisolone, medicines used to treat inflammation, asthma and allergies;
• ciclosporin, tacrolimus and rapamycin (also known as sirolimus), medicines used after organ transplantation;
• halofantrine, a medicine used to treat malaria;
• repaglinide, a medicine used to treat diabetes;
• certain medicines used to treat 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take this medicine during pregnancy.
Your doctor may prescribe this medicine only in cases of absolute necessity, if you have very serious, life-threatening infections.

Breastfeeding
If you are breastfeeding, consult your doctor, as a small amount of this medicine passes into breast milk. Your doctor will assess the potential risk to your baby against the expected benefit.

Fertility
If you are a woman of childbearing age, use adequate contraceptive measures to prevent pregnancy during treatment with ITRACONAZOLE DOC Generics and continue them until your next menstrual period after the end of treatment. Consult your doctor if you started therapy with ITRACONAZOLE DOC Generics without using adequate contraception.

Driving and using machines
This medicine may in some cases cause dizziness, visual disturbances or hearing loss. If you experience these symptoms, do not drive or operate machinery.

ITRACONAZOLE DOC Generics contains sucrose
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take ITRACONAZOLE DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Take ITRACONAZOLE 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 treatment depend on the type of infection and are indicated below:

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

Skin infections (Pityriasis versicolor and Dermatophytosis)
The recommended dose is 2 capsules once daily 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 daily for 7 days.
Oral infection (oral candidiasis)
The recommended dose is 1 capsule once daily for 15 days.
Your doctor may double the dose if you have problems with your immune defenses (immunosuppression).
Vulvovaginal infection (vulvovaginal candidiasis)
The recommended dose is 2 capsules once daily for 3 days or 2 capsules twice daily for 1 day.
Your doctor may double the dose if you have problems with your immune defenses (immunosuppression).
Nail infections (onychomycosis)
Treatment of nail infections requires treatment cycles.
One treatment cycle consists of taking 2 capsules twice daily for 1 week.
Each treatment cycle must be followed by a 3-week break from treatment.
If you have a nail infection on the hands, you must complete 2 treatment cycles. If you have a nail infection on the feet, you must complete 3 treatment cycles.
Your doctor may double the dose if you have problems with your immune defenses (immunosuppression).
Eye infection (fungal keratitis)
The recommended dose is 2 capsules once daily for 21 days.
For skin infections, the treatment will show its maximum effectiveness 2–4 weeks after completion. For nail infections, the treatment will show its maximum effectiveness 6–9 months after completion. This is because Itraconazole DOC Generici remains in the skin and nails for a long period of time after treatment ends.

• Treatment of systemic infections (widespread body infections)

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

• Aspergillosis: 2 capsules once daily for 2–5 months; in severe infections, your doctor may increase the dose to 2 capsules twice daily;
• Candidiasis: 1–2 capsules once daily. Treatment duration varies from 3 weeks to 7 months. In severe infections, your doctor may increase the dose to 2 capsules twice daily;
• Non-meningeal cryptococcosis: 2 capsules once daily. Treatment duration varies from 2 months to 1 year. The recommended maintenance therapy dose is 2 capsules once daily;
• Cryptococcal meningitis: 4 capsules once daily. Treatment duration varies from 2 months to 1 year. The recommended maintenance therapy dose is 2 capsules once daily;
• Histoplasmosis: the recommended dose may range from 1 capsule once daily to 2 capsules twice daily for 8 months;
• Sporotrichosis: 1 capsule once daily for 3 months;
• Paracoccidioidomycosis: 1 capsule once daily for 6 months;
• Chromoblastomycosis: 1–2 capsules once daily for 6 months;
• Blastomycosis: the recommended dose may range from 2 capsules once daily to 2 capsules twice daily for 6 months.

If you take more ITRACONAZOLE DOC Generici than you should
If you accidentally take an excessive dose of ITRACONAZOLE DOC Generici, contact your doctor immediately or go to the nearest hospital.
If you forget to take ITRACONAZOLE DOC Generici
Do not take a double dose to make up for the missed dose.
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 experiences them.
The following side effects may occur:
Common (may affect up to 1 in 10 people):

• stomach ache (abdominal pain), nausea;
• skin rash;
• inflammation of the nasal mucosa (sinusitis);
• upper respiratory tract infection;
• nasal congestion (rhinitis).

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

• allergic reactions (hypersensitivity);
• headache (cephalalgia), dizziness, altered sensation in arms and legs (paraesthesia);
• vomiting, diarrhoea, constipation, digestive problems (dyspepsia), altered taste (dysgeusia), flatulence;
• increased levels of certain substances in the blood (hyperbilirubinaemia, increased alanine aminotransferase, increased aspartate aminotransferase);
• skin irritation (urticaria), loss of hair and body hair (alopecia), itching (pruritus);
• menstrual disorders;
• swelling due to fluid accumulation (oedema).

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

• decrease in white blood cell count (leucopenia);
• reduced sensitivity and response to stimuli (hypoesthesia);
• vision disorders;
• perception of ringing in the ears (tinnitus);
• inflammation of the pancreas (pancreatitis);
• increased levels of liver enzymes;
• frequent passage of small amounts of urine (pollakiuria);
• fever (pyrexia).

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

• decrease in white blood cell count (neutropenia) and platelets (thrombocytopenia);
• allergic reactions, including severe ones (anaphylactic reaction, anaphylactoid reaction, serum sickness), facial and eye swelling due to fluid accumulation (angioneurotic oedema);
• low 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 oedema);
• liver problems (acute liver failure), liver inflammation (hepatitis), liver toxicity (hepatotoxicity);
• severe skin disorders characterised by the appearance of lesions (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis);
• skin sensitivity to light (photosensitivity);
• muscle pain (myalgia), joint pain (arthralgia);
• urinary incontinence;
• impotence (erectile dysfunction).

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 the website
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 ITRACONAZOLE DOC Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ITRACONAZOLE DOC Generici contains

• The active substance is itraconazole. Each tablet contains 100 mg of itraconazole.
• The other components are: sugar spheres, hypromellose, poloxamer 188; capsule composition: gelatin, titanium dioxide (E171), quinoline yellow (E 104), indigotine (E 132).

Description of the appearance of ITRACONAZOLE DOC Generici and pack contents
The pack contains 8 capsules in blister packs.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – 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.