Itraconazole Mylan Generics: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Itraconazole Mylan Generics 100 mg hard capsules

Itraconazole
Generic 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 their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Itraconazolo Mylan Generics is and what it is used for

Itraconazolo Mylan Generics belongs to a group of medicines called “antifungals”, used to treat fungal and yeast infections. This medicine can be used to treat the following infections:

Candidiasis (yeast infection) of the mouth, throat, or vagina
Fungal infections of the nails or skin (e.g. athlete’s foot, tinea, and a skin infection called pityriasis versicolor)
Lymphocutaneous sporotrichosis, paracoccidioidomycosis, blastomycosis (in immunocompetent patients), and histoplasmosis
Itraconazole may be used to treat patients with invasive aspergillosis who are resistant to or intolerant of standard therapy with amphotericin B.

2. What you need to know before taking Itraconazole Mylan Generics

Do not take Itraconazole Mylan Generics

If you are allergic to itraconazole or to any of the other ingredients of this medicine (listed in section 6)
If you suffer from shortness of breath and swelling in the ankles, or have a history of heart failure, unless your doctor has told you to take this medicine
If you are pregnant or might become pregnant (e.g., if you are not using any form of contraception), unless your doctor has told you to take this medicine (see "Pregnancy and Breast-feeding")
If you are already taking any of the following medicines:
o antihistamines such as terfenadine, astemizole, mizolastine or cisapride, used for stomach problems
o bepridil and nisoldipine, used to treat angina (chest pain)
o levacetylmethadone, used to treat opioid dependence
o midazolam (taken orally) or triazolam, to treat anxiety or help sleep
o dofetilide or quinidine, to treat irregular heart rhythm
o pimozide or sertindole, used to treat mental illnesses
o cholesterol-lowering medicines such as simvastatin, atorvastatin or lovastatin
o dihydroergotamine, ergotamine or eletriptan, used to treat migraine headaches
o methylergonovine or ergometrine, used after childbirth.

Warnings and precautions
Tell your doctor or pharmacist before taking itraconazole:

If you have liver or kidney problems
If you have previously taken other antifungal medicines and experienced an allergic reaction
If you have a history of heart problems
If you have had an organ transplant, suffer from acquired immunodeficiency syndrome (AIDS), or your immune system is not working properly
If you have reduced gastrointestinal motility (reduced movement of the digestive tract and food transit through it).

Other medicines and Itraconazole Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (also see “Do not take Itraconazole Mylan Generics”), including those without a prescription or the following:

antibiotics for the treatment of tuberculosis (such as rifampicin, rifabutin, isoniazid) or antiepileptic medicines (such as phenytoin, carbamazepine, phenobarbital, or St John's wort ( Hypericum perforatum )), as they may make itraconazole ineffective. Consult your doctor if you have stopped treatment with these medicines within the last two weeks
"calcium channel blockers" such as dihydropyridines (e.g., amlodipine, felodipine)
verapamil, digoxin or disopyramide for treating a heart condition
anticoagulants such as warfarin, cilostazol used to thin the blood
clarithromycin, erythromycin (antibiotics)
ritonavir, indinavir, saquinavir (antiretrovirals, used to treat HIV infection)
anticancer medicines such as busulfan, docetaxel, trimethrexate, vinca alkaloids
cyclosporine, sirolimus, tacrolimus (immunosuppressants)
buspirone, alprazolam, brotizolam for treating anxiety
midazolam (administered by injection), a sedative
reboxetine, for treating depression
ebastine, for treating allergy
alfentanil, fentanyl for pain treatment
methylprednisolone, dexamethasone, budesonide or fluticasone (anti-inflammatory medicines)
repaglinide (a medicine for diabetes)
halofantrine (an antimalarial medicine).

Do not take medicines used for treating heartburn, gastric ulcers, or indigestion within two hours after taking your dose of itraconazole. If you have low stomach acidity (e.g., if you are taking an anti-ulcer medicine such as esomeprazole), take itraconazole with a carbonated non-alcoholic beverage (containing carbon dioxide).
Pregnancy and breast-feeding If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take itraconazole if you are pregnant or planning a pregnancy unless your doctor has instructed you to do so. You must use adequate contraceptive precautions during and after treatment with this medicine (until your next menstrual cycle).
Breast-feeding
Breast-feeding is not recommended while taking this medicine, as a small amount of itraconazole passes into breast milk. Your doctor will decide whether you should breast-feed or discontinue the medicine.
Driving and using machines
Itraconazole should not interfere with your ability to drive; however, if you experience side effects such as dizziness, blurred vision or hearing loss, do not drive or operate machinery.
Itraconazole Mylan Generics contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE ITRACONAZOLE MYLAN GENERICS

Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Swallow the capsules whole with a glass of water during or immediately after a meal.
Do not chew the capsules.

The recommended dose is:

Adults and adolescents

Vaginal fungal infections (vulvovaginal candidiasis):
2 capsules in the morning and 2 in the evening for 1 day, or 2 capsules once daily for 3 days.

Skin fungal infections (tinea corporis/tinea cruris) and oral mucosa (oral candidiasis):
1 capsule once daily for 2 weeks.

Fungal infections of the feet and hands (tinea pedis/tinea manus):
1 capsule once daily for 4 weeks.

Pityriasis versicolor (erythema of trunk and proximal extremities):
2 capsules once daily for 1 week.

Nail infections (onychomycosis):

Intermittent treatment:
A treatment cycle consists of 2 capsules twice daily for 1 week, followed by 3 weeks without taking the medicine. For nail infections of the feet, usually 3 treatment cycles are performed in total; for nail infections of the hands, 2 treatment cycles are recommended.

Continuous treatment:
2 capsules once daily for 3 months. Treatment results will be maintained after discontinuation as the nails regrow.

Lymphocutaneous sporotrichosis*:
1 capsule once daily for 3 months.

Paracoccidioidomycosis*:
1 capsule once daily for 6 months.

Blastomycosis*:
1 capsule once daily for 6 months.
Your doctor may increase the dose to 2 capsules twice daily.

Histoplasmosis*:
2 capsules once daily for 8 months.
The dose may be increased to 2 capsules twice daily.

Systemic aspergillosis*:
2 capsules once daily until cultures are negative or lesions have disappeared.

Invasive aspergillosis:
Treatment starts with a dose of 2 capsules three times daily for 4 days, then continues with 2 capsules twice daily until the pathogen is no longer detectable in cultures or lesions have healed (after 2–5 months), or until certain white blood cell counts (neutrophil granulocytes) have returned to normal levels.

*The treatment durations specified are average values and may vary depending on the severity of the condition or the healing process (regarding symptoms and pathogens).

Itraconazole remains in the skin and nails longer than in the blood. Optimal healing (regarding symptoms) therefore occurs 1–4 weeks after discontinuation of treatment for skin infections and 6–9 months after discontinuation for nail infections.

Elderly
Itraconazole Mylan Generics is not recommended unless treatment with this medicine is strictly necessary.

Use in children
Itraconazole Mylan Generics is not recommended for use in children under 12 years of age.

Patients with kidney or liver problems
Your doctor will prescribe the appropriate dose of Itraconazole Mylan Generics (which may be lower than the doses listed above).

Patients with weakened immune systems (including HIV/AIDS patients)
Your doctor may require blood tests to monitor itraconazole levels in your body. In some cases, your doctor may increase your dose to 200 mg (2 capsules) twice daily.

If you take more Itraconazole Mylan Generics than you should
Contact your doctor or the nearest emergency department immediately. Remember to bring the container and any remaining capsules with you.

If you forget to take Itraconazole Mylan Generics
Take the missed dose as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed one.

If you stop taking Itraconazole Mylan Generics
Even if you feel better, it is important to continue taking the capsules for the full duration prescribed by your doctor. Stopping treatment early may cause the infection to return. In some cases, your doctor may prescribe continued treatment specifically to prevent recurrence of the infection.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If treatment lasts for a month or longer, adverse reactions are more likely to occur.
If any of the following adverse reactions occur, stop taking this medicine immediately and consult your doctor or go to the nearest emergency room:
Rare (may affect up to 1 in 1,000 people):

blood disorders that may lead to an increased risk of infection
severe stomach pain spreading to the back, which may be a sign of inflammation of the pancreas (pancreatitis)
widespread skin reaction with red skin, blisters, and fever
an allergic reaction causing swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing
swelling associated with red spots on the skin
symptoms of heart failure such as breathlessness and swollen ankles
severe skin reactions characterized by skin peeling and presence of blisters in the mouth, eyes, and genitals
liver problems with signs such as severe loss of appetite, feeling unwell (nausea), discomfort (vomiting), fatigue, stomach pain, muscle weakness, yellowing of the skin or whites of the eyes (jaundice), dark urine, and pale stools
difficulty breathing

Other possible adverse reactions:
Common (may affect up to 1 in 10 people):

abdominal pain, nausea
rash
headache

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

upper respiratory tract infections, e.g., cold (upper respiratory tract infection), sinusitis, inflammation of the nasal mucosa (rhinitis)
menstrual changes such as increased bleeding or irregular bleeding
vomiting, diarrhea, constipation, indigestion, flatulence
urticaria, itchy skin
changes in liver function tests (visible in blood tests)

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

delayed allergic reaction (serum sickness)
frequent urination
ringing in the ears (tinnitus), temporary or permanent hair loss
reduced sensation to touch
tingling, prickling, or numbness of the skin
visual disturbances, including blurred or double vision
swelling due to fluid retention
excessively high levels of triglycerides (fats) in the blood
changes in taste sensation
shortness of breath, difficulty breathing
hair loss
changes in blood test results (increased levels of creatine phosphokinase)
increased sensitivity to sunlight
erectile dysfunction

Additional side effects observed in studies with other pharmaceutical formulations of itraconazole,
e.g., intravenous (i.v.) formulations and itraconazole syrup:

Blood disorders that may cause increased infections and blood clotting problems (granulocytopenia, thrombocytopenia)
- An allergic reaction causing swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing (anaphylactic reaction)
- Blood test results showing changes in blood levels of glucose, potassium, and magnesium (hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia)
- Confusion
- Loss of sensation in fingers and toes (peripheral neuropathy), dizziness, feeling unusually calm and drowsy (somnolence), tremor
- Heart failure, meaning the heart muscle cannot pump blood strongly enough to supply all parts of the body. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid accumulation, rapid heartbeat (heart failure, left ventricular failure, tachycardia)
- Increased or decreased blood pressure (hypertension, hypotension)
- Fluid in the lungs (pulmonary edema), difficulty speaking (dysphonia), cough
- Gastrointestinal disorders
- Liver disorders causing yellowing of the skin and whites of the eyes (liver failure, hepatitis, jaundice)
- Red skin rashes (erythema from skin eruption), excessive sweating (hyperhidrosis)
- Muscle pain and joint pain (myalgia, arthralgia)
- Kidney disorders, inability to control the bladder (incontinence)
- Swelling of the body or face (generalized facial edema), chest pain, fever, fatigue, chills
Abnormal blood test results (increased levels of alanine aminotransferase, increased levels of aspartate aminotransferase, increased levels of alkaline phosphatase in blood, increased levels of lactate dehydrogenase in blood, increased blood urea levels, increased levels of gamma-glutamyl transferase, increased liver enzymes, abnormal urine test results)

Additional side effects in children and adolescents
Clinical studies show that similar adverse reactions occur in children and adolescents, but they may occur more frequently.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ITRACONAZOLE MYLAN GENERICS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Itraconazole Mylan Generics contains
The active substance is itraconazole. Each capsule contains 100 mg of itraconazole.
The other components are sugar spheres (containing sucrose and maize starch – See section 2 "Itraconazole Mylan Generics contains sucrose"), hypromellose (E464), sorbitan monostearate, and hydrated colloidal silica. The capsule shell is composed of gelatin, titanium dioxide (E171), and red iron oxide (E172).

Description of the appearance of Itraconazole Mylan Generics and pack contents
This medicine consists of long, opaque red gelatin capsules.
The capsules are available in blisters containing 4, 6, 7, 8, 10, 14, 15, 18, 20, 28, 30, 50, 56, 60, 84, 100, 140, 150, 200, 250, 280, 300, 500 or 1000 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturers
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road – Dublin 13
Ireland
Mylan BV
Dieselweg 25
3752 LB Bunschoten
The Netherlands
Generics [UK] Ltd
Station Close, Potters Bar
Hertfordshire EN6 1TL – United Kingdom
Mylan Hungary Kft., H-2900,
Komárom,
Mylan utca 1,
Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany - Itraconazol dura 100 mg Hartkapseln
Italy - Itraconazolo Mylan Generics 100 mg capsule rigide
Poland - Itragen
Portugal - Itraconazol Mylan 100 mg Capsulas
The Netherlands - Itraconazol Mylan 100mg capsules, capsule hard

This leaflet was last reviewed: