ITRACONAZOLO 100 mg Hard Capsule

Зміст інструкції

1. Itraconazole Mylan Generics 100 mg hard capsules
   1. What is Itraconazolo Mylan Generics and what it is used for
   2. What you need to know before taking Itraconazole Mylan Generics
   3. HOW TO TAKE ITRACONAZOLO MYLAN GENERICS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ITRACONAZOLO MYLAN GENERICS
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

Itraconazole Mylan Generics 100 mg hard capsules

Itraconazole

Equivalent 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 they have the same symptoms as you, 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 Mylan Generics is and what it is used for
• 2. What you need to know before you take Itraconazole Mylan Generics
• 3. How to take Itraconazole Mylan Generics
• 4. Possible side effects
• 5. How to store Itraconazole Mylan Generics
• 6. Contents of the pack and other information

1. What is Itraconazolo Mylan Generics 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 taken to treat the
following infections:

• Candidiasis (yeast infection) in the mouth, throat or vagina
• Fungal infections of the nails or skin (e.g. athlete's foot, tinea and skin infection called pityriasis versicolor)
• Sporotrichosis lymphocutaneous, paracoccidioidomycosis, blastomycosis (in immunocompetent patients) and histoplasmosis
• Itraconazolo can be used to treat patients suffering from invasive aspergillosis who are resistant or intolerant to standard amphotericin B therapy.

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

Do not take Itraconazole Mylan Generics

• If you are allergic to itraconazole or any of the other ingredients of this medicine (listed in section 6)
• If you suffer from shortness of breath and swelling of the ankles, or have a history of heart failure, unless your doctor has told you to take this medicine
• If you are pregnant or may 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 Breastfeeding”)
• 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 for the treatment of angina (chest pain)
o levacetylmethadol, used for the treatment of opioid dependence
o midazolam (taken orally) or triazolam, to treat anxiety or help with sleep
o dofetilide or quinidine, to treat an irregular heartbeat
o pimozide or sertindole used to treat mental illnesses
o medicines to lower cholesterol levels such as simvastatin, atorvastatinor
lovastatin
o dihydroergotamine, ergotamine or eletriptan used to treat headaches from
migraine
o methylergometrine, or ergometrine used after childbirth.

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

• If you have problems with your liver or kidneys
• If you have already taken other antifungal medicines and have suffered 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 movements of the digestive system and the transit of food through it.)

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

• antibiotics to treat tuberculosis (such as rifampicin, rifabutin, isoniazid) or antiepileptic medicines (such as phenytoin, carbamazepine, phenobarbital or the herbal medicine St John's Wort ( Hypericum perforatum)), as they may make itraconazole ineffective. Consult your doctor if you have stopped treatment with these medicines in the last two weeks
• “calcium channel blockers” such as dihydropyridine (e.g. amlodipine, felodipine)
• verapamil, digoxin or disopyramide to treat 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)
• anti-cancer medicines such as busulfan, docetaxel, trimetrexate, vinca alkaloids
• cyclosporine, sirolimus, tacrolimus (immunosuppressants)
• buspirone, alprazolam obrotizolam to treat anxiety
• midazolam (administered by injection), a sedative
• reboxetine, to treat depression
• ebastine, to treat allergies
• alfentanil, fentanyl for the treatment of pain
• methylprednisolone, dexamethasone, budesonide or fluticasone (an anti-inflammatory medicine)
• repaglinide (a medicine for diabetes)
• alofrantine (an antimalarial medicine).

Do not take medicines used to treat heartburn, stomach ulcers or
indigestion within two hours of taking your dose of itraconazole. If you suffer from
low stomach acid (e.g. if you are using an anti-ulcer medicine such as
esomeprazole), take itraconazole with a carbonated soft drink (with carbon dioxide).

Pregnancy and breastfeedingIf you are pregnant, suspect you may be pregnant or are planning a
pregnancy, or if you are breastfeeding, 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 told you to.
You must take adequate contraceptive precautions during and after
treatment with this medicine (until your next period (menstrual cycle)).

Breastfeeding
Breastfeeding is not recommended during the use of this medicine as a
small amount of itraconazole passes into breast milk. Your doctor will decide whether you should
breastfeed or not during treatment, or whether the treatment should be stopped.

Driving and using machines
Itraconazole should not interfere with your ability to drive vehicles; however,
if you experience side effects such as dizziness, blurred vision or hearing loss, do not
drive vehicles or use machines.

Itraconazole Mylan Generics contains sucrose. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE ITRACONAZOLO MYLAN GENERICS

Always take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, ask 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
Fungal infections of the vagina (vulvovaginal candidiasis):
2 capsules in the morning and 2 in the evening for 1 day or 2 capsules once a day for 3 days.

Fungal infections of the skin (tinea corporis/tinea cruris) and of the oral mucosa (oral candidiasis):
1 capsule once a day for 2 weeks.

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

Pityriasis versicolor (erythema of the trunk and proximal limbs):
2 capsules once a day for 1 week.

Nail infections (onychomycosis):
Intermittent treatment:
a treatment cycle consists of 2 capsules twice a day for one week followed by 3
weeks without taking the medicine. For nail infections of the feet, 3
treatment cycles are usually performed in total; for nail infections of the hands, 2 cycles of
treatment are recommended.

Continuous treatment:
2 capsules once a day for 3 months. The results of the treatment will be maintained even after
stopping treatment when the nails grow back.

Sporotrichosis lymphocutaneous*:
1 capsule once a day for 3 months.

Paracoccidioidomycosis*:
1 capsule once a day for 6 months.

Blastomycosis*:
1 capsule once a day for 6 months.
The doctor may increase the dose to 2 capsules twice a day.

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

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

Invasive aspergillosis:
Treatment begins with a dose of 2 capsules three times a day for 4 days and continues with a
dose of 2 capsules twice a day until the pathogen can no longer be found in the
colonies or the lesions have healed (after 2-5 months) or at least the number of some white blood cells
in the blood (neutrophil granulocytes) has returned to normal levels.
*The specified treatment periods are average values that 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) is therefore achieved 1-4 weeks after stopping treatment for
skin infections and 6-9 months after stopping treatment for nail infections.

Elderly
Itraconazolo Mylan Generics is not recommended unless treatment with this medicine
is really necessary.

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

Patients with kidney or liver problems
The doctor will prescribe the right dose of Itraconazolo Mylan Generics (which may be
lower than that stated above).

Patients with a weakened immune system (including patients with HIV/AIDS)
The doctor may require blood tests to monitor the amount of itraconazole in your
body. In some cases, the doctor may increase your dose to 200 mg (2 capsules) twice a
day.

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

If you forget to take Itraconazolo Mylan Generics
Take the forgotten dose as soon as you remember unless it is almost time to take the next
dose. Donot take a double dose to make up for a missed dose.

If you stop taking Itraconazolo Mylan Generics
Even if you feel better, it is important that you continue to take the capsules for the entire duration of
treatment prescribed by your doctor. If you stop earlier, the infection may
recur. In some cases, your doctor will prescribe continuing treatment precisely
to prevent the infection from recurring.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the treatment lasts a month or more, the occurrence of side effects is more likely.

If any of the following side effects occur, stop taking this medicine and
consult your doctor immediately or go to the nearest emergency room:
Rare (may affect up to 1 in 1,000 people):

• blood disorders that can lead to an increased risk of infection
• severe stomach pain that spreads 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 that causes swelling of the face, lips, tongue or throat, which can cause difficulty breathing or swallowing
• swelling associated with red spots on the skin
• symptoms of heart failure such as shortness of breath and swollen ankles
• severe skin reactions characterized by peeling of the skin and the presence of blisters on the mouth, eyes and genitals
• liver problems with signs such as severe loss of appetite, feeling unwell (nausea), discomfort (vomiting), feeling tired, stomach pain, muscle weakness, yellowing of the skin or whites of the eyes (jaundice), dark urine and pale stools
• difficulty breathing.

Other possible side effects:
Common (may affect up to 1 in 10 people):

• abdominal pain, nausea
• skin rash
• headache.

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

• upper respiratory tract infection, 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 from 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 sense of touch
• sensation of tingling, prickling or numbness of the skin
• visual disturbances, including blurred and double vision
• swelling due to fluid retention
• excessive levels of triglycerides (fats) in the blood
• changes in the sense of taste
• shortness of breath, difficulty breathing
• hair loss
• changes in blood test results (increased levels of creatine phosphokinase)
• increased sensitivity to sunlight
• erectile dysfunction

Further side effects observed in studies with other pharmaceutical formulations of itraconazole,
for example, intravenous (i.v.) formulations and itraconazole syrup.

• Blood disorders that can cause increased infections and blood clotting problems (granulocytopenia, thrombocytopenia)
• An allergic reaction that causes swelling of the face, lips, tongue or throat, which can cause difficulty breathing or swallowing (anaphylactic reaction)
• Blood test results showing changes in glucose, potassium and magnesium levels in the blood (hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia)
• Confusion
• Loss of sensation in the fingers and toes (peripheral neuropathy), dizziness, feeling unusually calm and insensitive (drowsiness), tremor
• Heart failure, meaning that the heart muscle is unable to pump blood strongly enough to supply all the blood needed to every part of the body. Symptoms of heart failure include shortness of breath and swelling of the feet and legs, due to fluid accumulation, rapid heartbeat (heart failure, left ventricular failure and tachycardia)
• Increased or decreased blood pressure (hypertension, hypotension)
• Fluid in the lungs, (pulmonary edema) difficulty speaking (dysphonia), cough
• Gastric disorders
• Liver disorders causing yellowing of the skin and whites of the eyes (hepatic failure, hepatitis, jaundice)
• Red skin rashes (erythema rash), 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, chills
• Abnormal blood test results (increased levels of alanine aminotransferase, increased levels of aspartate aminotransferase, increases in blood alkaline phosphatase levels, increased levels of blood lactate dehydrogenase, increased levels of blood urea, increased levels of gamma glutamyl transferase, increased liver enzymes, abnormal urine analysis.

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through
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 ITRACONAZOLO MYLAN GENERICS

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 pack or blister after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Medicines should 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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Itraconazolo Mylan Generics contains
The active ingredient is itraconazole. Each capsule contains 100 mg of itraconazole.
The other components are sugar spheres (containing sucrose and corn starch – See
section 2 “Itraconazolo Mylan Generics contains sucrose”), hypromellose (E464), sorbitan
stearate and hydrated colloidal silica. The capsule shell is made of gelatin, titanium dioxide
(E171) and red iron oxide (E172).

Description of the appearance of Itraconazolo Mylan Generics and contents of the pack
This medicine is constituted by opaque red and elongated 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
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 Member States of the European Economic Area under the
following denominations:
Germany - Itraconazol dura 100 mg Hartkapseln
Italy- Itraconazolo Mylan Generics 100 mg hard capsules
Poland- Itragen
Portugal - Itraconazol Mylan 100 mg Capsules
Netherlands– Itraconazol Mylan 100mg capsules, hard capsules

This leaflet was last revised: