Mycosyst

Patient Information Leaflet included in the packaging: Mycosyst, 200 mg, capsules
Fluconazole

Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Mycosyst is and what it is used for
2. Important information before taking Mycosyst
3. How to take Mycosyst
4. Possible side effects
5. How to store Mycosyst
6. Contents of the pack and other information

1. What Mycosyst is and what it is used for

Mycosyst belongs to a group of antifungal medicines. The active substance is fluconazole.
Mycosyst is used to treat infections caused by pathogenic fungi and can also be used to prevent Candida infections. The most common cause of fungal infections are yeasts of the genus Candida.

Adults
Your doctor may prescribe this medicine for the following fungal infections:

• cryptococcal meningitis – a fungal infection of the brain,
• coccidioidomycosis – a respiratory disease,
• infections caused by Candida yeasts detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
• mucosal candidiasis (thrush) – infection of the mucous membranes of the mouth, throat, and oral lesions associated with denture use,
• genital candidiasis – infections of the vagina or penis,
• skin mycoses – e.g. athlete’s foot, tinea of the trunk, groin, or nails.

Mycosyst may also be used:

• to prevent recurrence of cryptococcal meningitis,
• to prevent recurrence of mucosal candidiasis,
• to prevent recurrence of vaginal candidiasis,
• to prevent candidal infections (in patients with weakened or impaired immune systems).

Newborns, infants, children and adolescents (aged 0 to 17 years)
Your doctor may prescribe this medicine to treat the following fungal infections:

• mucosal candidiasis (thrush) – infections of the mucous membranes of the mouth or throat,
• infections caused by Candida yeasts detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
• cryptococcal meningitis – a fungal infection of the brain.

Mycosyst may also be used:

• to prevent candidal infections (in patients with a weakened or poorly functioning immune system),
• to prevent recurrence of cryptococcal meningitis.

2. Important information before using Mycosyst

When not to use Mycosyst

• If the patient is allergic to fluconazole, or to any other medicines used to treat fungal infections, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, redness of the skin, or difficulty breathing.
• If the patient is taking astemizole or terfenadine (antihistamine medicines used to treat allergies).
• If the patient is taking cisapride (used to treat stomach problems).
• If the patient is taking pimozide (used to treat mental disorders).
• If the patient is taking quinidine (used to treat heart rhythm disorders).
• If the patient is taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions
Before starting treatment with Mycosyst, discuss the following with your doctor or pharmacist:

• If the patient has kidney or liver function disorders,
• If the patient has heart conditions, including heart rhythm disorders,
• If the patient has abnormal blood levels of potassium, calcium, or magnesium,
• If the patient experiences severe skin reactions (such as itching, skin redness, or difficulty breathing),
• If the patient has ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking fluconazole,
• If the patient develops symptoms of "adrenal insufficiency", where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
• If the fungal infection does not improve, alternative antifungal treatment may be necessary.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred in patients treated with fluconazole. If any of the symptoms of severe skin reactions described in section 4 occur, the patient must stop taking Mycosyst immediately and seek medical help without delay.

Children and adolescents
A doctor may also prescribe Mycosyst to children and adolescents.

Mycosyst with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Immediately inform your doctor if the patient is taking astemizole, terfenadine (antihistamines used for allergies), cisapride (used for stomach disorders), pimozide (used for mental disorders), quinidine (used for heart rhythm disorders), or erythromycin (an antibiotic used to treat infections), because these should not be used together with Mycosyst (see section "When not to use Mycosyst").

Some other medicines may also interact with Mycosyst. If the patient is taking any of the following medicines, ensure the doctor is informed, as dose adjustment or monitoring may be necessary to ensure the medicines remain effective:

• rifampicin or rifabutin (antibiotics used to treat infections),
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema),
• alfentanil, fentanyl (anaesthetic medicines),
• amitriptyline, nortriptyline (antidepressant medicines),
• amphotericin B, voriconazole (antifungal medicines),
• anticoagulant medicines that prevent blood clotting (warfarin or similar medicines),
• benzodiazepines (midazolam, triazolam or similar medicines) used to aid sleep or for calming,
• carbamazepine, phenytoin (used to treat seizures),
• nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (used to treat high blood pressure),
• olaparib (used to treat ovarian cancer),
• cyclosporine, everolimus, sirolimus, or tacrolimus (used to prevent organ transplant rejection),
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used to treat cancer,
• halofantrine (used to treat malaria),
• statins (atorvastatin, simvastatin, and fluvastatin or similar medicines) used to lower cholesterol levels,
• methadone (a painkiller),
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs - NSAIDs),
• oral contraceptives,
• prednisone (a steroid),
• zidovudine, also known as AZT; saquinavir (used in HIV patients),
• antidiabetic medicines such as chlorpropamide, glyburide, glipizide, or tolbutamide,
• theophylline (used in asthma),
• tofacitinib (used to treat rheumatoid arthritis),
• tolvaptan [used to treat hyponatremia (low sodium levels in blood) or to slow worsening of kidney function],
• vitamin A (dietary supplement),
• ivacaftor (used alone or in combination with other medicines to treat cystic fibrosis),
• amiodarone (used to treat heart rhythm disorders – "arrhythmias"),
• hydrochlorothiazide (a diuretic),
• ibrutinib (used to treat blood cancer),
• lurasidone (used to treat schizophrenia).

Taking Mycosyst with food and drink
This medicine can be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

If the patient plans to become pregnant, it is recommended to wait one week after taking a single dose of fluconazole before attempting conception.

For longer treatment courses with fluconazole, discuss with your doctor the need for appropriate contraception during treatment and for one week after the last dose.

If the patient is pregnant, suspects she may be pregnant, or is planning to have a baby, she should not take fluconazole unless advised by a doctor. If the patient becomes pregnant or suspects she may be pregnant while taking this medicine or within one week after the last dose, she should contact her doctor.

Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage.

Fluconazole taken during the first trimester of pregnancy may increase the risk of congenital heart, bone, and/or muscle defects in the newborn.

Cases of children born with congenital skull, ear, femur, and elbow abnormalities have been reported in mothers treated for coccidioidomycosis with high doses of fluconazole (400–800 mg daily) for at least three months. The link between fluconazole use and these cases is not fully established.

Breastfeeding may be continued after a single 150 mg dose of Mycosyst.

Breastfeeding should not be undertaken if the patient is taking multiple doses of Mycosyst or high doses of the medicine.

Driving and using machines
When driving or operating machinery, it should be noted that dizziness or seizures may occasionally occur. If dizziness or feeling unwell occurs, the patient should not drive or operate machinery.

Mycosyst contains lactose (milk sugar)
Each Mycosyst capsule contains 148.5 mg of lactose. If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Mycosyst

This medicine should always be used as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
For doses that cannot be achieved with capsules of this strength, other strengths of this
medicinal product are available on the market.
The capsule should be swallowed whole, with a glass of water. It is best to take the capsules
daily at the same time. The capsule form of this medicine is not suitable for use in infants and young children, or in
patients who have difficulty swallowing. Oral liquid formulations of fluconazole are more appropriate
for this population. Mycosyst is not available in liquid form. In infants and young children, an alternative product containing the same active substance (fluconazole) should be used.
Recommended dosing of fluconazole, depending on the type of infection, is presented below.

Adults

| Type of infection | Dose | |------------------------|----------| | Treatment of cryptococcal meningitis | 400 mg on the first day, followed by 200 mg to 400 mg once daily for 6 to 8 weeks, or longer if necessary. The dose may sometimes be increased to 800 mg | | Prevention of recurrence of cryptococcal meningitis | 200 mg once daily until the doctor decides to discontinue treatment | | Treatment of coccidioidomycosis | 200 mg to 400 mg once daily for 11 to 24 months, or longer if necessary. The dose may sometimes be increased to 800 mg | | Treatment of systemic Candida infections | 800 mg on the first day, followed by 400 mg once daily until the doctor decides to discontinue treatment | | Treatment of oral, pharyngeal, and esophageal mucosal candidiasis associated with denture use | 200 mg to 400 mg on the first day, followed by 100 mg to 200 mg once daily until the doctor decides to discontinue treatment | | Mucosal candidiasis (thrush) – dose depends on location | 50 mg to 400 mg once daily for 7 to 30 days, until the doctor decides to discontinue treatment | | Prevention of recurrence of oral and pharyngeal mucosal infections | 100 mg to 200 mg once daily, or 200 mg three times weekly, if the patient is at increased risk of recurrence | | Treatment of vaginal yeast infections | Single dose of 150 mg | | Prevention of vaginal yeast infection recurrence | 150 mg every third day, for a total of 3 doses (day 1, 4, and 7), followed by once weekly for 6 months (if the patient is at increased risk of recurrence) | | Treatment of fungal skin and nail infections | Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300 mg to 400 mg once weekly for 1 to 4 weeks (in tinea pedis, treatment may need to continue for up to 6 weeks; in nail infections, treatment should continue until the infected nail is completely replaced by a new, healthy nail) | | Prevention of candidiasis (if the patient's immune system is impaired and not functioning properly) | 200 to 400 mg once daily, if the patient is at increased risk of recurrence |

Use in children and adolescents

Adolescents aged 12 to 17 years
Administer the dose prescribed by the physician (dosing as in adults or as in children).

Infants, young children, and children (aged 28 days to 11 years)
The maximum daily dose in children is 400 mg.
The dose will be determined based on the child's body weight in kilograms.

| Type of infection | Daily dose | |------------------------|----------------| | Mucosal candidiasis of the mouth and throat – dose and duration depend on severity and site of infection | 3 mg/kg body weight once daily (on the first day, a dose of 6 mg/kg body weight may be given) | | Cryptococcal meningitis or systemic candidiasis | 6 to 12 mg/kg body weight once daily | | Prevention of recurrence of cryptococcal meningitis | 6 mg/kg body weight once daily | | Prophylaxis of candidiasis in children (if the immune system is not functioning properly) | 3 to 12 mg/kg body weight once daily |

Dosing in newborns aged 0 to 4 weeks of life (aged 0 to 27 days)

Newborns under 2 weeks of life (aged 0 to 14 days)
Same dose in mg/kg body weight as for infants, young children, and children (see above), but administered once every 72 hours. Maximum dose is 12 mg/kg body weight every 72 hours.

Newborns aged 3 to 4 weeks of life (aged 15 to 27 days)
Same dose in mg/kg body weight as for infants, young children, and children (see above), but administered once every 48 hours. Maximum dose is 12 mg/kg body weight every 48 hours.

Elderly patients
The usual adult dose is administered unless the patient has impaired renal function.

Renal impairment
The physician may adjust the dosing regimen depending on renal function.

Hepatic impairment
Caution should be exercised when using fluconazole in patients with hepatic impairment; therefore, the physician will decide whether Mycosyst can be used.

Use of a higher than recommended dose of Mycosyst
Taking too many capsules at once may cause discomfort. Seek immediate medical attention from your doctor or the nearest hospital emergency department. Symptoms of overdose may include hearing, vision, and sensory disturbances, thinking about unreal things (hallucinations and paranoid behavior). Symptomatic treatment may be necessary (supportive care for vital functions and gastric lavage if required).

Missed dose of Mycosyst
Do not take a double dose to make up for a missed dose. If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose.

Stopping treatment with Mycosyst
If the patient wishes to discontinue this medicine, they should consult their doctor first. Too short a treatment duration may lead to recurrence of infection.

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

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone gets them.
If any of the following symptoms occur in a patient, treatment with Mycosyst should be discontinued and immediate medical help should be sought:

• extensive rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Some people may experience allergic reactions, although severe allergic reactions are rare. If any of the following symptoms occur, inform your doctor immediately:

• sudden wheezing, difficulty breathing, or chest tightness,
• swelling of the eyelids, face, or lips,
• itching all over the body, skin redness, or red, itchy blisters,
• skin rash,
• severe skin reactions, such as rash with blistering (may also affect the mouth and tongue).

Mycosyst may affect the liver. Symptoms related to the liver include:

• feeling of fatigue,
• loss of appetite,
• vomiting,
• yellowing of the skin or whites of the eyes (jaundice). If any of the above symptoms occur, treatment with Mycosyst should be discontinued and immediate contact with a doctor should be made.

Adverse reactions
If any adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Common adverse reactions (may occur in less than 1 in 10 patients) are:

• headache;
• abdominal pain, diarrhoea, nausea, vomiting;
• increased liver function test values;
• rash.

Uncommon adverse reactions (may occur in less than 1 in 100 patients) are:

• decrease in the number of red blood cells causing paleness, weakness, and shortness of breath,
• loss of appetite,
• insomnia, drowsiness,
• seizures, dizziness, vertigo, tingling, pricking, or burning sensations, taste disturbances,
• constipation, indigestion, bloating, dryness of the mouth,
• muscle pain,
• liver damage and yellowing of the skin and eyes (jaundice),
• blisters, rash (urticaria), itching, increased sweating,
• feeling of fatigue, malaise, fever.

Rare adverse reactions (may occur in less than 1 in 1,000 patients) are:

• decrease in the number of white blood cells involved in the body's defense against infections and in blood platelets that help stop bleeding,
• red or purple skin discolouration, possibly due to reduced platelet count or changes in other blood cells,
• changes in blood biochemical parameters (elevated cholesterol, blood lipids),
• decreased potassium levels in the blood,
• tremor,
• abnormalities in ECG, heart rate or heart rhythm disturbances,
• liver failure,
• allergic reactions (sometimes severe), including extensive blistering rash, skin peeling, severe skin reactions, swelling of the lips or face,
• hair loss.

Frequency unknown (frequency cannot be estimated from available data):

• hypersensitivity reaction with skin rash, fever, swollen lymph nodes, increased number of certain white blood cells (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and colon) [drug reaction or rash with eosinophilia and systemic symptoms (DRESS)].

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Mycosyst

Keep the medicine out of sight and reach of children.
Store the medicine below 30ºC.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Mycosyst contains

• The active substance is flukonazol. One capsule contains 200 mg of fluconazole.
• Other ingredients are: colloidal anhydrous silicon dioxide, magnesium stearate, talc, povidone (PVP K30), corn starch, anhydrous lactose (see section 2 of the Package Leaflet).
• Capsule cap: indigo carmine (E 132), titanium dioxide (E 171), gelatin
• Capsule body: titanium dioxide (E 171), gelatin

What Mycosyst looks like and contents of the pack
White gelatin capsule with a dark blue cap. The capsule is size number 0.
Capsules are packed in PVC/Aluminum blisters containing 7 capsules. Each cardboard box contains one or two blisters.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21,
1103 Budapest,
Hungary

For further information regarding this medicinal product, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]