MYCOSYST 200 mg Capsules

Contents of the leaflet

1. Leaflet included in the packaging: patient information
2. Mycosyst, 200 mg, capsules
   1. Table of contents of the leaflet
3. What is Mycosyst and what is it used for
4. Important information before taking Mycosyst
   1. When not to take Mycosyst
   2. Warnings and precautions
   3. Children and adolescents
   4. Mycosyst and other medicines
   5. Taking Mycosyst with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Mycosyst contains lactose (milk sugar)
5. How to take Mycosyst
   1. Dosage and duration of treatment
   2. Type of infection Dosage
   3. Dosage in children and adolescents
   4. Type of infection Daily dose
   5. Kidney problems
   6. Liver problems
   7. Taking too much Mycosyst
   8. Missing a dose of Mycosyst
   9. Stopping Mycosyst treatment
6. Possible side effects
   1. Side effects
   2. Reporting side effects
7. How to store Mycosyst
8. Contents of the packaging and other information
   1. What Mycosyst contains
   2. What Mycosyst looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet included in the packaging: patient information

Mycosyst, 200 mg, capsules

Fluconazole
Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leafletso that you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Mycosyst and what is it 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 packaging and other information

1. What is Mycosyst and what is it 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 fungal infections.
The most common cause of fungal infections is a type of yeast called Candida.
Adults
The doctor may prescribe this medicine for the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain,
• Coccidioidomycosis - a respiratory system disease,
• Infections caused by Candidayeast and detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
• Fungal infections (thrush) of the mucous membrane - infection of the mucous membrane of the mouth, throat, and mouth sores associated with the use of dental prostheses,
• Fungal infections of the genital organs - infections of the vagina or penis,
• Skin fungus - e.g. athlete's foot, fungal infection of the torso, groin, and fingernails.

Mycosyst can also be used to:

• prevent relapses of cryptococcal meningitis,
• prevent relapses of fungal infections of the mucous membrane of the mouth and throat,
• prevent relapses of vaginal yeast infections,
• prevent fungal infections (in patients with a weakened immune system).

Infants, children, and adolescents (from 0 to 17 years old)
The doctor may prescribe this medicine to treat the following fungal infections:

• Fungal infections (thrush) of the mucous membrane - infection of the mucous membrane of the mouth or throat,
• Infections caused by Candidayeast and detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
• Cryptococcal meningitis - a fungal infection of the brain.

Mycosyst can also be used to:

• prevent fungal infections (if the patient's immune system is weak and not functioning properly),
• prevent relapses of cryptococcal meningitis.

2. Important information before taking Mycosyst

When not to take Mycosyst

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

Warnings and precautions

Before starting to take Mycosyst, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney or liver problems,
• if the patient has heart disease, including heart rhythm disorders,
• if the patient has abnormalities in blood potassium, calcium, or magnesium levels,
• if the patient experiences severe skin reactions (hives, skin rash, or difficulty breathing),
• if the patient has ever had a severe skin rash or skin peeling after taking fluconazole,
• if the patient develops symptoms of "adrenal insufficiency" (chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
• if the fungal infection does not improve, other antifungal treatment may be necessary.

In patients treated with fluconazole, there have been reports of severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). If the patient experiences any of the severe skin reactions described in section 4, they should stop taking Mycosyst and seek medical help immediately.

Children and adolescents

The doctor may also prescribe Mycosyst to children and adolescents.

Mycosyst and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or plan to take.
The patient should immediatelyinform their doctor about taking astemizole, terfenadine (antihistamines used to treat allergies), or cisapride (used to treat stomach disorders), or pimozide (used to treat mental disorders), or quinidine (used to treat heart rhythm disorders), or erythromycin (an antibiotic used to treat infections), as they should not be taken with Mycosyst (see "When not to take Mycosyst").
Some other medicines may also interact with Mycosyst. If the patient is taking any of the following medicines, they should make sure their doctor is informed, as it may be necessary to adjust the dose or monitor the patient to check if the medicines are still effective:

• rifampicin or rifabutin (antibiotics for infections),
• abrocitinib (used to treat atopic dermatitis, also known as eczema),
• alfentanil, fentanyl (anesthetics),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• blood thinners that prevent blood clots (warfarin or similar medicines),
• benzodiazepines (midazolam, triazolam, or other similar medicines) that help with sleep or sedation,
• 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 (to prevent transplant rejection),
• cyclophosphamide, vincristine (used to treat cancer),
• halofantrine (used to treat malaria),
• statins (atorvastatin, simvastatin, and fluvastatin or other similar medicines) used to lower cholesterol levels,
• methadone (a pain reliever),
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory medicines - NSAIDs),
• oral contraceptives,
• prednisone (a steroid),
• zidovudine, also known as AZT; saquinavir (used in HIV patients),
• antidiabetic medicines, such as chlorpropamide, glibenclamide, glipizide, or tolbutamide,
• theophylline (used to treat asthma),
• tofacitinib (used to treat rheumatoid arthritis),
• tolvaptan (used to treat hyponatremia or to slow the worsening of kidney function),
• vitamin A (dietary supplement),
• ivacaftor (given alone or in combination with other medicines used to treat cystic fibrosis),
• amiodarone (used to treat heart rhythm disorders - "arrhythmia"),
• hydrochlorothiazide (a diuretic),
• ibrutinib (used to treat blood cancer),
• lurasydon (used to treat schizophrenia).

Taking Mycosyst with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
If the patient plans to become pregnant, it is recommended that they wait one week after taking a single dose of fluconazole before becoming pregnant.
In case of longer treatment cycles with fluconazole, the patient should discuss the need for proper contraception during treatment and for one week after the last dose with their doctor.
If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should not take fluconazole unless their doctor has advised them to do so. If the patient becomes pregnant or thinks they may be pregnant while taking this medicine or within one week of the last dose, they should contact their 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 birth defects of the heart, bones, and/or muscles.
There have been reports of children with birth defects of the skull, ears, and bones of the thigh and forearm, born to mothers treated with fluconazole for coccidioidomycosis for at least 3 months with high doses (400-800 mg per day). The relationship between fluconazole and these cases is unclear.
The patient can continue breastfeeding after taking a single dose of Mycosyst 150 mg.
The patient should not breastfeed if they are taking multiple doses of Mycosyst or if they are taking high doses of the medicine.

Driving and using machines

While driving or operating machines, the patient should consider that dizziness or seizures may occasionally occur. If the patient experiences dizziness or feels unwell, they should not drive or operate machines.

Mycosyst contains lactose (milk sugar)

Each Mycosyst capsule contains 148.5 mg of lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Mycosyst

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
For doses that cannot be obtained with the help of 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. Capsules are best taken at the same time every day. The capsule form is not suitable for infants, young children, and patients with swallowing difficulties. Liquid oral fluconazole preparations are more suitable for this population. Mycosyst is not available in a liquid form. In infants and young children, an alternative product containing the same active substance (fluconazole) should be used.

Dosage and duration of treatment

The recommended fluconazole dosage, depending on the type of infection, is presented below.

Type of infection Dosage

400 mg on the first day, then 200-400 mg once daily for 6-8 weeks or longer if necessary. Sometimes the dose is increased to 800 mg.
Treatment of cryptococcal meningitis
200 mg once daily until the doctor decides to stop treatment.
Treatment of coccidioidomycosis
200-400 mg once daily for 11-24 months or longer if necessary. Sometimes the dose may be increased to 800 mg.
Prevention of relapses of cryptococcal meningitis
Treatment of internal organ infections caused by Candidayeast
800 mg on the first day, then 400 mg once daily until the doctor decides to stop treatment.
Treatment of fungal infections of the mucous membrane of the mouth, throat, and mouth sores associated with the use of dental prostheses
200-400 mg on the first day, then 100-200 mg once daily until the doctor decides to stop treatment.
Fungal infections (thrush) of the mucous membrane - the dose depends on the location
50-400 mg once daily for 7-30 days, until the doctor decides to stop treatment.
Prevention of relapses of fungal infections of the mucous membrane of the mouth and throat
100-200 mg once daily, or 200 mg 3 times a week, if the patient is at high risk of relapse.
Treatment of fungal infections of the genital organs
A single dose of 150 mg.
Prevention of relapses of vaginal yeast infections
150 mg every third day, for a total of 3 doses (days 1, 4, and 7), and then once a week for 6 months (if the patient is at high risk of relapse).
Treatment of fungal skin and nail infections
Depending on the location of the infection, 50 mg once daily, 150 mg once a week, or 300-400 mg once a week for 1-4 weeks (in athlete's foot, treatment may be necessary for up to 6 weeks; in nail infections, treatment should be continued until the infected nail is replaced by a new, uninfected one).
200-400 mg once daily if the patient is at high risk of relapse.

Dosage in children and adolescents

Adolescents (12-17 years old)
The patient should take the dose prescribed by the doctor (the same dosage as for adults or children).
Prevention of fungal infections (if the patient's immune system is weak and not functioning properly)
Infants, young children, and children (from 28 days to 11 years old)
The maximum dose in children is 400 mg per day.
The dose will be determined based on the child's body weight in kilograms.

Type of infection Daily dose

Fungal infections of the mucous membrane of the mouth and throat - the dose and duration of treatment depend on the severity and location of the infection
3 mg/kg body weight once daily (on the first day, a dose of 6 mg/kg body weight may be given)
6-12 mg/kg body weight once daily
Cryptococcal meningitis or fungal infections of internal organs
6 mg/kg body weight once daily
Prevention of relapses of cryptococcal meningitis
Prevention of fungal infections in children (if the immune system is not functioning properly)
3-12 mg/kg body weight once daily
Dosage in newborns (from 0 to 4 weeks old)
Newborns under 2 weeks old (from 0 to 14 days old)
The same dose in mg/kg body weight as for infants, young children, and children (see above), but given every 72 hours. The maximum dose is 12 mg/kg every 72 hours.
Newborns from 3 to 4 weeks old (from 15 to 27 days old)
The same dose in mg/kg body weight as for infants, young children, and children (see above), but given every 48 hours. The maximum dose is 12 mg/kg every 48 hours.
Elderly patients
The usual adult dose is given, unless the patient has kidney problems.

Kidney problems

The doctor may recommend a dose change, depending on the patient's kidney function.

Liver problems

Caution should be exercised when using fluconazole in patients with liver problems, as the doctor will decide whether to use Mycosyst.

Taking too much Mycosyst

Taking too many capsules at once may cause discomfort. The patient should contact their doctor or the emergency department of the nearest hospital immediately. Symptoms of possible overdose may include hearing, vision, or sensation disturbances, and hallucinations or paranoid behavior. Supportive treatment (life-supporting treatment and stomach lavage if necessary) may be indicated.

Missing a dose of Mycosyst

The patient should not take a double dose to make up for a missed dose. If a dose is missed, the patient should take it as soon as they remember. If it is almost time for the next dose, the patient should not take the missed dose.

Stopping Mycosyst treatment

If the patient wants to stop taking this medicine, they should consult their doctor for advice. Stopping treatment too early may lead to a relapse of the infection.
In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they should stop taking Mycosyst and seek medical help immediately:

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

Some people may experience allergic reactions, although severe allergic reactions are rare. If the patient experiences any of the following symptoms, they should inform their doctor immediately:

• sudden wheezing, difficulty breathing, or chest tightness,
• swelling of the eyelids, face, or lips,
• hives, skin rash, or red or itchy blisters,
• skin rash,
• severe skin reactions, such as a rash with blisters (which can also affect the mouth and throat).

Mycosyst may affect the liver. Liver-related symptoms include:

• feeling tired,
• loss of appetite,
• nausea and vomiting,
• yellowing of the skin and eyes (jaundice). If the patient experiences any of these symptoms, they should stop taking Mycosyst and contact their doctor immediately.

Side effects

If any of the side effects get worse or if the patient experiences any side effects not listed in the leaflet, they should inform their doctor or pharmacist.
Common side effects (may occur in up to 1 in 10 patients) include:

• headache;
• stomach pain, diarrhea, nausea, vomiting;
• increased liver enzyme values;
• skin rash.

Uncommon side effects (may occur in up to 1 in 100 patients) include:

• decreased red blood cell count, which can cause pallor, weakness, and shortness of breath,
• decreased appetite,
• insomnia, drowsiness,
• seizures, dizziness, feeling of spinning, tingling, numbness, or altered taste,
• constipation, indigestion, bloating, dry mouth,
• muscle pain,
• liver damage and yellowing of the skin and eyes (jaundice),
• blisters, hives, itching, increased sweating,
• feeling tired, unwell, or feverish.

Rare side effects (may occur in up to 1 in 1,000 patients) include:

• decreased white blood cell count, which can increase the risk of infection, or decreased platelet count, which can increase the risk of bleeding,
• red or purple discoloration of the skin, which can be a sign of decreased platelet count or changes in other blood cells,
• changes in blood biochemistry parameters (high cholesterol or lipid levels),
• decreased potassium levels in the blood,
• diarrhea,
• abnormal ECG, arrhythmia, or heart rhythm disorders,
• liver failure,
• allergic reactions (sometimes severe), including extensive rash, skin peeling, and severe skin reactions, swelling of the lips or face,
• hair loss.

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

• drug reaction with eosinophilia and systemic symptoms (DRESS), which can cause rash, fever, and swelling of the lymph nodes, as well as inflammation of internal organs (liver, lungs, heart, kidneys, and intestines).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Mycosyst

The medicine should be kept out of the sight and reach of children.
The medicine should be stored at a temperature below 30°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Mycosyst contains

• -The active substance of the medicine is fluconazole. One capsule contains 200 mg of fluconazole.
• -The other ingredients are: colloidal silicon dioxide, magnesium stearate, talc, povidone (PVP K30), cornstarch, lactose (see section 2 of the leaflet). Capsule shell - cap: indigo carmine (E 132), titanium dioxide (E 171), gelatin. Capsule shell - 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 0.
Capsules are packaged in PVC/Aluminum blisters containing 7 capsules. The carton contains one or two blisters.

Marketing authorization holder and manufacturer

Gedeon Richter Plc.
Gyömrői út 19-21,
1103, Budapest,
Hungary
For more information about this medicine, the patient should 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]

Date of last revision of the leaflet: