Micosist

Package Leaflet: Information for the Patient

Mycosyst, 50 mg, Capsules

Mycosyst, 100 mg, Capsules

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

• Keep this leaflet. You may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed 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 mentioned 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 pack and other information

1. What is Mycosyst and what is it used for

Mycosyst belongs to a group of medicines called antifungals. The active substance is fluconazole.
Mycosyst is used to treat fungal infections and can also be used to prevent fungal infections.

• Cryptococcal meningitis - a fungal infection of the brain,
• Coccidioidomycosis - a disease of the respiratory system,
• Infections caused by Candida fungi and detected in the blood, internal organs (e.g., heart, lungs), or urinary tract,
• Fungal infections (thrush) of the mucous membranes - infection of the mucous membranes 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 fungi - e.g., athlete's foot, body fungus, groin fungus, nail fungus.

Mycosyst can also be used to:

• Prevent relapses of cryptococcal meningitis,
• Prevent relapses of fungal infections of the mucous membranes,
• Prevent relapses of vaginal fungal infections,
• Prevent fungal infections (in patients with a weakened immune system).

Newborns, infants, children, and adolescents (from 0 to 17 years old)
The doctor may prescribe this medicine for the treatment of the following fungal infections:

• Fungal infections (thrush) of the mucous membranes - infection of the mucous membranes of the mouth and throat,
• Infections caused by Candida fungi 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 medicines used to treat fungal infections or any of the other ingredients of this medicine (listed in section 6). Symptoms may include hives, skin redness, or difficulty breathing.
• If the patient is taking astemizole, 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 used to treat infections).

Warnings and precautions

Before starting treatment with Mycosyst, the patient should discuss the following 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 redness, difficulty breathing),
• if the patient has ever experienced 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, alternative antifungal treatment may be necessary.

In patients treated with fluconazole, severe skin reactions have occurred, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). If the patient experiences any symptoms of severe skin reactions, they should stop taking Mycosyst and seek medical attention immediately.

Children and adolescents

The doctor may also prescribe Mycosyst for children and adolescents.

Mycosyst and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should immediately inform 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 these medicines 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 the dose of the medicine or monitoring of the patient may be necessary to ensure the medicines continue to work as expected:

• rifampicin or rifabutin (antibiotics used to treat 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 (used to prevent transplant rejection),
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or other similar medicines) 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 (nonsteroidal 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, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine.
If the patient plans to become pregnant, it is recommended that they wait for 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 adequate 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 become pregnant, 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/or bones of the hip and elbow, born to mothers treated with high doses of fluconazole (400-800 mg per day) for at least 3 months for coccidioidomycosis. 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 take into account that dizziness or seizures may occasionally occur. If the patient experiences dizziness or feels unwell, they should not drive or operate machines.

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.
The capsule should be swallowed whole, with a glass of water. The capsules are best taken at the same time every day.
The medicine in capsule form is not suitable for infants, young children, and patients with swallowing difficulties. Liquid oral preparations of fluconazole 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.
The recommended fluconazole dosing depends on the type of infection and is presented below.

Adults

Type of infection Dosage

400 mg on the first day, then 200-400 mg once daily for 6-8 weeks or longer if necessary. The dose may be increased to 800 mg.
Prevention of relapses of cryptococcal meningitis
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. The dose may be increased to 800 mg.
Treatment of internal organ infections caused by Candida fungi
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 membranes 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 membranes - 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 membranes 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 fungal 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, healthy one)
Prevention of fungal infections (if the patient's immune system is weak and not functioning properly)
200-400 mg once daily, if the patient is at high risk of relapse

Use in children and adolescents

Adolescents (12-17 years old)
The doctor will prescribe a dose (the same as for adults or children).
Infants, young children, and children (from 28 days to 11 years old)
The maximum dose for children is 400 mg per day. The dose will be determined based on the child's weight in kilograms.

Type of infection Daily dose

Fungal infections of the mucous membranes of the mouth and throat - the dose and duration of treatment depend on the severity and location of the infection
3 mg/kg once daily (on the first day, a dose of 6 mg/kg may be given)
6-12 mg/kg once daily
Cryptococcal meningitis or fungal infections of internal organs
6 mg/kg 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 once daily
Dosing in newborns (0-4 weeks old)
Newborns under 2 weeks old (0-14 days old)
The same dose in mg/kg 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 3-4 weeks old (15-27 days old)
The same dose in mg/kg 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.

Renal impairment

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

Hepatic impairment

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

Overdose

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

Missed dose

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 missed dose should not be taken.

Stopping treatment

If the patient wants to stop treatment, 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 the use of 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 attention immediately:

• extensive rash, high fever, and swollen lymph nodes (DRESS or 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 immediately inform their doctor:

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

Mycosyst may affect the liver. Symptoms from the liver include:

• feeling tired,
• loss of appetite,
• nausea and vomiting,
• yellowing of the skin or whites of the eyes (jaundice).

If the patient experiences any of the above symptoms, they should stop taking Mycosyst and immediately contact their doctor.

Side effects

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

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

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

• reduced red blood cell count, which can cause pallor, weakness, and shortness of breath,
• reduced 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),
• hives, blisters (urticaria), itching, increased sweating,
• feeling tired, unwell, or feverish.

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

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

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

• hypersensitivity reaction with skin rash, fever, and swollen lymph nodes, increased white blood cell count (eosinophilia), and inflammation of internal organs (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS).

Reporting side effects

If the patient experiences any side effects, including any side effects not mentioned in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Mycosyst

Keep the medicine out of the sight and reach of children.
Do not store above 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 pack and other information

What Mycosyst contains

• -The active substance of the medicine is fluconazole. One capsule contains 50 mg of fluconazole. One capsule contains 100 mg of fluconazole.
• -The other ingredients are: lactose anhydrous (see section 2 of the leaflet), maize starch, colloidal silicon dioxide, magnesium stearate, talc, povidone (K30); capsule:indigo carmine (E 132), titanium dioxide (E 171), gelatin.

What Mycosyst looks like and contents of the pack

Mycosyst, 50 mg, capsules
White gelatin capsule with a light blue cap. The capsule is size 4.
Aluminum/PVC blisters containing 7 capsules. The carton contains 1 blister.
Mycosyst, 100 mg, capsules
White gelatin capsule with a turquoise cap. The capsule is size 2.
Aluminum/PVC blisters containing 7 capsules. The carton contains 1 blister (7 capsules) or 4 blisters (28 capsules).

Marketing authorization holder

Gedeon Richter Polska Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki

Manufacturer

Gedeon Richter Polska Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Gedeon Richter Plc.
Gyömrõi 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