Mycosyst

Patient Information Leaflet

Mycosyst, 50 mg, capsules
Mycosyst, 100 mg, capsules
Fluconazole
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet 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 medicines called antifungals. The active substance is fluconazole.
Mycosyst is used to treat fungal infections and may 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,
• Candida infections detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
• mucosal Candida infections (thrush) – infection of the mucous membranes of the mouth, throat, and denture-related stomatitis,
• genital Candida infections – vaginal or penile infections,
• 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,
• prevent recurrence of mucosal Candida infections,
• prevent recurrence of vaginal Candida infections,
• prevent Candida 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 Candida infections (thrush) – infections of the mucous membranes of the mouth and throat,
• Candida infections 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 Candida infections (if the patient's immune system is weak or not functioning properly),
• prevent recurrence of cryptococcal meningitis.

2. Important information before using Mycosyst

When not to use Mycosyst

• If the patient is allergic to fluconazole or 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, skin redness, 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 (itching, skin redness, difficulty breathing),
• If the patient has ever had 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 the patient experiences any of the symptoms of severe skin reactions described in section 4, treatment with Mycosyst must be stopped immediately and medical help must be sought without delay.

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

Mycosyst and 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), as these should not be taken together with Mycosyst (see section "When not to use Mycosyst").

Some other medicines may interact with Mycosyst. If the patient is taking any of the following medicines, ensure the doctor is informed, as dose adjustments 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 (antidepressants),
• Amphotericin B, voriconazole (antifungal medicines),
• Medicines that reduce blood clotting and prevent blood clots (warfarin or similar medicines),
• Benzodiazepines (midazolam, triazolam or similar medicines) used to help 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 transplant rejection),
• Cyclophosphamide, vinca alkaloids (vincristine, winblastine or similar medicines) used to treat cancer,
• Halofantrine (used to treat malaria),
• Statins (atorvastatin, simvastatin, 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 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 – "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, 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 specifically 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 immediately.
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 baby.
Cases of infants born with cranial, ear, femoral, and elbow bone malformations have been reported in mothers treated for coccidioidomycosis with high-dose fluconazole (400–800 mg daily) for at least three months. The causal relationship between fluconazole use and these cases is not clear.
Breastfeeding may continue after a single 150 mg dose of Mycosyst.
Breastfeeding should be avoided if the patient is taking multiple doses of Mycosyst or high doses of the medicine.

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

3. How to take Mycosyst

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.

The capsule should be swallowed whole with a glass of water. It is best to take the capsules at the same time each day.

The capsule form of this medicine is not suitable for use in infants, young children, or patients who have difficulty swallowing. Oral liquid formulations of fluconazole are more appropriate for these populations. Mycosyst is not available in liquid form. In infants and young children, an alternative product containing the same active substance (fluconazole) should be used.

The recommended dosage of fluconazole depends on the type of infection and is given below.

Adults

| Type of infection | Dose | |-------------------|------| | Treatment of cryptococcal meningitis | 400 mg on the first day, then 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 your doctor advises stopping 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 fungal infections | 800 mg on the first day, then 400 mg once daily until your doctor advises stopping treatment | | Treatment of oral, pharyngeal, and esophageal mucosal infections associated with denture use | 200 mg to 400 mg on the first day, then 100 mg to 200 mg once daily until your doctor advises stopping treatment | | Mucosal candidiasis (thrush) – dose depends on site of infection | 50 mg to 400 mg once daily for 7 to 30 days, until your doctor advises stopping 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 has an increased risk of recurrent infection | | Treatment of fungal infections of the genital organs | Single dose of 150 mg | | Prevention of recurrent vaginal infections | 150 mg every third day, for a total of 3 doses (days 1, 4, and 7), then once weekly for 6 months (if the patient has an increased risk of recurrent infection) | | 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 replaced by a healthy one) | | Prevention of fungal infections (in patients with weakened or impaired immune systems) | 200 mg to 400 mg once daily, if the patient has an increased risk of recurrent infection |

Use in children and adolescents

Adolescents aged 12 to 17 years

The dose prescribed by the doctor should be given (the same dosage as for adults or as for 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 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 fungal infections | 6 to 12 mg/kg body weight once daily | | Prevention of recurrence of cryptococcal meningitis | 6 mg/kg body weight once daily | | Prevention of fungal infections in children (if the immune system is impaired) | 3 to 12 mg/kg body weight once daily |

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

Newborns under 2 weeks of age (aged 0 to 14 days)

The same dose in mg/kg body weight as for infants, young children, and children (see above), but administered once every 72 hours. The maximum dose is 12 mg/kg body weight every 72 hours.

Newborns aged 3 to 4 weeks (aged 15 to 27 days)

The same dose in mg/kg body weight as for infants, young children, and children (see above), but administered once every 48 hours. The maximum dose is 12 mg/kg body weight every 48 hours.

Elderly patients

The usual adult dose is given unless the patient has impaired kidney function.

Impaired kidney function

Your doctor may adjust the dosing regimen depending on kidney function.

Impaired liver function

Caution should be exercised when administering fluconazole to patients with impaired liver function. Your doctor will decide whether Mycosyst can be used.

Taking more Mycosyst than prescribed

Taking too many capsules at once may cause you to feel unwell. You should contact your doctor or the nearest hospital emergency department immediately. Symptoms of overdose may include disturbances in hearing, vision, and sensation, thinking about things that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be required (supportive care for vital functions and gastric lavage if necessary).

If you miss a 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 your next dose, skip the missed dose and take the next dose at the usual time.

Stopping Mycosyst treatment

If you wish to stop taking this medicine, you should consult your doctor first. Stopping treatment too early may lead to recurrence of the 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 in everyone.
If any of the following symptoms occur in a patient, treatment with Mycosyst should be discontinued and immediate medical help should be sought:

• Widespread 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 shortness of breath, difficulty breathing, or chest tightness,
• Swelling of the eyelids, face, or lips,
• Itching of the whole body, skin redness, or red, itchy blisters,
• Skin rash,
• Severe skin reactions, such as blistering rash (may also affect the mouth and tongue).

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

• Feeling of fatigue,
• Loss of appetite,
• Nausea and vomiting,
• Yellowing of the skin or whites of the eyes (jaundice).

If any of the above symptoms occur, stop taking Mycosyst and contact your doctor immediately.

Adverse reactions
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Very common adverse reactions (may affect more than 1 in 10 people) are:

• Headache;
• Abdominal pain, diarrhoea, nausea, vomiting;
• Increased liver function test values;
• Rash.

Not very common adverse reactions (may affect up to 1 in 100 people) are:

• Decreased number of red blood cells, causing paleness, weakness, and shortness of breath,
• Loss of appetite,
• Insomnia, drowsiness,
• Seizures, dizziness, spinning sensation, tingling, pricking, or numbness, taste disturbances,
• Constipation, indigestion, bloating, dry mouth,
• Muscle pain,
• Liver damage and yellowing of the skin and eyes (jaundice),
• Itching, blisters, hives (urticaria), increased sweating,
• Feeling of fatigue, malaise, fever.

Rare adverse reactions (may affect up to 1 in 1000 people) are:

• Decreased number of white blood cells involved in the body's defence against infections and blood cells helping to 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 blood,
• Tremor,
• Abnormalities in ECG, heart rate and rhythm disturbances,
• Liver failure,
• Allergic reactions (sometimes severe), including widespread blistering rash, skin peeling, severe skin reactions, swelling of 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 those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Mycosyst

Keep this medicine out of 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 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 fluconazole. One capsule contains 50 mg of fluconazole. One capsule contains 100 mg of fluconazole.
• Other ingredients are: anhydrous lactose (see section 2 of the Package Leaflet), maize starch, anhydrous colloidal silicon dioxide, magnesium stearate, talc, povidone (K30); capsule shell: indigotine (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 number 4.
Aluminium/PVC blisters containing 7 capsules. Each cardboard box contains 1 blister.
Mycosyst 100 mg capsules
White gelatin capsule with a turquoise cap. The capsule is size number 2.
Aluminium/PVC blisters containing 7 capsules. Each cardboard box contains either 1 blister (7 capsules) or 4 blisters (28 capsules).

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

Manufacturer
Gedeon Richter Polska Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

For further information about this medicine, 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]