Flumicon

Leaflet attached to the packaging: information for the user

Flumycon, 50 mg, hard capsules

Flumycon, 100 mg, hard capsules

Flumycon, 150 mg, hard capsules

Flumycon, 200 mg, hard capsules

Fluconazole

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Flumycon and what is it used for

Flumycon belongs to a group of medicines called "antifungals". The active substance is fluconazole.
Fluconazole is used to treat infections caused by pathogenic fungi and can also be used to prevent yeast infections. The most common cause of fungal infections is yeast called Candida.

Adults

The doctor may recommend taking this medicine for the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain
• Coccidioidomycosis - a disease of the respiratory system
• Infections caused by Candidadetected in the blood, internal organs (e.g. heart, lungs) or urinary tract
• Yeast infections of the mucous membranes - infection of the mucous membrane of the mouth, throat and mouth ulcers associated with the use of dental prostheses
• Yeast infections of the genital organs - infections of the vagina or penis
• Fungal skin infections - e.g. athlete's foot (foot fungus), body fungus, groin fungus, nail fungus.

Flumycon can also be used to:

• prevent relapses of cryptococcal meningitis
• prevent relapses of yeast infections of the mucous membranes
• reduce the frequency of relapses of yeast infections of the vagina
• prevent infections caused by Candida(if the patient's immune system is weak and not functioning properly).

Children and adolescents (from 0 to 17 years old)

The doctor may recommend taking this medicine to treat the following fungal infections:

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

Flumycon can also be used to:

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

2. Important information before taking Flumycon

When not to take Flumycon

• if the patient is allergic to fluconazole, other medicines used to treat fungal infections, or 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, terfenadine (antihistamine medicines used to treat allergies)
• if the patient is taking cisapride (used to treat stomach disorders)
• 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 to take Flumycon, the patient should discuss it with their doctor or pharmacist:

• if the patient has liver or kidney problems
• if the patient has heart disease, including heart rhythm disorders
• if the patient has abnormal levels of potassium, calcium or magnesium in the blood
• if the patient has severe skin reactions (itching, redness of the skin, difficulty breathing)
• if the patient experiences symptoms of "adrenal insufficiency", in which the adrenal glands do not produce enough of certain steroid hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
• if the patient has ever experienced a severe skin rash or peeling of the skin after taking fluconazole.

In patients treated with fluconazole, there have been cases of severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS). If the patient experiences any of the symptoms of severe skin reactions described in section 4, they should stop taking Flumycon and seek medical help immediately.
The patient should talk to their doctor or pharmacist if the fungal infection does not improve, as alternative antifungal therapy may be needed.

Flumycon with other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
The patient should immediatelytell their doctor about taking astemizole, terfenadine (antihistamine medicines 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 fluconazole (see "When not to take Flumycon").
There are also other medicines that may interact with fluconazole. The patient should make sure their doctor knows if they are taking any of the following medicines, as it may be necessary to adjust the dose or monitor to check if the medicines are still working:

• 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)
• blood-thinning medicines, which prevent blood clots (warfarin or similar medicines)
• benzodiazepines (midazolam, triazolam or other similar medicines) that help with sleep or have a calming effect
• carbamazepine, phenytoin (used to treat epilepsy)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used to treat high blood pressure)
• olaparib (used to treat ovarian cancer)
• cyclosporin, 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 and other similar medicines) used to lower cholesterol
• methadone (pain relief medicine)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory medicines - NSAIDs)
• oral contraceptives
• prednisone (steroid)
• zidovudine, also known as AZT; saquinavir (used in patients with HIV)
• 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 (low sodium levels in the blood) or to slow the 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 irregular heartbeat, i.e. arrhythmia)
• hydrochlorothiazide (diuretic medicine)
• ibrutinib (used to treat blood cancer)
• lurasydon (used to treat schizophrenia).

Flumycon with food and drink

The medicine can be taken with or without food.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or are planning 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 for a week after taking a single dose of fluconazole before becoming pregnant.
In the case of longer treatment cycles with fluconazole, the patient should discuss with their doctor the need for appropriate contraception during treatment and for a week after taking the last dose.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or is planning to have a baby, they should not take Flumycon unless their doctor has told them to. If the patient becomes pregnant while taking this medicine or within 1 week of taking 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 congenital heart, bone and/or muscle defects in the newborn baby.
There have been cases of children with congenital skull, ear and/or femur and ulna defects born to mothers treated for coccidioidomycosis with high doses of fluconazole (400-800 mg per day) for at least 3 months. The relationship between fluconazole use and these cases is unclear.
The patient can continue breastfeeding after taking a single dose of 150 mg of Flumycon.
The patient should not breastfeed if they are taking multiple doses of Flumycon.

Driving and using machines

When driving or using machines, the patient should take into account that dizziness or seizures may occasionally occur.

Flumycon contains lactose and sodium

Lactose: If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
Sodium: The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

Flumycon 200 mg also contains azorubine (E 122)

The medicine may cause allergic reactions.

3. How to take Flumycon

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, 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 capsules can be taken with or without food.
The recommended dosage, depending on the type of infection, is presented below:

Adults

Indication Dosage

Treatment of cryptococcal meningitis
400 mg on the first day, then 200 mg to 400 mg once a day for 6 to 8 weeks or longer if necessary. Sometimes the dose is increased to 800 mg.
Prevention of relapses of cryptococcal meningitis
200 mg once a day until the doctor recommends stopping treatment.
Treatment of coccidioidomycosis
200 mg to 400 mg once a day for 11 months to 24 months or longer if necessary. Sometimes the dose may be increased to 800 mg.
Treatment of internal organ infections caused by Candida
800 mg on the first day, then 400 mg once a day until the doctor recommends stopping treatment.
Treatment of yeast infections of the mucous membranes of the mouth, throat and mouth ulcers associated with the use of dental prostheses
200 mg to 400 mg on the first day, then 100 mg to 200 mg once a day until the doctor recommends stopping treatment.
Yeast infections of the mucous membranes - the dose depends on the location
50 mg to 400 mg once a day for 7 to 30 days, until the doctor recommends stopping treatment.
Prevention of relapses of yeast infections of the mouth and throat
100 mg to 200 mg once a day, or 200 mg 3 times a week, if the patient is at increased risk of relapse.
Treatment of yeast infections of the genital organs
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 increased risk of relapse.
Treatment of fungal skin and nail infections Depending on the location of the infection, 50 mg once a day, 150 mg once a week, 300 mg to 400 mg once a week for 1 to 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).
Prevention of infections caused by Candida(if the patient's immune system is weak and not functioning properly)
200 mg to 400 mg once a day, if the patient is at increased risk of relapse.

Use in children and adolescents

Adolescents from 12 to 17 years old

The dose prescribed by the doctor should be taken (as for adult patients or as for children).

Children up 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.

Indication Daily dose

Yeast infections of the mucous membranes of the mouth and throat caused by Candida- the dose and duration of treatment depend on the severity and location of the infection
3 mg per kg of body weight once a day (on the first day, a dose of 6 mg per kg of body weight can be given)
Cryptococcal meningitis or internal organ infections caused by Candida
6 mg to 12 mg per kg of body weight once a day
Prevention of relapses of cryptococcal meningitis
6 mg per kg of body weight once a day
3 mg to 12 mg per kg of body weight once a day
Prevention of infections caused by Candidain children (if the immune system is not functioning properly)

Use in children from 0 to 4 weeks old

Use in children from 3 to 4 weeks old:

• The same dose as above, but given every other day. The maximum dose is 12 mg per kg of body weight every 48 hours.

Use in children under 2 weeks old:

• The same dose as above, given every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.

Sometimes the doctor may recommend a different dosage. This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.

Elderly patients

The usual dose for adults is given, unless the patient has kidney problems.

Patients with kidney problems

The doctor may recommend changing the dosage, depending on the patient's kidney function.

Taking more Flumycon than recommended

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, thinking about untrue things (hallucinations and paranoid behaviour). Symptomatic treatment (life-supporting treatment and stomach lavage, if necessary) may be indicated.

Missing a dose of Flumycon

The patient should nottake a double dose to make up for a missed dose.
If the patient misses a dose, they 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.
If the patient has any further doubts about taking this medicine, they 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 Flumycon and seek medical help immediately:

• widespread rash, high fever and swollen lymph nodes (DRESS or hypersensitivity syndrome), Some patients may experience allergic reactions, however, severe allergic reactions are rare. If the patient experiences any of the following symptoms, they should immediatelytell their doctor :
• sudden wheezing, difficulty breathing or chest tightness
• swelling of the eyelids, face or lips
• itching all over the body, redness of the skin or itchy, red, blistering skin
• skin rash
• severe skin reactions, such as blistering rash (which may affect the mouth and tongue).

Flumycon may affect the liver. Symptoms of liver problems include:

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

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

Other side effects:

Additionally, if any of the side effects get worse or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist.
Common side effects, which may affect up to 1 in 10 people:

• headache
• rash
• stomach problems, nausea, vomiting, diarrhoea
• increased liver enzyme activity (in liver function tests)

Uncommon side effects, which may affect up to 1 in 100 people:

• reduced number of red blood cells, which can cause pallor, weakness and shortness of breath
• reduced appetite
• insomnia, drowsiness
• seizures, dizziness, feeling of spinning, disturbances of sensation, changes in taste
• constipation, indigestion, gas, dry mouth
• muscle pain
• liver damage or yellowing of the skin or eyes (jaundice)
• blisters, hives (urticaria), itching, increased sweating
• fatigue, general feeling of being unwell, fever.

Rare side effects, which may affect up to 1 in 1,000 people:

• reduced number of white blood cells, which help the body to fight infection, and platelets, which help the blood to clot
• 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, lipid levels in the blood)
• reduced potassium levels in the blood
• tremors
• abnormalities in ECG, changes in heart rate or rhythm disorders
• liver failure
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face
• hair loss.

Frequency not known, but may occur (frequency cannot be estimated from the available data):
Reaction of hypersensitivity with skin rash, fever, swollen lymph nodes, increased white blood cell count (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (DRESS)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 authorisation holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Flumycon

The medicine should be stored out of the sight and reach of children.

Do not store above 30°C. Do not transfer the capsules to another container.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Flumycon contains

• -The active substance of the medicine is fluconazole. Each hard capsule contains 50 mg, 100 mg, 150 mg or 200 mg of fluconazole.
• -The other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, sodium lauryl sulfate and magnesium stearate. The capsule shell contains gelatin and the following colorants: 50 mg, 100 mg, 150 mg capsules: titanium dioxide (E171) and brilliant blue (E133)

200 mg capsules: titanium dioxide (E171), azorubine (E122) and brilliant blue (E133)

What Flumycon looks like and contents of the pack

Flumycon, 50 mg, hard capsules are unmarked gelatin capsules, approximately 14 mm in size, with a light blue opaque cap and a white opaque body.
Available in blisters containing 1, 7, 10, 14, 20, 28, 30, 50, 100 or 500 capsules.
Flumycon, 100 mg, hard capsules are unmarked gelatin capsules, approximately 18 mm in size, with a blue opaque cap and a white opaque body.
Available in blisters containing 7, 10, 14, 16, 20, 28, 30, 50 (1 x 50), 60 or 100 capsules.
Flumycon, 150 mg, hard capsules are unmarked gelatin capsules, approximately 19 mm in size, with a light blue opaque cap and a light blue opaque body.
Available in blisters containing 1, 2, 4, 6, 7 or 12 capsules.
Flumycon, 200 mg, hard capsules are unmarked gelatin capsules, approximately 22 mm in size, with a purple opaque cap and a white opaque body. Available in blisters containing 1, 2, 4, 7, 10, 12, 14, 20, 30, 50 or 100 capsules.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva B.V.
Swensweg 5, 2031 GA Haarlem
Netherlands

Manufacturer

TEVA Gyógyszergyár Zrt.
Debrecen, Pallagi út 13,
H-4042, Hungary
Pharmachemie B.V.,
Swensweg 5, 2031 GA Haarlem,
Netherlands;

To obtain more detailed information on the medicine, the patient should contact the representative of the marketing authorisation holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, phone: (22) 345 93 00.

This medicine is authorised in the Member States of the European Economic Area under the following names:

Italy
Fluconazolo Teva Italia
Austria
Fluconazol ratiopharm 50 mg Kapseln
Fluconazol ratiopharm 100 mg Kapseln
Fluconazol ratiopharm 150 mg Kapseln
Fluconazol ratiopharm 200 mg Kapseln
Bulgaria
Фунголон 50 mg твърди капсули
Fungolon 50 mg hard capsules
Фунголон 100 mg твърди капсули
Fungolon 100 mg hard capsules
Фунголон 150 mg твърди капсули
Fungolon 150 mg hard capsules
Фунголон 200 mg твърди капсули
Fungolon 200 mg hard capsules
Estonia
Fluconazole Teva
Finland
Fluconazol Teva 150 mg kapseli, kova
Hungary
Fluconazole-Teva 50 mg kemény kapszula
Fluconazole-Teva 100 mg kemény kapszula
Fluconazole-Teva 150 mg kemény kapszula
Fluconazole-Teva 200 mg kemény kapszula
Iceland
Candizol
Lithuania
Fluconazole Teva 150 mg kietosios kapsulės
Latvia
Fluconazole Teva 150 mg cietās kapsulas
Poland
Flumycon
Portugal
Fluconazol ratiopharm
Sweden
Fluconazole Teva

Date of last revision of the leaflet: February 2024