Fluxazol

Leaflet accompanying the packaging: information for the user

Fluxazol, 50 mg, hard capsules

Fluxazol, 100 mg, hard capsules

Fluxazol, 150 mg, hard capsules

Fluxazol, 200 mg, hard capsules

Fluconazole

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Fluxazol and what is it used for

Fluxazol belongs to a group of antifungal medicines. The active substance of the medicine is fluconazole.
Fluxazol is used to treat infections caused by pathogenic fungi. It can also be used to prevent yeast infections. The most common cause of fungal infections is yeast of the genus Candida.

Adult patients

The doctor may recommend taking Fluxazol for the following fungal infections:

• cryptococcal meningitis - a fungal infection of the brain,
• coccidioidomycosis - a disease of the respiratory system,
• infections caused by Candida yeast detected in the blood, internal organs (e.g., heart, lungs), or urinary tract,
• yeast infections (thrush) of the mucous membranes - infection of the mucous membrane of the mouth or throat, thrush in the mouth 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, fungal infections of the torso, groin, or nails.

Fluxazol can also be used to:

• prevent relapses of cryptococcal meningitis,
• prevent relapses of yeast infections of the mucous membranes,
• prevent relapses of yeast infections of the vagina,
• prevent yeast infections (in patients with a weakened and improperly functioning immune system).

Children and adolescents (from 0 to 17 years old)

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

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

Fluxazol can also be used to:

• prevent infections caused by Candida yeast (if the patient's immune system is weak and does not function properly),
• prevent relapses of cryptococcal meningitis.

2. Important information before taking Fluxazol

When not to take Fluxazol

• If the patient is allergic to fluconazole, other antifungal medicines, 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 (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 to take Fluxazol, the patient should discuss it with their doctor or pharmacist:

• if the fungal infection does not improve, it may be necessary to use another antifungal treatment,
• if the patient has liver or kidney function disorders,
• if the patient has heart disease, including heart rhythm disorders,
• if the patient has abnormalities in potassium, calcium, or magnesium levels in the blood,
• if the patient experiences severe skin reactions (e.g., itching, redness of the skin, difficulty breathing),
• if the patient develops symptoms of "adrenal insufficiency", when 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 after taking Fluxazol.

In patients treated with Fluxazol, 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 Fluxazol and seek medical help immediately.

Fluxazol and other medicines

The patient should tell 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 immediatelytell 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 Fluxazol (see "When not to take Fluxazol").
There are also other medicines that may interact with Fluxazol.
If the patient is taking any of the following medicines, they should make sure their doctor is informed:

• rifampicin or rifabutin (antibiotics used to treat infections),
• alfentanil, fentanyl (anesthetics),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• medicines that reduce blood clotting, prevent blood clots (warfarin or similar medicines),
• benzodiazepines (midazolam, triazolam, or similar medicines) that facilitate sleep or have a calming effect,
• carbamazepine, phenytoin (used to treat epilepsy),
• nifedipine, isradipine, amlodipine, felodipine, and losartan (used to treat high blood pressure),
• olaparib (a medicine used to treat cervical cancer),
• cyclosporine, everolimus, sirolimus, or tacrolimus (medicines that prevent transplant rejection),
• cyclophosphamide, vincristine (used to treat cancer),
• halofantrine (used to treat malaria),
• statins (atorvastatin, simvastatin, and fluvastatin or 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 (medicines used to treat HIV infection),
• antidiabetic medicines, such as chlorpropamide, glibenclamide, glipizide, or tolbutamide,
• theophylline (used to treat asthma),
• vitamin A (used as a dietary supplement),
• ivacaftor (used to treat cystic fibrosis),
• amiodarone (used to treat heart rhythm disorders - "arrhythmia"),
• hydrochlorothiazide (a diuretic).

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Fluxazol 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 plans to have a child, they should not take Fluxazol unless their doctor has advised them to do so.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage.
Fluconazole taken in low doses during the first trimester of pregnancy may slightly increase the risk of congenital bone and/or muscle defects in the newborn.
Breastfeeding can be continued after taking a single dose of Fluxazol not exceeding 150 mg. Breastfeeding should not be continued if the patient is taking multiple doses of Fluxazol.

Driving and using machines

When driving or operating machinery, the patient should consider that dizziness or seizures may occasionally occur.

Fluxazol contains lactose

The medicine contains small amounts of lactose (milk sugar). If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Fluxazol

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

Adult patients

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. The dose may be 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. The dose may be increased to 800 mg.
Treatment of internal organ infections caused by Candida yeast
800 mg on the first day, then 400 mg once a day until the doctor recommends stopping treatment.
Treatment of yeast infections of the mouth, throat, and thrush in the mouth associated with the use of dental prostheses
200 mg to 400 mg on the first day, then 100 mg to 200 mg until the doctor recommends stopping treatment.
Yeast infections of the mucous membranes - the dose depends on the location of the infection
50 mg to 400 mg once a day for 7 to 30 days, until the doctor recommends stopping treatment.
Prevention 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
150 mg as a single dose.
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 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 yeast (if the patient's immune system is weak and does not function properly)
  200 mg to 400 mg once a day, if the patient is at increased risk of relapse.

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/kg body weight (on the first day, a dose of 6 mg/kg body weight can be given).
Cryptococcal meningitis or Candida yeast infections of internal organs
6 to 12 mg/kg body weight.
3 to 12 mg/kg body weight.
Prevention of yeast infections in children (if the immune system does not function properly)

Use in children from 1 day to 4 weeks of age

• Use in children 3 to 4 weeks old: The same dose as in the above table should be used every 2 days. The maximum daily dose is 12 mg/kg body weight every 48 hours.
• Use in children under 2 weeks old: The same dose as in the above table should be used every 3 days. The maximum daily dose is 12 mg/kg body weight every 72 hours.

Elderly patients

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

Patients with kidney function disorders

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

Taking more than the recommended dose of Fluxazol

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

Missing a dose of Fluxazol

The patient should not take a double dose to make up for a missed dose. If a dose is missed, it should be taken as soon as remembered. If it is almost time for the next dose, the missed dose should not be taken.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Fluxazol can cause side effects, although not everybody gets them.
Some patients may experience allergic reactions, but severe allergic reactions are rare.
If the patient experiences any side effects, they should consult their doctor or pharmacist. This also applies to any side effects not listed in this leaflet.

If the patient experiences any of the following symptoms, they should stop taking Fluxazol and seek medical help immediately:

Fluxazol:

• sudden wheezing, difficulty breathing, or chest tightness,
• swelling of the eyelids, face, or lips,
• itching all over the body, redness of the skin, or red, itchy blisters,
• rash,
• severe skin reactions, such as a rash with blisters (may also affect the mouth and tongue),
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Fluxazol may affect the liver. Symptoms of liver disorders include:

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

Fluxazol may affect the adrenal glands and the production of steroid hormones.
Symptoms of adrenal gland disorders include:

• fatigue,
• muscle weakness,
• loss of appetite,
• weight loss,
• abdominal pain.

Other side effects

Additionally, if any of the side effects worsen or if any side effects not listed in this leaflet occur, the patient should tell their doctor or pharmacist.
Frequent side effects(may occur in 1 in 10 patients):

• headache,
• abdominal pain, diarrhea, nausea, vomiting,
• increased liver enzyme activity,
• rash.

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

• decrease in red blood cell count, causing pallor, weakness, and shortness of breath,
• decrease in appetite,
• insomnia, drowsiness,
• seizures, dizziness, balance disorders (feeling of spinning), sensation disorders, most often in the form of tingling, prickling, or numbness, taste changes,
• 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, fever.

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

• decrease in white blood cell count and platelet count,
• red or purple skin discoloration, which may be a sign of a decrease in platelet count or changes in other blood cells,
• changes in blood biochemistry parameters (high cholesterol, lipid levels in the blood),
• decrease in potassium levels in the blood,
• tremors,
• abnormalities in ECG recordings, heart 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.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: 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 will help gather more information on the safety of the medicine.

5. How to store Fluxazol

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
Store at a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
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 Fluxazol contains

• The active substance of the medicine is fluconazole. Each hard capsule contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole.
• Other ingredients are: Fluxazol, 50 mg lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate; capsule body and cap: gelatin, quinoline yellow (E 104), patent blue V (E 131), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171). Fluxazol, 100 mg lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate; capsule body: gelatin, titanium dioxide (E 171); capsule cap: gelatin, quinoline yellow (E 104), indigo carmine (E 132), titanium dioxide (E 171). Fluxazol, 150 mg lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate; capsule body and cap: gelatin, titanium dioxide (E 171). Fluxazol, 200 mg lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate; capsule body and cap: gelatin, titanium dioxide (E 171).

What Fluxazol looks like and contents of the packaging

Fluxazol, 50 mg, hard capsule:
hard capsule, gelatin, uniform, dark green.
Fluxazol, 100 mg, hard capsule:
hard capsule, gelatin, uniform, white and dark green.
Fluxazol, 150 mg, hard capsule:
hard capsule, gelatin, uniform, white.
Fluxazol, 200 mg, hard capsule:
hard capsule, gelatin, uniform, white.
Available packaging sizes:
Fluxazol, 50 mg, 100 mg, 200 mg - 7 capsules.
Fluxazol, 150 mg - 1 capsule.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw

Importer

Grand Medical Poland Sp. z o.o.
M. Faradaya Street 2
03-233 Warsaw
Alterno Labs d.o.o.,
Brnčičeva Street 29,
Ljubljana – Črnuče, 1231
Slovenia
Date of last update of the leaflet:February 2023