Fluconazole

Package leaflet: 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
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Fluxazol is and what it is used for

Fluxazol belongs to a group of antifungal medicines. The active substance is fluconazole.
Fluxazol is used to treat infections caused by disease-causing fungi. It may also be used to prevent Candida yeast infections. The most common cause of fungal infections are yeasts of the genus Candida.

Adult patients
Your doctor may prescribe Fluxazol for the following fungal infections:

• cryptococcal meningitis – a fungal infection of the brain,
• coccidioidomycosis – a respiratory disease,
• Candida yeast infections detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
• mucosal yeast infections (thrush) – infection of the mucous membranes of the mouth or throat, or denture-related stomatitis,
• genital yeast infections – vaginal or penile infections,
• skin fungal infections – e.g. athlete’s foot, tinea of the body, groin, or fungal nail infections.

Fluxazol may also be used to:

• prevent recurrence of cryptococcal meningitis,
• prevent recurrence of mucosal yeast infections,
• prevent recurrence of vaginal yeast infections,
• prevent yeast infections (in patients with weakened or impaired immune systems).

Children and adolescents (aged 0 to 17 years)
Your doctor may prescribe this medicine to treat the following fungal infections:

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

Fluxazol may also be used to:

• prevent Candida yeast infections (in patients with a weakened or poorly functioning immune system),
• prevent recurrence of cryptococcal meningitis.

2. Important information before using Fluxazol

When not to use 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, 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 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 Fluxazol, discuss with your doctor or pharmacist if:

• The fungal infection does not improve, alternative antifungal treatment may be necessary.
• The patient has liver or kidney function disorders.
• The patient has heart diseases, including heart rhythm disorders.
• The patient has blood abnormalities in potassium, calcium, or magnesium levels.
• The patient experiences severe skin reactions (e.g., itching, skin redness, difficulty breathing).
• The patient develops symptoms of adrenal insufficiency, when the adrenal glands do not produce sufficient amounts of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
• The patient has previously experienced severe skin rash, skin peeling, blisters, and/or oral mucosal ulcers after taking Fluxazol.

Patients treated with Fluxazol have experienced cases of severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS). If the patient develops any of the symptoms of severe skin reactions described in section 4, treatment with Fluxazol must be discontinued immediately and medical help must be sought without delay.

Fluxazol and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Immediately inform your doctor if you are 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 Fluxazol (see section: "When not to use Fluxazol").

There are also other medicines that may interact with Fluxazol.
If the patient is taking any of the following medicines, ensure the doctor is informed:

• Rifampicin or rifabutin (antibiotics used to treat infections),
• 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 aid sleep or for calming,
• Carbamazepine, phenytoin (used to treat epilepsy),
• Nifedipine, isradipine, amlodipine, felodipine, and losartan (used to treat high blood pressure),
• Olaparib (a medicine used in cervical cancer),
• Cyclosporine, everolimus, sirolimus, or tacrolimus (medicines used to prevent transplant rejection),
• Cyclophosphamide, vinca alkaloids (vincristine, vinblastine 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 (medicines used to treat HIV infection),
• Antidiabetic medicines such as: chlorpropamide, glyburide, 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 – "arrhythmias"),
• Hydrochlorothiazide (a diuretic).

Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Fluxazol with food and drink
This medicine can be taken with or without food.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should not take Fluxazol unless otherwise advised by a doctor.

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 abnormalities in the newborn.

Breastfeeding may continue after a single dose of Fluxazol not exceeding 150 mg. Breastfeeding should not be continued if the patient receives multiple doses of Fluxazol.

Driving and operating machinery
When driving or operating machinery, bear in mind that dizziness or seizures may occasionally occur.

Fluxazol contains lactose
This medicine contains a small amount of lactose (milk sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Fluxazol

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, 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 recommended dosage, depending on the type of infection, is given below.

Adult patients

| Indication | Dosage | |----------------|------------| | Treatment of cryptococcal meningitis | 400 mg on the first day, then 200 mg once daily; 400 mg once daily for 6 to 8 weeks, or longer if necessary. The dose may sometimes be increased to 800 mg. | | Prevention of relapse of cryptococcal meningitis | 200 mg once daily until the 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 infections | 800 mg on the first day, then 400 mg once daily until the doctor advises stopping treatment. | | Treatment of oral mucosal infections, pharyngitis and oral thrush associated with dental prostheses | 200 mg to 400 mg on the first day, then 100 mg to 200 mg until the doctor advises stopping treatment. | | Mucosal candidiasis (thrush) – dosage depends on the site of infection | 50 mg to 400 mg once daily for 7 to 30 days, or until the doctor advises stopping treatment. | | Prevention of oral and pharyngeal mucosal infections | 100 mg to 200 mg once daily, or 200 mg three times weekly, if the patient is at increased risk of recurrent infection. | | Treatment of genital Candida infections | 150 mg as a single dose. | | Prevention of vaginal infection relapses | 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 is at 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 to 400 mg once weekly for 1 to 4 weeks (for tinea pedis, treatment may need to continue for up to 6 weeks; for nail infections, treatment should continue until the infected nail is completely replaced by a healthy, uninfected nail). | | Prevention of Candida infections (in patients with weakened or impaired immune systems) | 200 to 400 mg once daily, if the patient is at increased risk of recurrent infection. |

Adolescents aged 12 to 17 years
The dose prescribed by the doctor should be administered (as for adults or as for children).

Children up to 11 years of age
The maximum daily dose in children is 400 mg.
The dose will be determined based on the child's body weight in kilograms.

| Indication | Daily dose | |----------------|----------------| | Mucosal Candida infections of the oral cavity and pharynx – dose and duration depend on the severity and site of infection | 3 mg/kg body weight (on the first day, a dose of 6 mg/kg body weight may be given) | | Cryptococcal meningitis or systemic Candida infections | 6 to 12 mg/kg body weight | | Prevention of candidiasis in children (in those with impaired immune function) | 3 to 12 mg/kg body weight |

Use in children from 1 day to 4 weeks of age

• Children aged 3 to 4 weeks: Administer the same dose as in the table above every 2 days. Maximum daily dose is 12 mg/kg body weight every 48 hours.
• Children younger than 2 weeks: Administer the same dose as in the table above every 3 days. Maximum daily dose is 12 mg/kg body weight every 72 hours.

Elderly patients
The usual adult dose is administered, unless the patient has impaired kidney function.

Patients with impaired kidney function
The doctor may adjust the dosage depending on kidney function.

Overdose of Fluxazol
Taking too many capsules at once may cause discomfort. Seek immediate medical attention at the nearest hospital emergency department. Symptoms of overdose may include disturbances in hearing, vision, and sensation, as well as false beliefs (hallucinations and paranoid behavior). Symptomatic treatment may be required (supportive care for vital functions and gastric lavage if necessary).

Missed dose of Fluxazol
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 the next dose, skip the missed dose and continue with your regular schedule.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some patients may experience allergic reactions, although severe allergic reactions are rare.
If any adverse effect occurs, consult a doctor or pharmacist.
This applies also to adverse effects not listed in this leaflet.
If the patient experiences any of the following symptoms, stop taking Fluxazol immediately and seek medical help without delay:

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

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

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

Fluxazol may affect the adrenal cortex and the concentration of steroid hormones produced.
Symptoms of adrenal cortex disorders include:

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

Other adverse effects
Furthermore, if any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Common adverse effects (may occur in 1 out of 10 patients):

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

Uncommon adverse effects (may occur in 1 out of 100 patients):

• decreased number of red blood cells causing paleness, weakness and breathlessness,
• decreased appetite,
• insomnia, drowsiness,
• seizures, dizziness, balance disorders (sensation of spinning), sensory disturbances, most commonly as tingling, pricking or numbness, taste alterations,
• constipation, indigestion, bloating, dry mouth,
• muscle pain,
• liver damage and yellowing of the skin and eyes (jaundice),
• blisters, urticaria, itching, increased sweating,
• feeling of fatigue, malaise, fever.

Rare adverse effects (may occur in 1 out of 1,000 patients):

• 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 resulting from 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 readings, heart rhythm disorders,
• liver failure,
• allergic reactions (sometimes severe), including widespread blistering rash, skin peeling, severe skin reactions, swelling of lips or face,
• hair loss.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Fluxazol

Keep this medicine out of sight and reach of children.
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 stated month.
Store below 25°C.
Keep in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Fluxazol contains

• The active substance is fluconazole. Each hard capsule contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole.
• The other ingredients are:
  Fluxazol 50 mg: lactose monohydrate, corn starch, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate; capsule shell 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, corn starch, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate; capsule shell: 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, corn starch, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate; capsule shell and cap: gelatin, titanium dioxide (E 171).
  Fluxazol 200 mg: lactose monohydrate, corn starch, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate; capsule shell and cap: gelatin, titanium dioxide (E 171).

What Fluxazol looks like and contents of the pack
Fluxazol 50 mg, hard capsule:
Hard, gelatinous, uniformly dark green capsule.
Fluxazol 100 mg, hard capsule:
Hard, gelatinous, uniformly white-dark green capsule.
Fluxazol 150 mg, hard capsule:
Hard, gelatinous, uniformly white capsule.
Fluxazol 200 mg, hard capsule:
Hard, gelatinous, uniformly white capsule.

Pack sizes available:
Fluxazol 50 mg, 100 mg, 200 mg – 7 capsules.
Fluxazol 150 mg – 1 capsule.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw, Poland

Importer
Grand Medical Poland Sp. z o.o.
M. Faradaya 2 Street
03-233 Warsaw, Poland

Alterno Labs d.o.o.
Brnčičeva ulica 29
Ljubljana – Črnuče, 1231
Slovenia