Fluconazin

Package Leaflet: Information for the Patient

FLUCONAZOLE

5 mg/ml, syrup

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

Table of Contents of the Leaflet

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

1. What is Fluconazole and what is it used for

Fluconazole contains fluconazole, an antifungal medicine, which inhibits the production of the main component of the fungal cell wall and disrupts its normal functioning.
Fluconazole is used to treat infections caused by yeast-like fungi: vaginal candidiasis, oral candidiasis and esophageal candidiasis, systemic candidiasis (including candidemia, disseminated candidiasis and other forms of invasive candidiasis, such as pulmonary candidiasis, peritoneal candidiasis, and urinary tract candidiasis), cryptococcal meningitis, cryptococcal meningitis in AIDS patients, skin fungi.
In addition, Fluconazole is used to prevent the occurrence of candidiasis in patients at high risk (patients with malignant tumors, after organ transplants, and patients undergoing chemotherapy and/or radiotherapy), in accordance with current guidelines for the treatment of fungal infections.

2. Important information before taking Fluconazole

When not to take Fluconazole:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other azole derivatives;
• during treatment with terfenadine, pimozide, astemizole, cisapride.

Warnings and precautions

Before starting treatment with Fluconazole, discuss it with your doctor:
If you have ever experienced a severe skin rash or skin peeling 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, ang. drug reaction with eosinophilia and systemic symptoms). If you experience any of the symptoms of severe skin reactions described in section 4, you should stop taking Fluconazole and seek medical attention immediately.
In some people, especially those with serious illnesses, such as AIDS or cancer, as well as those with liver function disorders, regular monitoring of liver function is necessary to limit the risk of liver function disorders, and if symptoms of liver failure occur, the doctor will decide to discontinue fluconazole.
Rarely, during fluconazole treatment, skin changes (Stevens-Johnson syndrome, a variant of erythema multiforme, and toxic epidermal necrolysis) have been observed. AIDS patients are more prone to skin reactions during therapy with various medications.
If a rash occurs during fluconazole treatment for superficial fungal infections, the doctor will decide to discontinue fluconazole.
If a rash occurs during fluconazole treatment for systemic candidiasis or its invasive forms, fluconazole treatment can be continued, provided that the patient's condition is regularly monitored.
In the event of blistering or erythema multiforme, the doctor will decide to discontinue fluconazole.
If the fungal infection does not resolve, it may be necessary to use another antifungal treatment.
Anaphylaxis (see section 4, "Possible side effects") has also been reported.
Fluconazole treatment can rarely lead to changes in the ECG record (prolongation of the QT interval) or even to the occurrence of very serious heart rhythm disorders (multiform ventricular tachycardia, "Torsade de pointes").

• congenital or documented QT interval prolongation in the ECG record;
• cardiomyopathy (especially in patients with heart failure);
• sinus bradycardia;
• other heart rhythm disorders;
• concomitant administration of other medications that prolong the QT interval in the ECG record;
• electrolyte disorders (decreased potassium, magnesium, calcium levels in the blood).

Patients with renal impairment
In patients with renal failure, it is necessary to adjust the fluconazole dosage (see section 3, "How to take Fluconazole").
Children
See section 3, "How to take Fluconazole".

Fluconazole and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
In patients treated with fluconazole and other medicines, it may be necessary to adjust the dosage of the medicines used or change the current treatment, and sometimes even discontinue one of the medicines. The decision to introduce the appropriate change in therapy is made exclusively by the doctor after a thorough assessment of the patient's condition.
It is known that an increase in fluconazole dosage is sometimes necessary in patients treated with rifampicin.
A decrease in fluconazole dosage may be necessary in patients treated with hydrochlorothiazide.
Fluconazole enhances the effect of some sedatives - short-acting benzodiazepines (e.g., midazolam), so it is necessary to adjust the dosage and monitor the patient's condition.
Fluconazole enhances the effect of anticoagulant medications, which can lead to bleeding (bruises, nosebleeds, gastrointestinal bleeding, hematuria, and tarry stools). Therefore, in patients receiving coumarin derivative anticoagulants and fluconazole, the doctor should recommend close monitoring of blood coagulation parameters (prothrombin time).
Diabetic patients can be given fluconazole together with oral glucose-lowering medications (sulfonylurea derivatives: chlorpropamide, glibenclamide, glipizide, tolbutamide), but it is necessary to consider the possibility of hypoglycemic episodes.
If it is necessary to administer phenytoin and fluconazole concomitantly, it is necessary to monitor its blood levels and adjust the dosage to achieve the required therapeutic effect.
Taking fluconazole is unlikely to affect the effectiveness of oral contraceptives.
Fluconazole administration does not affect the activity of steroid hormones in women and only slightly changes their activity in men.
In patients who have undergone kidney transplantation and are taking cyclosporine and fluconazole, it is recommended to monitor cyclosporine blood levels. However, fluconazole did not affect cyclosporine blood levels in patients after bone marrow transplantation.
The condition of patients taking fluconazole and high doses of theophylline (or patients at risk of theophylline toxicity) should be closely monitored, and if necessary, the doctor should recommend modifying the treatment.
Due to the possibility of serious heart rhythm disorders (QT interval prolongation, ventricular tachycardia, dizziness, and chest pain) resulting from the increased effect of terfenadine in patients taking fluconazole, concomitant treatment with terfenadine and fluconazole is not recommended.
Similarly, due to the risk of serious heart rhythm disorders, including "Torsade de pointes", it is not recommended to take cisapride and fluconazole concomitantly.
Since fluconazole increases the blood levels of zidovudine, which increases the possibility of its side effects, the doctor should monitor the condition of patients undergoing such treatment.
Fluconazole increases the blood levels of rifabutin, so the condition of patients treated with rifabutin and fluconazole should be monitored.
Similarly, since fluconazole increases the blood levels of tacrolimus, due to the possibility of kidney damage, the condition of patients undergoing such treatment should be monitored.
Certain medications undergo metabolism in the body using the same enzyme systems responsible for fluconazole metabolism. Therefore, in some cases, concomitant administration of fluconazole and certain medications may reduce the safety of the treatment or reveal unwanted effects of the medications used, which is particularly important in the case of medications that affect heart rhythm, e.g., those that can prolong the QT interval in the ECG record, or change the effectiveness of fluconazole treatment.
When using fluconazole in patients taking astemizole or other medications metabolized with the participation of the cytochrome P-450 system, close monitoring of the patient's condition is necessary.
Taking fluconazole with food, cimetidine, antacids, or during radiation before bone marrow transplantation, practically does not affect fluconazole absorption.

Using Fluconazole with food and drink

Concomitant food intake does not affect fluconazole absorption.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, do not take Fluconazole unless your doctor has told you to.
If you plan to become pregnant, it is recommended that you wait one week after taking a single dose of fluconazole before becoming pregnant.
In the case of longer treatment cycles with fluconazole, you should discuss the need for appropriate contraception during treatment and for one week after the last dose with your 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 femur and humerus, born to mothers treated for coccidioidomycosis with high doses of fluconazole (400-800 mg/day) for at least 3 months. The relationship between fluconazole use and these cases is unclear.
Fluconazole should not be given to pregnant women or women of childbearing age unless effective contraception is used.
The drug passes into breast milk in concentrations lower than those in blood plasma. Breastfeeding can be continued after taking a single dose of 40 ml syrup (i.e., 200 mg fluconazole) per day or less (see section 3, "How to take Fluconazole"). Breastfeeding is not recommended after repeated fluconazole administration or high doses.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

Fluconazole contains maltitol

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking the medicine. The medicine may have a mild laxative effect.
Caloric value: 2.3 kcal/g maltitol.

Fluconazole contains sodium benzoate (E 211)

The medicine contains 1.808 mg of sodium benzoate in 1 ml of syrup.

Fluconazole contains propylene glycol (E 1520)

The medicine contains 60.797 mg of propylene glycol in 1 ml of syrup.
Before administering the medicine to a child under 5 years of age, you should consult a doctor or pharmacist, especially if the child is taking other medications containing propylene glycol or alcohol.
Women who are pregnant or breastfeeding should not take this medicine without consulting a doctor.
The doctor may decide to perform additional tests on such patients.
Patients with liver or kidney function disorders should not take this medicine without consulting a doctor. The doctor may decide to perform additional tests on such patients.

Fluconazole contains ethanol

This medicine contains 0.361 mg of ethanol in each ml of syrup. The amount of alcohol in 5 ml of syrup is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce noticeable effects.

Fluconazole contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of syrup, which means that the medicine is considered "sodium-free".

3. How to take Fluconazole

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The medicine is taken orally.
The medicine does not contain sugar.
General recommendations

Treatment should be continued until clinical symptoms resolve and mycological test results indicate the disappearance of yeast activity in the material collected.
Inadequate dosage or too short a treatment period may expose the patient to the risk of relapse. In AIDS patients and those with cryptococcal meningitis, it is usually necessary to continue maintenance therapy to prevent relapse of the infection.
Adult dosage
Treatment:

• vaginal candidiasis: a single dose of 150 mg fluconazole (i.e., 30 ml syrup);
• oral candidiasis: usually, the recommended dose is 50 mg fluconazole (i.e., 10 ml syrup) once a day, for 7 to 14 days. Treatment usually does not last longer than 14 days, except in patients with impaired immunity. In severe cases, the doctor may increase the dose to 100 mg fluconazole (i.e., 20 ml syrup) once a day;
• esophageal candidiasis: usually, the recommended dose is 50 mg fluconazole (i.e., 10 ml syrup) per day, in severe cases, the doctor may increase the dose to 100 mg fluconazole (i.e., 20 ml syrup) per day. Treatment usually lasts 14 to 30 days;
• systemic candidiasis, including candidemia, disseminated candidiasis, and other forms of invasive candidiasis (pulmonary candidiasis, peritoneal candidiasis, urinary tract candidiasis): on the first day, 400 mg fluconazole (i.e., 80 ml syrup), and then 200 mg fluconazole (i.e., 40 ml syrup) per day. Depending on the clinical response, the doctor may increase the dose to 400 mg fluconazole (i.e., 80 ml syrup) per day. The duration of treatment depends on the clinical response;
• cryptococcal meningitis: on the first day, 400 mg fluconazole (i.e., 80 ml syrup), and then 200 to 400 mg fluconazole (i.e., 40 to 80 ml syrup) once a day. The duration of treatment depends on the clinical effects and the achievement of negative mycological test results of cerebrospinal fluid, usually at least 6 to 8 weeks;
• prevention of relapse of cryptococcal meningitis: in AIDS patients, it is recommended to take 100 to 200 mg fluconazole (i.e., 20 to 40 ml syrup) per day after initial treatment;
• skin fungi: the recommended dose is 50 mg fluconazole (i.e., 10 ml syrup) once a day, for 2 to 4 weeks, and in the case of foot fungus - up to 6 weeks. The treatment period should not exceed 6 weeks.

Prophylactic use:

Prevention of candidiasis in persons at high risk of infection (patients with impaired immunity due to neutropenia resulting from chemotherapy with cytotoxic agents or radiotherapy)

: it is recommended to take 50 to 400 mg fluconazole (i.e., 10 to 80 ml syrup) once a day, depending on the degree of risk of infection. If there is a risk of prolonged neutropenia (e.g., in the case of bone marrow transplantation), it is recommended to take 400 mg fluconazole (i.e., 80 ml syrup) once a day, and treatment should be started a few days before the expected onset of neutropenia and continued for 7 days after the neutrophil count in the peripheral blood exceeds 1000/mm³.
Children's dosage
Syrup Fluconazole can be used in children over 1 year of age.
Children over 1 year of age:

• oral candidiasis, esophageal candidiasis: on the first day, 6 mg fluconazole/kg body weight (i.e., 1.2 ml syrup/kg body weight), and then 3 mg fluconazole/kg body weight (i.e., 0.6 ml syrup/kg body weight) per day;
• systemic candidiasis and cryptococcal meningitis: depending on the severity of the infection, 6 to 12 mg/kg body weight per day (i.e., 1.2 to 2.4 ml syrup/kg body weight per day);
• prevention of candidiasis in children at high risk of infection (in patients with impaired immunity due to neutropenia resulting from chemotherapy with cytotoxic agents or radiotherapy): it is recommended to take - depending on the degree and duration of neutropenia - 3 to 12 mg/kg body weight per day (i.e., 0.6 to 2.4 ml syrup/kg body weight per day). See: adults, prophylactic use.

  Do not exceed the daily dose of 400 mg fluconazole (i.e., 80 ml syrup) in children.
  Due to the limited amount of data on the use of fluconazole in the treatment of vaginal candidiasis in children under 16 years of age, its use is not recommended in these cases, unless there is no alternative treatment.

  Special dosage recommendations

  Dosage in elderly patients
  If renal function is not impaired (creatinine clearance exceeds 50 ml/min), no modification of fluconazole dosage is necessary in elderly patients.
  Dosage in patients with renal impairment
  A single dose of fluconazole does not require dosage adjustment in patients with renal impairment.
  When given repeatedly (also to children), on the first day, patients receive a dose according to the indications and age specified above, but subsequent daily doses should be adjusted by the doctor according to the following scheme:

  Calculation of creatinine clearance

  for adult men:
  (140 - patient's age in years) x patient's body weight in kg

  72 x serum creatinine concentration (in mg/100 ml)

  for adult women:the value calculated according to the above formula should be multiplied by a factor of 0.85.
  Creatinine clearance (ml/min)
  Percentage of the daily dose recommended for patients with renal impairment
   50
  100 % (no change)
  ≤ 50 (without dialysis)
  50 % (reduce by half)
  Patients undergoing regular hemodialysis
  100 % (no change) after each dialysis

  Overdose of Fluconazole

  In the event of an overdose of fluconazole, the doctor will use symptomatic treatment (if necessary, supported by gastric lavage) and forced diuresis. A three-hour hemodialysis reduces the drug concentration in the blood by 50%.

  Missed dose of Fluconazole

  Do not take a double dose to make up for a missed dose.
  If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

  4. Possible side effects

  Like all medicines, this medicine can cause side effects, although not everybody gets them.
  Fluconazole is usually well tolerated.

  If you experience any of the following symptoms, stop taking Fluconazole and seek medical attention immediately:

  • widespread rash, high fever, and lymph node enlargement (DRESS or hypersensitivity syndrome),
  • sudden breathing difficulties, speech, or swallowing,
  • itching of the lips, tongue, face, and neck,
  • severe dizziness or fainting,
  • itchy rash or blisters on the skin, with accompanying pain in the mouth or genital area.

  Other side effects:

  • headaches, dizziness, seizures, taste disorders,
  • liver damage, rare cases of death, and changes in laboratory blood test results (increased activity of enzymes: alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, and increased bilirubin levels), cases of liver failure, hepatitis, liver necrosis, jaundice,
  • rash, hair loss, excessive skin peeling, including Stevens-Johnson syndrome and toxic epidermal necrolysis,
  • dyspepsia, vomiting, abdominal pain, diarrhea, bloating, nausea. In some people, especially those with serious illnesses, such as AIDS or cancer, changes in liver, kidney, and blood test results have been observed,
  • changes in white blood cell and platelet counts (leukopenia with neutropenia and agranulocytosis, thrombocytopenia),
  • anaphylaxis (including angioedema, face swelling, itching), urticaria,
  • increased cholesterol and triglyceride levels, and decreased potassium levels in the blood,
  • heart rhythm disorders (QT interval prolongation, multiform ventricular tachycardia, "Torsade de pointes").

  Reporting side effects

  If you experience any side effects, including any not listed in this leaflet, please tell your 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:
  Aleje 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, you can help provide more information on the safety of this medicine.

  5. How to store Fluconazole

  Store in the original package, at a temperature below 25°C.
  Keep the medicine out of the sight and reach of children.
  Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month stated.
  Medicines should not be disposed of via wastewater or household waste. Ask your 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 Fluconazole contains

  • The active substance of the medicine is fluconazole. 1 ml of syrup contains 5 mg of fluconazole.
  • The other ingredients (excipients) are: maltitol liquid, propylene glycol (E 1520), citric acid monohydrate, sodium benzoate (E 211), strawberry flavor AR0012/F (contains ethanol and propylene glycol (E 1520)), sodium saccharin dihydrate, purified water.

  What Fluconazole looks like and contents of the pack

  The medicine is a syrup. One pack of the medicine contains 150 ml of syrup.

  Marketing authorization holder and manufacturer

  "PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
  51-131 Wrocław, ul. Żmigrodzka 242 E

  Medicine information

  tel.: 22 742 00 22
  e-mail: [email protected]

  Date of last revision of the leaflet: 02/2024