FLUKONAZOL 2 mg /Ml Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Fluconazole solution for infusion 2 mg/ml
   1. You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Fluconazole and what is it used for
   1. Adults
   2. Children and adolescents (from 0 to 17 years old)
4. Important information before taking Fluconazole
   1. When not to take Fluconazole
   2. Warnings and precautions
   3. Fluconazole and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
   6. Fluconazole contains sodium
5. How to take Fluconazole
   1. Use in children and adolescents
   2. Elderly patients
   3. Dosage in patients with impaired renal function
   4. Use of a higher than recommended dose of Fluconazole
   5. Missing a dose of Fluconazole
6. Possible side effects
   1. If the patient experiences any of the following symptoms, they should stop taking Fluconazole and seek medical help immediately:
   2. Fluconazole and
   3. DRESS or drug hypersensitivity syndrome
   4. Other side effects:
   5. Reporting side effects
7. How to store Fluconazole
8. Contents of the packaging and other information
   1. What Fluconazole contains
   2. What Fluconazole looks like and what the pack contains
   3. Marketing authorization holder and manufacturer:
   4. Marketing authorization holder
   5. Manufacturer/Importer:
   6. UAB Norameda
   7. Tramco sp. z o.o.
   8. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   9. Information intended for healthcare professionals only:

Leaflet accompanying the packaging: patient information

Fluconazole solution for infusion 2 mg/ml

(Fluconazolum)

You should 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, 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. This also applies to any side effects not listed in the leaflet. 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 packaging and other information

1. What is Fluconazole and what is it used for

Fluconazole belongs to a group of antifungal medicines. The active substance is fluconazole.
Fluconazole is indicated for the treatment of fungal infections and for the prevention of
candidal infections. The most common cause of fungal infections is Candida yeast.

Adults

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

• Cryptococcal meningitis - fungal brain infection,
• Coccidioidomycosis - a respiratory disease (bronchi and lungs),
• Infections caused by Candida yeast and developing in the bloodstream, internal organs (e.g. heart, lungs) or urinary tract,
• Mucosal thrush - infection of the mucous membrane of the mouth, throat, and mouth sores associated with wearing dentures.

Fluconazole can also be used to:

• prevent relapses of cryptococcal meningitis,
• prevent relapses of mucosal thrush of the mouth,
• prevent fungal infections caused by Candida yeast (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:

• Mucosal thrush - infection of the mucous membrane of the mouth or throat,
• Infections caused by Candida yeast and developing in the bloodstream, internal organs (e.g. heart, lungs) or urinary tract,
• Cryptococcal meningitis - fungal brain infection.

Fluconazole can also be used to:

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

2. Important information before taking Fluconazole

When not to take Fluconazole

Warnings and precautions

Before starting to take Fluconazole, the patient should discuss it with their doctor,

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 Fluconazole and seek medical help immediately.

Fluconazole and other medicines

The patient should immediatelytell their doctor about taking astemizole, terfenadine (antihistamines
used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental
disorders), quinidine (used to treat heart rhythm disorders), and erythromycin (an antibiotic used to
treat infections), as they should not be taken with Fluconazole (see section 2 "When not to take
Fluconazole").
There are also other medicines that may affect the action of Fluconazole. The patient should inform
their doctor about taking any of the following medicines:

• rifampicin or rifabutin (antibiotics used to treat infections),
• alfentanil, fentanyl (anesthetics),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• blood thinners to prevent blood clots (warfarin or similar medicines),
• benzodiazepines (midazolam, triazolam or similar medicines), used to facilitate sleep or treat anxiety disorders,
• carbamazepine, phenytoin (medicines used to treat epilepsy),
• nifedipine, isradipine, amlodipine, felodipine, and losartan (medicines used to treat high blood pressure),
• cyclosporine, everolimus, sirolimus, or tacrolimus (medicines that prevent transplant rejection),
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines) used to treat cancer,
• halofantrine (a medicine 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,
• prednisolone (a steroid medicine),
• zidovudine, also known as AZT; saquinavir (a medicine used in patients infected with the HIV virus),
• medicines for diabetics, such as chlorpropamide, glibenclamide, glipizide, or tolbutamide,
• theophylline (used to treat asthma),
• vitamin A (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, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
If the patient plans to become pregnant, it is recommended that after taking a single dose of fluconazole, and before becoming pregnant, they wait for a week.
In the case of longer treatment cycles with fluconazole, the patient should discuss the need for appropriate contraception during treatment and for a week after the last dose with their doctor.
Pregnancy
If the patient is pregnant, thinks they may be pregnant, or is trying to conceive, they should not take fluconazole unless their doctor has advised them to do so. If the patient becomes pregnant while taking this medicine or within a week of taking the last dose, they should contact their doctor.
Fluconazole taken in the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken in the first trimester of pregnancy may increase the risk of birth defects of the heart, bones, and/or muscles.
There have been cases of children with birth defects of the skull, ears, and femur and humerus bones, 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.
Breastfeeding
After taking a single dose of Fluconazole up to 200 mg, the patient can continue to breastfeed. However, if the patient is taking multiple doses of Fluconazole, they should not breastfeed.

Driving and using machines

While driving or operating machines, the patient should take into account the possibility of dizziness or seizures.

Fluconazole contains sodium

Fluconazole contains 0.154 mmol of sodium in each 1 ml. The sodium dose should be taken into account in patients controlling their sodium intake.

3. How to take Fluconazole

Fluconazole is intended for use only by a doctor or nurse in the form of a slow intravenous infusion (infusion). Fluconazole is supplied as a solution. The medicine will not be further diluted. Detailed information for medical staff and healthcare professionals is provided at the end of the leaflet.
The following dosages of Fluconazole are presented depending on the type of infection. The patient should ask their doctor or nurse if they are unsure why they are taking Fluconazole.
Adults

Use in children and adolescents

Adolescents from 12 to 17 years old
The patient should follow the doctor's recommendations (dosage as for adult patients or children).
Children up to 11 years old
The maximum dose in children is 400 mg per day.
The dose should be determined based on the child's body weight (in kilograms).

Children from 0 to 4 weeks old
Dosage in children from 3 to 4 weeks old:

• The same dose as above, given every 2 days. The maximum dose is 12 mg/kg body weight every 48 hours. Dosage in children under 2 weeks old:
• The same dose as above, given every 3 days. The maximum dose is 12 mg/kg body weight every 72 hours.

Sometimes the doctor may recommend a different dosage. The medicine should always be taken according to the doctor's, pharmacist's, or nurse's recommendations. If the patient has any doubts, they should consult their doctor, pharmacist, or nurse.

Elderly patients

In patients with normal kidney function, the dosage is the same as for adult patients.

Dosage in patients with impaired renal function

In patients with impaired renal function, the doctor may recommend changing the dosage depending on the degree of impairment.

Use of a higher than recommended dose of Fluconazole

If the patient is convinced that they have received too high a dose of Fluconazole, they should immediately inform their doctor or nurse about this. Symptoms of potential overdose may include hearing and vision disorders, as well as perceiving and thinking about unreal things (hallucinations and paranoid behavior).

Missing a dose of Fluconazole

Since this medicine is used under strict medical supervision, it is unlikely that a dose of the medicine will be missed. However, if the patient suspects that a dose has been missed, they should inform their doctor or nurse.
The patient should not take a double dose to make up for a missed dose.
If the patient has any further doubts about taking the medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Fluconazole 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 of the following symptoms, they should stop taking Fluconazole and seek medical help immediately:

Fluconazole and

• widespread rash, high fever, swollen lymph nodes (DRESS or drug hypersensitivity syndrome)

DRESS or drug hypersensitivity syndrome

• sudden wheezing, difficulty breathing, or feeling of heaviness in the chest;
• swelling of the eyelids, face, or lips;
• itching all over the body, skin redness, or appearance of red, itchy blisters,
• skin rash, sometimes with blisters, itching
• severe skin reactions, such as a rash causing blisters (may also affect the mouth and tongue). If the patient experiences any of the above symptoms, they should stop taking Fluconazole and seek medical help immediately.

Fluconazole may affect the liver. Symptoms of liver disorders 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 Fluconazole and seek medical help immediately.

Fluconazole may affect the adrenal glands and the level of steroid hormones produced by them. Symptoms of adrenal disorders include:

• fatigue,
• muscle weakness,
• loss of appetite,
• weight loss,
• abdominal pain. If the patient experiences any of the above symptoms, they should stop taking Fluconazole and seek medical help immediately.

Other side effects:

Frequent side effects (may affect up to 1 in 10 patients):

• headache;
• abdominal pain, diarrhea, nausea, vomiting;
• increased liver function test results;
• rash.

Uncommon side effects (may affect up to 1 in 100 patients):

• decreased red blood cell count causing pallor, weakness, and shortness of breath,
• decreased appetite,
• insomnia, drowsiness,
• seizures, dizziness, feeling of spinning, tingling, numbness, or prickling, changes in taste,
• constipation, indigestion, bloating, dry mouth,
• muscle pain,
• liver damage and yellowing of the skin and eyes (jaundice),
• blisters, hives, itching, increased sweating,
• fatigue, malaise, fever.

Rare side effects (may affect 1 in 10,000 patients):

• decreased white blood cell count responsible for protecting against infections and blood cells responsible for stopping bleeding,
• red or purple skin discoloration, which may be due to a decrease in platelet count or changes in other blood cells,
• changes in blood biochemical parameters (high cholesterol, lipid levels in the blood),
• tremors,
• low potassium levels in the blood,
• abnormal electrocardiogram (ECG) readings, heart rhythm disorders,
• liver damage,
• allergic reactions (sometimes severe), including widespread rash with blisters and skin peeling, severe skin reactions, swelling of the mouth or face,
• hair loss.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Fluconazole

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not freeze.
The vial should be stored in the outer carton to protect from light.

Do not use this medicine after the expiry date stated on the outer packaging after "EXP". The expiry date refers to the last day of the given month.
This medicinal product is intended for single use only. After opening, any unused infusion solution should be discarded.
The solution can only be used if it is clear and free of visible particles.
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 Fluconazole contains

• The active substance of the medicine is fluconazole. Each 1 ml contains 2 mg of fluconazole. Each 100 ml of infusion solution contains 200 mg of fluconazole.
• The excipients are sodium chloride and water for injections.

What Fluconazole looks like and what the pack contains

Fluconazole is a clear and colorless infusion solution, available in a 100 ml glass vial.
Fluconazole is available in packs containing 1 vial with 100 ml of infusion solution.
Not all pack sizes are marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Baxter Holding B.V.
Kobaltweg 49,
3542 CE Utrecht
Netherlands

Manufacturer/Importer:

Bieffe Medital S.P.A
Via Nuova Provinciale
23034 Grosotto (SO),
Italy

UAB Norameda

Meistru 8a, 02189, Vilnius,
Lithuania

Tramco sp. z o.o.

Wolskie, ul. Wolska 14
05-860 Płochocin
Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:January 2024 Other sources of information:
Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPLWMiPB):
http://www.urpl.gov.pl
______________________________________________________________________________

Information intended for healthcare professionals only:

Intravenous infusion should be administered at a rate not exceeding 10 ml/min.
In patients requiring fluid or sodium restriction, attention should be paid to the rate of fluid administration.
The fluconazole infusion solution is compatible with the following infusion solutions:
a) 5% and 20% D-glucose solution
b) Ringer's solution
c) Ringer's lactate solution
d) potassium chloride solution in glucose solution
e) 4.2% and 5% sodium bicarbonate solution
f) Aminosyn 3.5%
g) 9 mg/ml (0.9%) sodium chloride solution
h) Dialaflex (peritoneal dialysis solution 6.36%)
Fluconazole may be administered through an existing intravenous access line with one of the above fluids. Although no specific incompatibilities have been observed, it is not recommended to mix fluconazole with other medicinal products before administration.
The infusion solution is intended for single use only.
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions before use.
The storage time should not exceed 24 hours at a temperature between 2 and 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Dilution should be performed under aseptic conditions. The solution should be inspected visually for any change in color or the presence of particulate matter before administration. The solution should only be used if it is clear and free of visible particles.
Any unused product or waste material should be disposed of in accordance with local regulations.