FLUCONAZOLE 2 mg /Ml Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: Information for the user
2. Fluconazole B. Braun 2 mg/ml, solution for infusion
   1. Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Fluconazole B. Braun and what is it used for
4. Important information before using Fluconazole B. Braun
   1. When not to use Fluconazole B. Braun:
   2. Warnings and precautions
   3. Other medicines and Fluconazole B. Braun
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Fluconazole B. Braun contains sodium
5. How to use Fluconazole B. Braun
   1. Using a higher dose of Fluconazole B. Braun than recommended
   2. Missing a dose of Fluconazole B. Braun
6. Possible side effects
   1. In rare cases, patients may experience allergic reactions, although severe allergic reactions are rare (may occur in 1 in 1000 patients). If the patient experiences any of the following symptoms, they should immediately inform their doctor:
   2. Other side effects:
   3. Reporting side effects
7. How to store Fluconazole B. Braun
8. Contents of the packaging and other information
   1. What Fluconazole B. Braun contains
   2. What Fluconazole B. Braun looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   6. Date of last revision of the leaflet: 2024-02-22
   7. Information intended for healthcare professionals only
   8. Shelf life after first opening of the packaging
   9. Shelf life after dilution in accordance with the instructions

Leaflet accompanying the packaging: Information for the user

Fluconazole B. Braun 2 mg/ml, solution for infusion

fluconazole

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

Please keep this leaflet, so that you can read it again if you need to.
Please consult a doctor or pharmacist if you have any doubts.
If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist.

Table of contents of the leaflet

• 1. What is Fluconazole B. Braun and what is it used for
• 2. Important information before using Fluconazole B. Braun
• 3. How to use Fluconazole B. Braun
• 4. Possible side effects
• 5. How to store Fluconazole B. Braun
• 6. Contents of the packaging and other information

1. What is Fluconazole B. Braun and what is it used for

Fluconazole B. Braun belongs to a group of medicines called "antifungal medicines". The active substance of the medicine is fluconazole.
Fluconazole is used to treat infections caused by fungi, and it can also be used as a prophylaxis against yeast infections. The most common cause of fungal infections is the yeast Candida.
Adults
The doctor may prescribe this medicine to the patient to treat the following types of fungal infections:
Cryptococcal meningitis - a fungal infection of the brain.
Coccidioidomycosis - a disease of the respiratory system.
Infections caused by Candida yeast and occurring in the bloodstream, body organs (e.g. heart, lungs) or urinary system.
Mucosal thrush - infections involving the mucous membranes lining the mouth and throat, as well as inflammation caused by the pressure of a dental prosthesis.
The patient may also receive Fluconazole B. Braun to:
prevent the recurrence of cryptococcal meningitis,
prevent the recurrence of mucosal thrush,
prevent infections caused by Candida yeast (if the patient's immune system is weakened and not functioning properly).
Children and adolescents (from 0 to 17 years)
The doctor may prescribe this medicine to the patient to treat the following types of fungal infections:
Mucosal thrush - infections involving the mucous membranes lining the mouth and throat, as well as inflammation caused by the pressure of a dental prosthesis.
Infections caused by Candida yeast and occurring in the bloodstream, body organs (e.g. heart, lungs) or urinary system.
Cryptococcal meningitis - a fungal infection of the brain.
The patient may also receive Fluconazole B. Braun to:
prevent infections caused by Candida yeast (if the patient's immune system is weakened and not functioning properly),
prevent the recurrence of cryptococcal meningitis,
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2. Important information before using Fluconazole B. Braun

When not to use Fluconazole B. Braun:

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 of an allergic reaction may include itching, redness of the skin, 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 illnesses),
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 using Fluconazole B. Braun, the patient should discuss with the doctor if:
the patient has liver or kidney problems,
the patient has heart disease, including heart rhythm disorders,
the patient has abnormal levels of potassium, calcium, or magnesium in the blood,
the patient experiences severe skin reactions (itching, redness of the skin) or difficulty breathing,
the patient experiences symptoms of "adrenal insufficiency", when the adrenal glands do not produce enough certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain),
the patient has ever experienced a severe skin rash or peeling of the skin, blisters, and (or) ulcers of the mouth after using Fluconazole B. Braun,
the fungal infection does not improve, other antifungal treatment may be necessary
Patients treated with Fluconazole B. Braun have experienced 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 using Fluconazole B. Braun and seek medical help immediately.

Other medicines and Fluconazole B. Braun

The patient should tell the 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 immediately inform the doctor if they are taking astemizole or terfenadine (antihistamine medicines used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental illnesses), quinidine (used to treat heart rhythm disorders), or erythromycin (an antibiotic used to treat infections), as these medicines should not be taken with Fluconazole B. Braun (see "When not to use Fluconazole B. Braun").
Some medicines may interact with Fluconazole B. Braun. If the patient is taking any of the following medicines, they should make sure the doctor knows:
rifampicin, rifabutin, or azithromycin (antibiotics used to treat infections),
abrocitinib (used to treat atopic dermatitis, also known as atopic eczema),
alfentanil, fentanyl (anesthetics),
amiodarone (used to treat irregular heartbeat - arrhythmia),
amitriptyline, nortriptyline (used as antidepressants),
amphotericin B, voriconazole (antifungal medicines),
blood thinners to prevent blood clots (warfarin or similar medicines),
benzodiazepine derivatives (midazolam, triazolam, or similar medicines) used as sleeping pills or anxiolytics,
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carbamazepine, phenytoin (used to treat epileptic seizures),
nifedipine, isradipine, amlodipine, felodipine, verapamil, hydrochlorothiazide (diuretic) and losartan (medicines used to treat high blood pressure),
olaparib (used to treat ovarian cancer),
cyclosporine, everolimus, sirolimus, or tacrolimus (used to 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, fluvastatin, or similar medicines) used to lower high 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 (used in HIV-infected patients),
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 to treat cystic fibrosis),
ibrutinib (used to treat blood cancer),
luraxizumab (used to treat schizophrenia).

Pregnancy and breastfeeding

If the patient is pregnant, trying to become pregnant, or breastfeeding, they should tell their doctor.
Before taking any medicine, the patient should consult their doctor or pharmacist.
If the patient plans to become pregnant, it is recommended that they wait for one week after taking a single dose of fluconazole before becoming pregnant.
In case of longer treatment cycles with fluconazole, the patient should discuss with their doctor the need for adequate contraception during treatment and for one week after the last dose.
If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should not take Fluconazole B. Braun unless their doctor has told them to. If the patient becomes pregnant while taking this medicine or within one week of 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.
There have been reports of children with congenital 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.
It is safe to breastfeed after taking a single dose of 150 mg of fluconazole.
The patient should not breastfeed if they are taking multiple doses of fluconazole.

Driving and using machines

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

Fluconazole B. Braun contains sodium

The medicine contains 177 mg of sodium (the main component of common salt) in each 50 ml vial. This corresponds to 8.9% of the maximum recommended daily intake of sodium in the diet for adults.
The medicine contains 354 mg of sodium (the main component of common salt) in each 100 ml vial. This corresponds to 17.7% of the maximum recommended daily intake of sodium in the diet for adults.
The medicine contains 709 mg of sodium (the main component of common salt) in each 200 ml vial. This corresponds to 35.5% of the maximum recommended daily intake of sodium in the diet for adults.
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3. How to use Fluconazole B. Braun

This medicine will be administered by a doctor or nurse as a slow injection (infusion) into a vein. Fluconazole B. Braun is supplied as a solution. This solution will not be further diluted. More information for healthcare professionals can be found at the end of the leaflet.
Typical doses of this medicine used for different infections are given below. If the patient is unsure why they are being given Fluconazole B. Braun, they should ask their doctor or nurse.
Adults

Adolescents from 12 to 17 years
According to the doctor's recommendation (dosage prescribed for adults or children)
Children up to 11 years
The maximum dose for children should not exceed 400 mg per day.
The dose will be based on the child's body weight in kilograms.

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Use in children from 0 to 4 weeks
Use in children from 3 to 4 weeks:
The same dose as above, but given every 2 days. The maximum dose is 12 mg per kilogram of body weight every 48 hours.
Use in children under 2 weeks:
The same dose as above, but given every 3 days. The maximum dose is 12 mg per kilogram of body weight every 72 hours.
Use in elderly patients
The usual adult dose should be used, unless the patient has kidney problems.
Use in patients with kidney problems
The doctor may change the dose depending on the patient's kidney function.

Using a higher dose of Fluconazole B. Braun than recommended

If the patient is concerned that they may have received too much Fluconazole B. Braun, they should tell their doctor or nurse immediately. Symptoms of possible overdose include hearing, seeing, feeling, or thinking things that are not there (hallucinations and paranoid behavior).

Missing a dose of Fluconazole B. Braun

Since this medicine is given under the close supervision of a doctor, it is unlikely that a dose will be missed. However, if the patient thinks they have missed a dose, they should tell their doctor or pharmacist.
If the patient has any further questions about using the medicine, they should ask their doctor, pharmacist, or nurse.

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 using Fluconazole B. Braun and seek medical help immediately:

• Fluconazole B. Braun and seek medical help immediately:
• widespread rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity syndrome).

In rare cases, patients may experience allergic reactions, although severe allergic reactions are rare (may occur in 1 in 1000 patients). If the patient experiences any of the following symptoms, they should immediately inform their doctor:

sudden onset of wheezing, shortness of breath, or chest tightness,
swelling of the eyelids, face, and/or lips,
itching all over the body, redness of the skin, or a red itchy rash,
skin rash,
severe skin reactions, such as a rash with blisters (may appear in the mouth and on the tongue).
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Fluconazole B. Braun 2 mg/ml may have an adverse effect on the liver. Symptoms of liver problems include:
fatigue,
loss of appetite,
nausea and vomiting,
yellowing of the skin and/or whites of the eyes (jaundice).
If the patient experiences any of these symptoms, they should stop using Fluconazole B. Braun and immediately inform their doctor.

• Fluconazole B. Braun and immediately inform their doctor.

Other side effects:

In addition, if any of the following side effects become severe or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist.
Common side effects (may affect up to 1 in 10 people):
headache,
stomach discomfort, diarrhea, nausea, vomiting,
abnormal liver function test results from blood,
rash .
Uncommon side effects (may affect up to 1 in 100 people):
reduced red blood cell count, which can cause pale skin, weakness, or shortness of breath,
reduced appetite,
insomnia, drowsiness,
seizures, dizziness, feeling of spinning, tingling, or numbness,
changes in taste,
constipation, indigestion, gas, dry mouth,
muscle pain,
liver damage and yellowing of the skin and/or eyes (jaundice),
blisters, hives, itching, increased sweating, fever.
Rare side effects (may affect up to 1 in 1000 people):
reduced white blood cell count, which can increase the risk of infection, and reduced platelet count, which can increase the risk of bleeding,
red or purple discoloration of the skin, which can be caused by a low platelet count, changes in other blood cell counts,
changes in blood chemistry (high cholesterol and fat levels in the blood),
tremors,
low potassium levels in the blood,
abnormal ECG (electrocardiogram), changes in heart rate or rhythm,
liver failure,
allergic reactions (sometimes severe) including widespread rash with blisters and peeling of the skin, severe skin reactions, swelling of the lips and/or face,
hair loss.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
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Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
By reporting side effects, more information can be collected on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Fluconazole B. Braun

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP".
The expiry date refers to the last day of the month stated.
Do not store above 25°C.
Do not freeze.
This medicine should be used immediately after opening the container.
Only a solution without solid particles is suitable for use. Do not use if the vial is damaged.
The vials are for single use only. After use, the vials and any remaining contents should be disposed of.
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 need. This will help protect the environment.

6. Contents of the packaging and other information

What Fluconazole B. Braun contains

The active substance of the medicine is fluconazole.
Each ml contains 2 mg of fluconazole.
The other ingredients (excipients) are sodium chloride and water for injections.

What Fluconazole B. Braun looks like and contents of the pack

Fluconazole B. Braun is a clear, colorless solution of the above ingredients in water.
It is available in polyethylene vials containing 50 ml, 100 ml, or 200 ml.
Pack size: packs of 10, 20, or 50 vials.
Not all pack sizes may be marketed.

Marketing authorization holder:

• B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany Mailing address:34209 Melsungen Page 7 of 9

Germany
Phone: +49-5661-71-0
Fax: +49-5661-71-45 67

Manufacturer:

• B. Braun Medical S.A. Carretera de Terrassa, 121 08191 Rubí (Barcelona) Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: 2024-02-22

Information intended for healthcare professionals only

Infusions should be administered at a rate not exceeding 10 ml/minute. Fluconazole B. Braun solution for infusion contains sodium chloride at a concentration of 9 mg/ml (0.9%); for every 200 mg of fluconazole (100 ml vial), there are 15 mmol of Na+ and Cl- ions. Since Fluconazole B. Braun is available as a diluted sodium chloride solution, patients requiring sodium or fluid restriction should be monitored for the rate of infusion.

• B. Braun solution for infusion is compatible with the following solutions:
• a) glucose solution for infusion 200 mg/ml (if available)
• b) Ringer's solution for infusion
• c) Hartmann's solution, Ringer's solution with lactate (if available)
• d) potassium chloride solution 20 mEq/l in glucose solution 50 mg/ml (if available)
• e) sodium bicarbonate solution for infusion 84 mg/ml (8.4%) (if available)
• f) sodium chloride solution for infusion 9 mg/ml (0.9%)
• g) Sterofundin ISO solution for infusion (if available).

Fluconazole may be administered through a pre-existing intravenous line with the above-mentioned fluids, although no specific incompatibilities have been observed.
The solution for infusion is for single use only.

Shelf life after first opening of the packaging

The medicinal product should be used immediately after opening the packaging.

Shelf life after dilution in accordance with the instructions

Chemical and physical stability of mixtures with the solutions listed below has been demonstrated for 72 hours at 25°C.
From a microbiological point of view, the product should be diluted just before use. If the solution is not used immediately after preparation, the responsibility for its storage and conditions before use lies with the user. The storage time should not normally exceed 24 hours at 2 to 8°C, unless dilution is performed under controlled and validated aseptic conditions .
Dilution must be performed under aseptic conditions .Before use, the solution should be inspected visually for particulate matter or discoloration. Only a solution without solid particles is suitable for use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
To obtain comprehensive information on this medicinal product, the summary of product characteristics should be consulted.
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