Leaflet: information for the user

Fluconazole B. Braun 2 mg/ml infusion solution EFG

Fluconazole

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to use Fluconazole B. Braun

3. How to use Fluconazole B. Braun

4. Possible side effects

5. Storage of Fluconazole B. Braun

6. Contents of the pack and additional information

Fluconazol B. Braun is one of the medicationsin the group called “antifungals”. The active ingredient is fluconazol.

Fluconazol is used to treatinfections caused by fungi,and it may also be used to prevent the appearance of a fungal infection. The most common cause of fungal infections is a yeast calledCandida.

Adults

Your doctor may prescribe this medication to treat the following types of fungal infections:

• Cryptococcal meningitis, a fungal infection in the brain;
• Coccidioidomycosis, a disease of the bronchopulmonary system;
• Infections caused byCandidalocated in the bloodstream, in organs of the body (e.g., heart, lungs) or in the urinary tract;
• Mucosal candidiasis – an infection that affects the mucous membrane of the mouth, throat, or associated with dental prostheses.

Your doctor may also prescribe Fluconazol B. Braun to:

• Prevent the recurrence of cryptococcal meningitis.
• Prevent the recurrence of mucosal infections.
• Prevent the transmission of infections caused by Candida (if your immune system is weak and does not function properly).

Childrenand adolescents(from0 to17 years)

Your doctor may prescribe this medication to treat the following types of fungal infections:

• Mucosal candidiasis – an infection that affects the mucous membrane of the mouth or throat.
• Infections caused by Candida located in the bloodstream, in organs of the body (e.g., heart, lungs) or in the urinary tract.
• Cryptococcal meningitis – a fungal infection in the brain.

Your doctor may also give you Fluconazol B. Braun to:

• Prevent the transmission of infections caused by Candida (if your immune system is weak and does not function properly).
• Prevent the recurrence of cryptococcal meningitis.

Do not use Fluconazol B. Braunif

• You are allergic to fluconazole, other medications you have taken to treat fungal infections, or any of the other components of fluconazole (see section 6). Symptoms may include itching, skin redness, or difficulty breathing.
• You are taking astemizole, terfenadine (antihistamines for allergies).
• You are taking cisapride (used to treat stomach discomfort).
• You are taking pimozide (used to treat mental illnesses).
• You are taking quinidine (used to treat heart arrhythmias).
• You are taking erythromycin (an antibiotic for infections).

Warnings and precautions

Consult your doctor before starting to use Fluconazol B. Braun

• If you have liver or kidney problems.
• If you have a heart disease, including heart rhythm problems.
• If you have abnormal levels of potassium, calcium, or magnesium in your blood.
• If you experience severe skin reactions (itching, skin redness, or difficulty breathing).

• If you experience signs of "adrenal insufficiency" when your adrenal glands do not produce enough of certain steroid hormones such as cortisol (chronic fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
• If you have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after using Fluconazol B. Braun.

• If the fungal infection does not improve, an alternative antifungal treatment may be necessary.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Fluconazol B. Braun treatment. Stop using Fluconazol B. Braun and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Using Fluconazol B. Braun with other medications

Inform your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for allergies), cisapride (used to treat stomach discomfort), pimozide (used to treat mental illnesses), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic for infections), as these medications should not be taken with Fluconazol B. Braun (see section: "Do not use Fluconazol B. Braun").

There are several medications that may interact with Fluconazol B. Braun.Make sure your doctor knows if you are taking any of the following medications:

• Rifampicin, rifabutin, or azithromycin (antibiotics for infections);
• Abrocitinib (used to treat atopic dermatitis, also known as eczema);
• Alfentanil, fentanyl (used as anesthetics);

• Amlodarone (used to treat irregular heartbeats),

• Amitriptyline, nortriptyline (used as antidepressants);
• Ampotericin B, voriconazole (antifungals);
• Medications that make blood less viscous to prevent clot formation (warfarin or similar medications);
• Benzodiazepines (midazolam, triazolam, or similar medications) used to help sleep or for anxiety;
• Carbamazepine, phenytoin (used to treat seizures);
• Nifedipine, isradipine, amlodipine, felodipine, verapamil, hydrochlorothiazide (a diuretic) and losartan (for hypertension - high blood pressure);
• Olaparib (used to treat ovarian cancer);
• Ciclosporin, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection);
• Cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medications) used to treat cancer;
• Halofantrine (used to treat malaria);
• Statins (atorvastatin, simvastatin, and fluvastatin, or similar medications) used to reduce high cholesterol levels;
• Methadone (used for pain);
• Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Nonsteroidal Anti-Inflammatory Drugs - NSAIDs);
• Oral contraceptives;
• Prednisone (steroid);
• Zidovudine, also known as AZT; saquinavir (used in patients infected with HIV);
• Medications for diabetes, such as chlorpropamide, glibenclamide, glipizide, or tolbutamide;
• Theophylline (used to control asthma);
• Tofacitinib (used to treat rheumatoid arthritis);
• Tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to delay renal function deterioration);
• Vitamin A (nutritional supplement);

• Ivacaftor (alone or in combination with other medications to treat cystic fibrosis);
• Ibrutinib (used to treat blood cancer);
• Lurasidone (used to treat schizophrenia).

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before this medication is administered.

If you plan to become pregnant, it is recommended that you wait one week after a single dose of fluconazole before becoming pregnant.

For longer fluconazole treatment cycles, consult your doctor about the need to use appropriate contraceptive methods during treatment, which should be maintained for one week after the last dose.

Do not administer Fluconazol B. Braun if you are pregnant, think you may be pregnant, or plan to become pregnant or breastfeed, unless your doctor has instructed you to do so. If you become pregnant while being treated with this medication or within one week of the most recent dose, consult your doctor.

Fluconazole administered during the first or second trimester of pregnancy may increase the risk of spontaneous abortion. Fluconazole during the first trimester may increase the risk of a baby being born with congenital anomalies affecting the heart, bones, and/or muscles.

Cases of babies born with congenital anomalies affecting the skull, ears, and leg and elbow bones have been reported in women treated for three months or more with high doses (400-800 mg daily) of fluconazole for coccidioidomycosis. The relationship between fluconazole and these cases is unclear.

You can continue breastfeeding after taking a single dose of 150 mg fluconazole.

Do not breastfeed if you are taking repeated doses of fluconazole.

Driving and operating machines

When driving or operating machines, be aware that occasional dizziness or seizures may occur.

Fluconazol B. Braun containssodium

This medication contains 177 mg of sodium (main component of table salt/for cooking) in each 50 ml bottle.This is equivalent to 8.9% of the maximum daily sodium intake recommended for an adult.

This medication contains 354 mg of sodium (main component of table salt/for cooking) in each 100 ml bottle.This is equivalent to 17.7% of the maximum daily sodium intake recommended for an adult.

This medication contains 709 mg of sodium (main component of table salt/for cooking) in each 200 ml bottle.This is equivalent to 35.5% of the maximum daily sodium intake recommended for an adult.

Your doctor or nurse will administer this medication through a slow injection (infusion) directly into your vein. Fluconazol B.Braun is supplied as a solution. It does not need to be diluted. Additional information for healthcare professionals is provided in the final section of this leaflet.

The following indicates the recommended dose of this medication for different types of infections. Check with your doctor or nurse if you are unsure whether you should receive treatment with Fluconazol B. Braun.

Adults

Adolescents aged12 to17 years

Follow the doseindicatedby your doctor (the adult dose or the pediatric dose).

Children up to 11 years

The maximum daily dose forchildrenis 400 mg per day.

The dose will be based on the child's weight in kilograms.

Use in children 0 to4 weeks

Use in children aged 3 to 4 weeks:

• The same dose as described in the table, but administered once 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 described in the table, but administered once every 3 days. The maximum dose is 12 mg per kilogram of body weight every 72 hours.

Geriatric patients

The usual adult dose, unless you have kidney problems.

Patients with kidney disease

Your doctor may change your dose, depending on how well your kidneys are functioning.

Receiving more Fluconazol B. Braun than prescribed

If you are concerned that you may have been given too much Fluconazol B.Braun, consult your doctor or nurse immediately. Symptoms of a possible overdose may include hearing, seeing, feeling, and thinking things that are not real (hallucinations and paranoid behavior).

Missing a dose of Fluconazol B. Braun

Since this medication will be administered under strict medical supervision, it is unlikely that a dose will be missed. However, if you think you may have missed a dose, consult your doctor or pharmacist.

If you have any other questions about the use of thismedication, ask your doctor,pharmacist, or nurse.

Like all medicines, Fluconazol B. Braun may cause side effects, although not everyone will experience them.

Stop usingFluconazol B.Braunand seek immediate medical attention if you notice any of the following symptoms:

• Skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Some people developallergic reactions, although severe allergic reactions are rare (they can affect up to 1 in 1000 patients). If any of the following symptoms appear,inform your doctor immediately.

• Sudden onset of wheezing, difficulty breathing, or chest tightness.
• Swelling of the eyelids, face, or lips.
• Itching all over the body, redness of the skin, or red spots with itching.
• Skin rash.
• Severe skin reactions, such as a rash that causes blisters (this can affect the mouth and tongue).

Fluconazol B. Braun may affect your liver.The signs that indicate liver problems are:

• Tiredness;
• Loss of appetite;
• Vomiting;

• Yellowing of the skin or white of the eyes (jaundice).

If you experience any of these symptoms, stop using Fluconazol B.Braun andinform your doctor immediately.

Other side effects

In addition, if you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

• Headache.
• Stomach discomfort, diarrhea, nausea, vomiting.
• Abnormal blood test results indicating liver function.
• Skin rash.

Rare side effects that may affect up to1 in 100 patients:

• Reduction of red blood cells, which can cause pale skin and weakness or difficulty breathing.
• Loss of appetite.
• Inability to sleep, numbness.
• Convulsions, dizziness, feeling of spinning, tingling, pins and needles, changes in taste.
• Constipation, heavy digestion, gas, dry mouth.
• Muscle pain.
• Liver damage and yellowing of the skin and eyes (jaundice).
• Rashes, blisters (pustules), itching, increased sweating.
• Tiredness, general feeling of discomfort, fever.

Rare side effects that may affect up to 1 in 1000 patients:

• White blood cells in the blood that help us fight infections and blood cells that help stop bleeding, lower than normal.
• Red or purple discoloration of the skin, which may be due to a low number of platelets, other changes in blood cells.
• Abnormal blood test results (high levels of cholesterol, fats).
• Low levels of potassium in the blood.
• Tremors.
• Abnormal electrocardiogram (ECG), changes in heart rate or rhythm.
• Liver failure.
• Allergic reactions (sometimes severe), including widespread rash with blisters and skin peeling, severe allergic reactions, swelling of the lips or face.
• Hair loss.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and in the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Do not freeze.

This medication must be used immediately after opening the container.

Use only this medication if the solution is transparent and does not contain visible particles. Do not use if the bottle is damaged.

This medication is for single use only.

Once opened, the unused infusion must be discarded.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Fluconazole B. Braun

• The active ingredient is fluconazole. Each ml contains 2 mg of fluconazole.

• The other components aresodium chloride andwater for injection preparations.

Appearance of the productand contents of the package

Fluconazole B. Braun is a transparent colorless solution that contains the ingredients mentioned above in water.

It is presentedin polyethylene bottles of 50 ml, 100 ml or 200 ml.

Packaging formats:10, 20 or 50 bottles.

Only somepackage sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Postal address:

34209 Melsungen

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 medicinehas beenauthorized in the member statesof the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Last review date of thisleaflet: 02/2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

Intravenous infusion should be administered at a rate that does not exceed10 ml/min. Fluconazole B. Braun is formulated with a 0.9% sodium chloride solution; each 200 mg (100 ml bottle) contains 15 mmol of Na+and Cl-. Due to the fact that Fluconazole B. Braun is available as a diluted sodium chloride solution,in patients with sodium or fluid restrictions, the rate of fluid administration should be taken into account.

Fluconazole B. Braun 2 mg/ml is compatible with the following infusion fluids:

a)Glucose infusion solution 200 mg/ml (if available)

b)Solution for infusion of Ringer's solution

c) Hartmann's solution, lactate Ringer's solution(if available)

d)Potassium chloride solution 20 mEq/l in glucose 50 mg/ml(if available)

e) Sodium bicarbonate solution for infusion 84 mg/ml (8.4%)(if available)

f) Sodium chloride solution 9 mg/ml (0.9%)

g) Isofundin infusion solution(if available)

Fluconazole can be infused through an existing route along with one of the above-mentioned fluids. Although no specific incompatibilities have been observed, it is not recommended to mix Fluconazole B.Braun with other medications before infusion.

The infusion solution is for single use only.

Valid period after opening the package:

The medicine should be used immediately after the first opening of the package.

Valid period after mixing according to instructions:

Chemical stability has been demonstrated at 25 °C for 72 hours

From a microbiological point of view, the dilutions should be used immediately. If not used immediately, the storage times and conditions in use are the responsibility of the user and should not normally exceed 24 hours at a temperature of 2 °C to 8 °C, unless the dilution has been prepared in facilities with controlled and validated aseptic conditions.

The dilution should be prepared in aseptic conditions. Before administration, the solution should be inspected to check for visible particles or discoloration. Only the solution should be used if it is transparent and free of particles.

The elimination of unused medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.

If you want the complete information on this medicine, consult the product technical file.