FLUCONAZOLE B. BRAUN 2 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Fluconazole B. Braun 2 mg/ml Solution for Infusion EFG

Fluconazole

Read all of this leaflet carefully before you start using 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, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fluconazole B. Braun and what is it used for
2. What you need to know before you 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 further information

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

Fluconazole B. Braun is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Fluconazole is used to treat infections caused by fungi, and it can also be used to prevent fungal infections from occurring. The most common cause of fungal infections is a yeast called Candida.

Adults

Your doctor may prescribe this medicine 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 by Candidalocalized in the bloodstream, in body organs (e.g., heart, lungs) or in the urinary tract;
• Mucosal candidiasis – an infection that affects the lining of the mouth, throat, or associated with dental prostheses.

They may also prescribe Fluconazole B. Braun for:

• Preventing the recurrence of cryptococcal meningitis.
• Preventing the recurrence of mucosal infections.
• Preventing the spread of Candidainfections (if your immune system is weak and not working properly).

Childrenand adolescents(from 0 to 17 years)

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

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

They may also give you Fluconazole B. Braun for:

• Preventing the spread of Candidainfections (if your immune system is weak and not working properly).
• Preventing the recurrence of cryptococcal meningitis.

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

Do not use Fluconazole B. Braunif

• You are allergic to fluconazole, to other medicines used to treat fungal infections, or to any of the other ingredients of fluconazole (see section 6). Symptoms may include itching, skin rash, or difficulty breathing.
• You are taking astemizole, terfenadine (antihistamine medicines for treating allergies).
• You are taking cisapride (used to treat stomach upset).
• You are taking pimozide (used to treat mental illness).
• You are taking quinidine (used to treat heart arrhythmias).
• You are taking erythromycin (an antibiotic for treating infections).

Warnings and precautions

Tell your doctor before you start using Fluconazole B. Braun

• If you have liver or kidney problems.
• If you have a heart condition, 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 rash, or difficulty breathing).

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

• If the fungal infection does not improve, you may need alternative antifungal treatment.

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

Using Fluconazole B. Braun with other medicines

Tell your doctor immediatelyif you are taking astemizole, terfenadine (an antihistamine for treating allergies), cisapride (used to treat stomach upset), pimozide (used to treat mental illness), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic for treating infections), as these medicines should not be taken with Fluconazole B. Braun (see section: "Do not use Fluconazole B. Braun").

There are several medicines that can interact with Fluconazole B. Braun. Make sure your doctor knows if you are taking any of the following medicines:

• rifampicin, rifabutin, or azithromycin (antibiotics for treating infections);
• abrocitinib (used to treat atopic dermatitis, also known as eczema);
• alfentanil, fentanyl (used as anesthetics);

• amiodarone (used to treat irregular heartbeats),

• amitriptyline, nortriptyline (used as antidepressants);
• amphotericin B, voriconazole (antifungal);
• medicines that make the blood less viscous, to prevent the formation of clots (warfarin or similar medicines);
• benzodiazepines (midazolam, triazolam, or similar medicines); used to help you sleep or for anxiety;
• carbamazepine, phenytoin (used to treat seizures);
• nifedipine, isradipine, amlodipine, felodipine, verapamil, hydrochlorothiazide (a diuretic), and losartan (for high blood pressure);
• olaparib (used to treat ovarian cancer);
• cyclosporine, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection);
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines) used to treat cancer;
• halofantrine (used to treat malaria);
• statins (atorvastatin, simvastatin, and fluvastatin or similar medicines) used to reduce high cholesterol levels;
• methadone (used for pain);
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs - NSAIDs);
• oral contraceptives;
• prednisone (steroid);
• zidovudine, also known as AZT; saquinavir (used in HIV-infected patients);
• medicines 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 the blood] or to delay the deterioration of kidney function);
• vitamin A (nutritional supplement);

• ivacaftor (alone or in combination with other medicines to treat cystic fibrosis);
• ibrutinib (used to treat blood cancer);
• lurasidone (used to treat schizophrenia).

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before they administer this medicine to you.

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

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

You should not be given Fluconazole B. Braun if you are pregnant, think you may be pregnant, or plan to become pregnant or breastfeed, unless your doctor has told you to. If you become pregnant while being administered this medicine or within one week of the last 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.

There have been reports of babies born with congenital anomalies affecting the skull, ears, and bones of the thigh and elbow 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 fluconazole 150 mg.

You should not breastfeed if you are taking repeated doses of fluconazole.

Driving and using machines

When driving or operating machinery, you should take into account that dizziness or seizures may occasionally occur.

Fluconazole B. Braun containssodium

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

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

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

3. How to use Fluconazole B. Braun

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

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

Adults

Adolescents from 12 to 17 years

Follow the dose indicated by your doctor (either the adult or child dose).

Children up to 11 years

The maximum daily dose for children is 400 mg per day.

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

Use in children from 0 to 4 weeks

Use in children 3 to 4 weeks old:

• The same dose as described in the table, but administered once every 2 days. The maximum dose is 12 mg per kg 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 kg of body weight every 72 hours.

Elderly 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 working.

If you receive more Fluconazole B. Braun than you should

If you are concerned that you may have been given too much Fluconazole B. Braun, talk to 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).

If you miss a dose of Fluconazole B. Braun

Since this medicine will be administered under close medical supervision, it is unlikely that you will miss a dose. However, if you think a dose may have been missed, talk to your doctor or pharmacist.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, Fluconazol B. Braun can cause adverse effects, although not all people suffer from them.

Stop using Fluconazol B. Braun and seek immediate medical attention if you notice any of the following symptoms:

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

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

• Sudden wheezing, difficulty breathing, or chest tightness.
• Swelling of the eyelids, face, or lips.
• Itching all over the body, skin redness, 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:

• fatigue;
• loss of appetite;
• nausea;

• yellowing of the skin or the whites of the eyes (jaundice).

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

Other Adverse Effects

Additionally, if you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

• Headache.
• Stomach upset, diarrhea, discomfort, nausea.
• Elevated blood test results indicating liver function.
• Rash.

Uncommon adverse effects that may affect up to 1 in 100 patients:

• Reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing.
• Decreased appetite.
• Insomnia, feeling of numbness.
• Seizures, dizziness, feeling of spinning, tingling, pinching, or numbness, changes in taste sensation.
• Constipation, heavy digestion, gas, dry mouth.
• Muscle pain.
• Liver damage and yellowing of the skin and eyes (jaundice).
• Hives, blisters (hives), itching, increased sweating.
• Fatigue, general feeling of discomfort, fever.

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

• White blood cells in the blood that help defend against infections and blood cells that help stop bleeding, lower than normal.
• Purple or reddish discoloration of the skin, which may be due to a low platelet count, other changes in blood cells.
• Changes in blood tests (high cholesterol, fat levels).
• Low potassium levels in the blood.
• Tremors.
• Abnormal electrocardiogram (ECG), changes in heart rate or rhythm.
• Liver function 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 Adverse Effects

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

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

5. Storage of Fluconazol B. Braun

Keep this medicine out of sight and reach of children.

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

Do not store above 25°C. Do not freeze.

This medicine must be used immediately after opening the container.

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

This medicine is for single use.

Once opened, the unused infusion must be discarded.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fluconazol B. Braun

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

• The other ingredients are sodium chloride and water for injectable preparations.

Product Appearance and Package Contents

Fluconazol B. Braun is a clear, colorless solution that contains the ingredients mentioned above in water.

It is presented in 50 ml, 100 ml, or 200 ml polyethylene bottles.

Package formats: 10, 20, or 50 bottles.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

• Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Mailing Address:

34209 Melsungen

Tel.: +49-5661-71-0

Fax: +49-5661-71-45 67

Manufacturer:

• Braun Medical S.A.

Carretera de Terrassa, 121

08191 Rubí (Barcelona)

Spain

This medicine has been authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of the Last Revision of this Prospectus: 02/2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

This information is intended only for healthcare professionals:

Intravenous infusion should be administered at a rate not exceeding 10 ml/min. Fluconazol B. Braun is formulated with a 9 mg/ml sodium chloride solution (0.9%); each 200 mg (100 ml bottle) contains 15 mmol of Na+ and Cl-. Since Fluconazol B. Braun is available in a diluted sodium chloride solution, in patients with sodium or fluid restriction, the fluid administration rate should be taken into account.

Fluconazol B. Braun 2 mg/ml is compatible with the following administration fluids:

• Glucose solution for infusion 200 mg/ml (if available)

• Ringer's solution for infusion

• Hartmann's solution, Lactated Ringer's solution (if available)

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

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

• Sodium chloride solution for infusion 9 mg/ml (0.9%)

• Isofundin solution for infusion (if available)

Fluconazol can be infused through an existing line along with one of the fluids listed above. Although no specific incompatibilities have been observed, it is not recommended to mix Fluconazol B. Braun with other medicines before infusion.

The infusion solution is for single use.

Validity Period after Opening the Container:

The medicine must be used immediately after the first opening of the container.

Validity Period after Mixing according to Instructions:

For mixtures with the solutions mentioned above, 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 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 performed in facilities with controlled and validated asepsis conditions.

Dilution should be performed under aseptic conditions. Before administration, the solution should be inspected to check for visible particles or discoloration. The solution should only be used if it is transparent and particle-free.

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

If you want complete information on this medicine, consult the product's technical data sheet.