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

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Fluconazole B. Braun is and what it is 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. How to store Fluconazole B. Braun
6. Contents of the pack and other information

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

Fluconazole B. Braun is one of the medicines belonging to a group called "antifungals". The active substance is fluconazole.

Fluconazole is used to treat fungal infections, and it can also be used to prevent the occurrence of a fungal infection. 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 of the brain;
• Coccidioidomycosis, a disease affecting the bronchopulmonary system;
• Infections caused by Candida located in the bloodstream, in body organs (e.g., heart, lungs), or in the urinary tract;
• Mucosal candidiasis – infection affecting the lining of the mouth, throat, or associated with dental prostheses.

Fluconazole B. Braun may also be prescribed to:

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

Children and adolescents (from 0 to 17 years old)

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

• Mucosal candidiasis – infection affecting the mucosal lining of the mouth or throat;
• Infections caused by Candida located in the bloodstream, in body organs (e.g., heart, lungs), or in the urinary tract;
• Cryptococcal meningitis – a fungal infection of the brain.

Fluconazole B. Braun may also be prescribed to:

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

2. What you need to know before using Fluconazol B. Braun

Do not use Fluconazol B. Braun if

• You are allergic to fluconazole, to other antifungal medicines you have taken, or to any of the other ingredients of fluconazole (see section 6). Symptoms may include itching, skin redness, or difficulty breathing.
• You are taking astemizole or terfenadine (antihistamine medicines used to treat 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 used to treat infections).

Warnings and precautions

Talk to your doctor before using Fluconazol B. Braun

• If you have liver or kidney problems.

• If you have a heart condition, including heart rhythm disorders.

• If you have abnormal levels of potassium, calcium, or magnesium in your blood.

• If you develop severe skin reactions (itching, skin redness, or difficulty breathing).

• If you experience signs of “adrenal insufficiency,” when the adrenal glands do not produce sufficient amounts of certain steroid hormones such as cortisol (e.g., chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).

• If you have ever developed a severe skin rash, 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 needed.

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported during treatment with Fluconazol B. Braun. Stop using Fluconazol B. Braun and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Using Fluconazol B. Braun with other medicines

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

Several medicines may interact with Fluconazol B. Braun. Make sure your doctor knows if you are taking any of the following:

• rifampicin, rifabutin, or azithromycin (antibiotics used to treat infections);

• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema);

• alfentanil, fentanyl (used as anesthetics);

• amiodarone (used to treat irregular heartbeats “arrhythmias”);

• amitriptyline, nortriptyline (used as antidepressants);

• amphotericin B, voriconazole (antifungals);

• medicines that reduce blood clotting (warfarin or similar medicines);

• benzodiazepines (midazolam, triazolam, or similar medicines); used to help 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, fluvastatin, or similar medicines) used to lower high cholesterol levels;

• methadone (used for pain);

• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs - NSAIDs);

• oral contraceptives;

• prednisone (a steroid);

• zidovudine, also known as AZT; saquinavir (used in HIV-infected patients);

• diabetes medicines such as chlorpropamide, glyburide, 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 the decline in kidney function);

• vitamin A (nutritional supplement);

• ivacaftor (alone or combined 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 need to use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before receiving this medicine.

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

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

Do not take Fluconazol B. Braun if you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding, unless your doctor has instructed you to do so. If you become pregnant while receiving this medicine or within one week after 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 use during the first trimester may increase the risk of congenital abnormalities affecting the heart, bones, and/or muscles in the baby.

Cases of babies born with congenital abnormalities affecting the skull, ears, and thigh 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 not clear.

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

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

Driving and using machines

When driving or operating machinery, be aware that dizziness or seizures may occasionally occur.

Fluconazol B. Braun contains sodium

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

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

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

3. How to use Fluconazole B. Braun

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

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

Adults

Adolescents aged 12 to 17 years

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

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 from 3 to 4 weeks of age:

• 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 of age:

• 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 adjust your dose depending on how well your kidneys are functioning.

If you receive more Fluconazol B. Braun than you should

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).

If you miss a dose of Fluconazol B. Braun

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

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

4. Possible adverse effects

Like all medicines, Fluconazole B. Braun may cause adverse effects, although not everyone experiences them.

Stop using Fluconazole 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 develop allergic reactions, although serious allergic reactions are rare (they may affect up to 1 in 1,000 patients). If any of the following symptoms occur, inform your doctor immediately.

• Sudden wheezing, difficulty breathing, or tightness in the chest.
• Swelling of the eyelids, face, or lips.
• Itching all over the body, skin redness, or itchy red spots.
• Skin rash.
• Severe skin reactions, such as blistering rash (this may affect the mouth and tongue).

Fluconazole B. Braun may affect your liver. Signs indicating liver problems include:

• fatigue;
• loss of appetite;
• vomiting;
• yellowing of the skin or whites of the eyes (jaundice).

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

Other adverse effects

Additionally, if you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Common adverse effects (may affect up to 1 in 10 patients):

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

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

• Reduction in red blood cells, which may cause pale skin, weakness, or difficulty breathing.
• Decreased appetite.
• Inability to sleep, numbness or tingling sensation.
• Seizures, dizziness, spinning sensation, tingling, pricking, or numbness, changes in taste sensation.
• Constipation, indigestion, flatulence, dry mouth.
• Muscle pain.
• Liver damage and yellowing of the skin and eyes (jaundice).
• Hives, blisters (wheals), itching, increased sweating.
• Fatigue, general feeling of discomfort, fever.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Lower than normal levels of white blood cells, which help defend against infections, and blood cells that help stop bleeding.
• Reddish or purplish skin discoloration, possibly due to low platelet count, other changes in blood cells.
• Changes in blood tests (high levels of cholesterol, fats).
• Low blood potassium levels.
• Tremors.
• Abnormal electrocardiogram (ECG), changes in heart rate or rhythm.
• Liver function failure.
• Allergic reactions (sometimes severe), including widespread blistering rash with skin peeling, severe allergic reactions, swelling of the lips or face.
• Hair loss.

Reporting of adverse effects

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

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluconazole B.Braun

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label and the carton after EXP. The expiry date is the last day of the month indicated.

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

This medicine should be used immediately after opening the container.

Use this medicine only if the solution is clear and free from visible particles. Do not use if the bottle is damaged.

This medicine is for single use only.

Any unused infusion must be discarded after opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluconazole B. Braun

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

• The other components are sodium chloride and water for injections.

Appearance of the product and contents of the container

Fluconazole B. Braun is a clear, colourless solution containing the ingredients listed above in water.

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

Pack sizes: 10, 20 or 50 bottles.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

• Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Postal 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 medicinal product has been authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the latest review of this summary: 02/2024

Up-to-date detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

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

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

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

• Ringer's infusion solution

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

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

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

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

• Isofundin infusion solution (if available)

Fluconazol may be infused through an existing line together 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 medicinal products prior to infusion.

The infusion solution is for single use only.

Shelf-life after container opening:

The medicinal product should be used immediately after first opening of the container.

Shelf-life 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 standpoint, dilutions should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2 °C to 8 °C, unless the dilution has been carried out under controlled and validated aseptic conditions.

Dilution must be performed under aseptic conditions. The solution should be inspected before administration to ensure absence of visible particles and discoloration. The solution should only be used if it is clear and free of particles.

Any unused medicinal product and all materials that have come into contact with it should be disposed of in accordance with local regulations.

For complete information on this medicinal product, please refer to the Summary of Product Characteristics.