Fluconazole B. Braun

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluconazole B. Braun 2 mg/ml infusion solution

Fluconazole
Equivalent medicine
Please read this leaflet carefully before 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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT IS FLUCONAZOLE B. BRAUN AND WHAT IS IT USED FOR

Fluconazole B. Braun belongs to a group of medicines known as "antifungals". The active substance is fluconazole.
Fluconazole is used to treat fungal infections and may be used to prevent Candida infections. The most common cause of fungal infections is a yeast called Candida.
Adults
Your doctor may prescribe this medicine to treat the following fungal infections:

• Cryptococcal meningitis – a fungal infection of the brain.
• Coccidioidomycosis – a disease affecting the bronchopulmonary system.
• Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs) or urinary tract.
• Mucosal candidiasis – infection of the oral mucosa, throat infection, and denture-related stomatitis.

Fluconazole B. Braun may be prescribed to:

• Prevent recurrence of cryptococcal meningitis,
• Prevent recurrence of mucosal candidiasis,
• Prevent Candida infections (if your immune system is weakened or not functioning properly).

Children and adolescents (from 0 to 17 years of age)
Your doctor may prescribe this medicine to treat the following fungal infections:

• Mucosal candidiasis – infection of the oral mucosa, throat infection.
• Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs) or urinary tract.
• Cryptococcal meningitis – a fungal infection of the brain.

Fluconazole B. Braun may be prescribed to:

• Prevent Candida infections (if your immune system is weakened or not functioning properly).
• Prevent recurrence of cryptococcal meningitis.

2. WHAT YOU SHOULD KNOW BEFORE USING FLUCONAZOLE B. BRAUN 2 MG/ML

Do not take Fluconazole B. Braun if you:

• are allergic to fluconazole, to other medicines used to treat fungal infections, or to any of the excipients in Fluconazole (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing
• are taking astemizole, terfenadine (antihistamines used for allergies)
• are taking cisapride (used to treat stomach disorders)
• are taking pimozide (used to treat mental disorders)
• are taking quinidine (used to treat cardiac arrhythmias)
• are taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions
Inform your doctor before using Fluconazole B. Braun 2 mg/ml if:

• you have liver or kidney problems,
• you suffer from heart conditions, including irregular heart rhythm,
• you have abnormal levels of potassium, calcium, or magnesium in your blood,
• you develop severe skin reactions (itching, skin redness, or difficulty breathing),
• you experience signs of “adrenal insufficiency”, meaning your adrenal glands do not produce sufficient amounts of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).

Other medicines and Fluconazole B. Braun 2 mg/ml
Inform your doctor if you are currently taking, have recently taken, or might take any other medicine.
Immediately inform your doctor if you are taking astemizole, terfenadine (an antihistamine used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental disorders), quinidine (used to treat cardiac arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with Fluconazole B. Braun 2 mg/ml (see section: “Do not take Fluconazole B. Braun 2 mg/ml if you”).
Some medicines may interact with Fluconazole B. Braun 2 mg/ml. Inform your doctor if you are taking any of the following medicines:

• rifampicin, rifabutin, or azithromycin (antibiotics for infections),
• alfentanil, fentanyl (used as anesthetics),
• amiodarone (used to treat irregular heartbeats or “arrhythmias”),
• amitriptyline, nortriptyline (used as antidepressants),
• amphotericin B, voriconazole (antifungals),
• blood-thinning medicines to prevent blood clots (warfarin or similar medicines),
• benzodiazepines (midazolam, triazolam, or similar medicines) used to help you sleep or for anxiety,
• carbamazepine, phenytoin (used to treat epileptic seizures),
• nifedipine, isradipine, amlodipine, felodipine, verapamil, hydrochlorothiazide (a diuretic), and losartan (used for hypertension – high blood pressure),
• ciclosporin, everolimus, sirolimus, or tacrolimus (used 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 reduce high cholesterol levels,
• methadone (used to treat 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 patients with HIV),
• diabetes medicines such as chlorpropamide, glibenclamide, glipizide, or tolbutamide,
• theophylline (used to control asthma),
• vitamin A (dietary supplement),
• ivacaftor (used to treat cystic fibrosis).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will decide whether you should take Fluconazole B. Braun 2 mg/ml.
You may continue breastfeeding after receiving a single dose of fluconazole equal to or less than 200 mg.
You must not breastfeed if you are taking repeated doses of fluconazole.

Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.

Fluconazole B. Braun 2 mg/ml contains sodium
Fluconazole B. Braun contains 3.54 mg of sodium per ml. This should be taken into consideration for patients on a controlled sodium diet.

3. HOW TO TAKE FLUCONAZOLE B. BRAUN 2 mg/ml

This medicine will be administered to you by a doctor or nurse as a slow injection (infusion) into a vein. Fluconazole B. Braun 2 mg/ml is available as a solution. It will not be further diluted. Instructions for healthcare professionals are included in a section at the end of this leaflet.
Recommended dose
The recommended doses of this medicine to be taken depending on the infection are listed below. If you have any doubts about why Fluconazole B. Braun 2 mg/ml has been prescribed for you, consult your doctor or nurse.
Adults

Adolescents aged 12 to 17 years
Always take the dose prescribed by your doctor (either the adult or pediatric dosage).
Children up to 11 years of age
The maximum dose in 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 of age
Use in children from 3 to 4 weeks of age:
The same dosage described above, 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 dosage described above, administered once every 3 days. The maximum dose is 12 mg per kg
of body weight every 72 hours.
Use in the Elderly
The same dose as recommended for adults should be used, unless you have renal problems.
Patients with renal impairment
Your doctor may adjust the dosage according to renal function.
If you receive more Fluconazolo B. Braun 2 mg/ml than you should
If you are concerned that you may have received an excessive dose of Fluconazolo B. Braun,
inform your doctor or nurse immediately. Symptoms of a possible overdose may include
feeling, seeing, or thinking things that are not real (hallucinations and paranoid behavior).
If a dose of Fluconazolo B. Braun 2 mg/ml has been missed
Since this medicine will be administered under close medical supervision, it is unlikely that a dose
will be missed. However, inform your doctor or pharmacist if you think a dose has been missed.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, fluconazole may cause adverse reactions, although not everyone experiences them.
Some people may have allergic reactions, although serious allergic reactions are rare (may occur in up to 1 in 1,000 people).
If you experience any of the following symptoms, inform your doctor immediately:

• sudden shortness of breath, difficulty breathing, or tightness in the chest,
• swelling of the eyelids, face, or lips,
• itching all over the body, skin redness, or itchy red rash,
• skin rashes,
• severe skin reactions, for example rashes causing blisters (may affect the mouth and tongue). Fluconazole B. Braun may affect the liver. Symptoms of liver problems include:
• fatigue,
• loss of appetite,
• vomiting,
• yellowing of the skin and whites of the eyes (jaundice). If you experience any of these symptoms, stop taking Fluconazole B. Braun and inform your doctor immediately.

Other adverse reactions:
If any of the adverse reactions worsen or if you notice any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Common adverse reactions (may occur in up to 1 in 10 people) are:

• headache,
• stomach upset, diarrhoea, nausea, vomiting,
• increased liver function test values in blood tests,
• skin rashes.

Uncommon adverse reactions (may occur in up to 1 in 100 people) are:

• reduction in red blood cells which may cause paleness, weakness, or breathlessness,
• decreased appetite,
• insomnia, drowsiness,
• seizures, dizziness, vertigo, tingling, prickling or numbness, taste disturbances,
• constipation, difficulty digesting, flatulence, dry mouth,
• muscle pain,
• liver damage and yellowing of the skin and eyes (jaundice),
• swelling, blisters (urticaria), itching, increased sweating,
• tiredness, general malaise, fever.

Rare adverse reactions (may occur in up to 1 in 1,000 people) are:

• lower than normal levels of white blood cells, which help defend against infections, and of platelets, which allow blood clotting,
• red or purple skin discoloration possibly caused by reduced platelet levels, other changes in blood cells,
• changes in blood chemistry (elevated cholesterol, fat levels),
• tremor,
• low potassium levels in the blood,
• altered electrocardiogram (ECG), changes in heart rhythm and rate,
• liver failure,
• allergic reactions (sometimes severe), including skin rash with widespread blistering and skin peeling, severe skin reactions, swelling of the lips and face,
• hair loss.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE FLUCONAZOLE B. BRAUN 2 mg/ml

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the label and carton after EXP. The expiry
date refers to the last day of the month.
Do not freeze.
Do not store above 25°C. The medicinal product should be used immediately after first opening the vial.
Use the solution only if it is clear and free from visible particles. Do not use if the vial is damaged.
The vials are for single use only. After use, any unused vials and remaining contents must be disposed of.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Fluconazolo B. Braun 2 mg/ml, solution for infusion contains
The active substance is fluconazole.
Each ml contains 2 mg of fluconazole.
The excipients are:
Sodium chloride, water for injections.

Description of the appearance of Fluconazolo B. Braun and contents of the pack
Fluconazolo B. Braun is a clear, colourless solution free from visible particles.
It is available in 50 ml, 100 ml or 200 ml polyethylene vials.
Pack sizes: 10, 20 or 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
B. 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:
B. Braun Medical S.A.
Carretera de Terrassa, 121,
08191 Rubí (Barcelona),
Spain

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

The following information is intended for healthcare professionals only:
The infusion rate must not exceed 10 ml/min. Fluconazole B. Braun is formulated in 9 mg/ml (0.9%) sodium chloride solution; each 200 mg (100 ml vial) contains 15 mmol of Na and Cl. Since Fluconazole B. Braun is supplied diluted in sodium chloride solution, the volume of fluid administered should be carefully considered in patients requiring restrictions in sodium or fluid intake.
Fluconazole B. Braun 2 mg/ml, solution for infusion, is compatible with the following infusion fluids:
a) 200 mg/ml glucose infusion solution (if available);
b) Ringer's infusion solution;
c) Hartmann's solution, Ringer lactate solution (if available);
d) Potassium Chloride 20 mEq/l in 50 mg/ml glucose (if available);
e) Sodium Bicarbonate 84 mg/ml (8.4%) solution for infusion (if available);
g) Sodium Chloride 9 mg/ml (0.9%) solution for infusion;
h) Sterofundin ISO solution for infusion (if available).
Fluconazole may be administered via an existing intravenous line containing one of the above solutions. Although no specific incompatibilities are known, mixing with other drugs prior to infusion is not recommended.
The infusion solution is for single use only.
Shelf life after first opening:
The medicinal product must be used immediately after first opening of the container.
Shelf life after dilution according to instructions:
For mixtures with the solutions listed above, chemical and physical stability has been demonstrated for 72 hours at 25°C.
From a microbiological standpoint, dilutions should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and generally should not exceed 24 hours at 2°C to 8°C, unless dilution has been carried out under controlled and validated aseptic conditions.
Dilution must be performed under aseptic conditions. The solution should be inspected visually for the presence of particles or discoloration before administration. The solution should be used only if it is clear and free from particles.
Unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with local regulations.
For complete information on this medicinal product, consult the product's summary of characteristics.