Fluconazole b. braun 2 mg/ml

Patient Information Leaflet

Fluconazole B. Braun 2 mg/ml, solution for infusion
fluconazole
Please read this leaflet carefully before using this medicine because it contains important
information for you.
Keep this leaflet so that you can read it again if necessary.
Ask your doctor or pharmacist if you have any questions.
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.

Table of contents

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 belongs to a group of medicines called "antifungal agents". The active substance is fluconazole.
Fluconazole is used to treat fungal infections and may also be used to prevent Candida yeast infections. The most common cause of fungal infections is Candida yeast.

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 respiratory disease.
Candida yeast infections affecting the bloodstream, internal organs (e.g. heart, lungs), or urinary tract.
Mucosal candidiasis – infections involving mucous membranes lining the mouth and throat, and inflammation caused by denture pressure.

You may also be given Fluconazole B. Braun to:
prevent recurrence of cryptococcal meningitis,
prevent recurrence of mucosal candidiasis,
prevent Candida yeast infections (if your immune system is weakened and not functioning properly).

Children and adolescents (from 0 to 17 years of age)
Your doctor may prescribe this medicine to treat the following types of fungal infections:
Mucosal candidiasis – infections involving mucous membranes lining the mouth and throat, and inflammation caused by denture pressure.
Candida yeast infections affecting the bloodstream, internal organs (e.g. heart, lungs), or urinary tract.
Cryptococcal meningitis – a fungal infection of the brain.

You may also be given Fluconazole B. Braun to:
prevent Candida yeast infections (if your immune system is weakened and not functioning properly),
prevent 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 antifungal medicines, or
any of the other ingredients of this medicine (listed in section 6). Symptoms of allergy 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 psychiatric disorders),
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, 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 blood levels of potassium, calcium, or magnesium,
the patient develops severe skin reactions (itching, redness of the skin) or difficulty breathing,
the patient develops symptoms of "adrenal insufficiency", when adrenal glands do not produce enough of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain),
the patient has previously experienced severe skin rash or skin peeling, blisters and (or) mouth ulcers after taking Fluconazole B. Braun,
the fungal infection does not improve, alternative antifungal treatment may be necessary.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients treated with Fluconazole B. Braun. If the patient experiences any of the symptoms of severe skin reactions described in section 4, treatment with Fluconazole B. Braun must be discontinued immediately and medical help should be sought without delay.

Other medicines and Fluconazole B. Braun
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Inform the doctor immediately if the patient is taking astemizole or terfenadine (antihistamines used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat psychiatric disorders), quinidine (used to treat heart rhythm disorders), or erythromycin (an antibiotic used to treat infections), as these medicines must not be taken together with Fluconazole B. Braun (see section "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, ensure the doctor is aware:
rifampicin, rifabutin, or azithromycin (antibiotics used to treat infections),
abrocitinib (used to treat atopic dermatitis, also known as atopic eczema),
alfentanil, fentanyl (anaesthetics),
amiodarone (used to treat irregular heartbeat – arrhythmia),
amitriptyline, nortriptyline (used as antidepressants),
amphotericin B, voriconazole (antifungal medicines),
blood-thinning medicines to prevent blood clots (warfarin or similar medicines),
benzodiazepine derivatives (midazolam, triazolam or similar medicines) used as sleeping or anti-anxiety medicines,
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carbamazepine, phenytoin (used to treat epileptic seizures),
nifedipine, isradipine, amlodipine, felodipine, verapamil, hydrochlorothiazide (a 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 in cancer treatment,
halofantrine (a medicine used to treat malaria),
statins (atorvastatin, simvastatin, fluvastatin or similar medicines) used to lower high cholesterol levels,
methadone (a painkiller),
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),
antidiabetic medicines such as chlorpropamide, glyburide, glipizide, or tolbutamide,
theophylline (used to treat asthma),
tofacitinib (used to treat rheumatoid arthritis),
tolvaptan used to treat hyponatremia (low blood sodium levels) or to slow the worsening of kidney function,
vitamin A (dietary supplement),
ivacaftor (used to treat cystic fibrosis),
ibrutinib (used to treat blood cancer),
lurasidone (used to treat schizophrenia).

Pregnancy and breastfeeding
If the patient is pregnant, trying to become pregnant, or breastfeeding, she should inform her doctor.
Before taking any medicine, consult a doctor or pharmacist.

If the patient is planning to become pregnant, it is recommended to wait one week after taking a single dose of fluconazole before attempting conception.

For longer treatment courses with fluconazole, discuss with the doctor the need for appropriate contraception during treatment and for one week after the last dose.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should not take Fluconazole B. Braun unless advised otherwise by her doctor. If the patient becomes pregnant while taking this medicine or within one week after the last dose, she should contact her 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 malformations in the newborn.

Cases of infants born with congenital malformations of the skull, ears, and femur and elbow bones have been reported in mothers treated for coccidioidomycosis with high doses of fluconazole (400–800 mg daily) for at least 3 months. The relationship between fluconazole use and these cases is not clear.

Breastfeeding may continue after a single 150 mg dose of fluconazole.
Breastfeeding should not be continued if the patient is taking multiple doses of fluconazole.

Driving and operating machinery
When driving or operating machinery, bear in mind that dizziness or seizures may occasionally occur.

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

3. How to use Fluconazole B. Braun

This medicine will be administered by a doctor or nurse as a slow injection (intravenous 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 various infections are given below. If the patient is unsure
why they are receiving Fluconazole B. Braun, they should ask their doctor or nurse.
Adults

Adolescents aged 12 to 17 years
As directed by a physician (dosing as recommended for adults or children)
Children up to 11 years of age
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 of age
Use in children from 3 to 4 weeks of age:
The same dose as above, but administered every 2 days. The maximum dose is 12 mg per kilogram
of body weight every 48 hours.
Use in children under 2 weeks of age:
The same dose as above, but administered 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 adjust the dose depending on the patient's kidney function.
Use of a higher than recommended dose of Fluconazole B. Braun
If the patient is concerned that they may have received too high a dose of Fluconazole B. Braun, they should immediately
inform their doctor or nurse. Symptoms of possible overdose include hearing, seeing, feeling, or thinking about things that are not real (hallucinations and paranoid behavior).
Missed dose of Fluconazole B. Braun
Since this medicine is administered under strict medical supervision, it is unlikely that a dose will be missed. However, if the patient believes a dose has been missed, they should inform their doctor
or pharmacist.
If there are any further questions regarding the use of this medicine, consult the doctor,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur in the patient, treatment with Fluconazole B. Braun should be discontinued immediately and medical help must be sought without delay:

• extensive rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Allergic reactions may occur in a small number of patients; however, serious allergic reactions are rare (may occur in 1 out of 1,000 patients). If any of the following symptoms occur in the patient, a doctor should be contacted immediately:
sudden onset of wheezing, breathlessness, or chest tightness,
swelling of the eyelids, face and/or lips,
itching of the entire body, skin redness, or red itchy rash,
skin rash,
severe skin reactions, such as blistering rash (may appear in the mouth and on the tongue).
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Fluconazole B. Braun 2 mg/ml may have adverse effects on the liver. Symptoms of liver problems include:
fatigue,
loss of appetite,
vomiting,
yellowing of the skin and/or whites of the eyes (jaundice).
If any of these symptoms occur in the patient, treatment with Fluconazole B. Braun should be discontinued immediately and a doctor should be notified without delay.
Other adverse reactions:
Additionally, if any of the following adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, consult a doctor or pharmacist.
Common adverse reactions (may occur in less than 1 in 10 patients):
headache,
gastric discomfort, diarrhoea, nausea, vomiting,
abnormal results of blood liver function tests,
rash.
Uncommon adverse reactions (may occur in less than 1 in 100 patients):
decreased number of red blood cells, leading to pale skin, weakness or breathlessness,
loss of appetite,
difficulty sleeping, drowsiness,
seizures, dizziness, sensation of spinning, prickling or tingling, numbness,
changes in taste perception,
constipation, indigestion, flatulence, dry mouth,
muscle pain,
liver damage and yellowing of the skin and/or eyes (jaundice),
hives, blisters on the skin, itching, increased sweating,
fatigue, malaise, fever.
Rare adverse reactions (may occur in less than 1 in 1,000 patients):
decreased number of white blood cells (which protect against infections) and platelets (blood cells that prevent bleeding),
red or purple skin discolouration, which may be caused by low platelet count, changes in the number of other blood cells,
changes in blood chemistry (high levels of cholesterol and fats in the blood),
tremor,
low blood potassium levels,
abnormal ECG (electrocardiogram), changes in heart rate or rhythm,
liver failure,
allergic reactions (sometimes severe), including widespread blistering rash with peeling skin, severe skin reactions, swelling of lips and/or face,
hair loss.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: + 48 22 49 21 301
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Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, more information can be gathered about the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store 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 carton under "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Do not freeze.
This medicine should be used immediately after first opening the container.
Only use solutions that do not contain solid particles. Do not use if the bottle is damaged.
Bottles are intended for single use only. After use, bottles and any remaining contents should be disposed of.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Fluconazole B. Braun contains
The active substance 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, colourless solution of the above ingredients in water.
It is available in polyethylene bottles containing 50 ml, 100 ml or 200 ml.
Pack sizes: packs of 10, 20 or 50 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany
Postal address:
34209 Melsungen
Germany
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 European Economic Area countries
and in the United Kingdom (Northern Ireland) under the following names:

Information intended solely for healthcare professionals

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

Fluconazole B. Braun 2 mg/ml is compatible with the following solutions: a) infusion solution of glucose 200 mg/ml (if available)
b) Ringer's infusion solution
c) Hartmann's solution, Ringer's solution with lactate (if available)
d) potassium chloride 20 mEq/l in glucose 50 mg/ml infusion solution (if available)
e) sodium bicarbonate infusion solution 84 mg/ml (8.4%) (if available)
f) sodium chloride infusion solution 9 mg/ml (0.9%)
g) Sterofundin ISO infusion solution (if available).

Fluconazole may be administered via an established infusion line together with the above-mentioned fluids. Premixing prior to infusion with other medicinal products is not recommended, although no specific incompatibilities have been observed.

The infusion solution is for single use only.

Shelf-life after first opening of the packaging
The medicinal product should be used immediately after first opening of the packaging.

Shelf-life after dilution according to 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 immediately before use. If the solution is not used immediately after preparation, the user is responsible for storage conditions and duration prior to use. Storage should not generally exceed 24 hours at 2 to 8°C, unless dilution is carried out under controlled and validated aseptic conditions.

Dilution must be performed under aseptic conditions. The solution should be inspected visually for particulate matter and discoloration prior to use. Only clear solution free from particulate matter should be used.

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

For comprehensive information on this medicinal product, please consult the product characteristics document.

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