Leaflet: information for the user

Fluconazol Kabi 2mg/ml infusion solution EFG

Fluconazol

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, pharmacist or nurse.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Fluconazol Kabi and what it is used for

2. What you need to know before starting to use Fluconazol Kabi

3. How to use Fluconazol Kabi

4. Possible side effects

5. Storage of Fluconazol Kabi

6. Contents of the pack and additional information

Fluconazol Kabiis one of the medications in the group called “antifungals”. The active ingredient is fluconazole.

Fluconazol Kabi is used to treat infections 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 Kabi for:

• To prevent the recurrence of cryptococcal meningitis
• To prevent the recurrence of mucosal infections
• To prevent the transmission of infections caused byCandida(if your immune system is weak and does not function properly)

Children and adolescents (0 to 17 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 byCandidalocated 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 Kabi for:

• To prevent the transmission of infections caused byCandida(if your immune system is weak and does not function properly). To prevent the recurrence of cryptococcal meningitis.

Do not use Fluconazol Kabi

• if you are allergic to fluconazole or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other medicines you have taken to treat fungal infections. Symptoms may include itching, skin redness or difficulty breathing
• if you are taking cisapride (used to treat stomach discomfort)
• if you are taking astemizole, terfenadine (antihistamines to treat allergies)
• if you are taking pimozide (used to treat mental illnesses)
• if you are taking quinidine (used to treat irregular heartbeats “arrhythmias”)
• if you are taking erythromycin (an antibiotic to treat infections)

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Fluconazol Kabi

• 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 show signs of adrenal insufficiency where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
• if the fungal infection does not improve, as it may be necessary to use an alternative antifungal treatment
• if you have ever developed a severe skin rash or skin peeling, blisters and/or mouth sores after using Fluconazol Kabi.

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

Use of Fluconazol Kabi with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine

Informimmediatelyyour doctor if you are taking astemizole, terfenadine (an antihistamine to treat allergies), cisapride (used to treat stomach discomfort), pimozide (used to treat mental illnesses), quinidine (used to treat irregular heartbeats) or erythromycin (an antibiotic to treat infections), as these medicines should not be taken with Fluconazol Kabi (see section: “Do not use Fluconazol Kabi”).

There are some medicines that may interact with Fluconazol Kabi. Make sure your doctor knows if you are taking any of the following medicines, as it may be necessary to adjust the dose or monitor to ensure the medicines continue to have the desired effect:

• rifampicin or rifabutin (antibiotics for infections)
• abrocitinib (used to treat atopic dermatitis, also known as eczema)
• alfentanil, fentanyl (used as anesthetics)
• amitriptyline, nortriptyline (used as antidepressants)
• amphotericin B, voriconazole (antifungals)
• medicines that make the blood less viscous, to prevent the formation of blood clots (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, verapamil, felodipine and losartan (for 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 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 patients infected with HIV)
• 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 slow the deterioration of kidney function)
• vitamin A (nutritional supplement)
• ivacaftor (alone or in combination with other medicines used to treat cystic fibrosis)
• amiodarone (used to treat irregular heartbeats)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used to treat blood cancer)
• lurasidone (used to treat schizophrenia)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine

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 suitable contraceptive methods during treatment, which should be continued for one week after the last dose

You should not takeFluconazol Kabiif you are pregnant, think you may be pregnant, are trying to become pregnant or are breastfeeding, unless your doctor has told you to

If you become pregnant while taking this medicine or within one week of the most recent dose, consult your doctor

Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester may increase the risk of birth defects affecting the heart, bones and/or muscles

Cases of babies born with congenital abnormalities affecting the skull, ears and leg and arm 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 up to 150 mg ofFluconazol Kabi.

You should not continue breastfeeding if you are taking repeated doses ofFluconazol Kabi.

Driving and operating machines

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

Fluconazol Kabi contains sodium

This medicine contains 88.5 mg of sodium (main component of table salt/for cooking) per 25 ml. This is equivalent to 4.4% of the maximum recommended daily intake of sodium for an adult

Consult your doctor or pharmacist if you need to take Fluconazol Kabi daily for a prolonged period, especially if you have been advised to follow a low-sodium diet

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Your doctor or nurse will administer this medicine through a slow injection (infusion) directly into your vein. Fluconazol Kabi 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 are the recommended doses of this medicine for different types of infections. Check with your doctor or nurse if you are unsure whether you should receive treatment with Fluconazol Kabi.

Adults

Adolescents aged 12 to 17 years

Follow the dose indicated by your doctor (the adult dose or the pediatric 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 infants aged 0 to 4 weeks

Infants between 15 and 27 days of age:

?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.

Infants between 0 and 14 days of age:

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

In some cases, doctors may prescribe different doses. Follow the administration instructions exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Older adults

The usual adult dose, unless you have kidney problems.

Patients with kidney problems

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

If you receive more Fluconazol Kabi than you should

If you are concerned that you may have been given too much Fluconazol Kabi, 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 forget to administer Fluconazol Kabi

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some people developallergic reactionsalthough severe allergic reactions are rare.If any of the following symptoms appear,inform your doctor immediately.

Common side effects(may affect up to 1 in 10 people):

• skin rash

Uncommon side effects(may affect up to 1 in 100 people):

• itching all over the body, skin redness or red spots with itching

Rare side effects(may affect up to 1 in 1,000 people):

• sudden wheezing, difficulty breathing or chest tightness
• swelling of the eyelids, face or lips
• severe skin reactions, such as a rash that causes blisters (this may affect the mouth and tongue).

If any of these symptoms occur, stop using Fluconazol Kabi andinform your doctor immediately.

Fluconazol Kabi may affect your liver. Signs that indicate liver problems include:

Common side effects(may affect up to 1 in 10 people):

• vomiting

Uncommon side effects(may affect up to 1 in 100 people):

• fatigue
• loss of appetite
• yellowing of the skin or white of the eyes (jaundice)

Fluconazol Kabi may also affect other organs, which may cause the following symptoms:

Uncommon side effects(may affect up to 1 in 100 people):

• seizures

Rare side effects(may affect up to 1 in 1,000 people):

• white blood cells in the blood that help us fight infections and blood cells that help stop bleeding, lower than normal, leading to bruises or unexplained bleeding, sudden fever, sore throat, mouth ulcers.

If any of these symptoms occur, stop using Fluconazol Kabi andinform your doctor immediately.

Other side effects:

Additionally, 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.

Common side effects (may affect up to 1 in 10 people):

• headache
• stomach discomfort, diarrhea, unease
• high results in blood tests indicating liver function
• skin rash

Uncommon side effects (may affect up to 1 in 100 people):

• reduction of red blood cells, which may make your skin pale and cause weakness or difficulty breathing.
• insomnia, numbness
• dizziness, feeling of spinning, tingling, pins and needles, changes in taste
• constipation, heavy digestion, gas, dry mouth
• muscle pain
• liver damage
• hives, blisters (pustules), itching, increased sweating
• general feeling of unease, fever

Rare side effects (may affect up to 1 in 1,000 people):

• red or purple discoloration of the skin, which may be due to a low number of platelets, other changes in blood cells
• changes in blood tests (high levels of cholesterol, fats)
• agitation
• low levels of potassium in the blood
• abnormal electrocardiogram (ECG), changes in heart rate or rhythm
• liver function failure
• hair loss.

Unknown frequency (cannot be estimated from available data):

• hypersensitivity reaction with skin rash, fever, swollen glands, increased eosinophils and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))

Stop using Fluconazol Kabi and seek medical attention immediately if you notice any of the following symptoms:

- Generalized skin rash, elevated body temperature and increased lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://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 indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Bags (freeflex): Do not store above 25°C. Do not freeze.

Bottles (KabiPac®):Do not freeze.

The medication must be used immediately after opening the packaging.

Do not use this medication if you observe that the solution is not transparent or if you observe visible particles. Do not use if the packaging shows visible signs of deterioration.

This medication is for single use only. After use, discard the bottle or bag and any remaining contents.

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

Composition of Fluconazol Kabi

The active ingredient is fluconazole.

Each ml of solution contains 2 mg of fluconazole.

The other components are: sodium chloride, water for injection preparations, and sodium hydroxide (to adjust the pH).

Appearance of the product and contents of the package

• Fluconazol Kabi is a transparent, colorless solution without visible particles.
• Formats:

1, 10, 20, 25, 30, 40, 50, 60 vials/bags of 50 ml containing 100 mg of fluconazole

1, 10, 20, 25, 30, 40, 50, 60 vials/bags of 100 ml containing 200 mg of fluconazole

1, 10, 20, 25, 30, 40 vials/bags of 200 ml containing 400 mg of fluconazole.

Only some formats may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Kabi España S.A.U.

c/ Marina 16-18,

08005 Barcelona

Spain

Responsible for manufacturing

Bottles (KabiPac®):

Fresenius Kabi Polska Sp. Zo.o

Ul. Sienkiewicza 25, 99-300 Kutno

Poland

Bags (Freeflex®):

Fresenius Kabi France

6, Rue de Rempart

F-27400 Louviers

France

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

BelgiumFluconazole Fresenius Kabi 2mg/ml solution for infusion

Czech RepublicFluconazol Kabi

DenmarkFluconazol Fresenius Kabi

FinlandFluconazol Fresenius Kabi

FranceFluconazole Kabi 2mg/ml

GermanyFluconazol Kabi 2mg/ml Infusionslösung

GreeceFluconazole/Kabi 2mg/ml δι?λυμα για ?γχυση

HungaryFluconazol Kabi

ItalyFluconazolo Kabi

LuxembourgFluconazol Kabi 2mg/ml Infusionslösung

MaltaFluconazole Kabi 2mg/ml solution for infusion

NetherlandsFluconazole Fresenius Kabi 2mg/ml oplossing voor infusie

PolandFluconazol Kabi

PortugalFluconazol Kabi

RomaniaFluconazol Kabi 2mg/ml solutie perfuzabila

SlovakiaFluconazol Kabi 2mg/ml, infúzny roztok

SpainFluconazol Kabi 2 mg/ml solución para perfusión

SwedenFluconazol Fresenius Kabi

United Kingdom

(Northern Ireland)Fluconazole 2mg/ml solution for infusion

Last review date of this leaflet:February 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/

The following information is intended only for healthcare professionals:

The intravenous infusion should be administered at a rate not exceeding 10 ml/min.

Fluconazol Kabi is formulated with a 9 mg/ml (0.9%) sodium chloride solution for infusion. Each 200 mg (100 ml vial) contains 15 mmol of Na+ and also Cl-. Due to the fact that Fluconazol Kabi is available in the form of a diluted sodium chloride solution, in patients with sodium or fluid restrictions, the rate of fluid administration should be taken into account.

Fluconazole is compatible with the following solutions:

a) 20% glucose solution

b) Ringer's solution

c) Ringer Lactate solution

d) Potassium chloride solution in 5% glucose solution

e) Sodium bicarbonate 4.2% solution

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

Fluconazole can be infused through an existing line with one of the listed fluids. Although no specific incompatibilities have been described, it is not recommended to mix Fluconazol Kabi with other medications before infusion.

The infusion solution is for single use.

The physical-chemical stability of the diluted product has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the dilutions should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and are normally not greater than 24 hours at 2-8°C, unless the dilution was made in validated aseptic conditions.

The dilution should be made in aseptic conditions. Before administration, the solution should be inspected to check that there are no visible particles or discoloration. Only the solution should be used if it is transparent and free of particles.

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