Fluconazole Kabi 2 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluconazole Kabi 2mg/ml solution for infusion EFG

Fluconazole

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

Leaflet contents:

1. What Fluconazole Kabi is and what it is used for
2. What you need to know before using Fluconazole Kabi
3. How to use Fluconazole Kabi
4. Possible side effects
5. How to store Fluconazole Kabi
6. Contents of the pack and other information

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

Fluconazol Kabi is a medicine belonging to a group of drugs called "antifungals". The active substance is fluconazole.

Fluconazol Kabi is used to treat fungal infections and may 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
• Candida infections located in the bloodstream, in body organs (e.g. heart, lungs), or in the urinary tract
• Mucosal candidiasis – infection affecting the mucous membranes of the mouth, throat, or associated with dental prostheses

Fluconazol Kabi may also be prescribed to:

• prevent recurrence of cryptococcal meningitis
• prevent recurrence of mucosal infections
• prevent transmission of Candida infections (if your immune system is weakened and not functioning properly)

Children and adolescents (0 to 17 years)

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

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

Fluconazol Kabi may also be given to:

• prevent transmission of Candida infections (if your immune system is weakened and not functioning properly)
• prevent recurrence of cryptococcal meningitis

2. What you need to know before using Fluconazole Kabi

Do not use Fluconazole Kabi

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Fluconazole Kabi

• 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 develop severe skin reactions (itching, skin redness, or difficulty breathing).
• if you show signs of adrenal insufficiency, in which the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or long-term fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
• if the fungal infection does not improve, as alternative antifungal treatment may be needed.
• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after using Fluconazole Kabi.

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

Using Fluconazole Kabi with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Some medicines may interact with Fluconazole Kabi. Make sure your doctor knows if you are taking any of the following medicines, as dose adjustment or monitoring may be needed to ensure these medicines remain effective:

• rifampicin or rifabutin (antibiotics for infections).
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema).
• alfentanil, fentanyl (used as anesthetics).
• amitriptyline, nortriptyline (used as antidepressants).
• amphotericin B, voriconazole (antifungals).
• medicines that make the blood less viscous, to prevent 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 hypertension – 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, 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, glibenclamide, 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 used to treat cystic fibrosis).
• amiodarone (used to treat irregular heartbeats “arrhythmias”).
• hydrochlorothiazide (a diuretic).
• ibrutinib (used to treat blood cancer).
• lurasidone (used to treat schizophrenia).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using 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 treatment courses with fluconazole, consult your doctor about the need to use appropriate contraceptive methods during treatment, which should be continued for one week after the last dose.

You must not take Fluconazole Kabi if you are pregnant, think you may be pregnant, are trying to become pregnant, or are breastfeeding, unless your doctor has specifically instructed you to do so.

If you become pregnant while taking this medicine or within one week after 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 the baby being born with birth defects affecting the heart, bones, and/or muscles.

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 dose of up to 150 mg of Fluconazole Kabi.

You must not continue breastfeeding if you are taking repeated doses of Fluconazole Kabi.

Driving and using machines

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

Fluconazole Kabi contains sodium

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

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

3. How to use Fluconazole Kabi

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.

Your doctor or nurse will administer this medicine by slow intravenous injection (infusion) directly into your vein. Fluconazole Kabi is supplied as a solution. It does not need to be diluted. Additional information for healthcare professionals is provided at the end 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 Fluconazole Kabi.

Adults

Adolescents aged 12 to 17 years

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

Children up to 11 years of age

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 from 0 to 4 weeks of age

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 kg 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 kg of body weight every 72 hours.

Occasionally, physicians may prescribe doses different from those described. Always follow exactly the administration instructions given by your physician. Consult your physician or pharmacist if you have any doubts.

Elderly patients

The usual adult dose, unless you have kidney problems.

Patients with kidney problems

Your doctor may adjust 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 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 product, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Some people may develop allergic reactions, although serious allergic reactions are rare. If any of the following symptoms occur, inform your doctor immediately.

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

• Rash

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

• Itching all over the body, skin redness, or itchy red spots

Rare adverse 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 blistering rash (this may affect the mouth and tongue)

If you experience any of these symptoms, stop using Fluconazol Kabi and inform your doctor immediately.

Fluconazol Kabi may affect your liver. Signs indicating liver problems include:

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

• Vomiting

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

• Tiredness
• Loss of appetite
• Yellowing of the skin or whites of the eyes (jaundice)

Fluconazol Kabi may also affect other organs, leading to the following symptoms:

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

• Seizures

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

• Lower than normal levels of white blood cells (which help fight infections) and blood platelets (which help stop bleeding), leading to unexplained bruising or bleeding, sudden fever, sore throat, or mouth ulcers

If you experience any of these symptoms, stop using Fluconazol Kabi 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 people):

• Headache
• Stomach discomfort, diarrhoea, malaise
• Elevated blood test results indicating liver function
• Rash

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

• Reduction in red blood cells, which may cause paleness of the skin, weakness, or difficulty breathing
• Insomnia, numbness
• Dizziness, sensation of spinning, tingling, pricking, or numbness, changes in taste sensation
• Constipation, indigestion, flatulence, dry mouth
• Muscle pain
• Liver damage
• Hives, blisters (wheals), itching, increased sweating
• General feeling of being unwell, fever

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

• Reddish or purple skin rash, possibly due to low platelet count or other changes in blood cells
• Changes in blood tests (high levels of cholesterol, fats)
• Agitation
• Low blood potassium levels
• Abnormal electrocardiogram (ECG), changes in heart rate or rhythm
• Liver function failure
• Hair loss

Frequency not known (cannot be estimated from available data):

• Hypersensitivity reaction with skin rash, fever, swollen glands, increased levels of a type of white blood cells (eosinophilia), 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 immediate medical attention if you notice any of the following symptoms:

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

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluconazole Kabi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

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

Vials (KabiPac®): Do not freeze.

The medicine should be used immediately after opening the container.

Do not use this medicine if the solution is not clear or if visible particles are present. Do not use if the container shows visible signs of damage.

This medicine is for single use only. After use, dispose of the vial or bag and any remaining contents.

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

6. Contents of the pack and other information

Composition of Fluconazol Kabi

The active substance is fluconazole.

Each ml of solution contains 2 mg of fluconazole.

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

Nature of the product and pack contents

• Fluconazol Kabi is a clear, colourless solution free from visible particles.
• Pack sizes:

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 of these pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi España S.A.U.

Marina 16-18,

08005 Barcelona

Spain

Manufacturer

Vials (KabiPac®):

Fresenius Kabi Polska Sp. z o.o.

Ul. Sienkiewicza 25, 99-300 Kutno

Poland

Bags (Freeflex®):

Fresenius Kabi France

6, Rue de Rempart

F-27400 Louviers

France

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

Belgium Fluconazole Fresenius Kabi 2mg/ml solution for infusion

Czech Republic Fluconazol Kabi

Denmark Fluconazol Fresenius Kabi

Finland Fluconazol Fresenius Kabi

France Fluconazole Kabi 2mg/ml

Germany Fluconazol Kabi 2mg/ml Infusionslösung

Greece Fluconazole/Kabi 2mg/ml διάλυμα για έγχυση

Hungary Fluconazol Kabi

Italy Fluconazolo Kabi

Luxembourg Fluconazol Kabi 2mg/ml Infusionslösung

Malta Fluconazole Kabi 2mg/ml solution for infusion

Netherlands Fluconazole Fresenius Kabi 2mg/ml oplossing voor infusie

Poland Fluconazol Kabi

Portugal Fluconazol Kabi

Romania Fluconazol Kabi 2mg/ml solutie perfuzabila

Slovakia Fluconazol Kabi 2mg/ml, infúzny roztok

Spain Fluconazol Kabi 2 mg/ml solution for infusion

Sweden Fluconazol Fresenius Kabi

United Kingdom

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

Date of the most recent review of this leaflet: February 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

The following information is intended for healthcare professionals only:

Intravenous infusion must be administered at a rate not exceeding 10 ml/min.

Fluconazol Kabi is formulated in 9 mg/ml (0.9%) sodium chloride infusion solution. Each 200 mg (100 ml vial) contains 15 mmol of Na+ and also of Cl-. Since Fluconazol Kabi is supplied as a diluted sodium chloride solution, the infusion rate should be considered in patients with sodium or fluid restrictions.

Fluconazole is compatible with the following solutions:

• 20% glucose solution
• Ringer's solution
• Ringer's lactate solution
• Potassium chloride in 5% glucose solution
• Sodium bicarbonate 4.2% solution
• Sodium chloride 9 mg/ml (0.9%) solution

Fluconazole may be infused through an existing intravenous line together with any of the fluids listed above. Although no specific incompatibilities have been reported, mixing Fluconazol Kabi with other medicinal products prior to infusion is not recommended.

The infusion solution is for single use only.

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

From a microbiological standpoint, dilutions should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless the dilution has been carried out under validated aseptic conditions.

Dilution must be performed under aseptic conditions. Before administration, the solution should be inspected visually for visible particles and discoloration. The solution should only be used if it is clear and free from particles.

Disposal of unused medicinal product and of all materials that have been in contact with it must be carried out in accordance with local regulations.