Prospect: Information for the user

Fluconazole Normon 2 mg/ml infusion solution EFG

Read this prospect carefully before starting to use the medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isFluconazole Normonand for what it is used.

2. What you need to know before starting to useFluconazole Normon.

3. How to useFluconazole Normon.

4. Possible adverse effects .

5. Storage ofFluconazole Normon.

6. Contents of the package and additional information.

Fluconazol Normon is one of the medications in the group called "antifungals". The active ingredient is fluconazol.

Fluconazol is used to treat infections caused by fungi, and it may also be used to prevent the onset of a fungal infection. The most common cause of fungal infections is a fungus 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.

- Bloodstream infections caused byCandidalocated 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 for:

- Preventing the recurrence of cryptococcal meningitis.

- Preventing the recurrence of mucosal infections.

- Preventing the transmission of infections caused byCandida(if your immune system is weak and not functioning 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.

- Bloodstream infections caused byCandidalocated 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 for:

- Preventing the transmission of infections caused byCandida(if your immune system is weak and not functioning properly).

- Preventing the recurrence of cryptococcal meningitis

No use Fluconazol Normon

- If you are allergic to fluconazole, other medications you have taken to treat fungal infections, or any of the other components of this medication (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing.

- If you are taking astemizole, terfenadine (antihistamines for treating allergies).

- If you are taking cisaprida (used to treat stomach discomfort).

- If you are taking pimozida (used to treat mental illnesses).

- If you are taking quinidina (used to treat heart arrhythmias).

- If you are taking erythromycin (an antibiotic for treating infections).

Warnings and Precautions

Consult your doctor before using Fluconazol Normon

- 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 experience signs of “adrenal insufficiency”, where the adrenal glands do not produce enough of certain steroid hormones, such as cortisol (chronic fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).

- If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking fluconazole.

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

Inform your doctor or pharmacist if the fungal infection does not improve, as alternative antifungal treatment may be necessary.

Other Medications and Fluconazol Normon

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

Informimmediatelyyour doctor if you are taking astemizole, terfenadine (an antihistamine for treating allergies), cisaprida (used for stomach discomfort), pimozida (used to treat mental illnesses), quinidina (used to treat heart arrhythmias), or erythromycin (an antibiotic for treating infections), as these medications should not be taken with this medication (see section: “Do not take Fluconazol Normon”).

Some medications may interact with Fluconazol Normon. Make sure your doctor knows if you are taking any of the following medications, as it may be necessary to adjust the dose or monitor to ensure the medications 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).

- Medications that make blood less viscous, to prevent clot formation (warfarin or similar medications).

- Benzodiazepines (midazolam, triazolam, or similar medications) used to help sleep or for anxiety.

- Carbamazepine, phenytoin (used to treat seizures).

- Nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (for hypertension).

- Olaparib (used to treat ovarian cancer).

- Cyclosporine, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection).

- Cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medications) used to treat cancer.

- Halofantrine (used to treat malaria).

- Statins (atorvastatin, simvastatin, and fluvastatin, or similar medications) used to reduce high cholesterol levels.

- Methadone (used for pain).

- Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Nonsteroidal Anti-Inflammatory Drugs - NSAIDs).

- Oral contraceptives.

- Prednisone (steroid).

- Zidovudine, also known as AZT; saquinavir (used in patients infected with HIV).

- Medications 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 combined with other medications used to treat cystic fibrosis).

- Amiodarone (used to treat irregular heartbeats).

- Hydrochlorothiazide (diuretic).

- Ibrutinib (used to treat blood cancer).

- Lurasidone (used to treat schizophrenia).

Pregnancy, Breastfeeding, and Fertility

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

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

You should not take fluconazole if you are pregnant, think you may be pregnant, or intend to become pregnant or breastfeed, unless your doctor has told you to do so. If you become pregnant while taking this medication 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 spontaneous abortion. Fluconazole taken during the first trimester may increase the risk of congenital anomalies affecting the heart, bones, and/or muscles.

Cases of babies born with congenital anomalies 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 of this medication.

You should not continue breastfeeding if you are taking repeated doses of this medication.

Driving and Operating Machinery

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

Fluconazol Normon contains sodium:

This medication contains 177.1 mg, 354.2 mg, and 708.4 mg of sodium (main component of table salt/for cooking) in each 50 ml, 100 ml, and 200 ml solution, respectively. This corresponds to 8.86%, 17.71%, and 35.42% of the maximum daily sodium intake recommended for an adult.

The maximum daily recommended dose of this medication contains 1416.8 mg of sodium. This corresponds to 70.84% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need, per day, 110 ml or more of this medication for a prolonged period, especially if you have been recommended a low-sodium diet.

Your doctor or nurse will administer this medication through a slow injection (infusion) directly into your vein. Fluconazol Normon 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 medication for different types of infections. Consult with your doctor or nurse if you are unsure whether you should receive treatment with this medication.

Adults

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

Stop using Fluconazol Normon and seek medical attentionimmediatelyif you notice any of the following symptoms:

- Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Some people developallergic reactionsalthough severe allergic reactions are rare.If any of the following side effects appear, talk to your doctor or pharmacist, even if they are not listed in this leaflet. If any of the following symptoms appear,inform your doctor immediately.

- Sudden heart palpitations, difficulty breathing, or chest tightness.

- Swelling of the eyelids, face, or lips.

- Itching all over the body, skin redness, or red spots with itching.

- Skin rash.

- Severe skin reactions, such as a rash that causes blisters (this can affect the mouth and tongue).

Fluconazol Normonmay affect your liver. Signs that indicate liver problems include:

- Fatigue.

- Loss of appetite.

- Vomiting.

- Yellowing of the skin or white of the eyes (jaundice).

If you experience any of these symptoms, stop using this medicineandinform 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.

The common side effects (may affect up to 1 in 10 people) are:

- Headache.

- Stomach discomfort, diarrhea, nausea, vomiting.

- Elevated blood test results indicating liver function.

- Rash.

The uncommon side effects (may affect up to 1 in 100 people) are:

- Reduced red blood cells, which can cause pale skin and weakness or difficulty breathing.

- Decreased appetite.

- Insomnia, numbness.

- Convulsions, dizziness, feeling of spinning, tingling, pins and needles, changes in taste.

- Constipation, heavy digestion, gas, dry mouth.

- Muscle pain.

- Liver damage and yellowing of the skin and eyes (jaundice).

- Hives, blisters (pustules), itching, increased sweating.

- Fatigue, general feeling of discomfort, fever.

The rare side effects (may affect up to 1 in 1,000 people) are:

- White blood cells in the blood that help us fight infections and blood cells that help stop bleeding, lower than normal.

- 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).

- Low levels of potassium in the blood.

- Tremors.

- Abnormal electrocardiogram (ECG), changes in heart rate or rhythm

- Liver failure.

- Allergic reactions (sometimes severe), including widespread rash with blisters and skin peeling, severe allergic reactions, swelling of the lips or face.

- Hair loss.

Frequency not known, but may occur (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)).

Reporting side effects:

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

Store below 30°C.

This medication is for single use only. Once opened, unused infusion must be discarded.

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

Composition of Fluconazol Normon solution for intravenous infusion

- The active ingredient is fluconazol.

- Each ml contains 2 mg of fluconazol.

- The other components (excipients) are: sodium chloride and water for injection preparations.

Appearance of Fluconazol Normon solution for intravenous infusion and contents of the package

- Fluconazol Normon is a transparent and clear solution.

- It is presented in plastic bags of 50 ml, 100 ml, and 200 ml containing a total of 100 mg, 200 mg, or 400 mg of fluconazol, respectively.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet:September 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/

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This information is intended solely for doctors and healthcare professionals:

The intravenous infusion should be administered at a rate not exceeding 10 ml/min. Fluconazol Normon is formulated with a sodium chloride 9 mg/ml (0.9%) solution for infusion. Each 200 mg (100 ml bag) contains 15 mmol of Na+ and also Cl-. Due to the fact that this medication is available in the form of a diluted sodium chloride solution, in patients with sodium or fluid restrictions, the administration rate of the fluid should be taken into account.

Fluconazol for intravenous infusion is compatible with the following fluids:

a) Glucose 20%

b) Ringer's solution

c) Hartmann's solution

d) Potassium chloride in glucose

e) Sodium bicarbonate 4.2%

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

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

The infusion solution is for single use.

From a microbiological point of view, the dilutions should be used immediately. If not used immediately, the times and conditions of storage in use are the responsibility of the user and should not normally be more than 24 hours at a temperature of 2 to 8 °C, unless the dilution has been made in facilities with controlled and 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.