Fluconazole Normon 2 mg/ml solution for intravenous infusion EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Fluconazol Normon is and what it is used for
- 2. What you need to know before using Fluconazole Normon
- 3. How to use Fluconazol Normon
- 4. Possible adverse effects
- 5. Storage of Fluconazole Normon
- 6. Contents of the container and other information
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Fluconazole Normon 2 mg/ml infusion solution EFG
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 or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Fluconazole Normon is and what it is used for.
- What you need to know before using Fluconazole Normon.
- How to use Fluconazole Normon.
- Possible side effects.
- How to store Fluconazole Normon.
- Contents of the pack and other information.
1. What Fluconazol Normon is and what it is used for
Fluconazol Normon is a medicine belonging to a group called "antifungals". The active substance is fluconazole.
Fluconazole is used to treat fungal infections, and it can 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.
- Infections caused by Candida located in the bloodstream, in body organs (e.g. heart, lungs) or in the urinary tract.
- Mucosal candidiasis – infection affecting the lining of the mouth, throat, or associated with dental prostheses.
Fluconazol may also be prescribed to:
- Prevent recurrence of cryptococcal meningitis.
- Prevent recurrence of mucosal infections.
- Prevent infection caused by Candida (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 mucous lining of the mouth or throat.
- Infections caused by Candida 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 may also be given to:
- Prevent infection caused by Candida (if your immune system is weakened and not functioning properly).
- Prevent recurrence of cryptococcal meningitis.
2. What you need to know before using Fluconazole Normon
Do not use Fluconazole Normon
- if you are allergic to fluconazole, to other antifungal medicines you have taken, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing.
- if you are taking astemizole or terfenadine (antihistamine medicines used to treat allergies).
- if you are taking cisapride (used to treat stomach discomfort).
- if you are taking pimozide (used to treat mental illnesses).
- if you are taking quinidine (used to treat heart arrhythmias).
- if you are taking erythromycin (an antibiotic used to treat infections).
Warnings and precautions
Consult your doctor before using Fluconazole Normon
- if you have liver or kidney problems.
- if you suffer from a heart condition, including heart rhythm disorders.
- if you have abnormal levels of potassium, calcium, or magnesium in your blood.
- if severe skin reactions occur (such as itching, skin redness, or difficulty breathing).
- if signs of “adrenal insufficiency” appear, in which the 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).
- if you have ever developed a severe skin rash, 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 during treatment with this medicine. Stop using Fluconazole Normon and seek immediate medical attention 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 medicines and Fluconazole Normon
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Inform your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for allergies), cisapride (used for stomach discomfort), pimozide (used to treat mental illnesses), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic for infections), as these medicines must not be taken with this medicine (see section: “Do not take Fluconazole Normon”).
Some medicines may interact with Fluconazole Normon. Make sure your doctor knows if you are taking any of the following medicines, as dose adjustments 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).
- Cyclosporine, 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, breastfeeding, and fertility
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 that you wait one week after a single dose of fluconazole before trying to conceive.
For longer fluconazole treatment courses, 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 if you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, unless specifically instructed by your doctor. 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 spontaneous abortion. Fluconazole use during the first trimester may increase the risk of congenital abnormalities affecting the heart, bones, and/or muscles in the baby.
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.
Breastfeeding may continue after a single dose of up to 150 mg of this medicine.
Breastfeeding must not continue if you are taking repeated doses of this medicine.
Driving and use of machines
When driving or operating machinery, bear in mind that dizziness or seizures may occasionally occur.
Fluconazole Normon contains sodium
This medicine contains 177.1 mg, 354.2 mg, and 708.4 mg of sodium (the main component of table/cooking salt) in each 50 ml, 100 ml, and 200 ml bag of solution, respectively. This corresponds to 8.86%, 17.71%, and 35.42% of the maximum daily sodium intake recommended for an adult.
The maximum recommended daily dose of this medicine contains 1,416.8 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 to take 110 ml or more of this medicine per day for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.
3. How to use Fluconazol Normon
Your doctor or nurse will administer this medicine to you as a slow injection (infusion) directly into your vein. Fluconazol Normon is supplied as a solution and does not need to be diluted. Additional information for healthcare professionals is provided at the end of this leaflet.
The recommended doses of this medicine for different types of infections are given below. If you are unsure whether you should receive treatment with this medicine, consult your doctor or nurse.
Adults
Condition | Dosage | |||||||||
To treat cryptococcal meningitis | 400 mg on the first day, followed by 200 mg to 400 mg once daily for 6 to 8 weeks, or longer if necessary. The dose may occasionally be increased up to 800 mg | |||||||||
To prevent recurrence of cryptococcal meningitis | 200 mg once daily for as long as directed by your doctor | |||||||||
To treat coccidioidomycosis | 200 mg to 400 mg once daily for 11 to 24 months, or longer if necessary. The dose may occasionally be increased up to 800 mg | |||||||||
To treat systemic fungal infections caused by Candida | 800 mg on the first day, followed by 400 mg once daily for as long as directed by your doctor | |||||||||
To treat mucosal infections affecting the lining of the mouth, throat, or associated with dental prostheses | 200 mg to 400 mg on the first day, then 100 mg to 200 mg once daily for as long as directed by your doctor | |||||||||
To treat mucosal candidiasis – dosage depends on the site of infection | 50 mg to 400 mg once daily for 7 to 30 days, or for as long as directed by your doctor | |||||||||
To prevent mucosal infections affecting the lining of the mouth and throat | 100 mg to 200 mg once daily, or 200 mg three times per week, for as long as the risk of developing an infection persists | |||||||||
To prevent Candida infections (if the immune system is weakened and not functioning properly) | 200 mg to 400 mg once daily for as long as the risk of developing an infection persists | |||||||||
Adolescents aged 12 to 17 years Follow the dose prescribed by your doctor (either the adult or 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 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:
Use in children under 2 weeks of age:
Sometimes, doctors may prescribe doses different from those described. Consult your doctor or nurse if you have any doubts. Older 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 use more Fluconazol Normon than you should If you are concerned that you may have been given too much Fluconazol Normon, consult your doctor or nurse immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken. 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 use Fluconazol Normon 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 medicine, 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.
Stop using Fluconazole Normon and seek medical attention immediately if you notice any of the following symptoms:
- Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Some people may develop allergic reactions, although severe allergic reactions are rare. If any of the following adverse effects occur, speak with your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. If any of the following symptoms occur, inform your doctor immediately.
- Sudden wheezing, difficulty breathing, or chest tightness.
- Swelling of the eyelids, face, or lips.
- Itching all over the body, skin redness, or itchy red spots.
- Skin rash.
- Severe skin reactions, such as blistering rash (this may affect the mouth and tongue).
Fluconazole Normon may affect your liver. Signs indicating liver problems include:
- Fatigue.
- Loss of appetite.
- Vomiting.
- Yellowing of the skin or whites of the eyes (jaundice).
If you experience any of these symptoms, stop using this medicine 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 effect not mentioned in this leaflet, inform your doctor or pharmacist.
Frequent adverse effects (may affect up to 1 in 10 people) are:
- Headache.
- Stomach discomfort, diarrhea, nausea, vomiting.
- Elevated blood test results indicating liver function abnormalities.
- Rash.
Uncommon adverse effects (may affect up to 1 in 100 people) are:
- Reduction in red blood cells, which may cause pale skin, weakness, or difficulty breathing.
- Decreased appetite.
- Inability to sleep, numbness sensation.
- Seizures, dizziness, spinning sensation, tingling, prickling, or numbness, changes in taste sensation.
- Constipation, indigestion, flatulence, dry mouth.
- Muscle pain.
- Liver damage and yellowing of the skin and eyes (jaundice).
- Hives, blisters (wheals), itching, increased sweating.
- Fatigue, general malaise, fever.
Rare adverse effects (may affect up to 1 in 1,000 people) are:
- Lower than normal levels of white blood cells, which help defend the body against infections, and blood cells that help stop bleeding.
- Reddish or purple skin discoloration, possibly due to low platelet count, other changes in blood cells.
- Changes in blood tests (high levels of cholesterol, fats).
- Low blood potassium levels.
- Tremors.
- Abnormal electrocardiogram (ECG), changes in heart rate or rhythm.
- Liver function failure.
- Allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe allergic reactions, swelling of the lips or face.
- Hair loss.
Frequency not known, but possible (cannot be estimated from available data):
- Hypersensitivity reaction with skin rash, fever, swollen glands, increase in 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)).
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fluconazole Normon
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Store below 30°C.
This medicine is for single use only. After opening, any unused infusion solution must be discarded.
Medicines should not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Fluconazole Normon intravenous infusion solution
- The active substance is fluconazole.
- Each ml contains 2 mg of fluconazole.
- The other components (excipients) are: sodium chloride and water for injections.
Appearance of Fluconazole Normon intravenous infusion solution and contents of the container
- Fluconazole Normon is a clear, transparent solution.
- It is supplied in plastic bags of 50 ml, 100 ml, and 200 ml containing a total of 100 mg, 200 mg, or 400 mg of fluconazole, respectively.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
Date of latest revision of this leaflet: September 2024
Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/
This information is intended for healthcare professionals only:
The intravenous infusion must be administered at a rate not exceeding 10 ml/min. Fluconazole Normon is formulated with sodium chloride 9 mg/ml (0.9%) infusion solution. Each 200 mg (100 ml bag) contains 15 mmol of Na+ and also of Cl-. Since this medicine is available as a diluted sodium chloride solution, the infusion rate should be taken into account in patients requiring restriction of sodium or fluid intake.
Fluconazole for intravenous infusion is compatible with the following fluids:
- 20% Glucose
- Ringer's solution
- Hartmann's solution
- Potassium chloride in glucose
- Sodium bicarbonate 4.2%
- Sodium chloride 9 mg/ml (0.9%)
Fluconazole may be infused through an existing line together with any of the fluids listed above. Although no specific incompatibilities have been reported, mixing Fluconazole Normon with other medicines prior to infusion is not recommended.
The infusion solution is for single use only.
From a microbiological standpoint, diluted solutions should be used immediately. If not used immediately, storage conditions and duration are the responsibility of the user and normally should not exceed 24 hours at 2 to 8 °C, unless dilution has been carried out under controlled and validated aseptic conditions.
Dilution must be performed under aseptic conditions. Before administration, the solution should be inspected visually for particulate matter and discoloration. The solution should only be used if it is clear and free of particles.
Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.