FLUCONAZOLE NORMON 2 mg/ml SOLUTION FOR INTRAVENOUS INFUSION
How to use FLUCONAZOLE NORMON 2 mg/ml SOLUTION FOR INTRAVENOUS INFUSION
Introduction
Package Leaflet: Information for the User
Fluconazole Normon 2 mg/ml solution for infusion EFG
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Fluconazole Normon and what is it used for.
- What you need to know before you use Fluconazole Normon.
- How to use Fluconazole Normon.
- Possible side effects.
- Storing Fluconazole Normon.
- Contents of the pack and other information.
1. What is Fluconazole Normon and what is it used for
Fluconazole Normon is one of a group of medicines called “antifungals”. The active substance is fluconazole.
Fluconazole is used to treat infections caused by fungi, and it can also be used to prevent fungal infections from occurring. 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 in the brain.
- Coccidioidomycosis – a disease of the bronchopulmonary system.
- Infections caused by Candida that are in the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
- Mucosal candidiasis – an infection that affects the lining of the mouth, throat or associated with dental prostheses.
They may also prescribe Fluconazole for:
- Preventing the recurrence of cryptococcal meningitis.
- Preventing the recurrence of mucosal infections.
- Preventing the spread of Candida infections (if your immune system is weak and not working properly).
Children and adolescents (0 to 17 years)
Your doctor may prescribe this medicine to treat the following types of fungal infections:
- Mucosal candidiasis – an infection that affects the lining of the mouth or throat.
- Infections caused by Candida that are 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.
They may also give you Fluconazole for:
- Preventing the spread of Candida infections (if your immune system is weak and not working properly).
- Preventing the recurrence of cryptococcal meningitis.
2. What you need to know before you use Fluconazole Normon
Do not use Fluconazole Normon
- if you are allergic to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of this medicine (listed in section 6). The symptoms can include itching, skin rash or difficulty breathing.
- if you are taking astemizole, terfenadine (antihistamine medicines for treating allergies).
- if you are taking cisapride (used for stomach upset).
- if you are taking pimozide (used for treating mental illness).
- if you are taking quinidine (used for treating heart arrhythmias).
- if you are taking erythromycin (an antibiotic for treating infections).
Warnings and precautions
Tell your doctor before using Fluconazole Normon
- 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 experience severe skin reactions (itching, skin rash 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 or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
- if you have ever developed a severe skin rash or peeling of the skin, blisters and/or sores in the mouth after taking fluconazole.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to treatment with this medicine. Stop using Fluconazole Normon and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
Tell your doctor or pharmacist if the fungal infection does not improve, as it may be necessary to use an alternative antifungal treatment.
Other medicines and Fluconazole Normon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor immediatelyif you are taking astemizole, terfenadine (an antihistamine for treating allergies), cisapride (used for stomach upset), pimozide (used for treating mental illness), quinidine (used for treating heart arrhythmias) or erythromycin (an antibiotic for treating infections), as these medicines should not be taken with this medicine (see section: “Do not take Fluconazole Normon”).
There are some medicines that can interact with Fluconazole Normon. 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 check that the medicines are still working as they should:
- Rifampicin or rifabutin (antibiotics for infections).
- Abrocitinib (used for treating atopic dermatitis, also known as eczema).
- Alfentanil, fentanyl (used as anaesthetics).
- Amitriptyline, nortriptyline (used as antidepressants).
- Amphotericin B, voriconazole (antifungals).
- Medicines that make the blood less viscous, to prevent the formation of clots (warfarin or similar medicines).
- Benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety.
- Carbamazepine, phenytoin (used for treating convulsions).
- Nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (for high blood pressure).
- Olaparib (used for treating ovarian cancer).
- Ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection).
- Cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating cancer.
- Halofantrine (used for treating malaria).
- Statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels.
- Methadone (used for pain relief).
- 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 HIV-infected patients).
- Medicines for diabetes, such as chlorpropamide, glibenclamide, glipizide or tolbutamide.
- Theophylline (used for controlling asthma).
- Tofacitinib (used for treating rheumatoid arthritis)
- Tolvaptan, used for treating hyponatremia (low sodium levels in the blood) or to slow down the deterioration of kidney function.
- Vitamin A (nutritional supplement).
- Ivacaftor (alone or in combination with other medicines used for treating cystic fibrosis).
- Amiodarone (used for treating irregular heartbeats “arrhythmias”).
- Hydrochlorothiazide (diuretic).
- Ibrutinib (used for treating blood cancer).
- Lurasidone (used for treating schizophrenia).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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 adequate contraceptive methods during treatment, which should be continued for one week after the last dose.
Do not take fluconazole if you are pregnant, think you may be pregnant or are planning to become pregnant or breast-feed, unless your doctor has told you to. If you become pregnant while taking this medicine or in the week following the last dose, consult your doctor.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole during the first trimester may increase the risk of a baby being born with congenital anomalies affecting the heart, bones and/or muscles.
There have been reports of babies born with congenital anomalies affecting the skull, ears and bones of the thigh and elbow 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 can continue breast-feeding after taking a single dose of up to 150 mg of this medicine.
Do not continue breast-feeding if you are taking repeated doses of this medicine.
Driving and using machines
When driving or operating machinery, you should take into account that dizziness or convulsions can occasionally occur.
Fluconazole Normon contains sodium
This medicine contains respectively 177.1 mg, 354.2 mg and 708.4 mg of sodium (main component of cooking/table salt) in each 50 ml, 100 ml and 200 ml bag of solution. This is equivalent to respectively 8.86%, 17.71% and 35.42% of the maximum recommended daily intake of sodium for an adult.
The maximum recommended daily dose of this medicine contains 1416.8 mg of sodium. This is equivalent to 70.84% of the maximum recommended daily intake of sodium for an adult.
Consult your doctor or pharmacist if you need, per day, 110 ml or more of this medicine for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.
3. How to use Fluconazole Normon
Your doctor or nurse will administer this medicine to you by slow injection (infusion) directly into your vein. Fluconazole Normon is supplied as a solution. It does not need to be diluted. Further information is provided in the last section of this leaflet for healthcare professionals.
The following are the recommended doses of this medicine for the different types of infections. Consult your doctor or nurse if you are unsure whether you should receive treatment with this medicine.
Adults
Condition | Dose | |||||||||
For treating cryptococcal meningitis | 400 mg on the first day and then 200 mg to 400 mg once a day for 6 to 8 weeks or longer if necessary. The dose may be increased up to 800 mg | |||||||||
For preventing the recurrence of cryptococcal meningitis | 200 mg once a day until your doctor tells you to stop | |||||||||
For treating coccidioidomycosis | 200 mg to 400 mg once a day from 11 months to 24 months or longer if necessary. The dose may be increased up to 800 mg | |||||||||
For treating internal fungal infections caused by Candida | 800 mg on the first day and then 400 mg once a day until your doctor tells you to stop | |||||||||
For treating mucosal infections that affect the lining of the mouth, throat or associated with dental prostheses | 200 mg to 400 mg on the first day and then 100 mg to 200 mg once a day until your doctor tells you to stop | |||||||||
For treating mucosal candidiasis – the dose depends on the location of the infection | 50 mg to 400 mg once a day for 7 to 30 days until your doctor tells you to stop | |||||||||
For preventing mucosal infections that affect the lining of the mouth and throat | 100 mg to 200 mg once a day, or 200 mg 3 times a week, while the risk of developing an infection continues | |||||||||
For preventing the development of a Candidainfection (if your immune system is weak and not working properly) | 200 mg to 400 mg once a day while the risk of developing an infection continues | |||||||||
Adolescents 12 to 17 years of age Follow the dose indicated by your doctor (the adult or child 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.
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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:
Doctors may sometimes prescribe different doses to those described. Consult your doctor or nurse if you have any doubts. Elderly patients 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 working. If you use more Fluconazole Normon than you should If you are concerned that you may have been given too much Fluconazole Normon, consult your doctor or nurse immediately. You can also call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken. The symptoms of a possible overdose may include hearing, seeing, feeling and thinking things that are not real (hallucinations and paranoid behaviour). If you forget to use Fluconazole Normon As this medicine will be administered under strict medical supervision, it is unlikely that a dose will be missed. However, if you think that a dose may have been missed, consult your doctor or pharmacist. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible Adverse EffectsLike all medicines, this medicine can cause adverse effects, although not all people suffer from them. Stop using Fluconazol Normon and seek medical attention immediatelyif you notice any of the following symptoms:
Some people develop allergic reactions, although severe allergic reactions are rare.If any of the following adverse effects appear, talk to your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus. If any of the following symptoms appear, inform your doctor immediately.
Fluconazol Normon may affect your liver. Signs that indicate liver problems include:
If you experience any of these symptoms, stop using this medicine and inform your doctor immediately. Other Adverse Effects: Additionally, if you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist. The frequent adverse effects (may affect up to 1 in 10 people) are:
The infrequent adverse effects (may affect up to 1 in 100 people) are:
The rare adverse effects (may affect up to 1 in 1,000 people) are:
Frequency not known, but may occur (cannot be estimated from available data):
Reporting Adverse Effects: If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine. 5. Conservation of Fluconazol NormonKeep this medicine out of sight and reach of children. Do not use this medicine 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 medicine is for single use. Once opened, the unused infusion should be discarded. Medicines should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment. 6. Package Contents and Additional InformationComposition of Fluconazol Normon Solution for Intravenous Infusion
Appearance of Fluconazol Normon Solution for Intravenous Infusion and Package Contents
Marketing Authorization Holder and Manufacturer LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN) Date of the Last Revision of this Prospectus:September 2024 Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/ -------------------------------------------------------------------------------------------------------------------- This information is intended only for doctors and healthcare professionals: Intravenous infusion should be administered at a speed that does not exceed 10 ml/min. Fluconazol Normon is formulated with a 9 mg/ml (0.9%) sodium chloride solution for infusion. Each 200 mg (100 ml bag) contains 15 mmol of Na+ and also Cl-. Since this medicine is available in a diluted sodium chloride solution, in patients with sodium or fluid restriction, the fluid administration rate should be taken into account. Fluconazol for intravenous infusion is compatible with the following fluids:
Fluconazol can be infused through an existing line along with any of the listed fluids. Although no specific incompatibilities have been described, it is not recommended to mix Fluconazol Normon with other medicines before infusion. The infusion solution is for single use. From a microbiological point of view, dilutions should be used immediately. If not used immediately, the storage times and conditions are the responsibility of the user and should not normally exceed 24 hours at a temperature of 2 to 8 °C, unless the dilution has been made in facilities with controlled and validated asepsis conditions. Dilution should be performed under aseptic conditions. Before administration, the solution should be inspected to check for visible particles or discoloration. The solution should only be used if it is transparent and particle-free. Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations. |
