How to use FLUCONAZOLE ALTAN 2 mg/ml SOLUTION FOR INFUSION
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Fluconazole Altan 2 mg/ml Solution for Infusion EFG
fluconazole
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, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Fluconazole Altan and what is it used for
- What you need to know before you use Fluconazole Altan
- How to use Fluconazole Altan
- Possible side effects
- Storing Fluconazole Altan
- Contents of the pack and other information
1. What is Fluconazole Altan and what is it used for
Fluconazole Altan 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 for you 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 Candidathat 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 mucous membranes 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 Candidainfections (if your immune system is weak and not working properly).
Children and adolescents (from 0 to 17 years)
Your doctor may prescribe this medicine for you to treat the following types of fungal infections:
- Mucosal candidiasis – an infection that affects the mucous membranes of the mouth or throat.
- Infections caused by Candidathat 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 Candidainfections (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 Altan
Do not use Fluconazole Altan
Warnings and precautions
Tell your doctor, pharmacist or nurse before using Fluconazole Altan:
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to fluconazole treatment. Stop using Fluconazole Altan and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.
Talk to your doctor or pharmacist if the fungal infection does not improve, as you may need alternative antifungal treatment.
Other medicines and Fluconazole Altan
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 irregular heartbeats), or erythromycin (an antibiotic for treating infections), as these medicines should not be taken with Fluconazole Altan (see section “Do not use Fluconazole Altan”).
There are some medicines that can interact with Fluconazole Altan. Make sure your doctor knows if you are taking any of the following medicines, as you may need a dose adjustment or monitoring to check that the medicines are still working:
- rifampicin or rifabutin (antibiotics for infections)
- abrocitinib (used to treat atopic dermatitis, also known as atopic 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 to treat seizures)
- nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (for high blood pressure - 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 lower 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 HIV-infected patients)
- 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 down the deterioration of kidney function.
- vitamin A (nutritional supplement)
- ivacaftor (used alone or in combination with other medicines 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, 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 Altan 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 unclear.
You can continue to breast-feed after taking a single dose of 150 mg of fluconazole.
Do not breast-feed if you are taking repeated doses of fluconazole.
Driving and using machines
When driving vehicles or operating machines, you should take into account that dizziness or seizures may occasionally occur.
Fluconazole Altan contains sodium
This medicine contains 177 mg of sodium (main component of cooking/table salt) in each 50 ml bag. This is equivalent to 8.9% of the maximum recommended daily intake of sodium for an adult.
This medicine contains 354 mg of sodium (main component of cooking/table salt) in each 100 ml bag. This is equivalent to 17.7% of the maximum recommended daily intake of sodium for an adult.
This medicine contains 709 mg of sodium (main component of cooking/table salt) in each 200 ml bag. This is equivalent to 35.5% of the maximum recommended daily intake of sodium for an adult.
Talk to your pharmacist or doctor if you need fluconazole every day for a long period of time, especially if you have been advised to follow a low-salt diet.
3. How to use Fluconazole Altan
Your doctor or nurse will administer this medicine to you by slow injection (infusion) directly into your vein. Fluconazole Altan is supplied as a solution. It does not need to be diluted. Further information is provided at the end of this leaflet for healthcare professionals.
The recommended dose of this medicine for the different types of infections is indicated below. Check with your doctor or nurse if you are unsure whether you should receive treatment with Fluconazole Altan.
Adults
Condition | Dose |
To treat 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 |
To prevent the recurrence of cryptococcal meningitis | 200 mg once a day until your doctor tells you to stop |
To treat 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 |
To treat 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 |
To treat 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 until your doctor tells you to stop |
To treat mucosal candidiasis – the dose depends on where the infection is located | 50 mg to 400 mg once a day for 7 to 30 days until your doctor tells you to stop |
To prevent the recurrence of 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 |
To prevent 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 from 12 to 17 years of age
Follow the dose indicated by your doctor (adult posology or pediatric posology).
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.
Condition | Daily dose |
Mucosal candidiasis and throat infections caused by Candida– the dose and duration of treatment depend on the severity of the infection and where it is located. | 3 mg per kg of body weight once a day (on the first day, 6 mg per kg of body weight may be given) |
Cryptococcal meningitis or internal fungal infections caused by Candida | 6 mg to 12 mg per kg of body weight once a day |
To prevent the recurrence of cryptococcal meningitis | 6 mg per kg of body weight once a day |
To prevent the child from getting a Candidainfection (if their immune system is not working properly) | 3 mg to 12 mg per kg of body weight |
Use in children from 0 to 4 weeks of age
Use in children from 3 to 4 weeks of age:
- The same dose as described in the table, but administered every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours.
Use in children under 2 weeks:
- The same dose as described in the table, but administered every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.
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 receive more Fluconazole Altan than you should
If you are concerned that you may have been given too much Fluconazole Altan, talk to your doctor or nurse immediately. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating 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 behavior).
If you miss a dose of Fluconazole Altan
Since this medicine will be administered under close medical supervision, it is unlikely that you will miss a dose. However, if you think you may have missed a dose, talk to your doctor or pharmacist.
If you have any further questions on 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 all people suffer from them.
Stop using Fluconazol Altan and seek medical attention immediatelyif you notice any of the following symptoms:
- Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
Some people develop allergic reactions, although severe allergic reactions are rare. If you experience any adverse effect, consult your doctor or pharmacist. This includes any possible adverse effect not mentioned in this prospectus. If you have any of the following symptoms, 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 red spots with itching.
- Skin rash.
- Severe skin reactions, such as a rash that causes blisters (this can affect the mouth and tongue).
Fluconazol Altan may affect your liver. Signs that indicate liver problems are:
- Fatigue.
- Loss of appetite.
- Vomiting.
- Yellowing of the skin or the whites of the eyes (jaundice).
If you experience any of these symptoms, stop using Fluconazol Altan 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.
Frequent Adverse Effects (may affect up to 1 in 10 people):
- Headache
- Stomach upset, diarrhea, discomfort, vomiting
- Elevated blood test results indicating liver function
- Rash
Uncommon Adverse Effects (may affect up to 1 in 100 people):
- Reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing
- Decreased appetite
- Insomnia, feeling of numbness
- Seizures, dizziness, feeling of spinning, tingling, pinching, or numbness, changes in taste
- Constipation, heavy digestion, gas, dry mouth
- Muscle pain
- Liver damage and yellowing of the skin and eyes (jaundice)
- Hives, blisters (hives), itching, increased sweating
- Fatigue, general feeling of discomfort, fever
Rare Adverse Effects (may affect up to 1 in 1000 people):
- White blood cells in the blood that help defend against 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 cholesterol, fat levels)
- Low potassium levels in the blood
- Tremors
- Abnormal electrocardiogram (ECG), changes in heart rate or rhythm
- Liver function failure
- Allergic reactions (sometimes severe), including widespread rash with blisters and skin peeling, severe allergic reactions, swelling of the lips or face
- Hair loss
Unknown Frequency (cannot be estimated from available data):
- Hypersensitivity reaction with skin rash, fever, inflamed glands, increased eosinophils, and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned 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 Altan
- Keep this medicine out of sight and reach of children.
- Do not use Fluconazol Altan after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
- PVC plastic bags with overbag: Store below 30°C. Do not freeze.
Once the product is opened, it must be used immediately. Once opened, the unused infusion must be discarded. This medicine is for single use
Do not use this medicine if you observe visible particles or if the solution is not transparent or colorless.
Medicines should not be thrown away through drains or into the trash. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.
6. Package Contents and Additional Information
Composition of Fluconazol Altan
- The active ingredient is fluconazole.
- Each ml contains 2 mg of fluconazole.
- The other components (excipients) are: sodium chloride and water for injectable preparations
Appearance of Fluconazol Altan Solution for Infusion and Package Contents
- Fluconazol Altan is a clear, colorless solution without visible particles.
- It is presented in 1 or 50 plastic bags with overbag that contain a total of 100 mg, 200 mg, or 400 mg of fluconazole.
Not all package sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Altan Pharmaceuticals, S.A.
c/ Cólquide, 6 Portal 2, 1ª Planta. Oficina F, Edificio Prisma
28230 Las Rozas
Madrid
Spain
Manufacturer:
Altan Pharmaceuticals, S.A. Polígono Industrial de Bernedo s/n 01118 - Bernedo (Álava)
Spain
Date of the Last Revision of this Prospectus:March 2025
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/
The following information is provided only for doctors and other healthcare professionals:
Intravenous infusion should be administered at a rate not exceeding 10 ml/min. Fluconazol Altan 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 Cl-. Since Fluconazol Altan 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:
- 20% Glucose
- Ringer's Solution
- Hartmann's Solution
- Potassium chloride in glucose
- Sodium hydrogen carbonate 4.2%
- Sodium chloride 9 mg/ml (0.9%)
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 Altan 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 normally should not 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 free of particles.
Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.
- Country of registration
- Dosage formINJECTABLE INFUSION, 2 mg/mL
- ATC codeJ02AC01
- Availability in pharmacies
Supply issue reported
Data from the Spanish Agency of Medicines (AEMPS) indicates a supply issue affecting this medicine.<br><br>Availability may be limited in some pharmacies.<br><br>For updates or alternatives, consult your pharmacist. - Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to FLUCONAZOLE ALTAN 2 mg/ml SOLUTION FOR INFUSIONDosage form: CAPSULE, 150 mg fluconazoleActive substance: fluconazoleManufacturer: Arafarma Group S.A.Prescription requiredDosage form: ORAL SOLUTION/SUSPENSION, 10 mg/mlActive substance: fluconazoleManufacturer: Vinci Farma, S.A.Prescription requiredDosage form: CAPSULE, 100 mgActive substance: fluconazoleManufacturer: Vinci Farma, S.A.Prescription required
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Frequently Asked Questions
FLUCONAZOLE ALTAN 2 mg/ml SOLUTION FOR INFUSION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in FLUCONAZOLE ALTAN 2 mg/ml SOLUTION FOR INFUSION is fluconazole. This information helps identify medicines with the same composition but different brand names.
FLUCONAZOLE ALTAN 2 mg/ml SOLUTION FOR INFUSION is manufactured by Altan Pharmaceuticals Sa. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether FLUCONAZOLE ALTAN 2 mg/ml SOLUTION FOR INFUSION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy FLUCONAZOLE ALTAN 2 mg/ml SOLUTION FOR INFUSION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (fluconazole) include CANDIFIX 150 mg HARD CAPSULES, DIFLUCAN 10 mg/ml POWDER FOR ORAL SUSPENSION, DIFLUCAN 100 mg HARD CAPSULES. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
