FLUCONAZOLE ALTAN 2 mg/ml SOLUTION FOR INFUSION

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

1. What is Fluconazole Altan and what is it used for
2. What you need to know before you use Fluconazole Altan
3. How to use Fluconazole Altan
4. Possible side effects
5. Storing Fluconazole Altan
6. 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

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.

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.