Fluconazole Altan 2 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluconazol Altan 2 mg/ml solution for infusion EFG

fluconazole

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, pharmacist or nurse.
• 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, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Fluconazol Altan is and what it is used for
2. What you need to know before using Fluconazol Altan
3. How to use Fluconazol Altan
4. Possible adverse effects
5. How to store Fluconazol Altan
6. Contents of the pack and other information

1. What Fluconazol Altan is and what it is used for

Fluconazol Altan 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.
• Candida infections located in the bloodstream, in body organs (e.g., heart, lungs), or in the urinary tract.
• Mucosal candidiasis – infection affecting the mucous membranes of the mouth, throat, or associated with dental prostheses.

Your doctor may also prescribe Fluconazole to:

• Prevent recurrence of cryptococcal meningitis.
• Prevent recurrence of mucosal infections.
• Prevent the occurrence of Candida infections (if your immune system is weakened and not functioning properly).

Children and adolescents (from 0 to 17 years of age)

Your doctor may prescribe this medicine to treat the following types of fungal infections:

• Mucosal candidiasis – infection affecting the mucous membranes of the mouth or throat.
• Candida infections located in the bloodstream, in body organs (e.g., heart, lungs), or in the urinary tract.
• Cryptococcal meningitis – a fungal infection of the brain.

Fluconazole may also be given to:

• Prevent the occurrence of Candida infections (if your immune system is weakened and not functioning properly).
• Prevent recurrence of cryptococcal meningitis.

2. What you need to know before using Fluconazol Altan

Do not use Fluconazol Altan 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
• you are taking astemizole or terfenadine (antihistamine medicines used to treat allergies)
  • you are taking cisapride (used to treat stomach discomfort)
  • you are taking pimozide (used to treat mental illnesses)
  • you are taking quinidine (used to treat irregular heartbeats “arrhythmias”)
  • you are taking erythromycin (an antibiotic used to treat infections)

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Fluconazol Altan:

• 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 severe skin reactions occur (itching, skin redness, or difficulty breathing)
• if you have ever had a severe skin rash, skin peeling, blisters, and/or mouth sores after using fluconazole
• if you experience signs of adrenal insufficiency, in which the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with fluconazole. Stop using Fluconazol Altan and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Talk to your doctor or pharmacist if your fungal infection does not improve, as alternative antifungal treatment may be needed.

Other medicines and Fluconazol Altan

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell 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 Fluconazol Altan (see section: “Do not use Fluconazol Altan”).

Some medicines may interact with Fluconazol Altan. Make sure your doctor knows if you are taking any of the following medicines, as dose adjustment or monitoring may be needed to ensure these medicines still have the desired effect:

• 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 clot formation (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)
• 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, 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 the blood) or to delay the decline in 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, 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 treatment courses 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.

Do not take Fluconazol Altan if you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding, unless your doctor has instructed you to do so. 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 taken during the first trimester may increase the risk of congenital abnormalities affecting the heart, bones, and/or muscles.

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.

You may continue breastfeeding after a single 150 mg dose of fluconazole.

Do not breastfeed if you are taking repeated doses of fluconazole.

Driving and using machines

When driving vehicles or operating machinery, keep in mind that dizziness or seizures may occasionally occur.

Fluconazol Altan contains sodium

This medicine contains 177 mg of sodium (main component of table/cooking salt) in each 50 ml bag. This corresponds to 8.9% of the maximum daily sodium intake recommended for an adult.

This medicine contains 354 mg of sodium (main component of table/cooking salt) in each 100 ml bag. This corresponds to 17.7% of the maximum daily sodium intake recommended for an adult.

This medicine contains 709 mg of sodium (main component of table/cooking salt) in each 200 ml bag. This corresponds to 35.5% of the maximum daily sodium intake recommended for an adult.

Talk to your pharmacist or doctor if you need fluconazole daily for a prolonged period, especially if you have been advised to follow a low-salt diet.

3. How to use Fluconazol Altan

Your doctor or nurse will administer this medicine by slow injection (infusion) directly into your vein. Fluconazol Altan 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 dose of this medicine for different types of infections is given below. Check with your doctor or nurse if you are unsure whether you should receive treatment with Fluconazol Altan.

Adults

Adolescents aged 12 to 17 years

Follow the dose indicated 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 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 once every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours.

Use in children less than 2 weeks of age:

• The same dose as described in the table, but administered once 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 adjust your dose depending on how well your kidneys are functioning.

If you receive more Fluconazol Altan than you should

If you are concerned that you may have been given too much Fluconazol Altan, consult your doctor or nurse immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating 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 have forgotten to receive Fluconazol Altan

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 experiences them.

Stop using Fluconazole Altan and seek medical attention immediately if you notice any of the following symptoms:

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

Some people may 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 listed in this leaflet. 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 itchy red spots.
• Skin rash.
• Severe skin reactions, such as blistering rash (this may affect the mouth and tongue).

Fluconazole Altan may affect your liver. Signs indicating liver problems include:

• Tiredness.
• Loss of appetite.
• Vomiting.
• Yellowing of the skin or whites of the eyes (jaundice).

If you experience any of these symptoms, stop using Fluconazole Altan 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):

• Headache
• Stomach discomfort, diarrhoea, nausea, vomiting
• Elevated blood test results indicating liver function abnormalities
• Rash

Uncommon adverse effects (may affect up to 1 in 100 people):

• Reduction in red blood cells, which may cause pale skin, weakness, or difficulty breathing
• Decreased appetite
• Difficulty sleeping, numbness sensation
• Seizures, dizziness, spinning sensation, tingling, prickling, or numbness, taste disturbances
• Constipation, indigestion, flatulence, dry mouth
• Muscle pain
• Liver damage and yellowing of the skin and eyes (jaundice)
• Hives, blisters (urticaria), itching, increased sweating
• Tiredness, general feeling of being unwell, fever

Rare adverse effects (may affect up to 1 in 1,000 people):

• Lower than normal levels of white blood cells (which help defend against infections) and blood cells that help stop bleeding (platelets)
• Reddish or purplish skin discolouration, possibly due to low platelet count, other changes in blood cells
• Changes in blood tests (high cholesterol, high fat levels)
• Low potassium levels in blood
• Tremors
• Abnormal electrocardiogram (ECG), changes in heart rate or rhythm
• Liver function failure
• Allergic reactions (sometimes severe), including widespread blistering and peeling rash, severe allergic reactions, swelling of lips or face
• Hair loss

Frequency not known (cannot be estimated from available data):

• Hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cell (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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Altan

• Keep this medicine out of the sight and reach of children.
• Do not use Fluconazole Altan after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
• PVC pouches with laminated overpouch: Store below 30°C. Do not freeze.

Once the product is opened, it must be used immediately. Unused infusion solution must be discarded after opening. This medicine is for single use only.

Do not use this medicine if you see visible particles or if the solution is not clear and colourless.

Medicines must not be disposed of via wastewater 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 pack and other information

Composition of Fluconazole Altan

• 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 Altan infusion solution and pack contents

• Fluconazole Altan is a clear, colourless solution free from visible particles.
• It is available in packs of 1 or 50 plastic-laminated bags containing a total of 100 mg, 200 mg, or 400 mg of fluconazole.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Altan Pharmaceuticals, S.A.

Cólquide Street, 6, Building 2, 1st Floor, Office F, Prisma Building
28230 Las Rozas
Madrid
Spain

Manufacturer:

Altan Pharmaceuticals, S.A.
Industrial Estate of Bernedo, s/n
01118 - Bernedo (Álava)
Spain

Date of the most recent review of this summary: March 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

The following information is intended only for physicians and other healthcare professionals:

Intravenous infusion must be administered at a rate not exceeding 10 ml/min. Fluconazole Altan is formulated in a sodium chloride 9 mg/ml (0.9%) infusion solution. Each 200 mg (100 ml vial) contains 15 mmol of Na+ and Cl-. Since Fluconazole Altan is supplied as a diluted solution in sodium chloride, administration rate should be carefully considered in patients with restricted 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 hydrogen carbonate 4.2%
• Sodium chloride 9 mg/ml (0.9%)

Fluconazole may be administered through an existing intravenous line together with any of the fluids listed above. Although no specific incompatibilities have been reported, mixing Fluconazole Altan with other medicinal products 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 prior to use are the user's responsibility and normally should not exceed 24 hours at a temperature of 2 to 8 °C, unless dilution has been carried out under validated aseptic and controlled conditions.

Dilution must be performed under aseptic conditions. Prior to administration, the solution should be inspected visually for the presence of visible particles and discoloration. The solution should only be used if it is clear and free from particles.

Disposal of unused medicine and of all materials that have been in contact with it must be carried out in accordance with local regulations.