Prospect: information for the user

Fluconazole Altan 2 mg/ml solution for infusion EFG

fluconazole

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to use Fluconazole Altan

3. How to use Fluconazole Altan

4. Possible adverse effects

5. Storage of Fluconazole Altan

6. Contents of the package and additional information

Fluconazol Altan is one of the medicationsin the group called “antifungals”. The active ingredient is fluconazole.

Fluconazole is used to treatinfections caused by fungi,and it may also be used to prevent the onset of a fungal infection. The most common cause of fungal infections is a yeast calledCandida.

Adults

Your doctor may prescribe this medication 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 byCandidalocated 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 membrane of the mouth, throat, or associated with dental prostheses.

Your doctor may also prescribe Fluconazole to:

• Prevent the recurrence of cryptococcal meningitis.
• Prevent the recurrence of mucosal infections.
• Prevent the transmission of infections caused byCandida(if your immune system is weak and does not function properly).

Childrenand adolescents(from0 to17 years)

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

• Mucosal candidiasis – an infection that affects the mucous membrane of the mouth or throat.
• Infections caused byCandidalocated 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.

Your doctor may also give you Fluconazole to:

• Prevent the transmission of infections caused byCandida(if your immune system is weak and does not function properly).
• Prevent the recurrence of cryptococcal meningitis.

No use Fluconazol Altan si

- si es alérgico al fluconazol, a otros medicamentos que haya tomado para tratar infecciones fúngicas o a alguno de los demás componentes de este medicamento (incluidos en la sección 6). Los síntomas pueden incluir picor, enrojecimiento de la piel o dificultad para respirar

- si está tomando astemizol, terfenadina (medicamentos antihistamínicos para tratar las alergias).

• si está tomando cisaprida (utilizada para tratar molestias de estómago).
• si está tomando pimozida (utilizado para tratar enfermedades mentales).
• si está tomando quinidina (utilizado para tratar los latidos irregulares del corazón“arritmias”).
• si está tomando eritromicina (un antibiótico para tratar infecciones)

Advertencias y precauciones

Consulte a su médico farmacéutico o enfermero antes de usar Fluconazol Altan:

• si tiene problemas de hígado o de los riñones.

• si sufre una enfermedad del corazón, incluido problemas del ritmo del corazón.
• si tiene niveles anormales de potasio, calcio o magnesio en la sangre.
• si aparecen reacciones graves de la piel (picor, enrojecimiento de la piel o dificultad para respirar).
• si alguna vez ha presentado una erupción cutánea grave o descamación de la piel, ampollas y/o llagas en la boca después de usar fluconazol.
• si presenta signos de insuficiencia suprarrenal en donde las glándulas suprarrenales no producen cantidades adecuadas de ciertas hormonas esteroideas como cortisol (fatiga crónica o de larga duración, debilidad muscular, pérdida de apetito, pérdida de peso, dolor abdominal).

Se han notificado reacciones cutáneas graves, incluida la reacción a fármacos con eosinofilia y síntomas sistémicos (DRESS), en relación con el tratamiento con fluconazol. Deje de usar Fluconazol Altan y busque atención médica inmediatamente si nota alguno de los síntomas relacionados con estas reacciones cutáneas graves que se describen en la sección 4.

Hable con su médico o farmacéutico si la infección por hongos no mejora, ya que puede ser necesario un tratamiento antifúngico alternativo.

Otros medicamentos y Fluconazol Altan

Informe a su médico o farmacéutico si está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento.

Informe inmediatamente a su médico si está tomando astemizol, terfenadina (un antihistamínico para tratar las alergias), cisaprida (utilizado para las molestias de estómago), pimozida (utilizada para tratar enfermedades mentales), quinidina (utilizada para tratar arritmias del corazón) o eritromicina (un antibiótico para tratar infecciones), ya que estos medicamentos no se deben tomar con Fluconazol Altan (ver sección: “No use Fluconazol Altan”).

Hay algunos medicamentos que pueden interaccionar con Fluconazol Altan. Asegúrese de que su médico sabe si está tomando alguno de los siguientes medicamentos ya que se puede necesitar un ajuste de dosis o un seguimiento para comprobar que los medicamentos tienen todavía el efecto deseado:

• rifampicina o rifabutina (antibióticos para las infecciones)
• alfentanilo, fentanilo (utilizados como anestésicos)
• amitriptilina, nortriptilina (utilizados como antidepresivos)
• anfotericina B, voriconazol (antifúngicos)
• medicamentos que hacen la sangre menos viscosa para prevenir la formación de coágulos (warfarina u otros medicamentos similares)
• benzodiazepinas (midazolam, triazolam o medicamentos similares) utilizados para ayudar a dormir o para la ansiedad
• carbamazepina, fenitoína (utilizados para tratar convulsiones)
• nifedipino, isradipino, amlodipino, verapamilo, felodipino y losartan (para la hipertensión - tensión arterial alta)
• olaparib (usado para tratar el cáncer ovárico)
• ciclosporina, everolimus, sirolimus o tacrolimus (para prevenir el rechazo a trasplantes).
• ciclofosfamida, alcaloides de la vinca (vincristina, vinblastina o medicamentos similares) utilizados para tratar el cáncer
• halofantrina (utilizado para tratar la malaria)
• estatinas (atorvastatina, simvastatina y fluvastatina o medicamentos similares) utilizados para reducir los niveles de colesterol altos
• metadona (utilizado para el dolor)
• celecoxib, flurbiprofeno, naproxeno, ibuprofeno, lornoxicam, meloxicam, diclofenaco (Anti-Inflamatorios No Esteroideos -AINEs-)
• anticonceptivos orales
• prednisona (esteroide)
• zidovudina, también conocida como AZT; saquinavir (utilizados en pacientes infectados por el VIH)
• medicamentos para la diabetes, tales como clorpropamida, glibenclamida, glipizida o tolbutamida
• teofilina (utilizado para controlar el asma)
• tofacitinib (utilizado para tratar la artritis reumatoide)
• tolvaptan utilizado para tratar la hiponatremia (niveles bajos de sodio en la sangre) o para retardar el deterioro de la función renal.
• vitamina A (complemento nutricional)
• ivacaftor (utilizado solo o en combinación con otros medicamentos para tratar la fibrosis quística)
• amiodarona (utilizada para tratar latidos irregulares del corazón “arritmias”)
• hidroclorotiazida (un diurético)
• ibrutinib (utilizado para tratar el cáncer de la sangre)
• lurasidona (utilizado para tratar la esquizofrenia)

Embarazo y lactancia

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

Si está planeando quedarse embarazada, se recomienda que espere una semana después de una dosis única de fluconazol antes de quedarse embarazada.

Para ciclos de tratamiento con fluconazol más largos, consulte a su médico sobre la necesidad de utilizar métodos anticonceptivos adecuados durante el tratamiento, cuyo uso deberá mantenerse durante una semana después de la última dosis.

No debe tomar Fluconazol Altan si está embarazada, cree que podría estar embarazada o tiene intención de quedarse embarazada o de dar el pecho, a menos que su médico se lo haya indicado. Si se queda embarazada mientras toma este medicamento o en el plazo de una semana tras la dosis más reciente, consulte a su médico.

Fluconazol tomado durante el primer o el segundo trimestre del embarazo puede aumentar el riesgo de aborto espontáneo. Fluconazol durante el primer trimestre puede aumentar el riesgo de que un bebé nazca con anomalías congénitas que afecten al corazón, a los huesos y/o músculos.

Se han notificado casos de bebés nacidos con anomalías congénitas que afectan al cráneo, los oídos y los huesos del muslo y del codo en mujeres tratadas durante tres meses o más con dosis altas (400-800 mg diarios) de fluconazol por coccidioidomicosis. La relación entre el fluconazol y estos casos no está clara.

Puede continuar dando el pecho tras la toma de una única dosis de 150 mg de fluconazol.

No debe dar el pecho si está tomando dosis repetidas de fluconazol.

Conducción y uso de máquinas

Cuando vaya a conducir vehículos o manejar máquinas debe tener en cuenta que ocasionalmente pueden producirse mareos o convulsiones.

Fluconazol Altan contiene sodio

Este medicamento contiene 177 mg de sodio (componente principal de la sal de mesa/para cocinar) en cada bolsa de 50 ml. Esto equivale al 8,9% de la ingesta diaria máxima de sodio recomendada para un adulto.

Este medicamento contiene 354 mg de sodio (componente principal de la sal de mesa/para cocinar) en cada bolsa de 100 ml. Esto equivale al 17,7% de la ingesta diaria máxima de sodio recomendada para un adulto.

Este medicamento contiene 709 mg de sodio (componente principal de la sal de mesa/para cocinar) en cada bolsa de 200 ml. Esto equivale al 35,5% de la ingesta diaria máxima de sodio recomendada para un adulto.

Hable con su farmacéutico o médico si necesita fluconazol a diario durante un periodo de tiempo prolongado, especialmente si le han aconsejado una dieta baja en sal.

Your doctor or nurse will administer this medication through a slow injection (infusion) directly into your vein. Fluconazol Altan is supplied as a solution. It does not need to be diluted. Additional information for healthcare professionals is provided in the final section of this leaflet.

The recommended dose of this medication for different types of infections is indicated below. Check with your doctor or nurse if you are unsure whether you should receive treatment with Fluconazol Altan.

Adults

Adolescents aged12 to17 years old

Follow the dose indicated by your doctor (either the adult dose or the pediatric dose).

Children up to 11 years old

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 aged0 to4 weeks old

Use in children aged3 to4 weeks old:

• 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 under 2 weeks:

• 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.

Geriatric 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 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 can also call the Toxicology Information Service, phone 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 administer Fluconazol Altan

Since this medication will be administered under strict medical supervision, it is unlikely that you will forget a dose. However, if you think you may have missed a dose, consult your doctor or pharmacist.

If you have any other questions about the use of thismedication, ask your doctor,pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop using Fluconazol Altan and seek medical attentionimmediatelyif you notice any of the following symptoms:

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

Some people developallergic reactions, although severe allergic reactions are rare. If you have any side effect, consult your doctor or pharmacist. This includes any possible side effect not mentioned in this leaflet. If you have any of the following symptoms,inform your doctor immediately

• Abnormal heartbeats, difficulty breathing, or chest tightness.

• Swelling of the eyelids, face, or lips.
• Itching all over the body, redness of the skin, 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.The signs that indicate liver problems are:

• Tiredness.
• Loss of appetite.
• Vomiting.

• Yellowing of the skin or white of the eyes (jaundice).

If you experience any of these symptoms, stop using Fluconazol Altan andinform your doctor immediately

Other side effects

In addition, if you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Frequent side effects (may affect up to 1 in 10 people):

• Headache
• Stomach discomfort, diarrhea, nausea, vomiting
• Abnormal liver function test results
• Rash

Less frequent side effects (may affect up to1 in 100 people):

• Reduction in red blood cells, which can cause pale skin and weakness or difficulty breathing
• Loss of appetite
• Inability to sleep, numbness
• Seizures, dizziness, feeling of spinning, tingling, pins and needles, changes in taste
• Constipation, heavy digestion, gas, dry mouth
• Muscle pain
• Liver damage and yellowing of the skin and eyes (jaundice)
• Rashes, blisters (pustules), itching, increased sweating
• Tiredness, general feeling of discomfort, fever

Rare side effects (may affect up to 1 in 1000 people):

• White blood cells in the blood that help us fight 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
• Abnormal blood test results (high cholesterol, fats)
• Low potassium levels in the blood
• Tremors
• Abnormal electrocardiogram (ECG), changes in heart rate or rhythm
• Liver 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):

• Reaction of hypersensitivity with skin rash, fever, swollen glands, increased eosinophils, and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use Fluconazole Altanafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• PVC plastic bagswith overwrapplasticized with PVC: Store below 30°C. Do not freeze.

Once opened, the product must be used immediately. Once opened, unused infusions must be discarded. This medication is for single use only.

Do not use this medication if you observe visible particles or if the solution is not transparent or colorless.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

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 infusion solution and packaging contentsand contents of the packaging

• Fluconazol Altanis a transparent, colorless solution without visible particles.
• It is presented in 1 or 50 bags with plastic overbags containing a total of 100 mg, 200 mg or 400 mg of fluconazole.

Not all packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Altan Pharmaceuticals, S.A.

c/ Cólquide, 6 Portal 2, 1st Floor. Office F, Prisma Building

28230 Las Rozas

Madrid

Spain

Responsible manufacturer:

Altan Pharmaceuticals, S.A.
Polígono Industrial de Bernedo s/n
01118 -Bernedo (Álava)

Spain

Last review date of this leaflet:February2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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 Altanis formulated with a sodium chloride 9mg/ml (0.9%) infusion solution. Each 200mg (100ml vial) contains 15mmol of Na+ and Cl-. Due to the fact that Fluconazol Altanis available in the form of a diluted sodium chloride solution, in patients with sodium or fluid restrictions, the administration rate of the fluid should be taken into account.

Fluconazole for intravenous infusion is compatible with the following fluids:

a) Dextrose 5% and 20%b) Ringer's solution

c) Hartmann's solution

d) Potassium chloride in dextrose

e) Sodium bicarbonate 4.2% and 5%

f) Aminosina 3.5%

g) Sodium chloride9 mg/ml (0.9%)

h) Dialaflex (intraperitoneal dialysis solution 6.36%).

Fluconazole may be infused through an existing line with one of the listed fluids. Although no specific incompatibilities have been described, it is not recommended to mixFluconazol Altanwith other medications before infusion.

The infusion solution is for single use.

From a microbiological point of view, the dilutions should be used immediately. If not used immediately, the storage times and conditions in use are the responsibility of the user and are normally not more than 24 hours at a temperature of 2 to 8 °C, unless the dilution has been prepared in facilities with controlled and validated aseptic conditions.

The dilution should be prepared in aseptic conditions. Before administration, the solution should be inspected to check that there are no visible particles or discoloration. Only the solution should be used if it is transparent and free of particles.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.