Label: information for the user

Diflucan 10 mg/ml powder for oral suspension

Diflucan 40 mg/ml powder for oral suspension

fluconazole

Read this label carefully before starting to take this medicine because it contains important information for you.

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

6. Contents of the pack and additional information

Diflucan is one of the medications in the group called "antifungals". The active ingredient is fluconazole.

Diflucan is used to treat infections caused by fungi, and it may also be used to prevent the appearance of an infection byCandida. 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.
• Genital candidiasis – an infection of the vagina or penis.
• Skin infections – e.g. athlete's foot, ringworm, inguinal ringworm, nail infection.

Your doctor may also prescribe Diflucan for:

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

Children and adolescents (0 to 17 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 prescribe Diflucan for:

• To prevent the transmission of infections caused byCandida(if your immune system is weak and does not function properly).

To prevent the recurrence of cryptococcal meningitis.

Do not take Diflucan

• if you are allergic (hypersensitive) to fluconazole, other medications you have taken to treat fungal infections, or any of the other components of this medication (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing.
• if you are taking astemizole, terfenadine (antihistamines for allergies).
• if you are taking cisaprida (used to treat stomach discomfort).
• if you are taking pimozida (used to treat mental illnesses).
• if you are taking quinidina (used to treat heart arrhythmias).
• if you are taking erythromycin (an antibiotic for infections).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diflucan

• 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 redness, or difficulty breathing).
• if you experience signs of “adrenal insufficiency”, where the adrenal glands do not produce enough of certain hormones, such as cortisol (chronic fatigue or prolonged weakness, muscle weakness, loss of appetite, weight loss, abdominal pain).
• if you have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Diflucan.
• Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Diflucan treatment. Stop taking Diflucan and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Speak with your doctor or pharmacist if the fungal infection does not improve, as an alternative antifungal treatment may be necessary.

Use of Diflucan with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Informimmediatelyyour doctor if you are taking astemizole, terfenadine (an antihistamine for allergies), cisaprida (used for stomach discomfort), pimozida (used to treat mental illnesses), quinidina (used to treat heart arrhythmias), or erythromycin (an antibiotic for infections), as these medications should not be taken with Diflucan (see section: “Do not take Diflucan”).

There are some medications that may interact with Diflucan. Make sure your doctor knows if you are taking any of the following medications, as it may be necessary to adjust the dose or monitor to ensure the medications continue to have the desired effect:

• Rifampicin or rifabutina (antibiotics for infections).
• Alfentanilo, fentanilo (used as anesthetics).
• Abrocitinib (used to treat atopic dermatitis, also known as eczema).
• Amitriptilina, nortriptilina (used as antidepressants).
• Amfotericina B, voriconazol (antifungals).
• Medications that make blood less viscous, to prevent clot formation (warfarina or similar medications).
• Benzodiazepines (midazolam, triazolam or similar medications) used to help sleep or for anxiety.
• Carbamazepina, fenitoína (used to treat seizures).
• Nifedipino, isradipino, amlodipino, verapamilo, felodipino, and losartán (for hypertension).
• Olaparib (used to treat ovarian cancer).
• Ciclosporina, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection).
• Ciclofosfamida, vinca alkaloids (vincristina, vinblastina or similar medications) used to treat cancer.
• Halofantrina (used to treat malaria).
• Estatinas (atorvastatina, simvastatina, and fluvastatina or similar medications) used to reduce high cholesterol levels.
• Metadona (used for pain).
• Celecoxib, flurbiprofeno, naproxeno, ibuprofeno, lornoxicam, meloxicam, diclofenaco (Nonsteroidal Anti-Inflammatory Drugs - NSAIDs).
• Oral contraceptives.
• Prednisona (steroid).
• Zidovudina, also known as AZT; saquinavir (used in patients infected with HIV).
• Medications for diabetes, such as clorpropamida, glibenclamida, glipizida, or tolbutamida.
• Teofilina (used to control asthma).
• Tofacitinib (used to treat rheumatoid arthritis).
• Tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to slow the deterioration of kidney function).
• Vitamin A (nutritional supplement).
• Ivacaftor (alone or combined with medications used to treat cystic fibrosis).
• Amiodarona (used to treat irregular heartbeats).

• Hidroclorotiazida (diuretic).
• Ibrutinib (used to treat blood cancer).
• Lurasidona (used to treat schizophrenia).

Taking Diflucan with food and drinks

You can take the medication with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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 appropriate contraceptive methods during treatment, which should be maintained for one week after the last dose.

You should not take Diflucan if you are pregnant, think you may be pregnant, or plan to become pregnant, unless your doctor has told you to do so. If you become pregnant while taking this medication or within one week of 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 leg and elbow bones have been reported in women treated for three months or more with high doses (400-800mg daily) of fluconazole for coccidioidomycosis. The relationship between fluconazole and these cases is unclear.

You can continue breastfeeding after taking a single dose of 150 mg of Diflucan. Do not continue breastfeeding if you are taking repeated doses of Diflucan.

Driving and operating machines

When driving or operating machines, be aware that occasional dizziness or seizures may occur.

Diflucan oral suspension powder contains saccharose (sugar), sodium benzoate, and sodium (salt).

If your doctor has told you that you have certain sugar intolerance, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 5.5 g or more of saccharose per 10 ml.

It may damage teeth if used for periods longer than 2 weeks.

The 60 ml capacity bottle contains83 mg of sodium benzoate per bottle, equivalent to 2.38mg/ml.

Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

Once reconstituted,1 ml of Diflucan 10 mg/ml oral suspension powder contains 1.13 mg of sodium per ml. This is equivalent to 4.5% of the maximum daily sodium intake recommended for an adult.

Once reconstituted, a 20 ml (maximum recommended dose) of Diflucan 40 mg/ml oral suspension powder contains less than 1 mmol of sodium (23 mg); this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is best to take your medications at the same time every day.

The following are the recommended doses of this medication for different types of infections:

Adults

Adolescents 12 to 17 years old

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

Children up to 11 years old

The maximum daily dose for children is 400 mg.

The dose will be based on the child's weight in kilograms.

Use in children 0 to 4 weeks old

Use in children 3 to 4 weeks old:

• The same dose as described in the table, but administered once every 2 days. The maximum dose is 12 mg per kg every 48 hours.

Use in children under 2 weeks old:

• The same dose as described in the table, but administered once every 3 days. The maximum dose is 12 mg per kg 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.

Instructions for preparing the suspension:

Your pharmacist should reconstitute the powder for oral suspension before giving it to you. However, if the pharmacist does not reconstitute this product, the instructions are provided in the section: “The following information is provided only for doctors and other healthcare professionals or for patients (if the pharmacist does not reconstitute this product).”

Instructions for use:

Shake the suspension bottle with the cap closed before each use.

Instructions for using the oral syringe:

1. Shake the prepared suspension well.

2. Open the bottle (safety closure);

3. Insert the oral syringe into the adapter on the neck of the bottle (Figure 1);

4. Turn the bottle with the syringe facing down and draw out the amount of suspension indicated by your doctor (Figure 2). The marks on the syringe indicate the ml.

Do not exceed the maximum daily dose of 400 mg in children (see section 3 “How to take Diflucan”).

5. Turn the bottle with the syringe facing up and remove the syringe from the bottle.

6. The medication can be administered directly into the mouth with the oral syringe. The patient should remain in an upright position during administration. Point the syringe at the inside of the cheek; slowly release the suspension into the patient's mouth (Figure 3).

7. Rinse the oral syringe.

8. Close the bottle with the safety closure; the adapter should remain on the neck of the bottle.

To convert the dose of the powder for oral suspension from mg/ml to ml/kg of body weight for pediatric patients, see section 6.

In adults, calculate the dose in ml to administer according to the recommended dose in mg and the product concentration.

If you take more Diflucan than you should

Taking too much Diflucan may make you feel unwell. Contact your doctor immediately or go to the nearest hospital. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication 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). It may be appropriate to initiate symptomatic treatment (with supportive measures and gastric lavage if necessary).

If you forget to take Diflucan

Do not take a double dose to make up for the missed doses. If you forget to take a dose, take it as soon as you remember. If there is little time left for the next dose, do not take the missed dose.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medication may cause side effects, although not everyone will experience them.

Stop taking Diflucan and seek medical attention immediately if 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 experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not mentioned in this leaflet. If you experience any of the following symptoms, informyour doctor immediately.

• abrupt onset of 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 rash that causes blisters (this may affect the mouth and tongue).

Diflucan may affect your liver. Signs that indicate liver problems include:

-fatigue.

-loss of appetite.

-vomiting.

-yellowing of the skin or white of the eyes (jaundice).

If you experience any of these symptoms, stop taking Diflucan 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 patients) are:

• headache.
• stomach discomfort, diarrhea, nausea, vomiting.
• abnormal liver function test results.
• skin rash.

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

• reduction in red blood cells, which may cause pale skin and weakness or difficulty breathing.
• loss of appetite.
• insomnia, 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.
• fatigue, general feeling ofunwellness, fever.

Rare side effects (may affect up to 1 in 1,000 patients) are:

• low white blood cell count, which helps fight infections, and low platelet count, which helps stop bleeding.
• red or purple discoloration of the skin, which may be due to low platelet count, other blood cell changes.
• 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.

Frequency not known, but may occur (cannot be estimated from available data):

• hypersensitivity reaction with skin rash, fever, swollen glands, increased eosinophils, and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or rash with eosinophilia and systemic symptoms [DRESS]).

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and the outer carton after CAD. The expiration date is the last day of the month indicated.

Before reconstitution: Store below 25°C. Keep the bottle perfectly closed.

After reconstitution: Store below 30°C. Do not freeze. The shelf life of the reconstituted suspension is 28 days. Write the expiration date of the reconstituted suspension on the bottle label.

Medicines should not be disposed of through drains or in the trash. Any remaining suspension should be discarded 28 days after reconstitution. Dispose of containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Diflucan

• The active ingredient is fluconazole, 1 ml of reconstituted suspension contains 10mg or 40mg of fluconazole.
• The other components (excipients) are sucrose, anhydrous colloidal silica, titanium dioxide (E 171), xanthan gum (E415), sodium citrate, anhydrous citric acid, sodium benzoate (E211) and natural orange flavor (contains orange essential oil and maltodextrin (contains glucose and cornstarch)(see section 2, Diflucan powder for oral suspension contains sucrose (sugar), glucose (sugar), sodium benzoate) and sodium (salt).

Appearance of the product and contents of the package

Oral suspension powder 10 mg/ml in a 60 ml capacity bottle: 35 ml of suspension after reconstitution:

• Diflucan 10 mg/ml oral suspension powder is presented in a 60 ml capacity bottle that contains 24.4 g of powder which gives 35 ml of suspension after reconstitution.
• Diflucan 10 mg/ml oral suspension powder is a white or almost white dry powder. After adding water to the powder (following the detailed instructions later in the leaflet) a white or almost white suspension with orange flavor is obtained.
• In each bottle, the mixture of powder with water produces 35 ml of suspension.
• The 35 ml suspension is supplied with a 5 ml oral graduated syringe and a pressure adapter to the bottle to measure the correct dose.

Oral suspension powder 40 mg/ml in a 60 ml capacity bottle: 35 ml of suspension after reconstitution:

• Diflucan 40 mg/ml oral suspension powder is presented in 60 ml capacity bottles that contain 24.4 g of powder which gives 35 ml of suspension after reconstitution.
• Diflucan 40 mg/ml oral suspension powder is a white or almost white dry powder. After adding water to the powder (following the detailed instructions later in the leaflet) a white or almost white suspension with orange flavor is obtained.
• In each bottle, the mixture of powder with water produces 35 ml of suspension.
• It is supplied with a 5 ml oral graduated syringe with a pressure adapter to the bottle, to measure the correct dose.

Marketing authorization holder and responsible for manufacturing

Marketing authorization holder:

Vinci Farma S.A. Avda de Europa, 20B. Parque Empresarial La Moraleja. 28108, Alcobendas (Madrid). Spain

Local representative:

Pfizer, S.L. Avda de Europa, 20B. Parque Empresarial La Moraleja. 28108, Alcobendas (Madrid). Spain

Responsible for manufacturing:

Fareva Amboise.Zone Industrielle. 29 Route des Industries.37530, Pocé-sur-Cisse.France.

Last review date of this leaflet:February 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/

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This information is intended for healthcare professionals and patients (in case the pharmacist does not reconstitute this product):

Instructions for preparing the suspension:

The reconstituted suspension will consist of a white or almost white suspension with orange flavor.

Oral suspension powder 10 mg/ml or 40 mg/ml in a 60 ml capacity bottle: 35 ml of suspension after reconstitution:

1. Give the bottle a few knocks to release the powder.

2.Reconstitute by adding 24ml of water. First,add a small amount of water and shake vigorously. Then, add water up to the fill line marked(?)on the bottle (in total, this corresponds to the addition of the 24 ml of water required).

3.Shake well for 1 or 2 minutes to obtain a homogeneous suspension.

4.After reconstitution, there will be a usable volume of 35 ml.

5. Write the expiration date of the reconstituted suspension on the bottle label (the shelf life of the reconstituted suspension is 28 days). The remaining suspension should not be used after this date and should be returned to your pharmacist.

Conversion of the dose of oral suspension powder from mg/ml to ml/kg of body weight:

Diflucan and associated denominations 10 mg/ml oral suspension powder:

In children,the dose of Diflucanoral suspension powder should be measured as accurately as possible according to the following equation:

The increments of the oral syringe graduation are 0.2 ml. Therefore, for weights and intermediate dosages, the dose to be administered in ml should be calculated and rounded up or down to the nearest graduation of the syringe:

For example, a child of 11 kg who has been prescribed 3 mg/kg/day of Diflucan should receive 33mg/day, which corresponds to 3.3 ml of the 10 mg/ml oral suspension. The dose can be rounded to 3.4 ml, the nearest graduation of the oral syringe to provide the full dose.

The maximum daily dose of 400 mg should not be exceeded in the pediatric population (see table *). The use of Diflucan 10mg/ml oral suspension powder is not recommended for doses > 15.0ml (highlighted in gray in the table). If doses exceed 15.0 ml, Diflucan 40 mg/ml oral suspension powder is recommended.

Table with dosage examples

Diflucan and associated denominations 40 mg/ml oral suspension powder:

In children, the dose of Diflucan oral suspension powder should be measured as accurately as possible according to the following equation:

The increments of the oral syringe graduation are 0.2 ml. Therefore, for weights and intermediate dosages, the dose to be administered in ml should be calculated and rounded up or down to the nearest graduation of the syringe:

For example, a child of 23 kg who has been prescribed 6 mg/kg/day of Diflucan should receive 138 mg/day, which corresponds to 3.45 ml of the 40 mg/ml oral suspension. The dose can be rounded to 3.4 ml, the nearest graduation of the oral syringe to provide the full dose.

The maximum daily dose of 400 mg should not be exceeded in the pediatric population (see table *). The use of Diflucan 40 mg/ml oral suspension powder is not recommended for weights below 15 kg. For weights below 15 kg, Diflucan 10 mg/ml oral suspension powder is recommended.

Table with dosage examples