Introduction

Package Insert: Information for the User

Diflucan 100 mg Hard Capsules

Diflucan 150 mg Hard Capsules

Diflucan 200 mg Hard Capsules

fluconazole

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

Keep this package insert, 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 you should not give it to others 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 package insert. See section 4.

1. What is Diflucan and what is it used for

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 lining 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 lining 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.

2. What you need to know before taking Diflucan

Do not take Diflucan

if you are allergic (hypersensitive) to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, skin redness or difficulty breathing.
if you are taking astemizole, terfenadine (antihistamines to treat allergies).
if you are taking cisapride (used to treat stomach discomfort).
if you are taking pimozide (used to treat mental illnesses).
if you are taking quinidina (used to treat heart arrhythmias).
if you are taking erythromycin (an antibiotic to treat 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 experienced 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 to your doctor or pharmacist if the fungal infection does not improve, as an alternative antifungal treatment may be necessary.

Taking Diflucan with other medicines

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

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

There are some medicines that may interact with Diflucan.

Make sure your doctor knows if you are taking any of the following medicines, as it may be necessary to adjust the dose or monitor to ensure the medicines continue to have the desired effect:

Rifampicin or rifabutina (antibiotics for infections).
Abrocitinib (used to treat atopic dermatitis, also known as eczema).
Alfentanilo, fentanilo (used as anesthetics).
Amitriptilina, nortriptilina (used as antidepressants).
Amfotericina B, voriconazol (antifungals).
Medicines that make the blood less viscous, to prevent the formation of blood clots (warfarina or other similar medicines).
Benzodiazepines (midazolam, triazolam or similar medicines) used to help sleep or for anxiety.
Carbamazepina, fenitoína (used to treat seizures).
Nifedipino, isradipino, amlodipino, verapamilo, felodipino and losartán (for hypertension - high blood pressure).
Olaparib (used to treat ovarian cancer).
Ciclosporina, everolimus, sirolimus or tacrolimus (to prevent transplant rejection).
Ciclofosfamida, alcaloides de la vinca (vincristina, vinblastina or similar medicines) used to treat cancer.
Halofantrina (used to treat malaria).
Estatinas (atorvastatina, simvastatina and fluvastatina or similar medicines) 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).
Medicines for diabetes, such as clorpropamida, glibenclamida, glipizida or tolbutamida.
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 the deterioration of kidney function).
Vitamin A (nutritional supplement).
Ivacaftor (alone or combined with medicines used to treat cystic fibrosis).
Amiodarona (used to treat irregular heartbeats “arrhythmias”).
Hidroclorotiazida (diuretic).
Ibrutinib (used to treat blood cancer).
Lurasidona(used to treat schizophrenia).

Taking Diflucan with food and drink

You can take the medicine with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking any 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 courses of fluconazole treatment, consult your doctor about the need to use suitable contraceptive methods during treatment, which should be continued for one week after the last dose.

You should not take Diflucan if you are pregnant, think you may be pregnant or are planning to become pregnant, unless your doctor has told you to do so. If you become pregnant while taking this medicine 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 a baby being born with congenital abnormalities affecting the heart, bones and/or muscles.

Cases of babies born with congenital abnormalities affecting the skull, ears and/or leg and arm 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 machinery

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

Diflucan contains lactose (milk sugar) and sodium (salt)

This medicine contains a small amount of lactose (milk sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Diflucan capsules also contain less than 1 mmol of sodium (23 mg) per capsule; that is, it is essentially “sodium-free”.

3. How to Take Diflucan

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

The capsules should be swallowed whole with the help of a glass of water. It is better to take your medications always at the same time of day.

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

Adults

Condition	Dose
To treat cryptococcal meningitis	400 mg on the first day and subsequently 200 mg to 400 mg once a day for 6 to 8 weeks or longer if necessary. In some cases, the dose is increased 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. In some cases, the dose is increased to 800 mg.
To treat internal fungal infections caused by Candida	800 mg on the first day and subsequently 400 mg once a day until your doctor tells you to stop.
To treat mucosal infections that affect the oral mucosa, throat, or associated with dental prostheses.	200 mg to 400 mg on the first day, and then 100 mg to 200 mg once a day until your doctor tells you to stop.
To treat mucosal candidiasis – the dose depends on the location of the infection	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 oral mucosa and throat	100 mg to 200 mg once a day, or 200 mg 3 times a week, as long as you are at risk of developing an infection.
To treat genital candidiasis	150 mg as a single dose.
To reduce the recurrence of vaginal candidiasis	150 mg every 3 days for a total of 3 doses (days 1, 4, and 7) and then once a week as long as you are at risk of developing an infection.
To treat fungal infections of the skin or nails	Depending on the location of the infection, 50 mg once a day, 150 mg once a week, 300 to 400 mg once a week for 1 to 4 weeks (for athlete's foot, up to 6 weeks may be necessary, and for nail infections, treatment should continue until a healthy nail grows).
To prevent the transmission of an infection caused by Candida (if your immune system is weakened and does not function properly)	200 mg to 400 mg once a day as long as you are at risk of developing an infection.

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.

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 its location.	3 mg per kg of body weight once a day (6 mg per kg on the first day 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 transmission of an infection caused by Candida (if your immune system does not function properly)	3 mg to 12 mg per kg of body weight once a day

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 of body weight 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 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 take more Diflucan than you should

Taking too many capsules at once may make you feel unwell. Contact your doctor immediately or go to the nearest hospital. You can also call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested. 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 it is almost time 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.

4. Possible Adverse Effects

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

Stop taking Diflucan 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 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.

sudden 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 blistering (this can affect the mouth and tongue).

Diflucan may affect your liver. Signs indicating liver problems include:

-fatigue.

-loss of appetite.

-vomiting.

-yellowing of the skin or the white part 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 can cause pale skin and weakness or difficulty breathing.
loss of appetite.
insomnia, numbness.
convulsions, 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 (bullae), itching, increased sweating.
fatigue, general feeling ofmalaise, 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 a 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 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.

5. Storage of Diflucan

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

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

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Diflucan

The active ingredient is fluconazole.
Each hard capsule contains50mg, 100mg, 150mg or 200mgof fluconazole.
The other components (excipients) are:

Hard capsule content:monohydrate lactose, cornstarch, anhydrous colloidal silica, magnesium stearate and sodium lauryl sulfate(see section 2, Diflucan contains lactose (milk sugar) and sodium (salt)).

Composition of gelatin capsules:

Diflucan 50 mg hard capsules:gelatin (E441), titanium dioxide(E171) and patent blueV(E131).

Diflucan 100 mg hard capsules:gelatin (E441), titanium dioxide(E171), erythrosine (E127) and patent blueV(E131).

Diflucan 150 mg hard capsules:gelatin (E441), titanium dioxide(E171) and patent blueV(E131).

Diflucan 200 mg hard capsules:gelatin (E441), titanium dioxide(E171), erythrosine (E127) and indigo carmine(E132).

Printing ink:shellac (lacquer), iron oxide black (E172), N-Butyl alcohol, anhydrous ethanol, purified water, propylene glycol (E1520), industrial methanol, isopropyl alcohol, concentrated ammonia solution, potassium hydroxide (E525).

Appearance of Diflucan and contents of the package

The Diflucan 50 mg capsules have a white body and a blue turquoise cap. They have “FLU‑50” and “Pfizer” printed in black ink.
The Diflucan 100 mg capsules have a white body and a blue cap. They have “FLU‑100” and “Pfizer” printed in black ink
The Diflucan 150 mg capsules have a blue turquoise body and cap. They have “FLU 150” and “Pfizer” printed in black ink.
The Diflucan 200 mg capsules have a white body and a violet cap. They have “FLU‑200” and “Pfizer” printed in black ink.

They are presented in packages of 1, 2, 3, 4, 6, 7, 10, 12, 14, 20, 28, 30, 42, 50, 60, 100 or 500hard capsules. Not all package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

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

Local representative:

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

Responsible manufacturer:

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

Last revision date of this leaflet:February 2024.

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.