DIFLUCAN 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Diflucan 50 mg Hard Capsules

Diflucan 100 mg Hard Capsules

Diflucan 150 mg Hard Capsules

Diflucan 200 mg Hard Capsules

fluconazole

Read all of this leaflet carefully before you start taking 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 and other information:

1. What is Diflucan and what is it used for.
2. What you need to know before you take Diflucan.
3. How to take Diflucan.
4. Possible side effects.
5. Storing Diflucan.

1. Contents of the pack and further information.

1. What is Diflucan and what is it used for

Diflucan is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Diflucan 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 to treat the following types of fungal infections:

• Cryptococcal meningitis – a fungal infection in the brain.
• Coccidioidomycosis – a disease of the bronchopulmonary system.
• Candidainfections of the bloodstream, organs (e.g. heart, lungs) or urinary tract.
• Mucosal candidiasis – infection affecting the lining of the mouth, throat, or associated with dental prosthetics.
• Genital candidiasis – infection of the vagina or penis.
• Skin infections – e.g. athlete's foot, ringworm, jock itch, nail infection.

It may also be prescribed to:

• prevent cryptococcal meningitis from coming back.
• prevent Candidamucosal infections from coming back.
• reduce the repeated appearance of Candidavaginal infections.
• prevent Candidainfections in people with weakened immune systems and who do not have a properly functioning immune system.

Children and adolescents (0 to 17 years)

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

• Mucosal candidiasis – infection affecting the lining of the mouth or throat.
• Candidainfections of the bloodstream, organs (e.g. heart, lungs) or urinary tract.
• Cryptococcal meningitis – a fungal infection in the brain.

It may also be prescribed to:

• prevent Candidainfections in people with weakened immune systems and who do not have a properly functioning immune system.

to prevent cryptococcal meningitis from coming back.

2. What you need to know before you take Diflucan

Do not take Diflucan

• if you are allergic (hypersensitive) to fluconazole, to other medicines used to treat fungal infections, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, redness of the skin, or difficulty breathing.
• if you are taking astemizole, terfenadine (antihistamine medicines for allergies).
• if you are taking cisapride (used for stomach upset).
• if you are taking pimozide (used for mental health conditions).
• if you are taking quinidine (used for heart rhythm disorders).
• if you are taking erythromycin (an antibiotic for infections).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Diflucan

• if you have liver or kidney problems.
• if you have a heart condition, including problems with your heart rhythm.
• if you have abnormal levels of potassium, calcium, or magnesium in your blood.
• if severe skin reactions occur (itching, redness of the skin, or difficulty breathing).
• if signs of "adrenal insufficiency" occur, where the adrenal glands do not produce enough of certain hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
• if you have ever had a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking Diflucan.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to treatment with Diflucan. 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.

Talk to your doctor or pharmacist if the fungal infection does not improve; you may need an alternative antifungal treatment.

Taking Diflucan with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Immediatelyinform your doctor if you are taking astemizole, terfenadine (an antihistamine for allergies), cisapride (used for stomach upset), pimozide (used for mental health conditions), quinidine (used for heart rhythm disorders), or erythromycin (an antibiotic for infections), as these medicines should not be taken with Diflucan (see section: “Do not take Diflucan”).

Some medicines may interact with Diflucan.

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

• Rifampicin or rifabutin (antibiotics for infections).
• Abrocitinib (used to treat atopic dermatitis, also known as 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 with sleep or anxiety.
• Carbamazepine, phenytoin (used to treat seizures).
• Nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (for high blood pressure).
• Olaparib (used to treat ovarian cancer).
• Cyclosporine, 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 relief).
• 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 kidney function deterioration).
• Vitamin A (nutritional supplement).
• Ivacaftor (alone or in combination with medicines used to treat cystic fibrosis).
• Amiodarone (used to treat irregular heartbeats).
• Hydrochlorothiazide (diuretic).
• Ibrutinib (used to treat blood cancer).
• Lurasidone (used to treat schizophrenia).

Taking Diflucan with food and drinks

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 have a baby, ask your doctor or pharmacist for advice before taking 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 Diflucan if you are pregnant, think you may be pregnant, or are planning to have a baby, unless your doctor has told you to do so. If you become pregnant while taking this medicine or within one week of the last dose, talk to 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 breastfeeding after taking a single dose of 150 mg of Diflucan. You should not continue breastfeeding if you are taking repeated doses of Diflucan.

Driving and using machines

When driving or operating machinery, keep in mind that dizziness or seizures may occasionally 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 an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Diflucan

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

The capsules should be swallowed whole with the help of a glass of water. It is best to take your medicines at the same time every day.

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

Adults

Adolescents 12 to 17 years of age

Follow the dose prescribed by your doctor (either the adult dose or the child dose).

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 once every 2 days. The maximum dose is 12 mg per kilogram of body weight every 48 hours.

Use in children under 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 kilogram 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 take more Diflucan than you should

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

If you forget to take Diflucan

Do not take a double dose to make up for forgotten doses. If you have forgotten to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking Diflucan and seek medical attention immediatelyif you notice any of the following symptoms:

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

Some people develop allergic reactions,although severe allergic reactions are rare.If any adverse effect appears, talk to your doctor or pharmacist, including any possible adverse effect not mentioned in this prospectus. If you experience any of the following symptoms, report immediately to your doctor.

• 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).

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

• fatigue.
• loss of appetite.
• vomiting.
• yellowing of the skin or the whites of the eyes (jaundice).

If you experience any of these symptoms, stop taking Diflucan 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.

Common adverse effects (may affect up to 1 in 10 patients) are:

• headache.
• stomach discomfort, diarrhea, nausea, vomiting.
• high blood test results indicating liver function.
• rash.

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

• reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing.
• decreased appetite.
• inability to sleep, feeling of numbness.
• seizures, dizziness, feeling of spinning, tingling, pinching, or numbness, changes in taste sensation.
• 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 1,000 patients) are:

• white blood cells in the blood that help defend against infections and blood cells that help stop bleeding, lower than normal.
• red or purple skin discoloration, which may be due to a low platelet count, 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.

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

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: http://www.aemps.gob.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Diflucan

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated 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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. 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. Package Contents and Additional Information

Diflucan Composition

• The active ingredient is fluconazole.
• Each hard capsule contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole.
• The other ingredients (excipients) are:

Capsule Contents:lactose monohydrate, cornstarch, colloidal anhydrous silica, magnesium stearate, and sodium lauryl sulfate (see section 2, Diflucan contains lactose [milk sugar] and sodium [salt]).

Gelatin Capsule Composition:

Diflucan 50 mg Hard Capsules:gelatin (E441), titanium dioxide (E171), and patent blue V (E131).

Diflucan 100 mg Hard Capsules:gelatin (E441), titanium dioxide (E171), erythrosine (E127), and patent blue V (E131).

Diflucan 150 mg Hard Capsules:gelatin (E441), titanium dioxide (E171), and patent blue V (E131).

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

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

Appearance of Diflucan and Package Contents

• Diflucan 50 mg capsules have a white body and a turquoise blue cap. They are printed with "FLU-50" and "Pfizer" in black ink.
• Diflucan 100 mg capsules have a white body and a blue cap. They are printed with "FLU-100" and "Pfizer" in black ink.
• Diflucan 150 mg capsules have a turquoise blue body and cap. They are printed with "FLU 150" and "Pfizer" in black ink.
• Diflucan 200 mg capsules have a white body and a purple cap. They are printed with "FLU-200" and "Pfizer" in black ink.

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

Marketing Authorization Holder and 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.

Manufacturer:

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

Date of Last Revision of this Prospectus:February 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS): http://www.aemps.gob.es/.