PATIENT INFORMATION LEAFLET

Fluconazol Viatris 200 mg Hard Capsules EFG

Read this leaflet carefully before you start taking 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. Do not give it 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 leaflet. See section 4.

Fluconazol Viatris is one of the medications in the group called “antifungals”. The active ingredient is fluconazol.

Fluconazol Viatris 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 – for example, athlete's foot, ringworm, inguinal ringworm, nail infection.

Your doctor may also prescribe Fluconazol Viatris 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 Fluconazol Viatris 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 Fluconazol Viatris

• If you are allergic 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 treating 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 quinidine (used to treat heart arrhythmias).
• If you are taking erythromycin (an antibiotic for treating infections).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluconazol Viatris if:

• You have liver or kidney problems.
• You have a heart disease, including heart rhythm problems.
• You have abnormal levels of potassium, calcium, or magnesium in your blood.
• You experience severe skin reactions (itching, skin redness, or difficulty breathing).
• 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).
• You have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking fluconazole.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to fluconazole treatment. Stop taking fluconazole 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; alternative antifungal treatment may be necessary.

Other medications and Fluconazol Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for treating allergies), cisapride (used for stomach discomfort), pimozide (used to treat mental illnesses), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic for treating infections), as these medications should not be taken with fluconazole (see section: “Do not take Fluconazol Viatris”).

There are some medications that may interact with fluconazole.

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 rifabutin (antibiotics for infections).
• Abrocitinib (used to treat atopic dermatitis, also known as eczema).
• Hidroclorotiazida (diuretic medication).
• Alfentanilo, fentanilo (used as anesthetics).
• Amitriptilina, nortriptilina (used as antidepressants).
• Amfotericina B, voriconazol (antifungals).
• Medications that make blood less viscous, to prevent clot formation (warfarin 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 - 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 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).
• Tolvaptán (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 “arrhythmias”).
• Ibrutinib (used to treat blood cancer).
• Lurasidona (used to treat schizophrenia).

Taking Fluconazol Viatris 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 taking any 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 fluconazole treatment cycles, consult your doctor about the need to use suitable contraceptive methods during treatment, which should be maintained for one week after the last dose.

You should not take fluconazole if you are pregnant, think you may be pregnant, or intend to become pregnant or breastfeed, 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 in low doses 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 leg 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 unclear.

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

Driving and operating machinery

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

Fluconazol Viatris contains lactose and sodium

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

Fluconazol Viatris also contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free.”

Follow exactly the administration instructions for Fluconazol Viatris as indicated by your doctor.If in doubt, 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 medications at the same time every day.

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

Adults

Use in children and adolescents

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 per day.

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 kilogram 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 kilogram of body weight every 72 hours.

Older adults

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 Fluconazol Viatris 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, 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). It may be appropriate to initiate symptomatic treatment (with supportive measures and gastric lavage if necessary).

If you forget to take Fluconazol Viatris

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 other questions about the use of this medication, ask your doctor or pharmacist.

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

Stop taking fluconazole 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 of the following symptoms, informyour doctor immediately. This includes any possible side effect not mentioned in this leaflet. If you experience any of the following symptoms, reportto your doctor immediately.

• Sudden palpitations while breathing, 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).

Fluconazole 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 fluconazole andinform your doctor immediately.

Other side effects:

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

Side effectsfrequent (may affect up to 1 in 10 patients):

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

Side effects infrequent (may affect up to 1 in 100 patients):

• Reduction of red blood cells, which can cause pale skin and weakness or difficulty breathing.
• Loss of appetite.
• Inability to sleep, numbness.
• Convulsions, dizziness, sensation 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 of discomfort, fever.

Side effects rare (may affect up to 1 in 1,000 patients):

• White blood cells in the blood, which help us fight infections and blood cells that help stop bleeding, lower than normal.
• Skin redness or purpura, 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 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 unknown (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: http://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 this medication after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required. Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications 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 medications you no longer need. By doing so, you will help protect the environment.

Composition of Fluconazol Viatris

• The active ingredient is fluconazole.
• Each hard capsule contains 200 mg of fluconazole.
• The other components are:

Contents of the capsule:monohydrate lactose, cornstarch, colloidal silicon dioxide, magnesium stearate, and sodium lauryl sulfate.

Composition of the gelatin capsules:indigotin (E-132), titanium dioxide (E-171), water, and gelatin.

Appearance of the product and contents of the packaging

Fluconazol Viatris are hard capsules with a blue opaque cap and a white opaque body.

It is presented in packaging of 7 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, 7

19200 - Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet:February 2024

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