FLUCONAZOLE VIATRIS 100 mg HARD CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluconazole Viatris 100 mg hard capsules EFG

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

1. What is Fluconazole Viatris and what is it used for
2. What you need to know before you take Fluconazole Viatris
3. How to take Fluconazole Viatris
4. Possible side effects
5. Storage of Fluconazole Viatris
6. Contents of the pack and other information

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

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

Fluconazole Viatris is used to treat infections caused by fungi and can also be used to prevent fungal infections.

The most common cause of fungal infections is a yeast called Candida.

Adults

Your doctor may prescribe this medicine for 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 prostheses.
• Genital candidiasis – infection of the vagina or penis.
• Skin infections – e.g. athlete's foot, ringworm, jock itch, nail infection.

They may also prescribe Fluconazole Viatris for:

• Preventing the recurrence of cryptococcal meningitis.
• Preventing the recurrence of mucosal Candidainfections.
• Reducing the recurrence of vaginal Candidainfections.
• Preventing Candidainfections (if your immune system is weak and not working properly).

Children and adolescents (0 to 17 years)

Your doctor may prescribe this medicine for 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.

They may also prescribe Fluconazole Viatris for:

• Preventing Candidainfections (if your immune system is weak and not working properly).

• Preventing the recurrence of cryptococcal meningitis.

2. What you need to know before you take Fluconazole Viatris

Do not take Fluconazole Viatris

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

Warnings and precautions

Consult your doctor or pharmacist before taking Fluconazole Viatris if:

• You have liver or kidney problems.
• You have a heart condition, including heart rhythm problems.
• You have abnormal levels of potassium, calcium, or magnesium in your blood.
• You experience severe skin reactions (itching, skin rash, or difficulty breathing).
• You experience signs of “adrenal insufficiency”, 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 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 immediate medical attention 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 alternative antifungal treatment.

Other medicines and Fluconazole Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

There are some medicines that may interact with fluconazole.

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 for treating atopic dermatitis, also known as eczema).
• Hydrochlorothiazide (a diuretic medicine).
• Alfentanil, fentanyl (used as anesthetics).
• Amitriptyline, nortriptyline (used as antidepressants).
• Amphotericin B, voriconazole (antifungals).
• Medicines that make the blood less viscous, to prevent the formation of clots (warfarin or similar medicines).

• Benzodiazepines (midazolam, triazolam, or similar medicines), used to help you sleep or for anxiety.
• Carbamazepine, phenytoin (used for treating seizures).
• Nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (for high blood pressure).
• Olaparib (used for ovarian cancer).

• Ciclosporin, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection).
• Cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines), used for treating cancer.

• Halofantrine (used for treating malaria).
• Statins (atorvastatin, simvastatin, and fluvastatin or similar medicines), used for reducing high cholesterol levels.

• Methadone (used for pain relief).
• Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)).
• Oral contraceptives.
• Prednisone (a steroid).
• Zidovudine, also known as AZT; saquinavir (used in patients infected with HIV).
• Medicines for diabetes, such as chlorpropamide, glibenclamide, glipizide, or tolbutamide.
• Theophylline (used for controlling asthma).
• Tofacitinib (used for treating rheumatoid arthritis).
• Tolvaptan (used for treating hyponatremia [low sodium levels in the blood] or to slow down kidney function deterioration).
• Vitamin A (a nutritional supplement).
• Ivacaftor (alone or in combination with medicines used for treating cystic fibrosis).
• Amiodarone (used for treating irregular heartbeats).
• Ibrutinib (used for treating blood cancer).
• Lurasidone (used for treating schizophrenia).

Taking Fluconazole Viatris with food and drinks

You can take the medicine with or without food.

Pregnancy and breastfeeding

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 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 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 fluconazole if you are pregnant, think you may be pregnant, or are planning to become pregnant or breastfeed, 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, consult your doctor.

Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken in low doses 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 Fluconazole Viatris. You should not continue breastfeeding if you are taking repeated doses of Fluconazole Viatris.

Driving and using machines

When driving or operating machinery, you should be aware that fluconazole can occasionally cause dizziness or seizures.

Fluconazole Viatris contains lactose and sodium

This medicine contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Fluconazole Viatris

Always take Fluconazole Viatris exactly as your doctor has told you.If you are not sure, check with your doctor or pharmacist.

The capsules should be swallowed whole with 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

Use in children and adolescents

Adolescents 12 to 17 years

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

Use in children from 3 to 4 weeks:

• The same dose as described in the table, but given 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 given every 3 days. The maximum dose is 12 mg per kg 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 Fluconazole Viatris 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, stating the medicine 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 start symptomatic treatment (with supportive measures and stomach lavage if necessary).

If you forget to take Fluconazole Viatris

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 further questions on 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 fluconazole and seek medical attention immediatelyif you notice any of the following symptoms:

• Widespread 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 of the following symptoms appear, inform your doctor immediately. This includes any possible adverse effect not mentioned in this prospectus. If you experience any of the following symptoms, inform your doctor immediately.

• 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 blistering rash (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 the whites of the eyes (jaundice).

If you experience any of these symptoms, stop taking fluconazole and inform your doctor immediately.

Other Adverse Effects:

Additionally, if you consider that any of the adverse effects you are suffering 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):

• Headache.
• Stomach upset, diarrhea, discomfort, vomiting.
• Elevated blood test results indicating liver function.
• Rash.

Uncommon Adverse Effects (may affect up to 1 in 100 patients):

• Reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing.
• Decreased appetite.
• Insomnia, 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):

• White blood cells in the blood, which help defend against 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.
• 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 extensive rash with blisters and skin peeling, severe allergic reactions, swelling of the lips or face.
• Hair loss.

Frequency Not Known (cannot be estimated from the 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 of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Fluconazole Viatris

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

Do not use this medicine after the expiration date stated 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.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of 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

Composition of Fluconazole Viatris

• The active ingredient is fluconazole.
• Each hard capsule contains 100 mg of fluconazole.
• The other ingredients are:

Capsule Content:lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate, and sodium lauryl sulfate.

Composition of the Gelatin Capsules:titanium dioxide (E-171), water, and gelatin.

Appearance of the Product and Package Contents

Fluconazole Viatris are capsules with a white opaque cap and body.

They are available in packages of 7 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, 7

19200 - Azuqueca de Henares (Guadalajara)

Spain

Date of the Last Revision of this Prospectus:February 2024

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