Fluconazole Viatris 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluconazole Viatris 200 mg hard capsules EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents

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

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

Fluconazol Viatris is one of the medicines belonging to the group called "antifungals". The active substance is fluconazole.

Fluconazol Viatris is used to treat fungal infections and may also be used to prevent the occurrence of a Candida infection. 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 of the brain.
• Coccidioidomycosis – a disease affecting the bronchopulmonary system.
• Infections caused by Candida located in the bloodstream, in internal organs (e.g., heart, lungs), or in the 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 – for example, athlete's foot, ringworm, jock itch, nail infections.

Fluconazol Viatris may also be prescribed to:

• Prevent recurrence of cryptococcal meningitis.
• Prevent recurrence of mucosal Candida infections.
• Reduce repeated episodes of vaginal Candida infections.
• Prevent transmission of Candida infections (if your immune system is weakened and not functioning properly).

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.
• Infections caused by Candida located in the bloodstream, in internal organs (e.g., heart, lungs), or in the urinary tract.
• Cryptococcal meningitis – a fungal infection of the brain.

Fluconazol Viatris may also be prescribed to:

• Prevent transmission of Candida infections (if your immune system is weakened and not functioning properly).
• Prevent recurrence of cryptococcal meningitis.

2. What you need to know before taking Fluconazole Viatris

Do not take Fluconazole Viatris

• If you are allergic to fluconazole, to other antifungal medicines, 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 or terfenadine (antihistamine medicines used 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 quinidine (used to treat heart arrhythmias).
• If you are taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions

Talk to 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.
• Severe skin reactions occur (such as itching, skin redness, or difficulty breathing).
• Signs of “adrenal insufficiency” appear, in which 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).
• You have previously experienced a severe skin rash, peeling skin, blisters, and/or mouth sores after taking fluconazole.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with fluconazole treatment. Stop taking fluconazole and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Talk to your doctor or pharmacist if your fungal infection does not improve, as alternative antifungal treatment may be needed.

Other medicines and Fluconazole Viatris

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

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

Some medicines may interact with fluconazole.

Make sure your doctor knows if you are taking any of the following medicines, as dose adjustments or monitoring may be needed to ensure these medicines remain effective:

• Rifampicin or rifabutin (antibiotics for infections).

• Abrocitinib (used to treat atopic dermatitis, also known as atopic 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 blood clots (warfarin or similar medicines).

• Benzodiazepines (midazolam, triazolam, or similar medicines), used to help sleep or for anxiety.

• Carbamazepine, phenytoin (used to treat seizures).

• Nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (for hypertension – high blood pressure).

• Olaparib (used for 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, fluvastatin, or similar medicines), used to lower high cholesterol levels.

• Methadone (used for pain).

• 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 HIV-infected patients).

• Medicines for diabetes, such as chlorpropamide, glyburide, glipizide, or tolbutamide.

• Theophylline (used to control asthma).

• Tofacitinib (used to treat rheumatoid arthritis).

• Tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to delay the decline in kidney function).

• Vitamin A (nutritional supplement).

• Ivacaftor (alone or combined with medicines used to treat cystic fibrosis).

• Amiodarone (used to treat irregular heartbeats “arrhythmias”).

• Ibrutinib (used to treat blood cancer).

• Lurasidone (used to treat schizophrenia).

Taking Fluconazole Viatris with food and drink

You may take this medicine with or without food.

Pregnancy and breastfeeding

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 trying to conceive.

For longer treatment courses with fluconazole, consult your doctor about the need to use appropriate 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, plan to become pregnant, or are breastfeeding, unless your doctor has specifically instructed you to do so. If you become pregnant while taking this medicine or within one week after 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 at low doses 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 thigh 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 not clear.

Breastfeeding may continue after a single 150 mg dose 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, bear in mind that dizziness or seizures may occasionally occur.

Fluconazole Viatris contains lactose and sodium

This medicine contains lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with 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

Follow exactly the instructions for taking Fluconazole Viatris as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

Adults

Use in children and adolescents

Adolescents aged 12 to 17 years

Follow the dose indicated by your doctor (either the adult dose or the pediatric 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 aged 0 to 4 weeks

Use in children aged 3 to 4 weeks:

• 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 of age:

• 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.

Elderly patients

The usual adult dose, unless you have kidney problems.

Patients with kidney problems

Your doctor may adjust 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 may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and amount ingested. Symptoms of 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 gastric lavage if necessary).

If you forget to take Fluconazol Viatris

Do not take a double dose to make up for missed doses. If you forget 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 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 everyone will experience them.

Stop taking fluconazole and seek medical attention immediately if you notice any of the following symptoms:

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

Some people may develop allergic reactions, although severe allergic reactions are rare. If any of the following symptoms occur, tell your doctor immediately. This includes any possible adverse effect not mentioned in this leaflet. If you experience any of the following symptoms, report them immediately to your doctor.

• Sudden wheezing, difficulty breathing, or tightness in the chest.
• Swelling of the eyelids, face, or lips.
• Itching all over the body, skin redness, or itchy red spots.
• Skin rash.
• Severe skin reactions, such as blistering rash (this may affect the mouth and tongue).

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

• Tiredness.
• Loss of appetite.
• Vomiting.
• Yellowing of the skin or whites of the eyes (jaundice).

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

Other adverse effects:

Additionally, if you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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

• Headache.
• Stomach discomfort, diarrhoea, nausea, vomiting.
• Elevated blood test results indicating liver function.
• Rash.

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

• Reduction in red blood cells, which may cause pale skin, weakness, or difficulty breathing.
• Decreased appetite.
• Inability to sleep, numbness sensation.
• Seizures, dizziness, spinning sensation, tingling, prickling, or numbness, changes in taste sensation.
• Constipation, indigestion, flatulence, dry mouth.
• Muscle pain.
• Liver damage and yellowing of the skin and eyes (jaundice).
• Hives, blisters (wheals), itching, increased sweating.
• Tiredness, general feeling of discomfort, fever.

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

• Lower than normal levels of white blood cells, which help defend against infections, and blood cells that help stop bleeding.
• Red or purple skin discolouration, possibly due to low platelet count, other changes in blood cells.
• Changes in blood tests (high levels of 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 blistering and peeling skin rash, severe allergic reactions, swelling of the lips or face.
• Hair loss.

Frequency not known (cannot be estimated from available data):

• Hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cells (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and colon) (drug reaction or eosinophilia with systemic symptoms [DRESS]).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after CAD or EXP. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluconazole Viatris

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

Capsule contents: lactose monohydrate, corn starch, colloidal silicon dioxide, magnesium stearate and sodium lauryl sulfate.

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

Appearance of the product and contents of the pack

Fluconazole Viatris are capsules with an opaque blue cap and an opaque white body.

They are available in packs containing 7 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, 7

19200 - Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent review of this leaflet: February 2024

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