Fluconazole Viatris 100 mg hard capsules EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fluconazole Viatris 100 mg hard capsules EFG
Read the entire leaflet carefully before you start taking this medicine, as 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. It may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Fluconazole Viatris is and what it is used for
- What you need to know before taking Fluconazole Viatris
- How to take Fluconazole Viatris
- Possible side effects
- How to store Fluconazole Viatris
- 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.
- Candida infections located in the bloodstream, in body 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 infections caused by Candida.
- Reduce repeated episodes of vaginal infections caused by Candida.
- 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.
- Candida infections located in the bloodstream, in body organs (for example, 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 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 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 starting Fluconazole Viatris if:
- You have liver or kidney problems.
- You have a heart condition, including heart rhythm disorders.
- 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 ever had a severe skin rash, 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 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.
Speak with 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 necessary to ensure these medicines remain effective:
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Rifampicin or rifabutin (antibiotics for infections).
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Abrocitinib (used to treat atopic dermatitis, also known as atopic eczema).
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Hydrochlorothiazide (a diuretic medicine).
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Alfentanil, fentanyl (used as anesthetics).
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Amitriptyline, nortriptyline (used as antidepressants).
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Amphotericin B, voriconazole (antifungals).
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Medicines that make the blood less viscous to prevent blood clots (warfarin or similar medicines).
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Benzodiazepines (midazolam, triazolam, or similar medicines), used to help sleep or for anxiety.
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Carbamazepine, phenytoin (used to treat seizures).
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Nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (for hypertension – high blood pressure).
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Olaparib (used for ovarian cancer).
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Cyclosporine, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection).
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Cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines), used to treat cancer.
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Halofantrine (used to treat malaria).
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Statins (atorvastatin, simvastatin, and fluvastatin or similar medicines), used to reduce high cholesterol levels.
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Methadone (used for pain).
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Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]).
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Oral contraceptives.
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Prednisone (a steroid).
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Zidovudine, also known as AZT; saquinavir (used in HIV-infected patients).
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Medicines for diabetes, such as chlorpropamide, glyburide, glipizide, or tolbutamide.
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Theophylline (used to control asthma).
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Tofacitinib (used to treat rheumatoid arthritis).
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Tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to delay the decline in kidney function).
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Vitamin A (nutritional supplement).
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Ivacaftor (alone or combined with medicines used to treat cystic fibrosis).
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Amiodarone (used to treat irregular heartbeats “arrhythmias”).
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Ibrutinib (used to treat blood cancer).
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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 plan to become pregnant, consult your doctor or pharmacist 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 attempting pregnancy.
For longer treatment cycles 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.
You must not take fluconazole if you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding, unless specifically instructed by your doctor. 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 miscarriage. 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 must 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
Condition | Dosage |
For the treatment of cryptococcal meningitis | 400 mg on the first day, followed by 200 mg to 400 mg once daily for 6 to 8 weeks, or longer if necessary. The dose may occasionally be increased up to 800 mg |
To prevent recurrence of cryptococcal meningitis | 200 mg once daily until directed otherwise by your doctor |
For the treatment of coccidioidomycosis | 200 mg to 400 mg once daily for 11 to 24 months, or longer if necessary. The dose may occasionally be increased up to 800 mg |
For the treatment of systemic fungal infections caused by Candida | 800 mg on the first day, followed by 400 mg once daily until directed otherwise by your doctor |
For the treatment of mucosal fungal infections affecting the lining of the mouth, throat, or associated with dental prostheses | 200 mg to 400 mg on the first day, followed by 100 mg to 200 mg once daily until directed otherwise by your doctor |
For the treatment of mucosal candidiasis – dosage depends on the site of infection | 50 mg to 400 mg once daily for 7 to 30 days, or until directed otherwise by your doctor |
To prevent recurrence of mucosal infections affecting the lining of the mouth and throat | 100 mg to 200 mg once daily, or 200 mg three times a week, for as long as the risk of developing an infection persists |
For the treatment of genital candidiasis | 150 mg as a single dose |
To reduce recurrent episodes of vaginal candidiasis | 150 mg every three days for a total of 3 doses (day 1, 4, and 7), followed by once weekly for as long as the risk of developing an infection persists |
For the treatment of fungal skin or nail infections | Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300 to 400 mg once weekly for 1 to 4 weeks (for athlete's foot, up to 6 weeks may be needed; for nail infections, continue treatment until a healthy nail has grown) |
To prevent infection caused by Candida (if your immune system is weakened and not functioning properly) | 200 mg to 400 mg once daily for as long as the risk of developing an infection persists |
Use in children and adolescents
Adolescents aged 12 to 17 years
Follow the dose indicated by your doctor (adult or pediatric dosage).
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.
Condition | Daily dose |
Oral 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 daily (on the first day, 6 mg per kg of body weight may be given) |
Cryptococcal meningitis or systemic fungal infections caused by Candida | 6 mg to 12 mg per kg of body weight once daily |
To prevent recurrence of cryptococcal meningitis | 6 mg per kg of body weight once daily |
To prevent the child from acquiring an infection caused by Candida (if their immune system is not functioning properly) | 3 mg to 12 mg per kg of body weight once daily |
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 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 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 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 a missed dose. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip 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 experiences them.
Stop taking fluconazole and seek medical attention immediately if you notice any of the following symptoms:
- Widespread rash, high body temperature, and swollen 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 chest tightness.
- 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 a rash causing blisters (this may affect the mouth and tongue).
Fluconazole may affect your liver. Signs indicating liver problems include:
- Fatigue.
- 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, diarrhea, nausea, vomiting.
- Elevated results in blood tests indicating liver function.
- Rash.
Uncommon adverse effects (may affect up to 1 in 100 patients):
- Reduction in red blood cells, which may make your skin pale and cause 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.
- Fatigue, general feeling of being unwell, 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.
- Reddish or purplish skin discoloration, which may be due to a 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 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 rash with eosinophilia and systemic symptoms [DRESS]).
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 refers to 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 or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of Fluconazole Viatris
- The active substance is fluconazole.
- Each hard capsule contains 100 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: titanium dioxide (E-171), water, and gelatin.
Description of the product and package contents
Fluconazole Viatris is a capsule with a white opaque cap and body.
It is 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 revision of this leaflet: February 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/