Fluconazole Teva 100 mg hard capsules EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fluconazole Teva 50 mg hard capsules EFG
Fluconazole Teva 100 mg hard capsules EFG
Fluconazole Teva 150 mg hard capsules EFG
Fluconazole Teva 200 mg hard capsules EFG
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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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, as it may harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Fluconazole Teva is and what it is used for.
- What you need to know before taking Fluconazole Teva.
- How to take Fluconazole Teva.
- Possible adverse effects.
- How to store Fluconazole Teva.
- Contents of the pack and other information.
1. What Fluconazol Teva is and what it is used for
Fluconazol Teva is one of the medicines belonging to the group called "antifungals". The active substance is fluconazole.
Fluconazol Teva is used to treat fungal infections, and it can 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 in the brain.
- Coccidioidomycosis – a disease affecting the bronchopulmonary system.
- Infections caused by Candida 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 – e.g. athlete's foot, ringworm, jock itch, nail infections.
Fluconazol Teva may also be prescribed to:
- prevent recurrence of cryptococcal meningitis.
- prevent recurrence of mucosal infections caused by Candida.
- reduce repeated occurrences of vaginal infections caused by Candida.
- prevent transmission of infections caused by Candida (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 body organs (e.g. heart, lungs), or in the urinary tract.
- Cryptococcal meningitis – a fungal infection in the brain.
Fluconazol Teva may also be prescribed to:
- prevent transmission of infections caused by Candida (if your immune system is weakened and not functioning properly).
- prevent recurrence of cryptococcal meningitis.
2. What you need to know before taking Fluconazole Teva
Do not take Fluconazole Teva if
- you are allergic (hypersensitive) to fluconazole, to other antifungal medicines you have taken, or to any of the other ingredients of this medicine listed in section 6. Symptoms may include itching, skin redness, or difficulty breathing.
- you are taking astemizole or terfenadine (antihistamine medicines used to treat allergies).
- you are taking cisapride (used to treat stomach discomfort).
- you are taking pimozide (used to treat mental illnesses).
- you are taking quinidine (used to treat heart arrhythmias).
- you are taking erythromycin (an antibiotic used to treat infections).
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluconazole Teva
- if you have liver or kidney problems.
- if you have a heart condition, including heart rhythm problems.
- if you have abnormal levels of potassium, calcium, or magnesium in your blood.
- if signs of "adrenal insufficiency" occur, in which the adrenal glands do not produce enough of certain hormones such as cortisol (symptoms include chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
- if you have previously developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Fluconazole Teva.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Fluconazole Teva. Stop taking Fluconazole Teva 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.
Taking Fluconazole Teva with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Inform your doctor immediately if you are taking astemizole, terfenadine (antihistamines used to treat allergies), cisapride (used for stomach discomfort), pimozide (used to treat mental illnesses), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic used to treat infections), as these medicines must not be taken together with Fluconazole Teva (see section: “Do not take Fluconazole Teva if”).
Some medicines may interact with Fluconazole Teva.
Make sure your doctor knows if you are taking any of the following medicines, as dose adjustment or monitoring may be necessary to ensure the medicines continue to have the desired effect:
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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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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 reduce blood clotting (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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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, fluvastatin, or similar medicines) used to lower 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 in combination with other medicines used to treat cystic fibrosis).
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Amiodarone (used to treat irregular heartbeats “arrhythmias”).
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Hydrochlorothiazide (a diuretic).
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Ibrutinib (used to treat blood cancer).
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Lurasidone (used to treat schizophrenia).
Taking Fluconazole Teva with food and drink
You may take this medicine with or without food.
Pregnancy, breast-feeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning 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 trying to conceive.
For longer fluconazole treatment courses, 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 Teva if you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding, unless your doctor has 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 during the first trimester may increase the risk of congenital malformations affecting the heart, bones, and/or muscles.
Cases of babies born with congenital malformations 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 fully established.
Breastfeeding may continue after a single 150 mg dose of Fluconazole Teva. You should not continue breastfeeding if you are taking repeated doses of Fluconazole Teva.
Driving and using machines
Be aware that dizziness or seizures may occasionally occur, so consider this when driving or operating machinery.
Important information about some of the ingredients of Fluconazole Teva
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule; this is essentially “sodium-free”.
Fluconazole Teva 200 mg may cause allergic reactions as it contains azorubine (carmoisine) (E-122). It may cause asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Fluconazole Teva
Follow exactly the instructions given by your doctor for taking this medicine. 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 |
To treat 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 for as long as directed by your doctor |
To treat 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 |
To treat systemic fungal infections caused by Candida | 800 mg on the first day, followed by 400 mg once daily for as long as directed by your doctor |
To treat mucosal fungal infections affecting the lining of the mouth, throat, or associated with dental prostheses | 200 mg to 400 mg on the first day, then 100 mg to 200 mg once daily for as long as directed by your doctor |
To treat mucosal candidiasis – dosage depends on the site of infection | 50 mg to 400 mg once daily for 7 to 30 days or as long as directed 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 infection persists |
To treat 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 150 mg once weekly for as long as the risk of developing infection persists |
To treat 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 Candida infection (if your immune system is weakened or not functioning properly) | 200 mg to 400 mg once daily for as long as the risk of developing infection persists |
Adolescents aged 12 to 17 years
Follow the dose prescribed by your doctor (either the adult dosage or the pediatric dosage).
Children up to 11 years of age
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 – 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 fungal infection caused by Candida in children with impaired immune function | 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.
Occasionally, doctors may prescribe doses different from those described. Always follow exactly the administration instructions given by your doctor. Consult your doctor or pharmacist if you have any doubts.
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 Teva 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 name of 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 start symptomatic treatment (with supportive measures and gastric lavage if necessary).
If you forget to take Fluconazol Teva
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 questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Fluconazole Teva may cause adverse effects, although not everyone experiences them.
Stop taking Fluconazole Teva and seek immediate medical attention 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 adverse effect occurs, speak to your doctor or pharmacist. This includes any possible adverse effects not listed in this leaflet. 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 itchy red spots.
- Skin rash.
- Severe skin reactions, such as blistering rash (this may affect the mouth and tongue).
Fluconazole Teva can 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 Teva and contact 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 effects not mentioned 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 abnormalities.
- 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, feeling of numbness.
- Seizures, dizziness, sensation of spinning, 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 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 purple skin discoloration, which may be due to low platelet count, other changes in blood cells.
- Changes in blood tests (elevated cholesterol, fat levels).
- Low blood potassium levels.
- Tremors.
- Abnormal electrocardiogram (ECG), changes in heart rate or rhythm.
- Liver function failure.
- Allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, 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 cell (eosinophilia), 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 or pharmacist, 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: www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fluconazole Teva
Keep this medicine out of sight and reach of children.
Do not use Fluconazole Teva after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly 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 Teva:
The active substance is fluconazole.
Each hard capsule contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole.
The other components (excipients) are:
Capsule contents: lactose monohydrate, corn starch, anhydrous colloidal silica, sodium lauryl sulfate, magnesium stearate.
Composition of the gelatin capsules:
Fluconazole Teva 50 mg: titanium dioxide (E171), brilliant blue FCF (E133), gelatin.
Fluconazole Teva 100 mg: titanium dioxide (E171), brilliant blue FCF (E133), gelatin.
Fluconazole Teva 150 mg: titanium dioxide (E171), brilliant blue FCF (E133), gelatin.
Fluconazole Teva 200 mg: titanium dioxide (E171), brilliant blue FCF (E133), ponceau 4R (carmoisine) (E122), gelatin.
See section 2, Important information about some of the components of Fluconazole Teva.
Appearance of Fluconazole and contents of the pack
Fluconazole Teva 50 mg capsules have a white body and a light blue cap.
Fluconazole Teva 100 mg capsules have a white body and a dark blue cap.
Fluconazole Teva 150 mg capsules have a light blue body and cap.
Fluconazole Teva 200 mg capsules have a white body and a purple cap.
They are available in blister packs containing:
Fluconazole Teva 50 mg: 7 and 500 (hospital pack) hard capsules.
Fluconazole Teva 100 mg: 7 and 100 (hospital pack) hard capsules.
Fluconazole Teva 150 mg: 1 or 4 hard capsules.
Fluconazole Teva 200 mg: 7 or 100 (hospital pack) hard capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Teva Pharma, S.L.U.
C/ Anabel Segura 11, Edificio Albatros B, 1st floor
Alcobendas, 28108 Madrid, Spain
Manufacturer:
Teva Pharmaceutical Works Private Limited Company.
Pallagi út, 13
Debrecen H-4042, Hungary
Date of the most recent revision of this leaflet: October 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): (http://www.aemps.gob.es/)
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69082/P_69082.html