FLUCONAZOLE TEVA 100 mg HARD CAPSULES

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 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 or pharmacist.

• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Fluconazole Teva and what is it used for.
2. What you need to know before you take Fluconazole Teva.
3. How to take Fluconazole Teva
4. Possible side effects.
5. Storage of Fluconazole Teva
6. Pack contents and further information

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

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

Fluconazole Teva is used to treat infections caused by fungi, and it can also be used to prevent fungal infections from occurring.

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.
• Infections caused by Candidain the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
• Mucosal candidiasis – an infection that affects the lining of the mouth, throat or associated with dental prostheses.
• Genital candidiasis – an infection of the vagina or penis.
• Skin infections – e.g. athlete's foot, ringworm, jock itch, nail infection.

It may also be prescribed for:

• preventing the recurrence of cryptococcal meningitis.
• preventing the recurrence of mucosal Candidainfections.
• reducing the repeated occurrence of vaginal Candidainfections.

• preventing the spread of 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 – an infection that affects the lining of the mouth or throat.
• Infections caused by Candidain the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
• Cryptococcal meningitis – a fungal infection in the brain.

It may also be prescribed for:

• Preventing the spread of 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 Teva

Do not take Fluconazole Teva if

• you are allergic (hypersensitive) 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. The symptoms can include itching, skin rash or difficulty breathing.
• you are taking astemizole, terfenadine (antihistamines for treating allergies).
• you are taking cisapride (used for stomach upset).
• you are taking pimozide (used for treating mental illness).
• you are taking quinidine (used for treating heart arrhythmias).
• you are taking erythromycin (an antibiotic for treating infections).

Warnings and precautions

Consult your doctor or pharmacist before taking Fluconazole Teva

• if you have liver or kidney problems.
• if you have a heart condition, including problems with your heart rhythm.
• if you have abnormal levels of potassium, calcium or magnesium in your blood.
• if you have signs of adrenal insufficiency, 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)
• if you have ever had a severe skin rash or skin peeling, blisters and/or sores in the mouth after taking Fluconazole Teva.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to Fluconazole Teva treatment. Stop taking Fluconazole Teva 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 an alternative antifungal treatment.

Taking Fluconazole Teva with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

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

There are some medicines that can interact with Fluconazole Teva.

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 to treat atopic dermatitis, also known as eczema)
• Alfentanil, fentanyl (used as anaesthetics).
• 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 to treat seizures).
• Nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (for high blood pressure).
• Ciclosporin, 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 and fluvastatin or similar medicines) used to reduce high cholesterol levels.
• Methadone (used for pain relief).
• Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs – NSAIDs-).
• Oral contraceptives.
• Prednisone (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 to control asthma).
• Tofacitinib (used to treat rheumatoid arthritis)
• Tolvaptan (used to treat hyponatremia [low sodium levels in the blood] or to slow down kidney function deterioration).
• Vitamin A (nutritional supplement).
• Ivacaftor (alone or in combination with medicines used to treat cystic fibrosis).
• Amiodarone (used to treat irregular heartbeats).
• Hydrochlorothiazide (diuretic)
• Ibrutinib (used to treat blood cancer)
• Lurasidone (used to treat schizophrenia)

Taking Fluconazole Teva with food and drinks

You can take the medicine with or without food.

Pregnancy, breastfeeding and fertility

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 Teva 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 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 Teva. You should not continue breastfeeding if you are taking repeated doses of Fluconazole Teva.

Driving and using machines

When driving or operating machinery, you should be aware that you may occasionally experience dizziness or convulsions.

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 some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol (23 mg) per capsule; this is essentially “sodium-free”.

Fluconazole Teva 200 mgmay cause allergic reactions because it contains azorubine (carmoisine) (E-122). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Fluconazole Teva

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are 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 medicines at the same time every day.

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

Adults

Adolescents from 12 to 17 years of age

Follow the dose indicated by your doctor (the adult posology or the pediatric posology).

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 of age

Use in children from 3 to 4 weeks of age:

• The same dose as described in the table, but administered 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 every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.

Sometimes, doctors may prescribe different doses than those described. Follow the administration instructions exactly as indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

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 Teva than you should

Taking too many capsules at once can make you feel unwell. Contact your doctor immediately or go to the nearest hospital. You can also call the Toxicology Information Service, telephone 91 562 04 20, indicating 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 behaviour). It may be appropriate to initiate symptomatic treatment (with supportive measures and stomach lavage if necessary).

If you forget to take Fluconazole Teva

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 doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Fluconazol Teva can cause adverse effects, although not all people suffer from them.

Stop taking Fluconazol Teva and seek immediate medical attention 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 develop allergic reactions, although severe allergic reactions are rare.If any adverse effect appears, talk to your doctor or pharmacist. 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 a rash that causes blisters (this can affect the mouth and tongue).

Fluconazol Teva 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 Fluconazol Teva and inform your doctor immediately.

Other Adverse Effects:

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

• headache.
• stomach upset, diarrhea, discomfort, vomiting.
• high blood test results indicating liver function.
• rash.

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

• reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing.
• decreased appetite.
• inability to sleep, 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) are:

• white blood cells in the blood that help defend against infections and blood cells that help stop bleeding, lower than normal.
• red or purple skin discoloration, which may be due to a low platelet count, 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 widespread rash with blisters and skin peeling, severe allergic reactions, swelling of the lips or face.
• hair loss.

Frequency not known, but may occur (cannot be estimated from 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 eruption with eosinophilia and systemic symptoms [DRESS]).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Fluconazol Teva

Keep this medicine out of sight and reach of children.

Do not use Fluconazol Teva after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Fluconazol Teva:

The active ingredient is fluconazole.

Each hard capsule contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole.

The other components (excipients) are:

Capsule content: lactose monohydrate, cornstarch, anhydrous colloidal silica, sodium lauryl sulfate, magnesium stearate.

Composition of the gelatin capsules:

Fluconazol Teva 50 mg: titanium dioxide (E171), brilliant blue FCF (E133), and gelatin.

Fluconazol Teva 100 mg: titanium dioxide (E171), brilliant blue FCF (E133), and gelatin.

Fluconazol Teva 150 mg: titanium dioxide (E171), brilliant blue FCF (E133), and gelatin.

Fluconazol Teva 200 mg: titanium dioxide (E171), brilliant blue FCF (E133), carmoisine (E122), and gelatin.

See section 2 Important information about some of the components of Fluconazol Teva.

Appearance of Fluconazol and Package Contents

The Fluconazol Teva 50 mg capsules have a white body and a light blue cap.

The Fluconazol Teva 100 mg capsules have a white body and a dark blue cap.

The Fluconazol Teva 150 mg capsules have a light blue body and cap.

The Fluconazol Teva 200 mg capsules have a white body and a purple cap.

They are presented in blister packs containing:

Fluconazol Teva 50 mg: contains 7 and 500 (clinical package) hard capsules.

Fluconazol Teva 100 mg: contains 7 and 100 (clinical package) hard capsules.

Fluconazol Teva 150 mg: contains 1 or 4 hard capsules.

Fluconazol Teva 200 mg: contains 7 or 100 (clinical package) hard capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta.

Alcobendas, 28108 Madrid.

Manufacturer:

Teva Pharmaceutical Works Private Limited Company.

Pallagi út, 13.

Debrecen H-4042, Hungary.

Date of the Last Revision of this Prospectus:October 2024.

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69082/P_69082.html.