FLUCONAZOLE TARBIS 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

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

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

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

Fluconazole Tarbis is used to treat infections caused by fungi, and it can also be used to prevent fungal infections from occurring. The most common cause of fungal infections is a yeast called Candida.

Adults

Your doctor may prescribe this medicine for you to treat the following types of fungal infections:

• Cryptococcal meningitis – a fungal infection in the brain.
• Coccidioidomycosis – a disease of the bronchopulmonary system.
• Candidainfections located in 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.

They may also prescribe Fluconazole Tarbis for you to:

• Prevent cryptococcal meningitis from coming back.
• Prevent mucosal infections from coming back.
• Reduce the repeated appearance of vaginal Candidainfections.
• Prevent 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 you to treat the following types of fungal infections:

• Mucosal candidiasis – an infection that affects the lining of the mouth or throat.
• Candidainfections located in the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
• Cryptococcal meningitis – a fungal infection in the brain.

They may also prescribe Fluconazole Tarbis for you to:

• Prevent the spread of Candidainfections (if your immune system is weak and not working properly).
• Prevent cryptococcal meningitis from coming back.

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

Do not take Fluconazole Tarbis if:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Fluconazole Tarbis 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, redness of the skin or difficulty breathing).

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

Taking Fluconazole Tarbis with other medicines

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 allergies), cisapride (used for stomach upset), pimozide (used for mental health conditions), quinidine (used for heart rhythm disorders) or erythromycin (an antibiotic for infections), as these medicines should not be taken with Fluconazole Tarbis (see section: “Do not take Fluconazole Tarbis if”).

There are some medicines that may interact with Fluconazole Tarbis.

Make sure your doctor knows if you are taking any of the following medicines:

• Rifampicin or rifabutin (antibiotics for infections).
• 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, 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 HIV-infected patients).
• Medicines for diabetes, such as chlorpropamide, glibenclamide, glipizide or tolbutamide.
• Theophylline (used to control asthma).
• Vitamin A (nutritional supplement).

Taking Fluconazole Tarbis with food, drinks and alcohol

You can take the 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 have a baby, ask your doctor or pharmacist for advice 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 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 Tarbis if you are pregnant, think you may be pregnant or are planning to become pregnant or breast-feed, unless your doctor has told you to. If you become pregnant while taking this medicine or in the week following 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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

When driving or operating machinery, you should be aware that occasionally dizziness or seizures may occur.

Fluconazole Tarbis contains lactose

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

3. How to take Fluconazole Tarbis

Always take this medicine exactly as your doctor or pharmacist 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 is the usual dose of this medicine for the different types of infections:

Adults

Use in adolescents 12 to 17 years of age

Follow the dose prescribed by your doctor (either the adult dose or the child dose).

Use in 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 given every 2 days. The maximum dose is 12 mg per kilogram of body weight every 48 hours.

Use in children under 2 weeks of age:

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

Occasionally, doctors may prescribe different doses than those described. Always follow the instructions for administration 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 change your dose, depending on how well your kidneys are working.

If you take more Fluconazole Tarbis than you should

Taking too many capsules at the same time can make you feel unwell. Contact your doctor or the nearest hospital immediately. 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 Tarbis

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 stop taking Fluconazole Tarbis

If you have any further questions on the use of this product, 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.

Some people develop allergic reactions, although severe allergic reactions are rare.If any of the following symptoms appear, 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 Tarbis may affect your liver. Signs that indicate liver problems include:

• Fatigue.
• Lack of appetite.
• Vomiting.
• Yellowing of the skin or the whites of the eyes (jaundice).

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

Stop taking Fluconazol Tarbis 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).

Other Adverse Effects:

Additionally, if you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

The following are common adverse effects that affect 1 to 10 out of every 100 patients:

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

The following are uncommon adverse effects that affect 1 to 10 patients out of every 1,000:

• Reduced red blood cells, which can cause pale skin and 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.

The following are rare adverse effects that affect 1 to 10 patients out of every 10,000:

• White blood cells 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.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this prospectus. You can also report it 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 Tarbis

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in 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 ofFluconazol Tarbis

The active ingredient is fluconazole.

Each hard capsule contains 100 mg of fluconazole.

The other components (excipients) are:

Capsule content: lactose monohydrate (lactose), pregelatinized corn starch (corn starch), colloidal hydrated silica, magnesium stearate, sodium lauryl sulfate.

Capsule composition: gelatin, titanium dioxide (E171), and quinoline (E104).

Product Appearance and Package Contents

The capsules have a white body and a yellow cap.

They are available in packages with 7 hard capsules and a clinical package with 100 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 - Barcelona

Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Date of the Last Revision of this Prospectus:February 2024

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