Package Insert: Information for the User

Fluconazole Tarbis 100 mg Hard Capsules EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Fluconazol Tarbis is one of the medications in the group called "antifungals". The active ingredient is fluconazole.

Fluconazol Tarbis is used to treat fungal infections, and it may also be used to prevent the occurrence of a fungal infection. The most common cause of fungal infections is a type of fungus called Candida.

Adults

Your doctor may prescribe this medication to treat the following types of fungal infections:

• Cryptococcal meningitis – a fungal infection in the brain.
• Coccidioidomycosis – a disease of the bronchopulmonary system.
• Fungal infections caused by Candida 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 mucous membrane 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, inguinal ringworm, nail infection.

Your doctor may also prescribe Fluconazol Tarbis for:

• To prevent the recurrence of cryptococcal meningitis.
• To prevent the recurrence of mucosal infections.
• To reduce the recurrence of vaginal infections caused by Candida.
• To prevent the transmission of fungal infections caused by Candida (if your immune system is weak and does not function properly).

Children and adolescents (0 to 17 years)

Your doctor may prescribe this medication to treat the following types of fungal infections:

• Mucosal candidiasis – an infection that affects the mucous membrane of the mouth or throat.
• Fungal infections caused by Candida 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.

Your doctor may also prescribe Fluconazol Tarbis for:

• To prevent the transmission of fungal infections caused by Candida (if your immune system is weak and does not function properly).
• To prevent the recurrence of cryptococcal meningitis.

Do not take Fluconazol Tarbis if:

• You are allergic to fluconazole, other medications you have taken to treat fungal infections, or any of the other components of this medication (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing.
• You are taking astemizole, terfenadine (allergy medications).
• 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 to treat infections).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluconazol Tarbis if

-You have liver or kidney problems.

-You have a heart disease, including heart rhythm problems.

-You have abnormal levels of potassium, calcium, or magnesium in your blood.

-You experience severe skin reactions (itching, skin redness, or difficulty breathing).

-If you have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Fluconazol Tarbis.

-If your fungal infection does not improve, you may need an alternative antifungal treatment.

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

Use of Fluconazol Tarbis with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Immediately inform your doctor if you are taking astemizole, terfenadine (an antihistamine to treat allergies), cisapride (used to treat stomach discomfort), pimozide (used to treat mental illnesses), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic to treat infections), as these medications should not be taken with Fluconazol Tarbis (see section: “Do not take Fluconazol Tarbis if”).

There are some medications that may interact with Fluconazol Tarbis.

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

• Rifampicin or rifabutin (antibiotics for infections).
• Alfentanil, fentanil (used as anesthetics).
• Amitriptyline, nortriptyline (used as antidepressants).
• Ampicillin B, voriconazole (antifungals).
• Medications that make blood less viscous, to prevent clot formation (warfarin or similar medications).
• Benzodiazepines (midazolam, triazolam or similar medications) used to help 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 medications) used to treat cancer.
• Halofantrine (used to treat malaria).
• Statins (atorvastatin, simvastatin, and fluvastatin or similar medications) used to reduce high cholesterol levels.
• Methadone (used for pain).
• Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Nonsteroidal Anti-Inflammatory Drugs – NSAIDs –).
• Oral contraceptives.
• Prednisone (steroid).
• Zidovudine, also known as AZT; saquinavir (used in patients infected with HIV).
• Medications for diabetes, such as chlorpropamide, glibenclamide, glipizide, or tolbutamide.
• Theophylline (used to control asthma).
• Vitamin A (nutritional supplement).

Taking Fluconazol Tarbis with food, drinks, and alcohol

You can take the medication with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

If you plan to become pregnant, it is recommended that you wait one week after a single dose of fluconazole before becoming pregnant.

For longer fluconazole treatment cycles, consult your doctor about the need to use appropriate contraceptive methods during treatment, which should be maintained for one week after the last dose.

Do not take Fluconazol Tarbis if you are pregnant, think you may be pregnant, or plan to become pregnant or breastfeed, unless your doctor has told you to.If you become pregnant while taking this medication 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 spontaneous abortion. Fluconazole during the first trimester may increase the risk of a baby being born with congenital anomalies affecting the heart, bones, and/or muscles.

Cases of babies born with congenital anomalies affecting the skull, ears, and leg 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 unclear.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

When driving or operating machinery, be aware that occasional dizziness or seizures may occur.

Fluconazol Tarbis contains lactose

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If 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 medication at the same time every day.

The following indicates the usual dose of this medication for different types of infections:

Adults

Use in adolescents aged 12 to 17 yearsold

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

Use in children up to 11 years old

The maximum daily dose for children is 400 mg.

The dose will be based on the child's weight in kilograms.

Use in children 0 to 4 weeks old

Use in children 3 to 4 weeks old:

• 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 old:

• 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.

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

Older adults

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 functioning.

If you take more Fluconazol Tarbis than you should

Taking too many capsules at once may make you feel unwell. Contact your doctor or the nearest hospital immediately. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 initiate symptomatic treatment (with supportive measures and gastric lavage if necessary).

If you forget to take Fluconazol Tarbis

Do not take a double dose to make up for the missed doses. If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose.

If you interrupt treatment with Fluconazol Tarbis

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some people developallergic reactionsalthough severe allergic reactions are rare.If any of the following symptoms appear,inform your doctor immediately.

• Abnormal heartbeats, difficulty breathing, or chest tightness.
• Swelling of the eyelids, face, or lips.
• Itching all over the body, redness of the skin, or red spots with itching.
• Skin rash.
• Severe skin reactions, such as blistering (this can affect the mouth and tongue).

Fluconazol Tarbis may affect your liver. Signs that indicate liver problems include:

-Fatigue.

-Loss of appetite.

-Vomiting.

-Yellowing of the skin or the white part of the eyes (jaundice).

If you experience any of these symptoms, stop takingFluconazol Tarbisandinform your doctor immediately.

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

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

Other side effects:

In addition, if you consider any of the side effects you experience to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

• Headache.
• Stomach discomfort, diarrhea, nausea, vomiting.
• Abnormal liver function test results.
• Rash.

The following are infrequent side effects that affect 1 to 10 patients of every 1,000:

• Reduction in red blood cells, which can cause pale skin and weakness or difficulty breathing.
• Loss of appetite.
• Inability to sleep, numbness.
• Seizures, dizziness, feeling of spinning, tingling, pins and needles, changes in taste.
• Constipation, heavy digestion, gas, dry mouth.
• Muscle pain.
• Liver damage and yellowing of the skin and eyes (jaundice).
• Rashes, blisters (pustules), itching, increased sweating.
• Fatigue, general feeling of discomfort, fever.

The following are rare side effects, affecting 1 to 10 patients of every 10,000:

• Low white blood cells that help us fight infections and platelets that help stop bleeding, lower than normal.
• Red or purple discoloration of the skin, which may be due to low platelet count, other changes in blood cells.
• Abnormal blood test results (high 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 rash with blisters and skin peeling, severe allergic reactions, swelling of the lips or face.
• Hair loss.

Reporting side effects

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

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

This medication does not require special storage conditions.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofFluconazol Tarbis

The active ingredient is fluconazole.

Each hard capsule contains100 mgof fluconazole.

The other components (excipients) are:

Content of the capsule: lactose monohydrate (lactose), pregelatinized cornstarch (cornstarch), hydrated colloidal silica, magnesium stearate, sodium lauryl sulfate.

Composition of the capsule: gelatin, titanium dioxide (E171) and quinoline (E 104).

Appearance of the product and contents of the packaging

The capsules have a white body and a yellow cap.

It is presented in packaging with 7 hard capsules and clinical packaging with 100 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 - Barcelona

Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Date of the last review of this leaflet:February 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/