Fluconazole Tarbis 50 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluconazole Tarbis 50 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Fluconazol Tarbis is one of the medicines belonging to a group called "antifungals". The active substance is fluconazole.

Fluconazol Tarbis is used to treat fungal infections, and it can also be used to prevent the occurrence of a fungal 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.
• 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 Tarbis may also be prescribed to:

• Prevent recurrence of cryptococcal meningitis.
• Prevent recurrence of mucosal infections.
• Reduce repeated episodes of vaginal Candida infections.
• 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.
• 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 of the brain.

Fluconazol Tarbis 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 Tarbis

Do not take Fluconazole Tarbis if:

• You are allergic to fluconazole, to other antifungal medicines, 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 starting Fluconazole Tarbis 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.
• You develop severe skin reactions (itching, skin redness, or difficulty breathing).
  • if you have ever experienced a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Fluconazole Tarbis.
  • if the fungal infection does not improve, alternative antifungal treatment may be needed.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Fluconazole Tarbis. Stop taking Fluconazole Tarbis and seek immediate medical attention if you notice any 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 need to take any other medicines.

Inform 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 Tarbis (see section: “Do not take Fluconazole Tarbis if”).

Some medicines 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 anesthetics).
• Amitriptyline, nortriptyline (used as antidepressants).
• Amphotericin B, voriconazole (antifungals).
• Medicines that reduce blood clotting (warfarin or similar medicines).
• Benzodiazepines (midazolam, triazolam, or similar medicines) used to help sleep or for anxiety.
• Carbamazepine, phenytoin (used to treat seizures).
• Nifedipine, isradipine, amlodipine, felodipine, and losartan (for hypertension – high blood pressure).
• Cyclosporine, 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, fluvastatin, or similar medicines) used to lower high cholesterol.
• Methadone (used for pain).
• Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs – NSAIDs).
• Oral contraceptives.
• Prednisone (a steroid).
• Zidovudine, also known as AZT; saquinavir (used in HIV-infected patients).
• Medicines for diabetes, such as chlorpropamide, glyburide, glipizide, or tolbutamide.
• Theophylline (used to control asthma).
• Vitamin A (nutritional supplement).

Taking Fluconazole Tarbis with food, drinks, and alcohol

You may take this medicine with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using 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 treatment courses 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 Tarbis if you are pregnant, think you may 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 miscarriage. Fluconazole taken 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.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

When driving or operating machinery, bear in mind that dizziness or seizures may occasionally occur.

Fluconazole Tarbis contains lactose

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

3. How to take Fluconazole Tarbis

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. 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 usual doses of this medicine for different types of infections are given below:

Adults

Use in adolescents aged 12 to 17 years

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

Use in 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.

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 Tarbis than you should

Taking too many capsules at once may make you feel unwell. Contact your doctor or the nearest hospital immediately. You may also call the Toxicology Information Service at telephone number 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 start 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 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 stop treatment with Fluconazol Tarbis

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.

Some people develop allergic reactions, although serious allergic reactions are rare. If any of the following symptoms occur, 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.
• Serious skin reactions, such as blistering rash (this may affect the mouth and tongue).

Fluconazole Tarbis may 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 Tarbis and inform your doctor immediately.

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

• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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 listed in this leaflet, inform your doctor or pharmacist.

The following are frequent adverse effects, affecting 1 to 10 in every 100 patients:

• Headache.
• Stomach discomfort, diarrhoea, nausea, vomiting.
• Elevated results in blood tests indicating liver function.
• Rash.

The following are uncommon adverse effects, affecting 1 to 10 in every 1,000 patients:

• Reduction in red blood cells, which may cause pale skin, 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.
• Tiredness, general malaise, fever.

The following are rare adverse effects, affecting 1 to 10 in every 10,000 patients:

• Lower than normal levels of white blood cells, which help defend against infections, and blood cells that help stop bleeding.
• Red or purple skin discolouration, which may be due to low platelet count or other changes in blood cells.
• Changes in blood tests (high levels of cholesterol, fats).
• Low levels of potassium in the blood.
• Tremors.
• Abnormal electrocardiogram (ECG), changes in heart rate or rhythm.
• Liver function failure.
• Allergic reactions (sometimes severe), including extensive blistering and peeling of the skin, severe allergic reactions, swelling of the lips or face.
• Hair loss.

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 Tarbis

This medicine does not require any special storage conditions.

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 EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Fluconazole Tarbis

The active substance is fluconazole.

Each hard capsule contains 50 mg of fluconazole.

The other components (excipients) are:

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

Capsule composition: gelatin, titanium dioxide (E171), and quinoline yellow (E 104).

Appearance of the product and contents of the pack

The capsules have yellow body and cap.

Available in packs containing 7 hard capsules and hospital pack containing 500 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 most recent revision of this leaflet: February 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/