PATIENT INFORMATION LEAFLET

Fluconazole Mabo 100 mg Hard Capsules EFG

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Fluconazole Mabo is one of the medications in the group called “antifungals”. The active ingredient is fluconazole.

Fluconazole Mabo is used to treat infections caused by fungi, and it may also be used to prevent the appearance of a fungal infection. The most common cause of fungal infections is a yeast calledCandida.

Adults

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

Your doctor may also prescribe Fluconazole Mabo for:

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

Children and adolescents (0 to17 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.
• Infections caused byCandidalocated 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 Fluconazole Mabo for:

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

Do not take Fluconazol Mabo if

Be especially careful with Fluconazol Mabo

Inform your doctor if

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

Use of other medications

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

There are some medications that may interact with Fluconazol Mabo.

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).

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

Taking Fluconazol Mabo with food and drinks

You can take the medication with or without food.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant, trying to become pregnant, or breastfeeding.

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

You should not take fluconazole if you are pregnant, think you may be pregnant, or intend to become pregnant or breastfeed, unless your doctor has told you to do so.If you become pregnant while taking this medication or within one week of 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 slightly increase the risk of a baby being born with congenital abnormalities affecting the heart, bones, and/or muscles.

Cases of babies born with congenital abnormalities 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 machines

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

Fluconazol Mabo contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Fluconazol Mabo contains sodium

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

Follow exactly the administration instructions of Fluconazol Mabo indicated by your doctor.Consult your doctor or pharmacist if you have doubts.

The capsules should be swallowed whole with the help of a glass of water. It is better to take your medications always at the same time of the day.

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

Adults

Adolescents from12 to17 years of age

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

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 from0 to4 weeks of age

Use in children from 3 to 4 weeks of age:

Use in children under 2 weeks of age:

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 doubts.

Older 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 function.

If you take more Fluconazol Mabo than you should

Taking too many capsules at once can make you feel bad. 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. The 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 forgot to take Fluconazol Mabo

Do not take a double dose to compensate for the missed doses. If you forgot to take a dose, take it as soon as you remember. If there is little time left for the next dose, do not take the missed dose.

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

Like all medicines, Fluconazol Mabo may 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.

Fluconazol Mabo may affect your liver. Signs indicating liver problems include:

If you experience any of these symptoms, stop taking Fluconazol Mabo andinform your doctor immediately.

Other side effects:

In addition, if you consider any of the side effects you are experiencing 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 per 1,000:

• Reduction in red blood cells, which may cause pale skin and weakness or difficulty breathing.
• Loss of appetite.
• Inability to sleep, numbness.
• Convulsions, dizziness, sensation 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 (bullae), itching, increased sweating.
• Tiredness, general feeling of discomfort, fever.

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

• White blood cells that help fight infections and blood cells that help stop bleeding, lower than normal.
• Red or purple discoloration of the skin, which may be due to a low platelet count, other blood cell changes.
• Changes in 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.

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed 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.

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

Do not use Fluconazol Mabo 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 disposed of through drains or in the trash. Dispose of the packaging and medicines 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 medicines you no longer need. In this way, you will help protect the environment.

Composition of Fluconazol Mabo 100 mg Hard Capsules EFG

Appearance of Fluconazol Mabo 100 mg Hard Capsules and Contents of the Package

The capsules have a white body and a yellow cap.

They are presented in packages of 7 hard capsules.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization:

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821, Coslada, Madrid

Spain

Responsible for Manufacturing:

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses, 2.

28108, Alcobendas, (Madrid) SPAIN

Last Review Date of this Leaflet July 2024

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