Prospect: Information for the user

Fluconazole Kern Pharma 150 mg hard capsules

Read this prospect carefully before starting to take the medicine.

−Keep this prospect as you may need to read it again.

−If you have any doubts, consult your doctor or pharmacist.

−This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

−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 prospect, inform your doctor or pharmacist.

1.What is Fluconazole Kern Pharma 150 mg hard capsules and for what it is used.

2.Before taking Fluconazole Kern Pharma 150 mg hard capsules.

3.How to take Fluconazole Kern Pharma 150 mg hard capsules.

4.Possible adverse effects.

5.Storage of Fluconazole Kern Pharma 150 mg hard capsules.

6.Additional information.

Fluconazol Kern Pharma is one of the medicines in the group called "antifungals". The active ingredient is fluconazole.

Fluconazol Kern Pharma 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 medicine to treat the following types of fungal infections:

• Meningitis cryptococcal – a fungal infection in the brain.
• Coccidioidomycosis – a disease of the bronchopulmonary system.
• Infections caused byCandidalocated 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, inguinal ringworm, nail infection.

Your doctor may also prescribe Fluconazol Kern Pharma 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 to 17 years)

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

• Mucosal candidiasis – an infection that affects the lining 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 Fluconazol Kern Pharma 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 Kern Pharma if

• You are allergic (hypersensitive) to fluconazole, to other medications you have taken to treat fungal infections, or to any of the other components of Fluconazol Kern Pharma. Symptoms may include itching, skin redness, or difficulty breathing.
• You are taking astemizole, terfenadine (antihistamines 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 to treat infections).

Be especially careful with Fluconazol Kern Pharma

Inform your doctor 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).
• You have ever had a severe skin rash or peeling, blisters, or mouth sores after taking Fluconazol.

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

• If the fungal infection does not improve, alternative antifungal treatment may be necessary.

Use of other medications

Inform your doctor immediately 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 Kern Pharma (see section: “Do not take Fluconazol Kern Pharma if”).

There are some medications that may interact with Fluconazol Kern Pharma.

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 hypertension).
• 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 HIV-infected patients).
• 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 Kern Pharma with food and drinks

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 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.

Do not take Fluconazol Kern Pharma 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 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 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 machines

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

Important information about some components of Fluconazol Kern Pharma

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 for Fluconazol Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 is the usual dose of this medication for different types of infections:

Adults

Adolescents 12 to 17 years old

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

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 once 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 once 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 Kern Pharma 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 necessary to initiate symptomatic treatment (with supportive measures and gastric lavage if necessary).

If you forget to take Fluconazol Kern Pharma

Do not take a double dose to make up for the missed dose. 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 have any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Fluconazol Kern Pharma may cause side effects, although not everyone will experience them.

Some people developallergic reactionsalthough severe allergic reactions are rare.Stop taking Fluconazol and seek medical attention immediately if you notice any of the following symptoms:

• Abnormal heartbeats, 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 blistering (this can affect the mouth and tongue).
• Generalized rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Fluconazol Kern Pharma capsules may affect your liver. Signs of liver problems include:

• Tiredness.
• Loss of appetite.
• Vomiting.
• Yellowing of the skin or the white part of the eyes (jaundice).

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

Other side effects:

Additionally, 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 uncommon side effects that affect 1 to 10 patients of every 1,000:

• Reduction of red blood cells, which can 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 (pustules), itching, increased sweating.
• Tiredness, general feeling of discomfort, fever.

The following are rare side effects, affecting 1 to 10 patients of every 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.
• 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 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.

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

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

This medication does not require special storage conditions.

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. By doing so, you will help protect the environment.

Composition of Fluconazol Kern Pharma

The active ingredient is fluconazole.

Each hard capsule contains 150 mg of fluconazole.

The other components (excipients) are:

Content of the capsule: lactose monohydrate (lactose), pregelatinized cornstarch (cornstarch), hydrated colloidal silica, sodium lauryl sulfate, and magnesium stearate. Composition of the capsule: gelatin, titanium dioxide (E-171), quinoline (E-104), and cochineal extract (E-132).

Appearance of Fluconazol Kern Pharma and content of the packaging

The capsules have a green body and a green cap and are packaged in aluminum/aluminum blisters.

They are presented in packaging of 1 and 4 hard capsules.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 – Colón II Industrial Estate

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí.

Barcelona

This leaflet has been reviewed in January 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/