Package Insert: Information for the User

Fluconazole Normon 200 mg Hard Capsules EFG

Read this package insert carefully before starting to take the medication.

• Keep this package insert as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor, pharmacist, or nurse.

Fluconazol Normon is one of the medications in the group called “antifungals”. The active ingredient is fluconazol.

Fluconazol is used to treat infections caused by fungi, and it may also be used to prevent the appearance of an infection byCandida. 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:

• Cryptococcal meningitis – 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 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 for:

• To prevent the recurrence of cryptococcal meningitis.
• To prevent the recurrence of mucosal infections byCandida.
• To reduce the recurrence of vaginal infections 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 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 fluconazol 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 Normon if:

• You are allergic (hypersensitive) to fluconazole, to other medications you have taken to treat fungal infections, or to any of the other components ofthis 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 Normon

• If you have liver or kidney problems.
• If you have a heart disease, including heart rhythm problems.
• If you have abnormal levels of potassium, calcium, or magnesium in your blood.
• If you experience severe skin reactions (itching, skin redness, or difficulty breathing).
• If you experience signs of “adrenal insufficiency”, where the adrenal glands do not produce enough of certain hormones, such as cortisol (chronic fatigue or prolonged weakness, muscle weakness, loss of appetite, weight loss, abdominal pain).
• If you have ever experienced severe skin rash or skin peeling, blisters, and/or mouth sores after taking Fluconazol Normon.

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

Talk to your doctor or pharmacist if the fungal infection does not improve, as an alternative antifungal treatment may be necessary.

Taking Fluconazol Normon with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Informimmediatelyyour 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 (see section: “Do not take Fluconazol Normon if”).

There are some medications that may interact with Fluconazol NORMON.

Make sure your doctor knows if you are taking any of the following medications, as it may be necessary to adjust the dose or monitor to ensure the medications continue to have the desired effect:

• Rifampicin or rifabutin (antibiotics for infections).
• Abrocitinib (used to treat atopic dermatitis, also known as eczema).
• Alfentanil, fentanyl (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, verapamil, felodipine, and losartan (for hypertension).
• Olaparib (used to treat ovarian cancer).
• 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).
• Tofacitinib (used to treat rheumatoid arthritis).
• Tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to slow the deterioration of kidney function).
• Vitamin A (nutritional supplement).
• Ivacaftor (alone or combined with medications used to treat cystic fibrosis).
• Amiodarone (used to treat irregular heartbeats).
• Hydrochlorothiazide (diuretic).
• Ibrutinib (used to treat blood cancer).
• Lurasidone (used to treat schizophrenia).

Taking Fluconazol Normon with food and drinks

You can take the medication with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before taking any 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 treatment cycles with fluconazole, 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 Fluconazol if you are pregnant, think you may be pregnant, or intend to become pregnant, 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 taken during the first trimester may increase the risk of 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.You can continue breastfeeding after taking a single dose of 150 mg of fluconazole. Do not continue breastfeeding if you are taking repeated doses of fluconazole.

Driving and operating machinery

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

Fluconazol Normon contains lactose and sodium

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

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

Follow exactly the administration instructions of this medication indicated by your doctor. 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 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 12 to 17 years of age

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

Children up to 11 years of age

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 of age

Use in children 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.

Geriatric 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 functioning.

If you take more Fluconazol Normon than you should

Taking too many capsules at once may make you feel unwell. Contact your doctor immediately or go to the nearest hospital. You can also call the Toxicology 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 forgot to take Fluconazol Normon

Do not take a double dose to make up for the missed doses. If you forgot 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 Normonmay cause side effects, although not everyone will experience them.

Stop using this medicine and seek medical attentionimmediatelyif you notice any of the following symptoms:

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

Some people developallergic reactions, although severe allergic reactions are rare. If any side effect occurs, talk to your doctor or pharmacist. This includes any possible side effect not mentioned in this leaflet. If you experience any of the following symptoms, informyour doctor immediately.

• Shortness of breath, 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 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 takingthis medicineandinform your doctor immediately.

Other side effects:

Additionally, if you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Frequent side effects (may affect up to 1 in 10 patients) are:

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

Less frequent side effects (may affect up to 1 in 100 patients) are:

• Reduction of red blood cells, which can cause pale skin and weakness or difficulty breathing.
• Loss of appetite.
• Inability to sleep, numbness.
• Convulsions, 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.

Rare side effects (may affect up to 1 in 1,000 patients) are:

• Low white blood cells in the blood that help us 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 number of platelets, 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.

Frequency not known, but may occur (cannot be estimated from available data):

• Severe hypersensitivity reaction with skin rash, fever, swollen glands, increased eosinophils, and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or rash with eosinophilia and systemic symptoms [DRESS]).

Reporting side effects

If you experience any type ofside effect, consult your doctor, pharmacist, or nurse, 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 this medication 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.

Store in the original packaging.

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 at 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 Normon

The active ingredient is fluconazole.

Each hard capsule contains200mg of fluconazole.

The other components (excipients) are:

Content of the capsules:lactose monohydrate (lactose), cornstarch, colloidal silicon dioxide (E-551), magnesium stearate (E-572) and sodium lauryl sulfate (E-470a). See section 2

Fluconazol Normon contains lactose and sodium.

Composition of the capsule:indigotin (E132), titanium dioxide (E171), water and gelatin.

Appearance ofFluconazol Normon200 mg hard capsules and packaging contents

The capsules have a white opaque body and a blue opaque cap.

It is presented in packagingwith 7 or 100 (EC) capsules in PVC-PVDC and Aluminum blister.

Not all packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Responsible Manufacturer:

LICONSA, S.A.

Avda. Miralcampo, Nº 7, Industrial Park Miralcampo

19200 Azuqueca de Henares (Guadalajara), Spain

This leaflet was approved in: August 2024

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