FLUCONAZOLE NORMON 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fluconazole Normon 50 mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Fluconazole Normon and what is it used for
2. Before taking Fluconazole Normon
3. How to take Fluconazole Normon
4. Possible side effects
5. Storing Fluconazole Normon
6. Further information.

1. What is Fluconazole Normon and what is it used for

Fluconazole Normon is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Fluconazole is used to treat infections caused by fungi, and it can also be used to prevent an infection from Candida. The most common cause of fungal infections is a yeast called Candida.

Adults

Your doctor may prescribe this medicine for you 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 by Candidathat are 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, jock itch, nail infection.

They may also prescribe fluconazole for:

• Preventing the recurrence of cryptococcal meningitis.
• Preventing the recurrence of mucosal Candidainfections.
• Reducing the repeated appearance of vaginal Candidainfections.
• Preventing the spread of Candidainfections (if your immune system is weak and not working properly).

Children and adolescents (0 to 17 years)

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

• Mucosal candidiasis – an infection that affects the lining of the mouth or throat.
• Infections caused by Candidathat are 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.

They may also prescribe fluconazole for:

• Preventing the spread of Candidainfections (if your immune system is weak and not working properly).
• Preventing the recurrence of cryptococcal meningitis.

2. Before taking Fluconazole Normon

Do not take Fluconazole Normon if:

• You are allergic (hypersensitive) to fluconazole, to other medicines you have taken to treat fungal infections, or to any of the other ingredients of this medicine (listed in section 6). The symptoms can include itching, skin redness, or difficulty breathing.
• You are taking astemizole, terfenadine (antihistamine medicines for treating allergies).
• You are taking cisapride (used to treat stomach upset).
• You are taking pimozide (used to treat mental illnesses).
• You are taking quinidine (used to treat heart arrhythmias).
• You are taking erythromycin (an antibiotic for treating infections).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluconazole Normon:

• If you have liver or kidney problems.
• If you have a heart condition, including heart rhythm problems.
• If you have abnormal levels of potassium, calcium, or magnesium in your blood.
• If severe skin reactions occur (itching, skin redness, or difficulty breathing).
• If signs of "adrenal insufficiency" appear, in which the adrenal glands do not produce enough of certain hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).

• If you have ever had a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking Fluconazole Normon.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to treatment with Fluconazole. Stop using this medicine and seek immediate medical attention 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; it may be necessary to use an alternative antifungal treatment.

Taking Fluconazole Normon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Immediatelyinform your doctor if you are taking astemizole, terfenadine (an antihistamine for treating allergies), cisapride (used for stomach upset), pimozide (used for treating mental illnesses), quinidine (used for treating heart arrhythmias), or erythromycin (an antibiotic for treating infections), as these medicines should not be taken with Fluconazole (see section: “Do not take Fluconazole Normon if”).

There are some medicines that can interact with Fluconazole.

Make sure your doctor knows if you are taking any of the following medicines, as it may be necessary to adjust the dose or monitor to check that the medicines are still having the desired effect:

• Rifampicin or rifabutin (antibiotics for infections).
• Abrocitinib (used to treat atopic dermatitis, also known as atopic eczema).
• Alfentanil, fentanyl (used as anesthetics).
• Amitriptyline, nortriptyline (used as antidepressants).
• Amphotericin B, voriconazole (antifungals).
• Medicines that make the blood less viscous, to prevent the formation of clots (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, verapamil, felodipine, and losartan (for hypertension – high blood pressure).
• Olaparib (used to treat ovarian cancer).
• Ciclosporin, 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, and fluvastatin or similar medicines) used to reduce high cholesterol levels.
• Methadone (used for pain).
• Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs – NSAIDs).
• Oral contraceptives.
• Prednisone (steroid).
• Zidovudine, also known as AZT; saquinavir (used in patients infected with HIV).
• Medicines 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 the blood] or to slow down the deterioration of kidney function).
• Vitamin A (nutritional supplement).
• Ivacaftor (alone or in combination with medicines used to treat cystic fibrosis).
• Amiodarone (used to treat irregular heartbeats [arrhythmias]).
• Hydrochlorothiazide (diuretic).
• Ibrutinib (used to treat blood cancer).
• Lurasidone (used to treat schizophrenia).

Taking Fluconazole Normon with food and drinks

You can take the medicine with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

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 adequate contraceptive methods during treatment, which should be continued for one week after the last dose.

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

There have been reports of babies born with congenital anomalies affecting the skull, ears, and bones of the thigh and elbow 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. You should not continue breastfeeding if you are taking repeated doses of fluconazole.

Driving and using machines

When driving or operating machinery, keep in mind that dizziness or seizures can occasionally occur.

Fluconazole Normon contains lactose and sodium

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

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

3. How to take Fluconazole Normon

Follow the instructions for administration of this medicine exactly as 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 best to take your medicines always at the same time of day.

The following is the usual dose of this medicine for the different types of infections:

Adults

Adolescents 12 to 17 years of age

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

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 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.

Elderly patients

The usual adult dose, unless you have kidney problems.

Patients with kidney problems

Your doctor may change the dose, depending on how well your kidneys are working.

If you take more Fluconazole Normon than you should

Taking too many capsules at once can make you feel unwell. Contact your doctor or go to the nearest hospital immediately. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 stomach lavage if necessary).

If you forget to take Fluconazole Normon

Do not take a double dose to make up for forgotten doses. If you have forgotten 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 medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Fluconazol Normon can cause adverse effects, although not all people suffer from them.

Stop using Fluconazol and seek immediate medical attention if you notice any of the following symptoms:

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

Some people develop allergic reactions, although severe allergic reactions are rare. If any adverse effect appears, talk to your doctor or pharmacist. This includes any possible adverse effect not mentioned in this prospectus. If you experience any of the following symptoms, 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 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 whites of the eyes (jaundice).

If you experience any of these symptoms, stop taking Fluconazol and inform your doctor immediately.

Other Adverse Effects:

Additionally, if you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Common adverse effects (may affect up to 1 in 10 patients) are:

• Headache.
• Stomach upset, diarrhea, discomfort, vomiting.
• Elevated blood test results indicating liver function.
• Rash.

Uncommon adverse effects (may affect up to 1 in 100 patients) are:

• Reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing.
• Decreased appetite.
• Insomnia, feeling of numbness.
• Seizures, dizziness, feeling of spinning, tingling, pinching, or numbness, changes in taste sensation.
• Constipation, heavy digestion, gas, dry mouth.
• Muscle pain.
• Liver damage and yellowing of the skin and eyes (jaundice).
• Hives, blisters (hives), itching, increased sweating.
• Fatigue, general feeling of discomfort, fever.

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

• White blood cells that help defend against infections and blood cells that help stop bleeding, lower than normal.
• Red or purple skin discoloration, which may be due to a low platelet count, other changes in blood cells.
• Changes in blood tests (high cholesterol, fat levels).
• 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):

• Hypersensitivity reaction with skin rash, fever, inflamed glands, increased eosinophils (a type of white blood cell), and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or rash with eosinophilia and systemic symptoms [DRESS]).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

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

5. Storage of Fluconazol Normon

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

Do not use this medicine after the expiration date stated 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.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition ofFluconazol Normon

The active ingredient is fluconazole.

Each hard capsule contains 50 mg of fluconazole.

The other components (excipients) are:

Capsule content: lactose monohydrate, 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.

Capsule composition: quinoline yellow (E104), titanium dioxide (E171), water, and gelatin.

Appearance of the Product and Packaging Content

The capsules have an opaque yellow body and cap.

They are available in packs of 7 or 500 (EC) capsules in PVC-PVDC and aluminum blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

LABORATORIOS NORMON, S.A.

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

Manufacturer:

LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), Spain

Date of the Last Revision of this Prospectus:August 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/