Package Leaflet: Information for the User

Fluconazole Cinfa 50 mg Hard Capsules EFG

Read this leaflet carefully before you start to take 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 give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

Fluconazole 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 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 fluconazole 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 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 fluconazole 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 cinfa

• If you are allergic to fluconazol, to other medicines you have taken to treat fungal infections, or to any of the other components of this medicine (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing.
• If you are taking astemizol, terfenadine (antihistamines for allergies).
• If you are taking cisaprida (used to treat stomach discomfort).
• If you are taking pimozida (used to treat mental illnesses).
• If you are taking quinidina (used to treat heart arrhythmias).
• If you are taking eritromicina (an antibiotic to treat infections).

Warnings and precautions

Consult your doctor or pharmacist before starting to take fluconazol cinfa.

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

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

Other medicines and fluconazol cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Inform your doctor immediately if you are taking astemizol, terfenadine (an antihistamine for allergies), cisaprida (used for stomach discomfort), pimozida (used to treat mental illnesses), quinidina (used to treat heart arrhythmias), or eritromicina (an antibiotic to treat infections), as these medicines should not be taken with fluconazol (see section: “Do not take fluconazol cinfa”).

There are some medicines that may interact with fluconazol.

Make sure your doctor knows if you are taking any of the following medicines:

• Rifampicina or rifabutina (antibiotics for infections).
• Alfentanilo, fentanilo (used as anesthetics).
• Amitriptilina, nortriptilina (used as antidepressants).
• Amfotericina B, voriconazol (antifungals).
• Medicines that make blood less viscous, to prevent clot formation (warfarina or similar medicines).
• Benzodiazepines (midazolam, triazolam or similar medicines) used to help sleep or for anxiety.
• Carbamazepina, fenitoína (used to treat seizures).
• Nifedipino, isradipino, amlodipino, verapamilo, felodipino, and losartán (for high blood pressure).
• Olaparib (used to treat ovarian cancer).
• Ciclosporina, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection).
• Ciclofosfamida, vinca alkaloids (vincristina, vinblastina or similar medicines) used to treat cancer.
• Halofantrina (used to treat malaria).
• Estatinas (atorvastatina, simvastatina, and fluvastatina or similar medicines) used to reduce high cholesterol levels.
• Metadona (used for pain).
• Celecoxib, flurbiprofeno, naproxeno, ibuprofeno, lornoxicam, meloxicam, diclofenaco (Nonsteroidal Anti-Inflammatory Drugs – NSAIDs).
• Oral contraceptives.
• Prednisona (steroid).
• Zidovudina, also known as AZT; saquinavir (used in patients infected with HIV).
• Medicines for diabetes, such as clorpropamida, glibenclamida, glipizida, or tolbutamida.
• Theophylline (used to control asthma).
• Tofacitinib (used to treat rheumatoid arthritis).
• Tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to slow down kidney function deterioration).
• Vitamin A (nutritional supplement).
• Ivacaftor (used to treat cystic fibrosis).
• Amiodarona (used to treat irregular heartbeats).
• Hidroclorotiazida (diuretic).
• Ibrutinib (used to treat blood cancer).

Fluconazol cinfa 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If you plan to become pregnant, it is recommended that you wait one week after a single dose of fluconazol before becoming pregnant.

For longer treatment cycles with fluconazol, 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 plan to become pregnant or breastfeed, unless your doctor has told you to. If you become pregnant while taking this medicine or within one week of the most recent dose, consult your doctor.

You can continue breastfeeding after taking a single dose of 150 mg of fluconazol. Do not continue breastfeeding if you are taking repeated doses of fluconazol.

Fluconazol taken during the first or second trimester of pregnancy may increase the risk of spontaneous abortion. Fluconazol 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 fluconazol for coccidioidomycosis. The relationship between fluconazol and these cases is unclear.

Driving and operating machinery

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

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

Fluconazol cinfa contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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 medications always at the same time of day.

The following are the recommended doses of this medication for different types of infections:

Adults

Use in adolescents aged 12 to 17 years

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

Use in children up to 11 years

The maximum daily dose for children is 400 mg.

The dose will be based on the child's weight in kilograms.

Use in children aged 0 to 4 weeks

Use in children aged 3 to 4 weeks:

• The same dose as described in the table, but administered once every 2 days. The maximum dose is 12 mg per kilogram 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 kilogram of body weight every 72 hours.

Geriatric patients

The recommended dose for adults, 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 cinfa than you should

Taking too many capsules at once may make you feel unwell.In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package insert and the medication packaging to the healthcare professional.

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 cinfa

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 there is little time left for the next dose, do not take the missed dose.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some people developallergic reactionsalthough severe allergic reactions are rare.If anyside effectappears, talk to your doctor or pharmacist.This includes anypossibleside effectnot mentioned in this leaflet.

Stop taking fluconazole and seek medical attention immediately if you notice any of the following symptoms:

• Abnormal heartbeat, difficulty breathing, or chest tightness.
• Swelling of the eyelids, face, or lips.
• Itching all over the body, redness of the skin, 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Fluconazole may affect your liver. Signs that indicate liver problems include:

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

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

Other side effects:

Additionally, if you consider that any of the side effects you are experiencing 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 liver function test results.
• Rash.

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

• Reduction in 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 (bullae), itching, increased sweating.
• Tiredness, general feeling of discomfort, fever.

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

• 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 changes in blood cells.
• Abnormal blood test results (high cholesterol, fats).
• Low potassium levels in the blood.
• Tremors.
• Abnormal electrocardiogram (ECG), changes in heart rate or rhythm.
• Liver failure.
• Allergic reactions (sometimes severe), including widespread rash with blisters and skin peeling, severe allergic reactions, swelling of the lips or face.
• Hair loss.

Unknown frequency (cannot be estimated from available data):

• Drug 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 of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://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.

This medication does not require special storage conditions.

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 of Fluconazol Cinfa

• The active ingredient is fluconazole.

Each hard capsule contains 50 mg of fluconazole.

• The other components (excipients) are:

Contents of the capsule: pregelatinized cornstarch, sodium carboxymethylcellulose (type A) (from potato), magnesium stearate, anhydrous colloidal silica, lactose monohydrate (lactose) and sodium lauryl sulfate

Composition of the capsule: gelatin, titanium dioxide (E-171), indigotin (E-132) and erythrosine (E-127).

Appearance of the product and contents of the packaging

The capsules have a white body and a purple cap.

They are presented in packaging of 7 or 500 (clinical packaging) hard capsules.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate.

31620 Huarte (Navarra)-Spain

Last review date of this leaflet:February 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/67927/P_67927.html

QR code to:https://cima.aemps.es/cima/dochtml/p/67927/P_67927.html