Package Insert: Information for the Patient

Fluconazol Sandoz 50 mg Hard CapsulesEFG

Fluconazol Sandoz 100 mg Hard CapsulesEFG

Fluconazol Sandoz 150 mg Hard CapsulesEFG

Fluconazol Sandoz 200 mg Hard CapsulesEFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should 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, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Fluconazole is one of the medications in the group called "antifungals". The active ingredient is fluconazole. Fluconazole is used for the treatment of infections caused by fungi, and it can 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 for the treatment of the following types of fungal infections:

• cryptococcal meningitis: a fungal infection in the brain,
• coccidioidomycosis: a disease of the bronchopulmonary system,
• infections caused byCandidalocalized in the bloodstream, in organs of the body (e.g., heart, lungs) or in the urinary tract,
• oral mucosa candidiasis: an infection that affects the lining of the mouth, throat, or associated with dental prostheses,
• genital candidiasis: vaginal or penile infection,
• skin infections: (e.g., athlete's foot, ringworm, inguinal ringworm, nail infection).

Your doctor may also prescribe Fluconazole Sandoz for:

• preventing the recurrence of cryptococcal meningitis,
• preventing the recurrence of oral mucosa infections byCandida,
• reducing the recurrence of vaginal infections byCandida,
• preventing 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 for the treatment of the following types of fungal infections:

• oral mucosa candidiasis: an infection that affects the lining of the mouth or throat,
• infections caused byCandidalocalized 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 prescribeFluconazole Sandozfor:

• preventing the transmission of infections caused byCandida(if your immune system is weak and does not function properly),

preventing the recurrence of cryptococcal meningitis.

Do not take Fluconazol Sandoz:

• if you are allergic to fluconazole, other medications for fungal infections, or any of the other components of this medication (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing,
• if you are taking astemizole, terfenadine (antihistamines for allergy treatment),
• if you are taking cisapride (used for stomach discomfort),
• if you are taking pimozide (used for mental health treatment),
• if you are taking quinidine (used for heart arrhythmia treatment),
• if you are taking erythromycin (an antibiotic for infection treatment).

Warnings and precautions

Consult your doctor or pharmacist before starting to take fluconazole if:

• you have liver or kidney problems,
• you have 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 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),
• you have ever experienced severe skin rash or skin peeling, blisters, and/or mouth sores after taking fluconazole,
• 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 fluconazole treatment. Stop taking fluconazole and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Other medications and Fluconazol Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.Inform your doctor immediatelyif you are taking, have taken recently, or may need to use the following medications that may interact with fluconazole: astemizole, terfenadine (an antihistamine for allergy treatment), cisapride (used for stomach discomfort), pimozide (used for mental health treatment), quinidine (used for heart arrhythmia treatment), or erythromycin (an antibiotic for infection treatment), as these medications should not be taken with fluconazole (see section: “Do not take Fluconazol Sandoz”).

There are some medications that may interact with fluconazole.

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),
• amphotericin 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 for seizure treatment),
• nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (for high blood pressure),
• olaparib (used for ovarian cancer treatment),
• ciclosporin, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection),
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medications) used for cancer treatment,
• halofantrine (used for malaria treatment),
• 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),
• tofacitinib (used for rheumatoid arthritis treatment),
• tolvaptan (used for hyponatremia treatment or to slow kidney function decline).
• vitamin A (nutritional supplement),
• ivacaftor (used for cystic fibrosis treatment),
• amiodarone (used for irregular heartbeat treatment),
• hydrochlorothiazide (diuretic),
• ibrutinib (used to treat blood cancer).

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

Fluconazol Sandoz intake with food and drinks

You can take the medication with or without food.

Fluconazol Sandoz and 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 to 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 continued for one week after the last dose.

You should not take fluconazole if you are pregnant, think you may be pregnant, or plan to become pregnant or breastfeed, unless your doctor has told you to do so.

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

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 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.

Driving and operating machinery

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

Fluconazol Sandoz 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 23 mg of sodium (1 mmol) per hard capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication 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 better to take your medications always at the same time of the day.

The recommended dose of this medication for different types of infections is as follows:

Adults

Adolescents aged12 to17 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 per day.

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

Infants from0 to4 weeks old

Infants from3 to4 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.

Infants 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.

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 Sandozthan you should

Taking too many capsules at once may make you feel unwell.Contact your doctor or the nearest hospital immediately.

If you have taken more fluconazole than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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 Sandoz

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 other questions about the use of this medication, ask your doctor or pharmacist.

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

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

• abrupt onset of wheezing, 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 a rash that causes blisters (this may affect the mouth and tongue).

Fluconazol Sandoz may affect your liver. Signs that indicate liver problems include:

• fatigue,
• loss of appetite,
• vomiting,
• yellowing of the skin or the white of the eyes (jaundice).

If you experience any of these symptoms, stop taking Fluconazol Sandoz 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.

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

• headache,
• stomach discomfort, diarrhea, nausea, vomiting,
• high results in blood tests indicating liver function,
• skin rash.

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

• reduction in red blood cells, which may cause pale skin and weakness or difficulty breathing,
• loss of appetite,
• difficulty sleeping, 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),
• hives, blisters (bullae), itching, increased sweating,
• fatigue, general feeling of discomfort, fever.

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

• 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,
• changes in blood tests (high levels of cholesterol, fats),
• low levels of potassium in the blood,
• tremors,
• altered 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):

• 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]).

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

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

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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: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 usethis medicationafter the expiration date that appears onthe packagingafter CAD. The expiration date is the last day of the month indicated.

Store in the original packaging.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofFluconazole Sandoz

• The active ingredient is fluconazole. Each hard capsule contains 50, 100, 150, or 200 mg of fluconazole.
• The other components (excipients) are:

Content of the capsules: lactose monohydrate (lactose), cornstarch, colloidal silicon dioxide, magnesium stearate, and sodium lauryl sulfate.

Composition of the capsules:

Fluconazole Sandoz 50 mg hard capsules: quinoline yellow (E104), titanium dioxide (E171), water, gelatin.

Fluconazole Sandoz 100 mg hard capsules: titanium dioxide (E171), water, gelatin.

Fluconazole Sandoz 150 mg hard capsules: yellow iron oxide (E172), titanium dioxide (E171), water, gelatin.

Fluconazole Sandoz 200 mg hard capsules: indigotin (E132), titanium dioxide (E171), water, gelatin.

Appearance of the product and contents of the package

Fluconazole Sandoz 50 mg hard capsules: hard gelatin capsule with a yellow opaque cap and body, in packages containing 7 capsules or 500 (EC) capsules.

Fluconazole Sandoz 100 mg hard capsules: hard gelatin capsule with a white opaque cap and body, in packages containing 7 capsules or 100 (EC) capsules.

Fluconazole Sandoz150 mg hard capsules:hard gelatin capsule with a yellow cream opaque cap and body, in packages containing 1 capsule, 4 capsules, or 100 (EC) capsules.

Fluconazole Sandoz200mg hard capsules:hard gelatin capsule with a blue opaque cap and a white opaque body, in packages containing 7 capsules or 100 (EC) capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

LICONSA, S.A.

Avda. Miralcampo, Nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of thisleaflet: March 2024

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