FLUCONAZOLE SANDOZ 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Fluconazole Sandoz 50 mg Hard CapsulesEFG

Fluconazole Sandoz 100 mg Hard CapsulesEFG

Fluconazole Sandoz 150 mg Hard CapsulesEFG

Fluconazole Sandoz 200 mg Hard CapsulesEFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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. See section 4.

Contents of the pack

1. What is Fluconazole Sandoz and what is it used for
2. What you need to know before you take Fluconazole Sandoz
3. How to take Fluconazole Sandoz
4. Possible side effects
5. Storage of Fluconazole Sandoz
6. Contents of the pack and other information

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

Fluconazole is one of a group of medicines called “antifungals”. The active substance is fluconazole. Fluconazole is used for the treatment of infections caused by fungi, and it can also be used to prevent fungal infections.

The most common cause of fungal infections is a yeast called Candida.

Adults

Your doctor may prescribe this medicine 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,
• Candidainfections located in the bloodstream, in body organs (e.g., heart, lungs) or in the urinary tract,
• mucosal candidiasis: infection affecting the lining of the mouth, throat, or associated with dental prostheses,
• genital candidiasis: infection of the vagina or penis,
• skin infections: (e.g., athlete's foot, ringworm, jock itch, nail infection).

They may also prescribe Fluconazole Sandoz for:

• preventing the recurrence of cryptococcal meningitis,
• preventing the recurrence of Candidamucosal infections,,
• 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 the treatment of the following types of fungal infections:

• mucosal candidiasis: infection affecting the lining of the mouth or throat,
• Candidainfections located in the bloodstream, in body organs (e.g., heart, lungs) or in the urinary tract,
• cryptococcal meningitis: a fungal infection in the brain.

They may also prescribe Fluconazole Sandoz for:

• preventing the spread of Candidainfections (if your immune system is weak and not working properly),

preventing the recurrence of cryptococcal meningitis.

2. What you need to know before you take Fluconazole Sandoz

Do not take Fluconazole Sandoz:

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

Warnings and precautions

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

• you have liver or kidney problems,
• you suffer from heart disease, including heart rhythm problems,
• you have abnormal levels of potassium, calcium, or magnesium in the blood,
• severe skin reactions occur (itching, skin rash, or difficulty breathing),
• if signs of “adrenal insufficiency” appear, in which the adrenal glands do not produce a sufficient amount 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,
• 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 immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Other medicines and Fluconazole Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inform your doctor immediatelyif you are taking, have recently taken, or might need to take the following medicines that may interact with fluconazole, such as astemizole, terfenadine (an antihistamine for the treatment of allergies), cisapride (used for stomach upset), pimozide (used for the treatment of mental illnesses), quinidine (used for the treatment of heart arrhythmias), or erythromycin (an antibiotic for the treatment of infections), as these medicines should not be taken with fluconazole (see section: “Do not take Fluconazole Sandoz”).

There are some medicines that may interact with fluconazole.

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

• rifampicin or rifabutin (antibiotics for infections),
• 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 for the treatment of seizures),
• nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (for high blood pressure),
• olaparib (used for the treatment of ovarian cancer),
• cyclosporine, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection),
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines) used for cancer treatment,
• halofantrine (used for the treatment of 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 HIV-infected patients),
• medicines for diabetes, such as chlorpropamide, glibenclamide, glipizide, or tolbutamide,
• theophylline (used to control asthma),
• tofacitinib (used for the treatment of rheumatoid arthritis),
• tolvaptan (used for the treatment of hyponatremia (low sodium levels in the blood) or to slow the deterioration of kidney function).
• vitamin A (nutritional supplement),
• ivacaftor (used for the treatment of cystic fibrosis),
• amiodarone (used for the treatment of irregular heartbeats),
• hydrochlorothiazide (diuretic),
• ibrutinib (used to treat blood cancer).

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Fluconazole Sandoz 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 this 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, whose use should be maintained 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 or breastfeed, unless your doctor has told you to.

You can continue breastfeeding after taking a single dose of up to 150 mg of fluconazole. You should 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 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.

Driving and using machines

When driving or using machines, you should take into account that dizziness or seizures may occasionally occur.

Fluconazole Sandoz contains lactose and sodium

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

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

3. How to take Fluconazole Sandoz

Follow exactly the administration instructions of this medicine 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 medicines always at the same time of day.

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

Adults

Adolescents from 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 of age

The maximum daily dose for children is 400 mg per day.

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

Children from 0 to 4 weeks of age

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.

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

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 working.

If you take more Fluconazole Sandoz than you should

Taking too many capsules at once can 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 medicine 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 stomach lavage if necessary).

If you forget to take Fluconazole Sandoz

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 your next dose, do not take the missed dose.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some people develop allergic reactions, although severe allergic reactions are rare. If any of the following adverse effects appear, talk to your doctor or pharmacist. This includes any 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 Sandoz may affect your liver. Signs that indicate liver problems include:

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

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

Other Adverse Effects:

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

Frequent Adverse Effects (may affect up to 1 in 10 patients):

• headache,
• stomach upset, diarrhea, discomfort, nausea and vomiting,
• elevated blood test results indicating liver function,
• rash.

Infrequent Adverse Effects (may affect up to 1 in 100 patients):

• reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing,
• decreased appetite,
• sleeplessness, 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):

• white blood cells in the blood that help defend against infections and blood cells that help stop bleeding, lower than normal,
• red or purple skin discoloration, which can 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,
• altered 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 (cannot be estimated from available data):

• hypersensitivity reaction with skin rash, fever, swollen 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]).

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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Fluconazol Sandoz

Keep this medicine out of 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.

Store in the original packaging.

No special storage conditions are required.

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 your 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. Package Contents and Additional Information

Composition ofFluconazol Sandoz

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

Capsule contents: lactose monohydrate (lactose), cornstarch, colloidal silicon dioxide, magnesium stearate, and sodium lauryl sulfate.

Capsule composition:

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

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

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

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

Product Appearance and Package Contents

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

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

Fluconazol Sandoz 150 mg hard capsules: hard gelatin capsule with opaque yellow cream cap and body, in packages containing 1 capsule, 4 capsules, or 100 (EC) capsules.

Fluconazol Sandoz 200 mg hard capsules: hard gelatin capsule with opaque blue cap and white opaque body, in packages containing 7 capsules or 100 (EC) capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 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 thisProspectus: March 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/