Patient Information Leaflet: Package Insert

Fluconazol Stada 200 mg Hard Capsules EFG

Read this leaflet carefully before you start taking 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 similar symptoms, 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.

6.Contents of the pack and additional information

Fluconazol Stada 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 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 fluconazol for:

• Preventing the recurrence of cryptococcal meningitis.
• Preventing the recurrence of mucosal 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 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 fluconazol for:

• 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 Stada

• 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). Symptoms may include itching, skin redness or difficulty breathing.
• if you are taking astemizole, terfenadine (antihistamines to treat allergies).
• if you are taking cisapride (used to treat stomach discomfort).
• if you are taking pimozide (used to treat mental illnesses).
• if you are taking quinidine (used to treat heart arrhythmias).
• if you are taking erythromycin (an antibiotic to treat infections).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluconazol Stada

• 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 have ever had a severe skin rash or skin peeling, blisters and/or mouth sores after taking fluconazole.

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

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

Taking Fluconazol Stada with other medicines

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 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 medicines should not be taken with fluconazole (see section: “Do not take Fluconazol Stada”).

There are some medicines that may 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 ensure the medicines 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).
• Medicines that make the blood less viscous, to prevent the formation of blood 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 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 HIV-infected patients).
• 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 the deterioration of kidney function).
• Vitamin A (nutritional supplement).
• Ivacaftor (alone or in combination with medicines usedto treat cystic fibrosis).
• Amiodarone (used to treat irregular heartbeats).
• Hydrochlorothiazide (diuretic).
• Ibrutinib (used to treat blood cancer).
• Lurasidone (used to treat schizophrenia).

Taking Fluconazol Stada with food and drink

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 become pregnant, consult your doctor or pharmacist 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 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 are planning to become pregnant or to 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.

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 abnormalities affecting the heart, bones and/or muscles.

Cases of babies born with congenital abnormalities affecting the skull, ears and leg and arm 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 convulsions may occur.

Fluconazol Stada contains lactose and sodium

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor. 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 medication always at the same time of the day.

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

Adults

Use in children and adolescents

Adolescents aged 12 to 17 years

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

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.

• 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 old:

• The same dose as described in the table, but administered once every 3 days. The maximum dose is 12mg per kilogram of body weight every 72hours.

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 Stada than you should

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 packaging and the medication leaflet to the healthcare professional.

Taking too many capsules at once may make you feel unwell. 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 Stada

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

Stop taking fluconazole 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, speak with 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.

• Abnormal heartbeats, 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 rash that causes blisters (this can affect the mouth and tongue).

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

• Fatigue.
• 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 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 people) are:

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

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

• Reduction of red blood cells, which may cause pale skin and weakness or difficulty breathing.
• Loss of appetite.
• Insomnia, 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).
• Rashes, blisters (pustules), itching, increased sweating.
• Fatigue, general feeling of discomfort, fever.

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

• White blood cells 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 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.

Unknown frequency, but may occur (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]).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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.

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 of Fluconazol Stada

-The active ingredient is fluconazole. Each hard capsule contains 200 mg of fluconazole.

• The other components (excipients) are:
• Content of the capsules: lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate, and sodium lauryl sulfate.
• Composition of the capsule: indigotin (E132), titanium dioxide (E171), water, and gelatin.

Appearance of the product and content of the packaging

Fluconazol Stada 200 mg capsules are presented in the form of hard gelatin capsules, with a blue-colored cap and a white body.

They are presented in packaging of 7 or 100 (clinical packaging) hard capsules.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Liconsa Laboratories, S.A.

Avda. Miralcampo, Nº 7,

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

or

Toll Manufacturing Services, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet:March 2024

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