Package Leaflet: Information for the User

Fluconazol Aurovitas 50 mg Hard Capsules EFG

Fluconazol Aurovitas 100 mg Hard Capsules EFG

Fluconazol Aurovitas 150 mg Hard Capsules EFG

Fluconazol Aurovitas 200 mg Hard Capsules EFG

fluconazole

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 doubts, consult 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.

1.What is Fluconazol Aurovitas and what it is used for

2.What you need to know before you start taking Fluconazol Aurovitas

3.How to take Fluconazol Aurovitas

4.Possible side effects

5.Storage of Fluconazol Aurovitas

6.Contents of the pack and additional information

This medication is one of the medications in the group called "antifungals". The active ingredient is fluconazole.

This medication is used to treat infections caused by fungi, and it can also be used to prevent the appearance of a candidiasis. 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 – vaginal or penile infection,
• skin infections – e.g. athlete's foot, ringworm, inguinal ringworm, nail infection.

Your doctor may also prescribe fluconazole to:

• prevent the recurrence of cryptococcal meningitis,
• prevent the recurrence of mucosal infections,
• reduce the recurrence of vaginal infections,
• prevent 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 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 to:

• prevent the transmission of infections caused byCandida(if your immune system is weak and does not function properly),
• prevent the recurrence of cryptococcal meningitis.

Do not take Fluconazol Aurovitas:

• if you are allergic to fluconazole, other medications you have taken to treat 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 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 for infections).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• 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 develop signs of adrenal insufficiency, where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or long-term, fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain),
• if you have ever experienced severe skin eruptions 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 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.

Talk to your doctor or pharmacist if the fungal infection does not improve, an alternative antifungal treatment may be necessary.

Other medications and Fluconazol Aurovitas

Informyour doctor immediatelyif you are taking astemizole, terfenadine (an antihistamine for allergies), cisapride (used for stomach discomfort), pimozide (used to treat mental illnesses), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic for infections), as these medications should not be taken with this medication (see section: “Do not take Fluconazol Aurovitas”).

There are some medications that may interact with this medication. Make sure your doctor knows if you are taking any of the following medications, as it may be necessary to adjust the dose or monitor to ensure the medications 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)
• amphotericin B, voriconazole (antifungals)
• medications that make blood less viscous, to prevent clot formation (warfarin or other similar medications)
• benzodiazepines (midazolam, triazolam, or similar medications) 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 for ovarian cancer)
• ciclosporin, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection)
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medications) used to treat cancer
• halofantrine (used to treat malaria)
• 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 patients infected with HIV)
• medications for diabetes, such as chlorpropamide, glibenclamide, glipizide, or tolbutamide
• theophylline (used to control asthma)
• tofacitinib (used for rheumatoid arthritis)
• tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to slow the deterioration of renal function)
• vitamin A (nutritional supplement)
• ivacaftor (alone or combined with medications used for cystic fibrosis)
• amiodarone (used to treat irregular heartbeats, ‘arrhythmias’)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used to treat blood cancer)
• lurasidone (used to treat schizophrenia).

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Taking Fluconazol Aurovitas with food, drinks, and alcohol

You can take the medication with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

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 fluconazole treatment cycles, consult your doctor about the need to use appropriate contraceptive methods during treatment, which should be maintained for one week after the last dose.

You should not take Fluconazol Aurovitas if you are pregnant, think you may be pregnant, or intend to become pregnant, or are breastfeeding, unless your doctor has told you to.If you become pregnant while taking this medication 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 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.

You can continue breastfeeding after taking a single dose of 150 mg of this medication.

You should not continue breastfeeding if you are taking repeated doses of this medication.

Driving and operating machinery

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

Fluconazol Aurovitas contains lactose monohydrate,a type of sugar.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Fluconazol Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per hard capsule, which is essentially “sodium-free”.

Follow exactly the usage instructions for 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 better to take your capsules at the same time every day.

Instructions for removing the capsule from the blister cavity:

Pressing the capsule cavity in the center may cause deformations/breaks of the capsule as shown in Figure A. To avoid such damage to the capsule, press the capsule cavity at one end to remove it from the blister as shown in Figure B.

Fig. AFig. B

Subsequently, the recommended dose of this medication for different types of infections is indicated below:

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

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 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 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.

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 Aurovitas 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 taken. It is recommended to bring the packaging and the medication leaflet 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 Aurovitas

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 can cause side effects, although not everyone will experience them.Stop taking Fluconazol Aurovitas and seek medical attention immediately if 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 you experience any of the following side effects, talk to your doctor or pharmacist. Thisincludes possible side effects not mentioned in this leaflet. If you suffer from any of the following side effects,inform your doctor or pharmacist 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 a rash that causes blisters (this can affect the mouth and tongue)

This medicine 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 this medicine andinform your doctor immediately

Other side effects:

In addition, 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):

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

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

• 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 (pustules), itching, increased sweating
• Fatigue, general feeling of discomfort, fever

Rare side effects (may affect up to 1 in 1000 people):

• 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 but may occur (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 out of 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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

Composition of Fluconazol Aurovitas

• The active ingredient is fluconazole.
• Each capsule contains 50 mg/ 100 mg/ 150 mg or 200 mg of fluconazole.
• The other components (excipients) are: lactose monohydrate, cornstarch, sodium lauryl sulfate, anhydrous colloidal silica, and magnesium stearate.

The composition of the capsules is titanium dioxide (E171), sodium lauryl sulfate, and gelatin.

The printing ink contains shellac and yellow iron oxide (E172).

Appearance of the product and contents of the package

Fluconazol Aurovitas 50 mg hard capsules EFG

Hard gelatin capsules of white to off-white opaque color, size “4”, filled with white to off-white powder, and printed with the letter “FL” on the white to off-white opaque face and with the number “50” on the white to off-white opaque body with yellow ink.

Fluconazol Aurovitas 100 mg hard capsules EFG

Hard gelatin capsules of white to off-white opaque color, size “2”, filled with white to off-white powder, and printed with the letter “FL” on the white to off-white opaque face and with the number “100” on the white to off-white opaque body with yellow ink.

Fluconazol Aurovitas 150 mg hard capsules EFG

Hard gelatin capsules of white to off-white opaque color, size “1”, filled with white to off-white powder, and printed with the letter “FL” on the white to off-white opaque face and with the number “150” on the white to off-white opaque body with yellow ink.

Fluconazol Aurovitas 200 mg hard capsules EFG

Hard gelatin capsules of white to off-white opaque color, size “0”, filled with white to off-white powder, and printed with the letter “FL” on the white to off-white opaque face and with the number “200” on the white to off-white opaque body with yellow ink.

Fluconazol Aurovitas hard capsules are available in PVC/PVDC-Aluminum blisters.

Pack sizes of 1, 2, 3, 4, 6, 7, 10, 12, 14, 20, 28, 30, 42, 50, 60, 100, and 500 hard capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. De Burgos, 16-D

28036 Madrid

Spain.

Responsible manufacturer:

APL Swift Services (Malta) Ltd

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

or

Generis Farmaceutica, S.A.

Rua João de Deus, n. o 19, Venda Nova

2700-487, Amadora

Portugal

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Bélgica:Fluconazol AB 50 mg/100 mg/150 mg/200 mg hard capsules

Luxemburgo:Fluconazol AB 50 mg/100 mg/150 mg/200 mg hard capsules

Polonia:Fluconazole Aurovitas

Portugal:Fluconazol Ritisca

España:Fluconazol Aurovitas 50 mg/100 mg/150 mg/200 mg hard capsules EFG.

Last review date of this leaflet:February 2024

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