FLUCONAZOLE ARISTO 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fluconazole ARISTO 100 mg hard capsules EFG

Fluconazole

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

Fluconazole ARISTO is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Fluconazole ARISTO is used to treat infections caused by fungi, and it can also be used to prevent fungal infections from occurring. 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 – 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, jock itch, nail infection.

They may also prescribe Fluconazole ARISTO for:

• Preventing the recurrence of cryptococcal meningitis.
• Preventing the recurrence of mucosal infections.
• Reducing the repeated occurrence of vaginal yeast infections.
• 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 – an infection that affects 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 ARISTO 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 taking Fluconazole ARISTO

Do not take Fluconazole ARISTO if

• You are allergic (hypersensitive) to fluconazole, to other medicines for treating fungal infections, or to any of the other ingredients of Fluconazole ARISTO. Symptoms may include itching, skin rash, or difficulty breathing.
• You are taking astemizole, terfenadine (antihistamines for treating allergies).
• You are taking cisapride (used for stomach upset).
• You are taking pimozide (used for treating mental illness).
• You are taking quinidine (used for treating heart arrhythmias).
• You are taking erythromycin (an antibiotic for treating infections).

Be cautious with Fluconazole ARISTO

Tell your doctor if

• You have liver or kidney problems.
• You have a heart condition, including heart rhythm problems.
• You have abnormal levels of potassium, calcium, or magnesium in your blood.
• You experience severe skin reactions (itching, skin rash, or difficulty breathing).
• You have ever had a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking Fluconazole ARISTO.

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

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

Using other medicines

Tell your doctor immediatelyif you are taking astemizole, terfenadine (an antihistamine for treating allergies), cisapride (used for stomach upset), pimozide (used for treating mental illness), quinidine (used for treating heart arrhythmias), or erythromycin (an antibiotic for treating infections), as these medicines should not be taken with Fluconazole ARISTO (see section: “Do not take Fluconazole ARISTO if”).

There are some medicines that may interact with Fluconazole ARISTO.

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 you sleep or for anxiety.
• Carbamazepine, phenytoin (used for treating seizures).
• Nifedipine, isradipine, amlodipine, felodipine, and losartan (for high blood pressure).
• Ciclosporin, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection).
• Cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines) used for treating cancer.
• Halofantrine (used for treating malaria).
• Statins (atorvastatin, simvastatin, and fluvastatin or similar medicines) used for reducing high cholesterol levels.
• Methadone (used for pain relief).
• 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 for controlling asthma).
• Vitamin A (nutritional supplement).

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Taking Fluconazole ARISTO with food and drinks

You can take the medicine with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using 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, which should be continued for one week after the last dose.

Do not take Fluconazole ARISTO if you are pregnant, think you may be pregnant, or are planning 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 last dose, consult your doctor.

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 the 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.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

When driving or operating machinery, keep in mind that dizziness or seizures may occasionally occur.

Important information about some of the ingredients of Fluconazole ARISTO

This medicine contains a small amount of lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Fluconazole ARISTO

Follow the instructions for taking Fluconazole ARISTO exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The capsules should be swallowed whole with the help of a glass of water. It is best to take your medicines at the same time every day.

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

Adults

Adolescents 12 to 17 years of age

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

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 from 0 to 4 weeks of age

Use in 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.

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.

Sometimes, doctors may prescribe different doses than those described. Follow the instructions for taking Fluconazole ARISTO exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Elderly patients

The usual adult dose, unless you have kidney problems.

Patients with kidney problems

Your doctor may change the dose, depending on how well your kidneys are working.

If you take more Fluconazole ARISTO than you should

Taking too many capsules at once can make you feel unwell. Contact your doctor or the nearest hospital immediately. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. 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 ARISTO

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 the next dose, do not take the missed dose.

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

4. Possible Adverse Effects

Like all medicines, Fluconazol ARISTO 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 symptoms appear, tell your doctor immediately.

• Sudden 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 can affect the mouth and tongue).

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

• Fatigue.
• Loss of appetite.
• Vomiting.
• Yellowing of the skin or the whites of the eyes (jaundice).

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

Stop taking Fluconazol ARISTO 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).

Other Adverse Effects:

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

The following are frequent adverse effects that affect 1 to 10 out of every 100 patients:

• Headache.
• Stomach upset, diarrhea, discomfort, vomiting.
• Elevated blood test results indicating liver function.
• Rash.

The following are infrequent adverse effects that affect 1 to 10 patients out of every 1,000:

• Reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing.
• Decreased appetite.
• Insomnia, 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.

The following are rare adverse effects that affect 1 to 10 patients out of every 10,000:

• White blood cells in the blood that help defend against 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 cholesterol, fat levels).
• 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.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not mentioned in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Fluconazol ARISTO

Keep this medicine out of the sight and reach of children.

Do not use Fluconazol ARISTO after the expiration date stated 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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fluconazol ARISTO

The active ingredient is fluconazole.

Each hard capsule contains 100 mg of fluconazole.

The other components (excipients) are:

Capsule content:

Lactose monohydrate (lactose).

Pregelatinized cornstarch (cornstarch).

Colloidal silicon dioxide.

Magnesium stearate (E 572).

Sodium lauryl sulfate.

Capsule composition:

Quinoline yellow

Titanium dioxide (E 171)

Gelatin

Appearance of Fluconazol ARISTO 100 mg Hard Capsules and Package Contents

Hard gelatin capsule of 100 mg, with a white body and a yellow cap.

It is presented in packages of 7 hard capsules and a clinical package with 100 hard capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer:

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses, 2.

28108 Alcobendas (Madrid) SPAIN.

Laboratorios Medicamentos Internacionales S.A. (MEDINSA)

C/Solana 26

28850, Torrejón de Ardoz

Madrid, Spain

This prospectus was approved in January 2024

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