FLUCONAZOLE CINFA 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fluconazole Cinfa 50 mg Hard Capsules EFG

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Fluconazole is used to treat infections caused by fungi, and it can also be used to prevent the appearance of a Candida infection. The most common cause of fungal infections is a yeast called Candida.

Adults

Your doctor may prescribe this medicine 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 by Candida localized 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 for:

• Avoiding the recurrence of cryptococcal meningitis.
• Avoiding the recurrence of mucosal Candida infections.
• Reducing the repeated appearance of vaginal Candida infections.
• Preventing the spread of Candida infections (if your immune system is weak and not working properly).

Children and adolescents (0 to 17 years)

Your doctor may prescribe this medicine to treat the following types of fungal infections:

• Mucosal candidiasis – an infection that affects the lining of the mouth or throat.
• Infections caused by Candida localized 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 for:

• Preventing the spread of Candida infections (if your immune system is weak and not working properly).

Avoiding the recurrence of cryptococcal meningitis.

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

Do not take Fluconazole Cinfa

• If you are allergic 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). The symptoms can include itching, skin redness, or difficulty breathing.
• If you are taking astemizole, terfenadine (antihistamine medicines for treating allergies).
• If you are taking cisapride (used for stomach upset).
• If you are taking pimozide (used for treating mental illnesses).
• If you are taking quinidine (used for treating heart arrhythmias).
• If you are taking erythromycin (an antibiotic for treating infections).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluconazole Cinfa

• If you have liver or kidney problems.
• If you have a heart condition, 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 experience signs of “adrenal insufficiency”, in which the adrenal glands do not produce enough 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, you may need an alternative antifungal treatment.

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 Cinfa

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

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

There are some medicines that can 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 you sleep or for anxiety.
• Carbamazepine, phenytoin (used for treating seizures).
• Nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (for high blood pressure).
• Olaparib (used for treating ovarian cancer).
• 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).
• Tofacitinib (used for treating rheumatoid arthritis).
• Tolvaptan (used for treating hyponatremia [low sodium levels in the blood] or to slow down the deterioration of kidney function).
• Vitamin A (nutritional supplement).
• Ivacaftor (used for treating cystic fibrosis).
• Amiodarone (used for treating irregular heartbeats [arrhythmias]).
• Hydrochlorothiazide (diuretic).
• Ibrutinib (used for treating blood cancer).

Taking Fluconazole Cinfa 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, which should be continued 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. If you become pregnant while taking this medicine or within one week of the last dose, consult your doctor.

You can continue breastfeeding after taking a single dose of 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 operating machinery, you should take into account that dizziness or seizures may occasionally occur.

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

Fluconazole Cinfa contains sodium

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

3. How to take Fluconazole Cinfa

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in 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 are the recommended doses of this medicine for the different types of infections:

Adults

Use in adolescents from 12 to 17 years of age

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

Use in 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.

Elderly patients

The recommended dose in adults, 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 Cinfa than you should

Taking too many capsules at once can make you feel unwell. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the leaflet and the packaging of the medicine 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 stomach lavage if necessary).

If you forget to take Fluconazole Cinfa

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 adverse effect appears, talk to your doctor or pharmacist. This includes any possible adverse effect not mentioned in this prospectus.

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

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

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

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

If you experience any of these symptoms, stop taking fluconazole 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) are:

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

Uncommon adverse effects (may affect up to 1 in 100 patients) are:

• 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.

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

• White blood cells that help defend against infections and blood cells that help stop bleeding, lower than normal.
• Red or purple skin discoloration, which may 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.
• 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.

Frequency not known (cannot be estimated from available data):

• Hypersensitivity reaction with skin rash, fever, inflamed 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]).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this prospectus. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's pharmacovigilance system: https://www.notificaram.es.

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

5. Storage of Fluconazole Cinfa

Keep this medicine out of the 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.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. 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 Fluconazole Cinfa

• The active ingredient is fluconazole.

Each hard capsule contains 50 mg of fluconazole.

• The other ingredients (excipients) are:

Capsule content: pregelatinized cornstarch, sodium carboxymethyl starch (type A) (from potato), magnesium stearate, anhydrous colloidal silica, lactose monohydrate (lactose), and sodium lauryl sulfate

Capsule composition: gelatin, titanium dioxide (E-171), indigo carmine (E-132), and erythrosine (E-127).

Appearance of the Product and Package Contents

The capsules have a white body and a purple cap.

They are available in packs of 7 or 500 (clinical packaging) hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra)-Spain

Date of the Last Revision of this Prospectus:February 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67927/P_67927.html

QR code to: https://cima.aemps.es/cima/dochtml/p/67927/P_67927.html