FLUCONAZOLE CINFA 150 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

fluconazol cinfa 150 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 fluconazol cinfa and what is it used for
2. What you need to know before you take fluconazol cinfa
3. How to take fluconazol cinfa
4. Possible side effects
5. Storing fluconazol cinfa
6. Contents of the pack and other information

1. What is fluconazol cinfa and what is it used for

fluconazol 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 an infection by Candida. The most common cause of fungal infections is a yeast called Candida.

Adults

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

• Cryptococcal meningitis – a fungal infection in the brain.
• Coccidioidomycosis – a disease of the bronchopulmonary system.
• Infections caused by Candidalocalized 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:

• Preventing the recurrence of cryptococcal meningitis.
• Preventing the recurrence of mucosal Candidainfections.
• 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 following types of fungal infections:

• Mucosal candidiasis – an infection that affects the lining of the mouth or throat.
• Infections caused by Candidalocalized 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 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 fluconazol cinfa

Do not take fluconazol 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 rash 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 illness).
• 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 taking fluconazol 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 severe skin reactions occur (itching, skin rash or difficulty breathing).
• If signs of "adrenal insufficiency" appear, 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, it may be necessary to use 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 fluconazol 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 fluconazol cinfa

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

Immediately inform your doctor if 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 (see section: “Do not take fluconazol 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 sleep or for anxiety.
• Carbamazepine, phenytoin (used for treating convulsions).
• 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).
• 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 kidney function deterioration).
• 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 fluconazol cinfa with food and drinks

You can take the medicine with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 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 breast-feed, 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 breast-feeding after taking a single dose of 150 mg of fluconazole. You should not continue breast-feeding 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 convulsions can occasionally occur.

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

fluconazol 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 fluconazol cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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 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 given 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 given 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 fluconazol 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 take the leaflet and the medicine packaging 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 start symptomatic treatment (with supportive measures and stomach lavage if necessary).

If you forget to take fluconazol 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 further questions on 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 leaflet.

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 enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Fluconazole 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 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 leaflet, inform your doctor or pharmacist.

Frequent adverse effects (may affect up to 1 in 10 patients) are:

• Headache.
• Stomach upset, diarrhea, discomfort, vomiting.
• High 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 leaflet. 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 any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. 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 150 mg of fluconazole.

• The other ingredients (excipients) are:

Capsule content: pregelatinized corn starch, 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), quinoline yellow (E-104), and erythrosine (E-127)

Appearance of the Product and Package Contents

The capsules have a yellow-orange body and a garnet cap.

They are available in packages of 1, 4, or 100 (clinical package) hard capsules.

Only some package 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 Leaflet: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 leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67928/P_67928.html

QR code to: https://cima.aemps.es/cima/dochtml/p/67928/P_67928.html