Fluconazole Cinfa 150 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

fluconazole 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 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Fluconazole cinfa is one of the medicines belonging to a group called "antifungals". The active substance is fluconazole.

Fluconazole is used to treat fungal infections and may also be used to prevent the occurrence 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 of the brain.
• Coccidioidomycosis – a disease affecting the bronchopulmonary system.
• Candida infections located in the bloodstream, in body organs (e.g. heart, lungs) or in the urinary tract.
• Mucosal candidiasis – infection affecting the lining of the mouth, throat, or associated with dental prostheses.
• Genital candidiasis – infection of the vagina or penis.
• Skin infections – e.g. athlete's foot, ringworm, jock itch, nail infections.

Fluconazole may also be prescribed to:

• Prevent recurrence of cryptococcal meningitis.
• Prevent recurrence of mucosal Candida infections.
• Reduce repeated episodes of vaginal Candida infections.
• Prevent Candida infections (if your immune system is weakened and not functioning properly).

Children and adolescents (0 to 17 years)

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

• Mucosal candidiasis – infection affecting the lining of the mouth or throat.
• Candida infections located in the bloodstream, in body organs (e.g. heart, lungs) or in the urinary tract.
• Cryptococcal meningitis – a fungal infection of the brain.

Fluconazole may also be prescribed to:

• Prevent Candida infections (if your immune system is weakened and not functioning properly).

Prevent recurrence of cryptococcal meningitis.

2. What you need to know before taking fluconazole cinfa

Do not take fluconazole cinfa

• If you are allergic to fluconazole, to other antifungal medicines you have taken, 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 or terfenadine (antihistamine medicines used 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 used to treat infections).

Warnings and precautions

Talk to your doctor or pharmacist before taking fluconazole cinfa

• If you have liver or kidney problems.
• If you have a heart condition, including heart rhythm disorders.
• If you have abnormal levels of potassium, calcium, or magnesium in your blood.
• If you develop 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, skin peeling, blisters, and/or mouth sores after taking fluconazole.
• If the fungal infection does not improve, alternative antifungal treatment may be necessary.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with fluconazole. Stop taking fluconazole and seek immediate medical attention if you notice any 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 need to take any other medicines.

Inform your doctor immediately if 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 medicines must not be taken with fluconazole (see section: “Do not take fluconazole cinfa”).

Some medicines may 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 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 hypertension – high blood pressure).
• Olaparib (used to treat ovarian cancer).
• Cyclosporine, 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, fluvastatin, or similar medicines) used to lower high cholesterol levels.
• Methadone (used for pain).
• Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs – NSAIDs).
• Oral contraceptives.
• Prednisone (a steroid).
• Zidovudine, also known as AZT; saquinavir (used in HIV-infected patients).
• Medicines for diabetes, such as chlorpropamide, glyburide, glipizide, or tolbutamide.
• Theophylline (used to control asthma).
• Tofacitinib (used to treat rheumatoid arthritis).
• Tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to delay worsening of kidney function).
• Vitamin A (nutritional supplement).
• Ivacaftor (used to treat cystic fibrosis).
• Amiodarone (used to treat irregular heartbeats “arrhythmias”).
• Hydrochlorothiazide (a diuretic).
• Ibrutinib (used to treat blood cancer).

Taking fluconazole cinfa with food and drink

You may take this medicine with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become 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 trying to conceive.

For longer treatment courses with fluconazole, consult your doctor about the need to use appropriate 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 might be pregnant, plan to become pregnant, or are breastfeeding, unless your doctor has instructed you to do so. If you become pregnant while taking this medicine or within one week after the most recent dose, consult your doctor.

Breastfeeding may continue after a single 150 mg dose 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 use 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 thigh 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 not clear.

Driving and using machines

Bear in mind that dizziness or seizures may occasionally occur when driving or operating machinery.

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

fluconazole cinfa contains sodium

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

3. How to take fluconazole cinfa

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended doses of this medicine for the different types of infections are listed below:

Adults

Use in adolescents aged 12 to 17 years

Follow the dose prescribed by your doctor (either the adult or pediatric dosage).

Use in children up to 11 years of age

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 adult dose, unless you have kidney problems.

Patients with kidney problems

Your doctor may adjust your dose depending on how well your kidneys are functioning.

If you take more fluconazol cinfa 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 at telephone number 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package leaflet and the medicine container to the healthcare professional.

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 forget to take fluconazol cinfa

Do not take a double dose to make up for missed doses. If you forget 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 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 everyone experiences them.

Some people develop allergic reactions, although serious allergic reactions are rare. If you experience any adverse effect, speak with 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 itchy red spots.
• Skin rash.
• Severe skin reactions, such as blistering rash (this may affect the mouth and tongue).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Fluconazole may affect your liver. Signs indicating liver problems include:

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

If you experience any of these symptoms, stop taking fluconazole and contact your doctor immediately.

Other adverse effects:

Additionally, if you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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

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

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

• Reduction in red blood cells, which may cause pale skin, weakness, or difficulty breathing.
• Decreased appetite.
• Inability to sleep, numbness.
• Seizures, dizziness, spinning sensation, tingling, prickling, or numbness, changes in taste sensation.
• Constipation, indigestion, flatulence, dry mouth.
• Muscle pain.
• Liver damage and yellowing of the skin and eyes (jaundice).
• Hives, blisters (wheals), itching, increased sweating.
• Fatigue, general feeling of discomfort, fever.

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

• Lower than normal levels of white blood cells, which help fight infections, and blood cells that help stop bleeding.
• Reddish or purple skin discoloration, which may be due to low platelet count or other changes in blood cells.
• Changes in blood tests (high levels of cholesterol, fats).
• Low blood potassium levels.
• Tremors.
• Abnormal electrocardiogram (ECG), changes in heart rate or rhythm.
• Liver function failure.
• Allergic reactions (sometimes severe), including widespread blistering rash 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, swollen glands, increase in a type of white blood cells (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and colon) (drug reaction or eosinophilia with systemic symptoms [DRESS]).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluconazole Cinfa

• The active substance is fluconazole.

Each hard capsule contains 150 mg of fluconazole.

• The other components (excipients) are:

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

Capsule composition: gelatin, titanium dioxide (E-171), indigotine (E-132), quinoline yellow (E-104), and erythrosine (E-127).

Appearance of the product and contents of the pack

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

They are available in packs of 1, 4 or 100 (hospital pack) hard capsules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra), Spain

Date of the most recent review of this leaflet: February 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67928/P_67928.html

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