Candifix 150 mg hard capsules EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Candifix 150 mg hard capsules EFG
Fluconazole
Please read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
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Keep this leaflet as you may need to read it again.
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If you have any questions, ask your doctor, pharmacist, or nurse.
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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.
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If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.
Leaflet Contents
- What Candifix is and what it is used for.
- What you need to know before taking Candifix.
- How to take Candifix.
- Possible side effects.
- How to store Candifix.
- Contents of the pack and other information.
1. What Candifix is and what it is used for
Candifix is one of the medicines belonging to the group called "antifungals". The active substance is fluconazole.
Candifix is used to treat fungal infections, and it can also be used to prevent the occurrence of a fungal 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 affecting the bronchopulmonary system.
- Infections caused by Candida 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.
This medicine may also be prescribed to:
- Prevent recurrence of cryptococcal meningitis.
- Prevent recurrence of mucosal infections caused by Candida.
- Reduce repeated occurrences of vaginal infections caused by Candida.
- Prevent transmission of infections caused by Candida (if your immune system is weak 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.
- Infections caused by Candida located in the bloodstream, in body organs (e.g. heart, lungs) or in the urinary tract.
- Cryptococcal meningitis – a fungal infection in the brain.
This medicine may also be prescribed to:
- Prevent transmission of infections caused by Candida (if your immune system is weak and not functioning properly).
- Prevent recurrence of cryptococcal meningitis.
2. What you need to know before taking Candifix
Do not take Candifix:
- If you are allergic (hypersensitive) to fluconazole, to other antifungal medicines you have taken to treat fungal infections, 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 quinidina (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 starting to take Candifix:
- 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 developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Candifix.
Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with fluconazole treatment. Stop taking fluconazole and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.
Talk to your doctor or pharmacist if your fungal infection does not improve, as an alternative antifungal treatment may be needed.
Other medicines and Candifix
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 Candifix (see section: “Do not take Candifix if”).
Some medicines may interact with Candifix.
Make sure your doctor knows if you are taking any of the following medicines, as dose adjustments or monitoring may be necessary to ensure these medicines remain effective:
- Rifampicin or rifabutin (antibiotics for infections).
- Abrocitinib (used to treat atopic dermatitis, also known as atopic eczema).
- Alfentanil, fentanyl (used as anesthetics).
- Amitriptyline, nortriptyline (used as antidepressants).
- Amphotericin B, voriconazole (antifungals).
- Medicines that make the blood less viscous, to prevent clot formation (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 reduce 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 the decline in kidney function).
- Vitamin A (nutritional supplement).
- Ivacaftor (alone or combined with medicines used to treat cystic fibrosis).
- Amiodarone (used to treat irregular heartbeats “arrhythmias”).
- Hydrochlorothiazide (a diuretic).
- Ibrutinib (used to treat blood cancer).
- Lurasidone (used to treat schizophrenia).
Taking Candifix with food and drinks
You may take this medicine with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 adequate contraceptive methods during treatment, which should be continued for one week after the last dose.
You must not take fluconazole if you are pregnant, think you may be pregnant, or intend to become pregnant, unless specifically instructed by your doctor. If you become pregnant while taking this medicine or within one week after 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 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.
Breastfeeding may continue after a single 150 mg dose of fluconazole. You must not continue breastfeeding if you are taking repeated doses of fluconazole.
Driving and using machines
When driving or operating machinery, keep in mind that dizziness or seizures may occasionally occur.
Candifix contains lactose
This medicine contains lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Candifix contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, it is essentially “sodium-free.”
3. How to take Candifix
Follow exactly the administration instructions for Candifix 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 medication at the same time of day each day.
The recommended dosage of this medicine for different types of infections is indicated below:
Adults
Condition | Dosage |
To treat cryptococcal meningitis | 400 mg on the first day, followed by 200 mg to 400 mg once daily for 6 to 8 weeks, or longer if necessary. The dose may occasionally be increased up to 800 mg |
To prevent recurrence of cryptococcal meningitis | 200 mg once daily until directed otherwise by your doctor |
To treat coccidioidomycosis | 200 mg to 400 mg once daily for 11 to 24 months, or longer if necessary. The dose may occasionally be increased up to 800 mg |
To treat systemic fungal infections caused by Candida | 800 mg on the first day, followed by 400 mg once daily until directed otherwise by your doctor |
To treat mucosal fungal infections affecting the lining of the mouth, throat, or associated with dental prostheses | 200 mg to 400 mg on the first day, then 100 mg to 200 mg once daily until directed otherwise by your doctor |
To treat mucosal candidiasis – dosage depends on the site of infection | 50 mg to 400 mg once daily for 7 to 30 days, or until directed otherwise by your doctor |
To prevent recurrence of mucosal infections affecting the lining of the mouth and throat | 100 mg to 200 mg once daily, or 200 mg three times per week, for as long as the risk of developing infection persists |
To treat genital candidiasis | 150 mg as a single dose |
To reduce recurrent episodes of vaginal candidiasis | 150 mg every third day for a total of 3 doses (day 1, 4, and 7), followed by once weekly for as long as the risk of developing infection persists |
To treat fungal skin or nail infections | Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300 to 400 mg once weekly for 1 to 4 weeks (for athlete's foot, up to 6 weeks may be needed; for nail infections, continue treatment until a healthy nail has fully grown) |
To prevent Candida infection (if your immune system is weakened and not functioning properly) | 200 mg to 400 mg once daily for as long as the risk of developing infection persists |
Use in adolescents aged 12 to 17 years
Follow the dose prescribed by your doctor (either the adult dose or the pediatric dose).
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.
Condition | Daily dose |
Oropharyngeal candidiasis and throat infections caused by Candida – dose and duration of treatment depend on the severity of the infection and its location. | 3 mg per kg of body weight once daily (on the first day, 6 mg per kg of body weight may be given) |
Cryptococcal meningitis or systemic fungal infections caused by Candida | 6 mg to 12 mg per kg of body weight once daily |
To prevent recurrence of cryptococcal meningitis | 6 mg per kg of body weight once daily |
To prevent Candida infection in children with impaired immune function | 3 mg to 12 mg per kg of body weight once daily |
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.
Occasionally, doctors may prescribe doses different from those described. Always follow your doctor's administration instructions exactly. 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 adjust your dose depending on how well your kidneys are functioning.
If you take more Candifix than you should
In case of overdose or accidental ingestion, consult your doctor, pharmacist, or go immediately to the nearest hospital. You may also call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount taken. Symptoms of a possible overdose may include hearing, seeing, feeling, and thinking things that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be appropriate (including supportive measures and gastric lavage if necessary).
If you forget to take Candifix
Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.
If you have any 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 will experience them.
Stop taking fluconazole 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).
Some people may develop allergic reactions, although severe allergic reactions are rare. If you experience any adverse effect, speak to your doctor or pharmacist. This includes any possible adverse effect not mentioned in this leaflet. If you experience any of the following symptoms, inform your doctor immediately:
- 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).
Fluconazole can affect your liver. Signs indicating liver problems include:
- Fatigue.
- Loss of appetite.
- Nausea or vomiting.
- Yellowing of the skin or whites of the eyes (jaundice).
If you experience any of these symptoms, stop taking the medicine and inform 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 malaise, fever.
Rare adverse effects (may affect up to 1 in 1,000 patients) are:
- Lower than normal levels of white blood cells that help defend against infections and blood cells that help stop bleeding.
- Reddish or purple skin discoloration, possibly due to low platelet count, 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 and peeling skin rash, severe allergic reactions, swelling of the lips or face.
- Hair loss.
Adverse effects with unknown frequency (cannot be estimated from available data):
- Hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and colon) (drug reaction or rash with eosinophilia and systemic symptoms [DRESS]).
Reporting of adverse effects
If you experience any adverse effect, consult your doctor, pharmacist, or nurse, 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: www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Candifix
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 is the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, 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 Candifix
The active substance is fluconazole. Each hard capsule contains 150 mg of fluconazole.
The other components (excipients) are:
- Capsule contents: lactose monohydrate (lactose), pregelatinized corn starch, magnesium stearate, anhydrous colloidal silica, and sodium lauryl sulfate.
- Capsule shell composition: gelatin and titanium dioxide (E171).
Appearance of the product and pack contents
The capsules have a white body and cap.
Available in blisters of 1 and 4 hard capsules, and in a clinical pack of 100 hard capsules.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
ARAFARMA GROUP S.A.
C/ Fray Gabriel de San Antonio 6-10
Pol. Ind. del Henares
19180 Marchamalo, Guadalajara, Spain
Manufacturer:
ARAFARMA GROUP S.A.
C/ Fray Gabriel de San Antonio 6-10
Pol. Ind. del Henares
19180 Marchamalo, Guadalajara, Spain
Date of the most recent review of this leaflet: September 2024
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/