Package Insert: Information for the User

Candifix 150 mg Hard Capsules EFG

Fluconazole

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Candifix is one of the medications in the group called “antifungals”. The active ingredient is fluconazole.

Candifix is used to treat infections caused by fungi, and it may also be used to prevent the appearance of a fungal infection. The most common cause of fungal infections is a yeast calledCandida.

Adults

Your doctor may prescribe this medication 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 byCandidalocated in the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
• Mucosal candidiasis – an infection that affects the mucous membrane 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, inguinal ringworm, nail infection.

They may also prescribe this medication to:

• Prevent the recurrence of cryptococcal meningitis.
• Prevent the recurrence of mucosal infections caused byCandida.
• Reduce the recurrence of vaginal infections caused byCandida.
• Prevent the transmission of infections caused byCandida(if your immune system is weak and does not function properly).

Children and adolescents (0 to 17 years)

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

• Mucosal candidiasis – an infection that affects the mucous membrane of the mouth or throat.
• Infections caused byCandidalocated in the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
• Cryptococcal meningitis – a fungal infection in the brain.

They may also prescribe this medication to:

• Prevent the transmission of infections caused byCandida(if your immune system is weak and does not function properly).
• Prevent the recurrence of cryptococcal meningitis.

Do not take Candifix:

• If you are allergic (hypersensitive) to fluconazole, or to other medicines you have taken to treat fungal infections or any of the other components of this medicine (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing.
• If you are taking astemizole, terfenadine (antihistamines for treating 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 for treating infections).

Warnings and precautions

Consult 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 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”, where the adrenal glands do not produce enough of certain hormones, such as cortisol (chronic fatigue or prolonged weakness, muscle weakness, loss of appetite, weight loss, abdominal pain).
• If you have ever had a severe skin rash or 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 in relation to fluconazole treatment. Stop taking fluconazole and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Talk to your doctor or pharmacist if the fungal infection does not improve, as an alternative antifungal treatment may be necessary.

Other medicines and Candifix

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

There are some medicines that may interact with Candifix.

Make sure your doctor knows if you are taking any of the following medicines, as it may be necessary to adjust the dose or monitor to ensure the medicines continue to have the desired effect:

:

• Rifampicin or rifabutin (antibiotics for infections).
• Abrocitinib (used to treat atopic dermatitis, also known as eczema).
• Alfentanil, fentanil (used as anesthetics).
• Amitriptyline, nortriptyline (used as antidepressants).
• Ampicillin B, voriconazole (antifungals).
• Medicines that make 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).
• Olaparib (used to treat ovarian cancer).
• Ciclosporin, 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, and fluvastatin, or similar medicines) used to reduce high cholesterol levels.
• Methadone (used for pain).
• Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Nonsteroidal Anti-Inflammatory Drugs – NSAIDs).
• Oral contraceptives.
• Prednisone (steroid).
• Zidovudine, also known as AZT; saquinavir (used in patients infected with HIV).
• Medicines for diabetes, such as chlorpropamide, glibenclamide, 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 slow the deterioration of kidney function).
• Vitamin A (nutritional supplement).
• Ivacaftor (alone or combined with medicines used to treat cystic fibrosis).
• Amiodarone (used to treat irregular heartbeats).
• Hydrochlorothiazide (diuretic).
• Ibrutinib (used to treat blood cancer).
• Lurasidone (used to treat schizophrenia).

Taking Candifix 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 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 becoming pregnant.

For longer courses of fluconazole treatment, consult your doctor about the need to use suitable contraceptive methods during treatment, which should be continued for one week after the last dose.

You should not take fluconazole if you are pregnant, think you may be pregnant, or plan to become pregnant, unless your doctor has told you to do so. If you become pregnant while taking this medicine or within one week of 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 taken 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 leg 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 unclear.

You can continue breastfeeding after taking a single dose of 150 mg of fluconazole. Do not continue breastfeeding if you are taking repeated doses of fluconazole.

Driving and operating machinery

When driving or operating machinery, be aware that occasional dizziness or seizures may occur.

Candifix contains lactose

This medicine contains lactose (milk sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Candifix contains sodium

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

Follow exactly the administration instructions for Candifix indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The capsules should be swallowed whole with the help of a glass of water. It is better to take your medication always at the same time of day.

The recommended dose of this medication for different types of infections is as follows:

Adults

Use in adolescents aged 12 to 17 years

Follow the dose indicated by your doctor (the adult dose or the pediatric 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 aged 0 to 4 weeks

Use in children aged 3 to 4 weeks:

• The same dose as described in the table, but administered once every 2 days. The maximum dose is 12 mg per kilogram 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 kilogram of body weight every 72 hours.

In some cases, doctors may prescribe different doses than those described. Follow exactly the administration instructions indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Older patients

The usual adult dose, unless you have kidney problems

Patients with kidney problems

Your doctor may change 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 to the nearest hospital immediately. You can also call the Toxicological Information Service, phone: 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). It may be appropriate to initiate symptomatic treatment (with supportive measures and gastric lavage if necessary).

If you forget to take Candifix

Do not take a double dose to make up for the missed doses. If you forget 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 medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking fluconazole and seek medical attentionimmediatelyif you notice any of the following symptoms:

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

Some people developallergic reactionsalthough severe allergic reactions are rare.If any side effect occurs, talk to your doctor or pharmacist. This includes any possible side effect not mentioned in this leaflet.If you experience any of the following symptoms,inform your doctor immediately.

• Sudden palpitations while breathing, 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 rash that causes blisters (this may affect the mouth and tongue).

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

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

If you experience any of these symptoms, stop taking the medicine andinform your doctor immediately.

Other side effects

In addition, if you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

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

Less frequent side effects (may affect up to 1 in 100 patients) are:

• Reduction of red blood cells, which may cause pale skin and weakness or difficulty breathing.
• Loss of appetite.
• Inability to sleep, numbness.
• Convulsions, dizziness, sensation of spinning, tingling, pins and needles, changes in taste.
• Constipation, heavy digestion, gas, dry mouth.
• Muscle pain.
• Liver damage and yellowing of the skin and eyes (jaundice).
• Rashes, blisters (pustules), itching, increased sweating.
• Fatigue, general feeling of discomfort, fever.

Rare side effects (may affect up to 1 in 1000 patients) are:

• White blood cells in the blood that help us fight 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 levels of cholesterol, fats).
• Low levels of potassium 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.

Side effects of unknown frequency, but which may occur (cannot be estimated from available data):

• Drug hypersensitivity reaction with skin rash, fever, swollen glands, increased eosinophils, and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or rash with eosinophilia and systemic symptoms [DRESS]).

Reporting side effects

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

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Candifix

The active ingredient is fluconazole. Each hard capsule contains 150 mg of fluconazole.

The other components (excipients) are:

• Content of the capsule:lactose monohydrate (lactose), pregelatinized cornstarch, magnesium stearate, anhydrous colloidal silica, and sodium lauryl sulfate.
• Composition of the capsule:gelatin and titanium dioxide (E171).

Appearance of the product and contents of the packaging

The capsules have a white body and cap.

It is presented in blisters of 1 and 4 hard capsules and in a clinical pack of 100 hard capsules.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

ARAFARMA GROUP S.A.

C/ Fray Gabriel de San Antonio 6-10

Pol. Ind. del Henares

19180 Marchamalo. Guadalajara. Spain

Responsible for manufacturing:

ARAFARMA GROUP S.A.

C/ Fray Gabriel de San Antonio 6-10

Pol. Ind. del Henares

19180 Marchamalo. Guadalajara. Spain

or

Laboratorio Farmacéutico C.T. SRL

Vía Dante Alighieri, 71

Sanremo I-18038-Italy

Last review date of this leaflet:September 2024

Other sources of information

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