Zerfun

Package leaflet: Information for the user

Zerfun 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Zerfun is and what it is used for

Zerfun belongs to a group of medicines called "antifungals". The active substance is fluconazole.
Zerfun is used to treat fungal infections and can also be used to prevent Candida infections. The most common cause of fungal infections is a yeast called Candida.
Adults
Your doctor may prescribe this medicine to treat the following fungal infections:

• Cryptococcal meningitis – a fungal infection of the brain
• Coccidioidomycosis – a disease affecting the bronchopulmonary system
• Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs), or urinary tract
• Mucosal candidiasis – infection of the oral mucosa, throat infection, and denture-related stomatitis
• Genital candidiasis – infection of the vagina or penis
• Skin infections – e.g. athlete’s foot, ringworm, genital itching, nail infections.

Zerfun may be prescribed to you for:

• preventing recurrence of cryptococcal meningitis
• preventing recurrence of mucosal candidiasis
• reducing recurrences of vaginal candidiasis
• preventing Candida infections (if your immune system is weakened or not functioning properly).

Children and adolescents (from 0 to 17 years of age)
Your doctor may prescribe this medicine to treat the following fungal infections:

• Mucosal candidiasis – infection of the oral mucosa, throat infection
• Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs), or urinary tract
• Cryptococcal meningitis – a fungal infection of the brain.

Zerfun may be prescribed to you for:

• preventing Candida infections (if your immune system is weakened or not functioning properly)
• preventing recurrence of cryptococcal meningitis.

2. What you need to know before taking Zerfun

Do not take Zerfun

• if you are allergic to fluconazole, to other medicines used 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, terfenadine (antihistamines used to treat allergies)
• if you are taking cisapride (used to treat stomach disorders)
• if you are taking pimozide (used to treat mental disorders)
• if you are taking quinidine (used to treat cardiac arrhythmias)
• if you are taking erythromycin (an antibiotic used to treat bacterial infections)

Warnings and precautions
Talk to your doctor or pharmacist before taking Zerfun

• if you have liver or kidney problems
• if you suffer from heart diseases, including cardiac arrhythmia
• if you have abnormal levels of potassium, calcium, or magnesium in your blood
• if severe skin reactions occur (such as itching, skin redness, or difficulty breathing)
• if signs of "adrenal insufficiency" appear, meaning your adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
• if you have ever developed a severe rash or skin peeling, blisters and/or mouth ulcers after taking Zerfun.

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with Zerfun treatment. Stop taking Zerfun and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.
Contact your doctor or pharmacist if the fungal infection does not improve, as an alternative antifungal therapy may be needed.

Other medicines and Zerfun
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 (antihistamines used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental disorders), quinidine (used to treat cardiac arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with Zerfun (see section: "Do not take Zerfun").

There are some medicines that may interact with Zerfun. Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring may be necessary to ensure these medicines continue to work as intended:

• rifampicin or rifabutin (antibiotics used to treat bacterial infections)
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
• alfentanil, fentanyl (anesthetics)
• amitriptyline, nortriptyline (antidepressants)
• amphotericin B, voriconazole (antifungals)
• blood-thinning medicines to prevent blood clots (warfarin or similar medicines)
• benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety
• carbamazepine, phenytoin (used to treat epileptic seizures)
• nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (used to treat high blood pressure)
• olaparib (used to treat ovarian cancer)
• ciclosporin, everolimus, sirolimus, or tacrolimus (used 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 and similar medicines) used to reduce high cholesterol levels
• methadone (used to treat 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 patients with HIV)
• diabetes medicines 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 the blood) or to slow the decline in kidney function
• vitamin A (dietary supplement)
• ivacaftor (alone or in combination with other medicines used to treat cystic fibrosis)
• amiodarone (used to treat "arrhythmias", irregular heartbeats)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used to treat blood cancer)
• lurasidone (used to treat schizophrenia)

Zerfun with food and drinks
You may take this medicine with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Zerfun if you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, unless otherwise directed by your doctor.
If you become pregnant while taking this medicine or within 1 week after the most recent dose, contact your doctor.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken at low doses during the first trimester may slightly increase the risk of the baby being born with bone and/or muscle malformations.
You may continue breastfeeding after taking a single dose of Zerfun 150 mg.
You must not breastfeed if you are taking repeated doses of Zerfun.

Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.

Zerfun contains lactose
This medicine contains a small amount of lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e., essentially "sodium-free".

3. How to take Zerfun

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. It is preferable to take the capsules at the same time each day.
The recommended doses of this medicine, depending on the infection, are listed below:
Adults

Adolescents aged 12 to 17
Always take the dose prescribed by your doctor (either the adult dosage or the pediatric dosage).
Children up to 11 years
The maximum dose in 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 dosage described above, 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 dosage described above, but administered once every 3 days. The maximum dose is
12 mg per kg of body weight every 72 hours.
Elderly
The same dose as recommended for adults should be used unless you have renal problems.
Patients with renal impairment
Your doctor may adjust the dosage according to your kidney function.
If you take more Zerfun than you should
Taking too many capsules at once could cause you problems. Contact your doctor immediately or go to the nearest hospital.
In case of accidental overdose, symptoms may include experiencing, seeing, sensing, and thinking things that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be advisable (with appropriate supportive measures and, if necessary, gastric lavage).
If you forget to take Zerfun
Do not take a double dose to make up for a missed dose. If you forget to take a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and take the next dose at the regular time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking Zerfun and contact your doctor immediately if you notice any of the following symptoms:

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

Some people may experience allergic reactions, although severe allergic reactions are rare. If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. If you experience any of the following symptoms, inform your doctor immediately:

• sudden shortness of breath, difficulty breathing, or chest tightness
• swelling of the eyelids, face, or lips
• itching all over the body, skin redness, or itchy red patches
• skin rashes
• severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue).

Zerfun may have effects on the liver. Symptoms of liver problems include:

• fatigue
• loss of appetite
• vomiting
• yellowing of the skin and whites of the eyes (jaundice).

If you experience any of these symptoms, stop taking Zerfun and contact your doctor immediately.
Other side effects:
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Common side effects (may affect up to 1 in 10 people) are:

• headache
• stomach discomfort, diarrhoea, nausea, vomiting
• increased liver function test values in blood tests
• skin rashes.

Uncommon side effects (may affect up to 1 in 100 people) are:

• reduction in red blood cells, which may cause paleness, weakness, or breathlessness
• decreased appetite
• insomnia, drowsiness
• seizures, dizziness, vertigo, tingling, prickling, or numbness, altered taste sensation
• constipation, difficulty digesting, flatulence, dry mouth
• muscle pain
• liver damage and yellowing of the skin and eyes (jaundice)
• swelling, blisters (urticaria), itching, increased sweating
• fatigue, general malaise, fever.

Rare side effects (may affect up to 1 in 1,000 people) are:

• lower than normal levels of white blood cells (which help defend against infections) and platelets (which enable blood clotting)
• skin discoloration (red or purplish), which may be caused by a reduction in platelets, or other changes in blood cells
• changes in blood chemistry (elevated cholesterol or fat levels)
• low potassium levels in the blood
• chills
• abnormal electrocardiogram (ECG), changes in heart rhythm and rate
• liver failure
• allergic reactions (sometimes severe), including skin rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face
• hair loss.

Frequency not known, but possible (frequency cannot be estimated from the 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 skin rash with eosinophilia and systemic symptoms (DRESS)).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zerfun

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zerfun contains

• The active substance is fluconazole. Each hard capsule contains 100 mg, 150 mg, or 200 mg of fluconazole.
• The other components are: Capsule core: lactose monohydrate, pregelatinized starch, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate. Capsule coating: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) (only in 100 mg capsules).

Description of the appearance of Zerfun 100 mg, 150 mg and 200 mg hard capsules and pack sizes

Zerfun 100 mg hard capsules are yellow. They are available in blisters of 10 capsules containing 100 mg each.
Zerfun 150 mg hard capsules are white. They are available in blisters of 2 capsules containing 150 mg each.
Zerfun 200 mg hard capsules are white. They are available in blisters of 7 capsules containing 200 mg each.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
IDI Farmaceutici S.r.l. – Via dei Castelli Romani, 83/85 – Pomezia (Rome)
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. – via Dante Alighieri 71 – 18038 Sanremo (Imperia)