Fungus

PACKAGE LEAFLET: INFORMATION FOR THE USER

FUNGUS "100 mg hard capsules", "150 mg hard capsules", "200 mg hard capsules"

Fluconazole
Generic Medicine
Read this leaflet carefully before taking this medicine.

• 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. Do not give it to others, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT FUNGUS IS AND WHAT IT IS USED FOR

FUNGUS belongs to a group of medicines called "antifungals". The active substance is fluconazole.
FUNGUS 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 for the treatment of 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

FUNGUS may be prescribed to:

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

Children and adolescents (0 to 17 years of age)
Your doctor may prescribe this medicine for the treatment of 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

FUNGUS may be prescribed to:

• Prevent Candida infections (if the immune system is weakened or not functioning properly)
• Prevent recurrence of cryptococcal meningitis

2. What you should know before taking FUNGUS

Do not take FUNGUS if you:

• are allergic (hypersensitive) to fluconazole, to other medicines you have used to treat fungal infections, or to any of the excipients of FUNGUS. Symptoms may include itching, skin redness, or difficulty breathing
• are taking astemizole or terfenadine (antihistamines used to treat allergies)
• are taking cisapride (used to treat stomach disorders)
• are taking pimozide (used to treat mental disorders)
• are taking quinidine (used to treat cardiac arrhythmias)
• are taking erythromycin (an antibiotic used to treat bacterial infections)

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking FUNGUS
If you develop signs of "adrenal insufficiency", in which the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
Tell your doctor if:

• you have liver or kidney problems
• you suffer from heart diseases, including cardiac arrhythmia
• you have abnormal levels of potassium, calcium, or magnesium in your blood
• the fungal infection does not improve; an alternative antifungal therapy may be needed
• severe skin reactions occur (itching, skin redness, or difficulty breathing)
• you have previously developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking Fungus
• you are taking any of the following medicines:
  • amiodarone (used to treat irregular heartbeat, "arrhythmia")
  • hydrochlorothiazide (a diuretic)
    Serious skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with FUNGUS treatment. Stop taking Fungus and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4. Inform your doctor or pharmacist if you are taking or have taken other medicines, even those without a prescription.

Other medicines and Fungus
Tell your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicine.
Contact your doctor immediately if you are taking astemizole or 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 Fungus (see section: "Do not take Fungus").
Some medicines may interact with Fungus. Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring may be needed 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)
• Medicines that thin the blood 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 hypertension - high blood pressure)
• Olaparib (used to treat ovarian carcinoma)
• Cyclosporine, 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)
• 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 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 (diuretic use)
• Ibrutinib (used to treat blood cancer)
• Lurasidone (used to treat schizophrenia)

Taking FUNGUS 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, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are planning a pregnancy, you should wait one week after a single dose of fluconazole before attempting to conceive.
For longer treatment cycles with fluconazole, consult your doctor to assess the need for adequate contraception during treatment, which should continue for one week after the last dose.
Do not take Fungus if you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, unless your doctor specifically tells you to. If you become pregnant while taking this medicine or within one week after the most recent dose, contact your doctor.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester may slightly increase the risk of birth defects affecting the baby’s heart, bones, and/or muscles.
Cases of babies born with birth defects involving 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 per day) of fluconazole for coccidioidomycosis. The link between fluconazole and these cases is not fully established.
You may continue breastfeeding after taking a single 150 mg dose of Fungus.
You must not breastfeed if you are taking repeated doses of Fungus.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.
FUNGUS contains lactose (milk sugar) and sodium (salt)
This medicine contains a very small amount of lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
FUNGUS capsules contain less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.

3. HOW TO TAKE FUNGUS

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

Adolescents aged 12 to 17 years
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 from 0 to 4 weeks of age
Use in children from 3 to 4 weeks of age:
The same dosage described above, 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, administered once every 3 days.
The maximum dose is 12 mg per kg of body weight every 72 hours.
The doctor may sometimes prescribe doses different from those indicated. Always take the medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Use in elderly patients
The same dose as that recommended for adults should be used, unless you have renal problems.
Use in patients with renal impairment
The doctor may adjust the dosage according to renal function.
If you take more FUNGUS than you should
Taking too many capsules at the same time may cause you problems. Immediately inform your doctor or go to the nearest hospital.
In case of accidental overdose, symptoms may include sensing, seeing, feeling, and thinking things that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be appropriate (with adequate supportive measures and, if necessary, gastric lavage).
If you forget to take FUNGUS
Do not take a double dose to make up for missed doses. 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 one at the regular time.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
FUNGUS is marketed only in hard capsules for oral use. It is not available in injectable formulations for intravenous use.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, FUNGUS may cause adverse reactions, although not everyone experiences them.
Some people may experience allergic reactions, although severe allergic reactions are rare.
Stop taking FUNGUS and contact your doctor immediately if you notice any of the following symptoms:

• sudden shortness of breath, difficulty breathing, or chest tightness
• swelling of the eyelids, face, or lips
• itching all over the body, skin redness, or red itchy rash
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)
• severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue).

FUNGUS may affect 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 FUNGUS and contact your doctor immediately.
Other adverse reactions
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.
Common adverse reactions (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 adverse reactions (may affect up to 1 in 100 people) are:

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

Rare adverse reactions (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
• altered skin colouration (red or purplish), which may be caused by a reduction in platelets, other changes in blood cells
• changes in blood chemistry (elevated cholesterol, 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 rashes with widespread blistering and skin peeling, severe skin reactions, swelling of the lips and face
• hair loss

Frequency not known, but possible (frequency 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 with eosinophilia and systemic symptoms (DRESS))

If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report adverse reactions directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FUNGUS

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use FUNGUS after the expiry date stated on the label (Exp.). The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What FUNGUS contains
The active substance is fluconazole.
Each hard capsule contains 100 mg, 150 mg or 200 mg of fluconazole.
The excipients are:
Capsule contents: monohydrate lactose, pregelatinized starch, anhydrous colloidal silica,
magnesium stearate and sodium lauryl sulfate.
Capsule shell composition:
100 mg hard capsules: gelatin, titanium dioxide (E171), yellow iron oxide (E172)
150 mg hard capsules: gelatin, titanium dioxide (E171)
200 mg hard capsules: gelatin, titanium dioxide (E171)

Appearance of FUNGUS 100 mg, 150 mg and 200 mg hard capsules and pack sizes
100 mg hard gelatin capsule, size No. 2, yellow in colour.
150 mg hard gelatin capsule, size No. 0, white in colour.
200 mg hard gelatin capsule, size No. 0, white in colour.

PHARMACEUTICAL FORM AND CONTENT
FUNGUS 100 mg hard capsules, pack of 10 capsules
FUNGUS 150 mg hard capsules, pack of 2 capsules
FUNGUS 200 mg hard capsules, pack of 7 capsules

MARKETING AUTHORISATION HOLDER
S.F. GROUP S.r.l. - Via Tiburtina, 1143 00156 Roma
MANUFACTURER
LA.FA.RE. srl – Via Sac. Benedetto Cozzolino n° 77 – 80056 Ercolano (NA)
Lachifarma Srl - Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Adriatica - Zona Industriale - 73010 Zollino (LE)
April 2024