ZERFUN 100 mg Hard Capsule

Зміст інструкції

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

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

Fluconazole

Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 ingredient is
fluconazole.
Zerfun is used for the treatment of fungal infections and may be used to prevent
Candidainfections. 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 of the bronchopulmonary system
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection and inflammation of the mouth from dentures
• Genital candidiasis - infection of the vagina or penis
• Skin infections - e.g. athlete's foot, ringworm, itching in the genital area, nail infections.

Zerfun may be prescribed for:

• preventing the recurrence of cryptococcal meningitis
• preventing the recurrence of candidiasis of the mucous membranes
• reducing recurrences of vaginal candidiasis
• preventing Candidainfections (if your immune system is weak or not functioning properly).

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

• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Cryptococcal meningitis - a fungal infection of the brain.

Zerfun may be prescribed for:

• preventing Candidainfections (if your immune system is weak or not functioning properly)
• preventing the 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 that you have used for the treatment of fungal infections or to any of the other components of this medicine (listed in section 6). The symptoms may be itching, redness of the skin or difficulty in breathing
• if you are taking astemizole, terfenadine (antihistamines used for the treatment of allergies)
• if you are taking cisapride (used for the treatment of stomach disorders)
• if you are taking pimozide (used for the treatment of mental disorders)
• if you are taking quinidine (used for the treatment of cardiac arrhythmias)
• if you are taking erythromycin (antibiotic used for the treatment of bacterial infections)

Warnings and precautions
Consult your doctor or pharmacist before taking Zerfun

• if you have liver or kidney problems
• if you suffer from heart disease, including cardiac arrhythmia
• if you have abnormal levels of potassium, calcium or magnesium in the blood
• if severe skin reactions appear (itching, redness of the skin or difficulty in breathing)
• if signs of “adrenal insufficiency” appear, where the 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 exfoliation, blisters and/or mouth ulcers after taking Zerfun.

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

Other medicines and Zerfun
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Immediatelyinform your doctor if you are taking astemizole, terfenadine (antihistamines used for the treatment of allergies) or cisapride (used for the treatment of stomach disorders) or pimozide (used for the treatment of mental disorders) or quinidine (used for the treatment of cardiac arrhythmias) or erythromycin (antibiotic used for the treatment of bacterial infections), as they cannot be taken with Zerfun (see section: ''Do not take Zerfun").
There are some medicines that can interact with Zerfun .Tell your doctor if you are taking any of the following medicines as a dose adjustment or monitoring may be necessary to ensure that the medicines continue to have the desired effect:

• rifampicin or rifabutin (antibiotics for the treatment of bacterial infections)
• abrocitinib (used for the treatment of atopic dermatitis, also known as atopic eczema)
• alfentanil, fentanyl (anaesthetics)
• 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 for the treatment of seizures)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used for the treatment of high blood pressure)
• olaparib (used for the treatment of ovarian cancer)
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent transplant rejection)
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for the treatment of cancer
• halofantrine (used for the treatment of malaria)
• statins (atorvastatin, simvastatin, fluvastatin and similar medicines) used to reduce high cholesterol levels
• methadone (used for the treatment of pain)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs - NSAIDs)
• oral contraceptives
• prednisone (steroid)
• zidovudine, also known as AZT; saquinavir (used in patients with HIV)
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used for asthma control)
• tofacitinib (used for the treatment of rheumatoid arthritis)
• tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline in kidney function
• vitamin A (food supplement)
• ivacaftor (alone or in combination with other drugs used to treat cystic fibrosis)
• amiodarone (used for the treatment of “arrhythmias”, irregular heartbeats)
• hydrochlorothiazide (a diuretic).
• ibrutinib (used for the treatment of blood cancer).
• lurasidone (used for the treatment of schizophrenia).

Zerfun with food and drink
You can take the medicine with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Zerfun if you are pregnant, suspect you may be pregnant or are breastfeeding, unless your doctor tells you to.
If you become pregnant while taking this medicine or within 1 week of the latest dose, consult 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 that the baby is born with bone and/or muscle malformations.
You can continue to breastfeed after taking a single dose of Zerfun 150 mg.
You should not breastfeed if you are taking repeated doses of Zerfun.

Driving and using machines
You should be aware that dizziness or convulsions may occur while driving or using machines.

Zerfun contains lactose
This medicine contains a small amount of lactose (milk sugar). If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, that is to say essentially “sodium-free”.

3. How to take Zerfun

Take this medicine following exactly the instructions of 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 every day
at the same time.
The recommended doses of this medicine to be taken depending on the infection are listed here
below:

Adults

Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (or the adult dosage or that of children).

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 infants aged 0 to 4 weeks
Use in infants aged 3 to 4 weeks:
The same dosage as described above but administered once every 2 days. The maximum dose is
12 mg per kg of body weight every 48 hours.
Use in infants under 2 weeks of age:
The same dosage as 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 provided for adults should be used unless you have kidney problems.

Patients with kidney problems
Your doctor may adjust the dosage based on kidney function.

If you take more Zerfun than you should
Taking too many capsules all at once could cause you problems. Immediately inform your
doctor or go to the nearest hospital.
In case of accidental overdose, symptoms may include seeing, hearing, perceiving and
thinking things that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be appropriate (with adequate supportive measures and possibly 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 time to take the next dose, do not take the
forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

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

• sudden shortness of breath, difficulty breathing or feeling of tightness in the chest
• swelling of the eyelids, face or lips
• itching all over the body, redness of the skin or itchy red patches
• rashes

• severe skin reactions, for example, rashes that cause blisters (can affect the mouth and tongue).

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

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

If you experience any of these symptoms, stop taking Zerfun and inform your doctor
immediately.

Other side effects:
If any of these side effects gets serious, or if you notice any side effect not listed here, tell your doctor or pharmacist. Common side effects (may affect up to 1 in 10 people) are:

• headache
• stomach upsets, diarrhoea, nausea, vomiting
• increases in liver function values in blood tests
• rashes.

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

• reduction in red blood cells which can cause paleness, weakness or shortness of breath
• decreased appetite
• insomnia, drowsiness
• convulsions, dizziness, feeling of spinning, tingling, prickling or numbness, altered taste
• constipation, difficulty digesting, flatulence, dry mouth
• muscle pain
• liver damage and yellowing of the skin and eyes (jaundice)
• swellings, blisters (urticaria), itching, increased sweating
• tiredness, feeling unwell, fever.

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

• lower than normal levels of white blood cells which help you fight infection, and platelets which help your blood clot
• altered skin colour (red or purple) which may be caused by a reduction in platelets, other changes in blood cells
• changes in blood chemistry (high levels of cholesterol, fats)
• low levels of potassium in the blood
• chills
• altered electrocardiogram (ECG), changes in heart rate and rhythm
• 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 may occur (frequency cannot be estimated from the available
data):

• hypersensitivity reaction with rash, fever, swollen glands, increased type of white blood cells (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (drug reaction or rash with eosinophilia and systemic symptoms (DRESS))

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 that is reported on the label after EXP.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zerfun contains

• The active ingredient is fluconazole. Each hard capsule contains 100 mg, 150 mg or 200 mg of fluconazole.
• The other ingredients are: Capsule core: lactose monohydrate, pregelatinized starch, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate. Capsule shell: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 contents
Zerfun 100 mg hard capsules are yellow. They are available in blisters of 10 capsules of 100 mg.
Zerfun 150 mg hard capsules are white. They are available in blisters of 2 capsules of 150
mg.
Zerfun 200 mg hard capsules are white. They are available in blisters of 7 capsules of 200
mg.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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)