AVIFLUCOX

Package leaflet: Information for the user

AVIFLUCOX 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

fluconazole
Generic medicine
Please read all of this leaflet carefully before you take 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 adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What AVIFLUCOX is and what it is used for

AVIFLUCOX belongs to a group of medicines known as "antifungals". The active substance is
fluconazole.
AVIFLUCOX 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.

AVIFLUCOX 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.

AVIFLUCOX 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 AVIFLUCOX

Do not take AVIFLUCOX

• if you are allergic (hypersensitive) to fluconazole, to other medicines you have 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 (antihistamine medicines 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 heart arrhythmias),
• if you are taking erythromycin (an antibiotic used to treat bacterial infections).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking AVIFLUCOX if:

• you have liver or kidney problems,
• you suffer from heart diseases, including heart arrhythmia,
• you have abnormal levels of potassium, calcium, or magnesium in your blood,
• severe skin reactions occur (itching, skin redness or difficulty breathing),
• you have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking AVIFLUCOX,
• signs of 'adrenal insufficiency' appear, whereby 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).

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

Other medicines and AVIFLUCOX
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicine.
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 heart arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with AVIFLUCOX (see section: “Do not take AVIFLUCOX”).

Some medicines may interact with AVIFLUCOX. 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 (anaesthetics),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungals),
• medicines that thin the blood to prevent clot formation (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, 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, glyburide, 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).

AVIFLUCOX with food and drink
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, ask your doctor or pharmacist for advice before taking this medicine.
Do not take AVIFLUCOX if you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, unless advised 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 AVIFLUCOX up to 150 mg.
You must not breastfeed if you are taking repeated doses of AVIFLUCOX.

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

AVIFLUCOX contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

AVIFLUCOX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. How to take AVIFLUCOX

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 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

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Adolescents from 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 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
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The same dose as that recommended for adults should be used, unless you have renal problems.
Patients with renal impairment
Your doctor may adjust the dosage according to kidney function.
If you take more AVIFLUCOX 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 sensations, seeing, hearing, or thinking things that are not real (hallucinations and paranoid behaviour). Symptomatic treatment may be appropriate (with adequate supportive measures and, if necessary, gastric lavage).
If you forget to take AVIFLUCOX
Do not take a double dose to make up for the forgotten 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 only your next scheduled dose.
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 AVIFLUCOX and contact your doctor 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 experience allergic reactions, although severe allergic reactions are rare.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. If you experience any of the following symptoms, contact 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).

AVIFLUCOX 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 AVIFLUCOX 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,
• 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),
• 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 levels of cholesterol, fats),
• 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, skin peeling, severe skin reactions, swelling of the lips and face,
• hair loss.

Frequency not known (cannot be estimated from available data):

• hypersensitivity reaction with 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 rash with eosinophilia and systemic symptoms (DRESS)).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 AVIFLUCOX

• Keep this medicine out of the sight and reach of children.
• Do not store above 30°C.

Do not use this medicine after the expiry date stated on the label after "Exp.". The expiry date refers to the last day of the month.
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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 AVIFLUCOX contains

• The active substance is fluconazole.
• Each hard capsule contains fluconazole 50 mg, 100 mg, 150 mg or 200 mg.

The other excipients are:
Capsule contents: Lactose, Colloidal silicon dioxide, Corn starch,
Magnesium stearate, Sodium lauryl sulfate.
Capsule shell contents:
50 mg hard capsules:
Titanium dioxide E171, Iron oxide yellow E172, Gelatin
100 mg hard capsules:
Titanium dioxide E171, Iron oxide yellow E172, Patent Blue V E131, Orange Yellow E110, Gelatin
150 mg hard capsules:
Titanium dioxide E171, Iron oxide yellow E172, Indigotine E132, Quinoline Yellow E104, Gelatin
200 mg hard capsules:
Titanium dioxide E171, Indigotine E132, Quinoline Yellow E104, Gelatin

Description of the appearance of AVIFLUCOX and pack contents

• Box containing 7 hard capsules of fluconazole 50 mg
• Box containing 10 hard capsules of fluconazole 100 mg
• Box containing 2 hard capsules of fluconazole 150 mg
• Box containing 7 hard capsules of fluconazole 200 mg

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bionativa S.p.A.,
Via Raffaello 15 - Loc. Sambuca V.P.
50028 Florence
Italy
Manufacturers:
LA.FA.RE. S.R.L. VIA SAC. BEN. COZZOLINO 77, ERCOLANO (NA) Italy
Only for 100 mg and 200 mg:
Lachifarma S.p.A. Laboratorio Chimico Salentino S.S.16 ZONA INDUSTRIALE - ZOLLINO (LE) Italy
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