AVIFLUCOX 50 mg Hard Capsules

Зміст інструкції

1. AVIFLUCOX 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What is AVIFLUCOX 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

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

fluconazole
Generic medicine

Read this leaflet carefully before taking thismedicine 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is AVIFLUCOX and what it is used for

AVIFLUCOX belongs to a group of medicines called “antifungals”. The active ingredient is
fluconazole.
AVIFLUCOX is used for the treatment of fungal infections and can 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.

AVIFLUCOX may be prescribed for:

• preventing the recurrence of cryptococcal meningitis,
• preventing the recurrence of candidiasis of the mucous membranes,

1/8

• reducing the recurrence 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.

AVIFLUCOX 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 AVIFLUCOX

Do not take AVIFLUCOX

• if you are allergic (hypersensitive) to fluconazole, to other medicines you have used for the treatment of fungal infections or to any of the other ingredients 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 heart arrhythmias),
• if you are taking erythromycin (antibiotic used for the treatment of 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 disease, including heart arrhythmia,
• you have abnormal levels of potassium, calcium or magnesium in your blood,
• you experience severe skin reactions (itching, redness of the skin or difficulty in breathing),
• you have ever developed a severe rash or skin exfoliation, blisters and/or ulcers in the mouth after taking AVIFLUCOX,
• you experience signs of ‘adrenal insufficiency’, where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or lasting 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 related to treatment with fluconazole. 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 the fungal infection does not improve, an alternative antifungal therapy may be necessary.

Other medicines and AVIFLUCOX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
2/8
Immediatelytell your doctor if you are taking astemizole, terfenadine (antihistamine 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 heart arrhythmias) or erythromycin (antibiotic used for the treatment of bacterial infections), as they cannot be taken with AVIFLUCOX (see section: “Do not take AVIFLUCOX”).
There are some medicines that can interact with AVIFLUCOX. 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, felodipine and losartan (used for the treatment of hypertension (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 (dietary 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).

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

Pregnancy, breastfeeding and fertility
3/8
If you are pregnant, suspect you are 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 AVIFLUCOX if you are pregnant, suspect you are pregnant or are breastfeeding unless your doctor tells you to. If you become pregnant while taking this medicine or within 1 week of 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 that the baby is born with bone and/or muscle malformations.
You can continue to breastfeed after taking a single dose of AVIFLUCOX up to 150 mg.
You should not breastfeed if you are taking repeated doses of AVIFLUCOX.

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

AVIFLUCOX contains lactose
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

AVIFLUCOX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, that is to say it is essentially ‘sodium-free’.

3. How to take AVIFLUCOX

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 best to take the capsules every day at the same time.
The usual doses of this medicine to be taken depending on the infection are listed below:

Adults

4/8

Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (or the adult dosage or the children's 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 infants from 0 to 4 weeks
Use in infants from 3 to 4 weeks:
The same dosage as described above but given once every 2 days. The maximum dose is 12 mg per
kg of body weight every 48 hours.
Use in infants under 2 weeks:
The same dosage as described above but given once every 3 days. The maximum dose is 12 mg per
kg of body weight every 72 hours.

Elderly
5/8
The same dose as intended for adults should be used unless you have kidney problems.

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

If you take more AVIFLUCOX than you should
Taking too many capsules all at once may cause you problems. Immediately inform your doctor or
go to the nearest hospital.
In case of accidental overdose, symptoms may include seeing, feeling, 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 AVIFLUCOX
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 dose you have
forgotten.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

Some people 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 a 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 spots,
• rashes,
• severe skin reactions, such as rashes that cause blisters (may affect the mouth and tongue).

AVIFLUCOX 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 AVIFLUCOX 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 in this leaflet, tell your doctor or pharmacist.
Common side effects (may affect up to 1 in 10 people) are:
6/8

• headache,
• stomach discomfort, 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,
• fatigue, general feeling of being 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 infections, 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, 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 number of a type of white blood cells (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 AVIFLUCOX

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

Do not use this medicine after the expiry date which is stated on the label after Scad. The expiry date
refers to the last day of the month.
7/8
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AVIFLUCOX contains

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

The other excipients are:

Capsule content:Lactose, Colloidal silicon dioxide, Corn starch,
Magnesium stearate, Sodium lauryl sulfate.

Capsule shell content:

50 mg hard capsules:
titanium dioxide E171, Yellow iron oxide E172, Gelatin

100 mg hard capsules:
titanium dioxide E171, Yellow iron oxide E172, Patent blue V E131, Yellow orange E110, Gelatin

150 mg hard capsules:
titanium dioxide E171, Yellow iron oxide E172, Indigo carmine E132, Quinoline yellow E104, Gelatin

200 mg hard capsules:
titanium dioxide E171, Indigo carmine E132, Quinoline yellow E104, Gelatin

Description of the appearance of AVIFLUCOX and contents of the pack

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

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 and 200 mg:
Lachifarma S.p.A. Laboratorio Chimico Salentino S.S.16 ZONA INDUSTRIALE - ZOLLINO (LE) Italy
8/8