FLUCONAZOLO 100 mg Kapsułka Twarda

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1. FLUCONAZOLO ALMUS 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What FLUCONAZOLO ALMUS is and what it is used for
   2. What you need to know before taking FLUCONAZOLO ALMUS
   3. How to take FLUCONAZOLO ALMUS
   4. Possible side effects
   5. How to store FLUCONAZOLO ALMUS
   6. Contents of the pack and other information

FLUCONAZOLO ALMUS 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

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 their symptoms are the same as yours, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What FLUCONAZOLO ALMUS is and what it is used for

FLUCONAZOLO ALMUS contains the active ingredient fluconazole which belongs to a group of
medicines called antimycotics. Antimycotics are used for the treatment of infections
caused by fungi and yeasts.

FLUCONAZOLO ALMUS is indicated in adults for the treatment of:

• infections of the tissues lining the brain caused by fungi (cryptococcal meningitis);
• infections of the mucous membranes (oropharyngeal candidiasis, esophageal candidiasis, candiduria and chronic mucocutaneous candidiasis, invasive candidiasis);
• infection of the mouth in cases where oral hygiene and other treatments are not sufficient (chronic atrophic oral candidiasis or denture stomatitis);
• infection of the genitals, in both women and men (acute or recurrent vaginal candidiasis, Candida balanitis), when local therapy is not appropriate;
• skin infections (dermatomycoses, including tinea pedis, tinea corporis, tinea cruris, tinea versicolor, Candida infections), when systemic therapy is indicated;
• nail infections (onychomycosis), when other treatments are not considered appropriate;
• other infections caused by fungi (coccidioidomycosis).

FLUCONAZOLO ALMUS is indicated in adults for:

• preventing an infection of the meninges (tissues lining the brain) if you have already suffered from it and there is a high risk that it may recur (relapse of cryptococcal meningitis);
• preventing an infection of the mouth or throat, if you have AIDS and are at high risk of relapse (relapse of oropharyngeal or esophageal candidiasis);
• reducing the frequency of vaginal infections, when it recurs 4 times or more during a year (recurrent vaginal candidiasis);
• preventing Candida infections (candidemia) if you have a low number of white blood cells for a long time (prolonged neutropenia), for example if you suffer from blood cancers (malignant hematological diseases) and are undergoing chemotherapy or if you receive a blood cell transplant (Hematopoietic Stem Cells).

Fluconazolo Almus is indicated in term newborns, infants, children and adolescents (from 0 to 17
years) for:

• treating Candida infections of the mouth and throat (oropharyngeal and esophageal candidiasis);
• treating Candida infections of organs (invasive candidiasis);
• treating infections of the tissues lining the brain (cryptococcal meningitis) and preventing its recurrence if the child has suffered from it in the past;
• preventing infections caused by Candida if the child has a weakened immune system (immunocompromised).

2. What you need to know before taking FLUCONAZOLO ALMUS

Do not take FLUCONAZOLO ALMUS

• if you are allergic to fluconazole, to similar medicines (azole compounds) or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking the following medicines (see sections “Other medicines and FLUCONAZOLO ALMUS” and “Warnings and precautions”):
• some medicines used to treat allergies such as astemizole and terfenadine;
• cisapride, a medicine used to treat some stomach problems;
• some medicines used to treat irregular heartbeat, such as quinidine;
• pimozide, a medicine used for some mental disorders;
• erythromycin, an antibiotic used to treat some infections caused by bacteria.

Warnings and precautions
Talk to your doctor or pharmacist before taking FLUCONAZOLO ALMUS.
Take this medicine with caution if:

• you have kidney problems (impaired kidney function);
• you have liver problems, because serious problems, including death, may occur. If symptoms of a liver problem such as loss of appetite (anorexia), nausea, vomiting, fatigue and yellowing of the skin and the white of the eyes (jaundice) occur, stop taking this medicine and inform your doctor immediately;
• you have heart problems, if you have an altered amount of salts in your blood (electrolyte imbalances) or if you are taking other medicines that can alter your normal heartbeat (see section “Other medicines and FLUCONAZOLO ALMUS”);
• you are taking terfenadine, a medicine used to treat allergies or are taking Alofantrine, a medicine used to treat malaria (see section “Other medicines and FLUCONAZOLO ALMUS”);
• you develop symptoms of ‘adrenal insufficiency’, caused by the decreased production by the adrenal glands of some steroid hormones such as cortisol (chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain). If you experience skin irritation (skin rashes) or other more serious disorders associated with the formation of blisters and lesions (exfoliative skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis) during treatment with this medicine, stop taking this medicine. These problems may be more likely to occur if you have AIDS.

Children and adolescents
FLUCONAZOLO ALMUS should not be used in children for the treatment of infections from
tinea capitis.

Other medicines and FLUCONAZOLO ALMUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Do not take FLUCONAZOLO ALMUS if you are taking any of the following medicines:

• cisapride, a medicine used to treat some stomach problems;
• terfenadine, a medicine used to treat allergies;
• astemizole, a medicine used to treat allergies;
• quinidine, a medicine used to treat irregular heartbeat;
• erythromycin, a medicine used to treat some infections caused by bacteria;
• pimozide, a medicine used for some mental disorders.

Tell your doctor if you are taking the following medicines because it may be necessary to adjust the
dose or perform specific checks:

• alofantrine, a medicine used to treat malaria;
• rifampicin, rifabutin, azithromycin, medicines used to treat some infections caused by bacteria;
• alfentanil and fentanyl, medicines used as painkillers;
• amitriptyline, nortriptyline, medicines used to treat depression;
• amphotericin B, voriconazole, medicines used to treat some infections caused by fungi;
• medicines used to slow down blood clotting (warfarin, similar medicines or medicines derived from indanedione);
• some medicines used to treat anxiety or as sedatives, such as midazolam and triazolam;
• medicines used to treat seizures (carbamazepine, phenytoin);
• some medicines used to treat heart problems (calcium antagonists, such as nifedipine, isradipine, amlodipine, verapamil and felodipine);
• some medicines used to treat some cancers (cyclophosphamide, vincristine, vinblastine);
• cyclosporine, everolimus, sirolimus and tacrolimus, medicines used after organ transplants, or to treat diseases of the immune system;
• losartan, a medicine used to treat high blood pressure;
• methadone, a medicine used to treat drug dependence;
• medicines used to treat inflammations such as non-steroidal anti-inflammatory drugs (NSAIDs), celecoxib, prednisone;
• saquinavir, zidovudine, medicines used to treat AIDS;
• medicines used to treat diabetes (chlorpropamide, glibenclamide, glipizide and tolbutamide);
• theophylline, a medicine used to treat some breathing problems;
• medicines based on vitamin A;
• medicines used to prevent pregnancy (contraceptive pills);
• atorvastatin, simvastatin, fluvastatin and similar medicines) used to reduce high levels of cholesterol;
• amiodarone, a medicine used to treat an irregular heartbeat called arrhythmia;
• hydrochlorothiazide, a medicine used to increase urine production.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy unless absolutely necessary, in which case your doctor
may prescribe this medicine if you have very serious or life-threatening infections.
Breastfeeding
Do not breastfeed if you have taken FLUCONAZOLO ALMUS at high doses or for prolonged
periods.
You can breastfeed if you have taken a single dose of less than or equal to 200 mg of FLUCONAZOLO
ALMUS.

Driving and using machines
No studies have been conducted to establish the effect of this medicine on the ability to drive and operate
machinery. However, if you experience side effects such as dizziness or convulsions, avoid driving or operating
machinery.

FLUCONAZOLO ALMUS contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking
this medicine.

3. How to take FLUCONAZOLO ALMUS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have doubts, consult your doctor or pharmacist.
The dose and duration of treatment depend on the severity and type of infection. Carefully
follow your doctor's instructions because an inadequate duration of treatment may not resolve the infection.
The capsules must be swallowed whole and independently of food intake.
The recommended doses of FLUCONAZOLO ALMUS depending on the infection are listed here
below:

Adults

Treatment of cryptococcal meningitis:
The recommended dose is 400 mg on the first day, then 200 - 400 mg once a day for 6 - 8 weeks or
longer, if necessary. Sometimes the doses are increased up to 800 mg.

Prevention of recurrence of cryptococcal meningitis in patients at high risk of relapse:
The recommended dose is 200 mg once a day, the doctor will establish the duration.

Treatment of Coccidioidomycosis:
The recommended dose is 200 - 400 mg once a day for 11 months to 24 months. Sometimes the doses
are increased up to 800 mg.

Treatment of Candida organ infections (invasive candidiasis):
The recommended dose is 800 mg on the first day, then 400 mg once a day.

Treatment of infections of the oral and throat mucosa (oropharyngeal candidiasis and esophageal

candidiasis):
The recommended dose is 200 mg - 400 mg on the first day, then 100 mg to 200 mg, the doctor will establish the
duration.

Treatment of urinary tract infection (candiduria):
The recommended dose is 200 - 400 mg once a day for 7- 21 days or until you are told to
stop.

Treatment of denture-related oral infections (chronic atrophic candidiasis)
The recommended dose is 50 mg once a day for 14 days

Treatment of Candida infections of the mucous membranes and skin (chronic mucocutaneous candidiasis)
The recommended dose is 50 - 100 mg once a day for up to 28 days or until you are told to
stop.

Prevention of oral and throat infections (oropharyngeal candidiasis, esophageal candidiasis):
The recommended dose for the prevention of oral (oral mucosa) infections is 100 mg - 200 mg
once a day, or 200 mg 3 times a week as long as you are at risk of contracting an infection.

Treatment of genital infection (acute vaginal candidiasis, Candida balanitis):
The recommended dose is 150 mg in a single administration.

Treatment and prevention of recurrences of genital infection (vaginal candidiasis):
The recommended dose to reduce the frequency of vaginal infections is 150 mg every three days for
a total of 3 doses (day 1, 4 and 7), and then once a week for 6 months when you are at risk of contracting
an infection.

Treatment of skin infections (tinea pedis dermatophytosis, tinea corporis, tinea cruris and

Candida):
The recommended dose is 150 mg once a week or 50 mg once a day, for 2 – 4
weeks. Infections with tinea pedismay require treatment for up to 6 weeks.

Treatment of skin infections (tinea versicolor dermatophytosis):
The recommended dose is 300 to 400 mg once a week, for 1 – 3 weeks or 50 mg once
a day, for 2 – 4 weeks.

Treatment of nail infections (tinea unguium onychomycosis):
The recommended dose is 150 mg once a week
Treatment must be continued until the infected nail is replaced (the healthy nail regrows).
Nail regrowth, of the fingers and toes, normally takes 3 to 6 months and 6
to 12 months, respectively. However, the rate of growth can vary greatly depending on the subjects and
age. After effective treatment of long-term chronic infections, the nails remain
occasionally altered.

Prevention (prophylaxis) of Candida infections in patients with a low number of white blood cells

in the blood for a long time (prolonged neutropenia):
The recommended dose is 200 - 400 mg once a day, the doctor will establish the duration.

Use in children and adolescents
In children, the maximum recommended dose is 400 mg per day.
As with adults, the duration of treatment depends on the severity and type of infection.
The dose is recommended with a single daily administration.
The dose will be established by the doctor based on the weight.

Treatment of infections of the mucous membranes caused by Candida (candidiasis of the mucous membranes):
The recommended dose is 3 mg per kg of body weight. The recommended dose on the first day is 6 mg per kg
of body weight.

Treatment of infection of the tissues lining the brain caused by meningococcus (cryptococcal meningitis) and other organ infections caused by Candida (invasive candidiasis):
The recommended dose ranges from 6 mg to 12 mg per kg of body weight, depending on the severity of the infection.

Prevention of recurrence of cryptococcal meningitis in children at high risk of relapse:
The recommended dose is 6 mg per kg of body weight, depending on the severity of the infection.

Prevention of Candida infections in patients with low immune defenses

(immunocompromised).
The recommended dose ranges from 3 to 12 mg per kg of body weight depending on the clinical conditions.

Use in children from 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 children 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. Use in the elderly
The doctor will establish the dose to be used taking into consideration the function of your kidneys.

Use in patients with kidney and liver (liver) problems
The doctor may modify the dosage based on the function of your kidneys and liver.

If you take more FLUCONAZOLO ALMUS than you should
Symptoms of overdose may include hallucinations (hearing, seeing, perceiving and thinking things
that are not real) and altered behavior (paranoid behavior).
If you accidentally ingest/take an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital.

If you forget to take FLUCONAZOLO ALMUS
Do not take a double dose to make up for a missed 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.
The following side effects may occur:

Common(may affect up to 1 in 10 people):

• headache;
• stomach pain (abdominal pain);
• nausea;
• vomiting;
• diarrhoea;
• skin rash;
• increased levels of enzymes produced by the liver.

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

• reduction in the number of red blood cells (anaemia);
• decreased appetite;
• drowsiness;
• insomnia;
• convulsions;
• altered sensitivity in the arms and legs (paraesthesia);
• dizziness;
• altered taste;
• vertigo;
• constipation;
• indigestion (dyspepsia);
• excessive production of gas in the intestine (flatulence);
• dry mouth;
• impaired flow of bile to the duodenum due to an internal obstruction in the liver (cholestasis);
• yellowing of the skin and the whites of the eyes (jaundice);
• increased bilirubin (a substance produced by the liver);
• drug eruption;
• urticaria;
• itching;
• increased sweating;
• muscle pain (myalgia);
• malaise;
• weakness (asthenia);
• fever.

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

• alteration in the number of white blood cells (agranulocytosis, leucopenia, neutropenia);
• decrease in the number of platelets in the blood (thrombocytopenia);
• severe allergic reaction (anaphylaxis);
• increased amount of cholesterol and fats in the blood (hypercholesterolaemia, hypertriglyceridaemia);
• decreased amount of potassium in the blood (hypokalaemia);
• tremor;
• alterations in heart rhythm (torsades de pointes, QT prolongation);
• liver problems (hepatic failure, hepatocellular necrosis, damage to liver cells);
• inflammation of the liver (hepatitis);
• severe allergic skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, pustular exanthematous rash);

The side effects observed in clinical studies in children are the same as those in adults.

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 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 FLUCONAZOLO ALMUS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FLUCONAZOLO ALMUS 100 mg hard capsules contains

• The active ingredient is fluconazole. Each capsule contains 100 mg of fluconazole.
• The other ingredients are: lactose monohydrate, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.
• Capsule shell: gelatin, titanium dioxide E 171, yellow iron oxide E 172.

What FLUCONAZOLO ALMUS 150 mg hard capsules contains

• The active ingredient is fluconazole. Each capsule contains 150 mg of fluconazole.
• The other ingredients are: lactose monohydrate, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.
• Capsule shell: gelatin, titanium dioxide E 171.

What FLUCONAZOLO ALMUS 200 mg hard capsules contains

• The active ingredient is fluconazole. Each capsule contains 200 mg of fluconazole.
• The other ingredients are: lactose monohydrate, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.
• Capsule shell: gelatin, titanium dioxide E 171.

Description of the appearance of FLUCONAZOLO ALMUS and contents of the pack
FLUCONAZOLO ALMUS 100 mg hard capsules
Pack of 10 yellow capsules.
FLUCONAZOLO ALMUS 150 mg hard capsules
Pack of 2 white capsules.
FLUCONAZOLO ALMUS 200 mg hard capsules
Pack of 7 white capsules.

Marketing authorisation holder
ALMUS S.r.l. - Via Cesarea, 11/10 -16121 Genova

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM)