Fluconazole Almus

Italy
Brand name Fluconazole Almus
Form capsules, hard gelatin
Active substance / Dosage
FLUCONAZOLE
Prescription type Prescription only
ATC code
J02AC01
Registration number 037864
Manufacturer ALMUS S.R.L.

Table of Contents

Package leaflet: Information for the patient

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

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 could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What FLUCONAZOLE ALMUS is and what it is used for
  2. What you need to know before taking FLUCONAZOLE ALMUS
  3. How to take FLUCONAZOLE ALMUS
  4. Possible side effects
  5. How to store FLUCONAZOLE 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 substance fluconazole, which belongs to a group of
medicines called antifungals. Antifungals are used to treat infections caused by fungi and yeasts.
FLUCONAZOLO ALMUS is indicated in adults for the treatment of:

  • infections of the tissues covering the brain caused by fungi (cryptococcal meningitis);
  • mucosal infections (oropharyngeal candidiasis, oesophageal candidiasis, candiduria, and chronic mucocutaneous candidiasis, invasive candidiasis);
  • mouth infection in cases where oral hygiene and other treatments are not sufficient (chronic atrophic candidiasis or denture stomatitis);
  • genital infection 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 fungal infections (coccidioidomycosis).

FLUCONAZOLO ALMUS is indicated in adults for:

  • prevention of meningitis (infection of the membranes covering the brain) if you have previously had it and are at high risk of recurrence (recurrent cryptococcal meningitis);
  • prevention of mouth or throat infection if you have AIDS and are at high risk of recurrence (recurrent oropharyngeal or oesophageal candidiasis);
  • reduction in the frequency of vaginal infections when they recur 4 or more times within a year (recurrent vaginal candidiasis);
  • prevention of Candida infections (candidaemia) if you have had a prolonged low white blood cell count (prolonged neutropenia), for example if you have blood cancers (malignant hematological disorders) and are undergoing chemotherapy, or if you receive blood stem cell transplantation (Hematopoietic Stem Cells).

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

  • treatment of Candida infections of the mouth and throat (oropharyngeal and oesophageal candidiasis);
  • treatment of invasive Candida infections of internal organs (invasive candidiasis);
  • treatment of infections of the tissues covering the brain (cryptococcal meningitis) and prevention of its recurrence if the child has had it in the past;
  • prevention of Candida infections 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 any of the following medicines (see section “Other medicines and FLUCONAZOLO ALMUS” and “Warnings and precautions”):
    • certain medicines used to treat allergies such as astemizole and terfenadine;
    • cisapride, a medicine used to treat certain stomach problems;
    • certain medicines used to treat irregular heartbeats, such as quinidine;
    • pimozide, a medicine used for certain mental disorders;
    • erythromycin, an antibiotic used to treat certain bacterial infections.

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

  • you have kidney problems (impaired renal function);
  • you have liver problems, as serious issues may occur, including death. If symptoms of liver problems develop, such as loss of appetite (anorexia), nausea, vomiting, fatigue, or yellowing of the skin and whites of the eyes (jaundice), stop treatment with this medicine and contact your doctor immediately;
  • you have heart problems, if you have an abnormal level of salts in your blood (electrolyte imbalances), or if you are taking other medicines that may affect your normal heartbeat (see section “Other medicines and FLUCONAZOLO ALMUS”);
  • you are taking terfenadine, a medicine used to treat allergies, or halofantrine, a medicine used to treat malaria (see section “Other medicines and FLUCONAZOLO ALMUS”);
  • if you develop symptoms of ‘adrenal insufficiency’ caused by reduced production by the adrenal glands of certain steroid hormones such as cortisol (chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain). If during treatment with this medicine you develop skin irritation (rashes) or more serious conditions associated with blistering and lesions (exfoliative skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis), stop treatment with this medicine. These problems are more likely if you have AIDS.

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

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

  • cisapride, a medicine used to treat certain stomach problems;
  • terfenadine, a medicine used to treat allergies;
  • astemizole, a medicine used to treat allergies;
  • quinidine, a medicine used to treat irregular heartbeats;
  • erythromycin, a medicine used to treat certain bacterial infections;
  • pimozide, a medicine used for certain mental disorders.

Tell your doctor if you are taking any of the following medicines, as it may be necessary to adjust your dose or perform specific monitoring:

  • halofantrine, a medicine used to treat malaria;
  • rifampicin, rifabutin, azithromycin, medicines used to treat certain bacterial infections;
  • alfentanil and fentanyl, medicines used as painkillers;
  • amitriptyline, nortriptyline, medicines used to treat depression;
  • amphotericin B, voriconazole, medicines used to treat certain fungal infections;
  • medicines used to delay blood clotting (warfarin, similar medicines or indanedione derivatives);
  • certain medicines used to treat anxiety or as tranquilizers, such as midazolam and triazolam;
  • medicines used to treat seizures (carbamazepine, phenytoin);
  • certain medicines used to treat heart problems (calcium channel blockers, such as nifedipine, isradipine, amlodipine, verapamil and felodipine);
  • certain medicines used to treat certain tumours (cyclophosphamide, vincristine, vinblastine);
  • ciclosporin, everolimus, sirolimus and tacrolimus, medicines used after organ transplants or to treat immune system disorders;
  • losartan, a medicine used to treat high blood pressure;
  • methadone, a medicine used to treat drug addiction;
  • medicines used to treat inflammation 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 certain breathing problems;
  • vitamin A-containing medicines;
  • medicines used to prevent pregnancy (oral contraceptives);
  • atorvastatin, simvastatin, fluvastatin and similar medicines used to reduce high cholesterol levels;
  • 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, think 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.
Pregnancy
Do not take this medicine during pregnancy, except in cases of absolute necessity, when your doctor may prescribe it 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 may breastfeed if you have taken a single dose of FLUCONAZOLO ALMUS equal to or less than 200 mg.

Driving and using machines
No studies have been conducted to determine the effect of this medicine on the ability to drive and use machines. However, if you experience side effects such as dizziness or seizures, avoid driving or using machines.
FLUCONAZOLO ALMUS contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take FLUCONAZOLO ALMUS

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dose and duration of treatment depend on the severity and type of infection. Follow your doctor's instructions carefully, as inadequate duration of treatment may fail to resolve the infection.
The capsules must be swallowed whole, with or without food.
The recommended doses of FLUCONAZOLO ALMUS according to the type of infection are listed below:
Adults
Treatment of cryptococcal meningitis:
The recommended dose is 400 mg on the first day, followed by 200–400 mg once daily for 6–8 weeks or longer, if necessary. Sometimes doses may be 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 daily; your doctor will determine the duration of treatment.
Treatment of Coccidioidomycosis:
The recommended dose is 200–400 mg once daily for 11 to 24 months. Sometimes doses may be increased up to 800 mg.
Treatment of systemic Candida infections (invasive candidiasis):
The recommended dose is 800 mg on the first day, followed by 400 mg once daily.
Treatment of oral and throat mucosal infections (oropharyngeal candidiasis and esophageal candidiasis):
The recommended dose is 200–400 mg on the first day, followed by 100–200 mg once daily; your doctor will determine the duration.
Treatment of urinary tract infections (candiduria):
The recommended dose is 200–400 mg once daily for 7–21 days or until instructed to stop.
Treatment of denture-related oral infections (chronic atrophic candidiasis):
The recommended dose is 50 mg once daily for 14 days.
Treatment of mucocutaneous Candida infections (chronic mucocutaneous candidiasis):
The recommended dose is 50–100 mg once daily for up to 28 days or until instructed to stop.
Prevention of oral and throat infections (oropharyngeal candidiasis, esophageal candidiasis):
The recommended dose for prevention of oral (oral mucosal) infections is 100–200 mg once daily, or 200 mg three times weekly, for as long as you remain at risk of infection.
Treatment of genital infections (acute vaginal candidiasis, candidal balanitis):
The recommended dose is 150 mg as a single dose.
Treatment and prevention of recurrent genital infections (vaginal candidiasis):
The recommended dose to reduce the frequency of vaginal infections is 150 mg every three days for a total of three doses (on days 1, 4, and 7), followed by once weekly for 6 months while at risk of infection.
Treatment of skin infections (dermatomycoses due to tinea pedis, tinea corporis, tinea cruris, and Candida):
The recommended dose is 150 mg once weekly or 50 mg once daily for 2–4 weeks.° Infections due to tinea pedis may require treatment for up to 6 weeks.
Treatment of skin infections (dermatomycoses due to tinea versicolor):
The recommended dose is 300–400 mg once weekly for 1–3 weeks or 50 mg once daily for 2–4 weeks.°
Treatment of nail infections (onychomycosis due to tinea unguium):
The recommended dose is 150 mg once weekly.
Treatment should continue until the infected nail is completely replaced (healthy nail regrows).
Nail regrowth on fingers and toes typically takes 3–6 months and 6–12 months, respectively. However, growth rate may vary significantly depending on the individual and age. After successful treatment of long-term chronic infections, nails may occasionally remain abnormal.
Prevention (prophylaxis) of Candida infections in patients with prolonged low white blood cell counts (prolonged neutropenia):
The recommended dose is 200–400 mg once daily; your doctor will determine the duration.
Use in children and adolescents
In children, the maximum recommended dose is 400 mg per day.
As in adults, the duration of treatment depends on the severity and type of infection.
The dose is recommended as a single daily administration.
The dose will be determined by the doctor based on body weight.
Treatment of mucosal infections caused by Candida (mucosal candidiasis):
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 infections of the tissues covering the brain caused by Cryptococcus (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 immunocompromised patients (patients with weakened immune systems):
The recommended dose ranges from 3 mg to 12 mg per kg of body weight, depending on clinical condition.
Use in children aged 3 to 4 weeks:
The same dosage as described above, but administered 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 every 3 days.
The maximum dose is 12 mg per kg of body weight every 72 hours.
Use in the elderly
Your doctor will determine the appropriate dose, taking into account your kidney function.
Use in patients with renal or hepatic impairment (liver problems)
Your doctor may adjust the dose based on your kidney and liver function.
If you take more FLUCONAZOLO ALMUS than you should
Symptoms of overdose may include hallucinations (hearing, seeing, sensing, or believing things that are not real) and behavioral changes (paranoid behavior).
In case of accidental ingestion or overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take FLUCONAZOLO ALMUS
Do not take a double dose to make up for the missed dose.
If you have any questions 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 everyone experiences them.
The following side effects may occur:
Common (may affect up to 1 in 10 people):

  • headache (cephalaea);
  • stomach ache (abdominal pain);
  • nausea;
  • vomiting;
  • diarrhoea;
  • rash;
  • increased levels of liver enzymes.

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

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

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

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

The side effects observed in clinical studies conducted in children were the same as those in adults.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report side effects directly via 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 above 30°C.
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 FLUCONAZOLO ALMUS 100 mg hard capsules contain

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

What FLUCONAZOLO ALMUS 150 mg hard capsules contain

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

What FLUCONAZOLO ALMUS 200 mg hard capsules contain

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

Description of the appearance of FLUCONAZOLO ALMUS and package contents
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 Authorization Holder
ALMUS S.r.l. - Via Cesarea, 11/10 - 16121 Genoa
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM)