GEMIFLUX 100 mg Hard Capsule

Зміст інструкції

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

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

1. What GEMIFLUX is and what it is used for

GEMIFLUX contains the active ingredient fluconazole which belongs to a group of medicines
called antifungals. Antifungals are used for the treatment of infections caused by
fungi and yeasts.
GEMIFLUX is indicated for the treatment of:

• infections caused by fungi (mycoses) such as infections of the tissues lining the brain (cryptococcal meningitis);
• infections of the mouth, throat and mucous membranes in general (oropharyngeal candidiasis, esophageal candidiasis, candiduria and chronic mucocutaneous candidiasis, invasive candidiasis);
• infection of the mouth in those cases where oral hygiene and other treatments are not sufficient (chronic atrophic oral candidiasis, denture stomatitis);
• infection of the genitals, in both women and men (acute or recurrent vaginal candidiasis, Candida balanitis);
• skin infections (tinea pedis, tinea corporis, tinea cruris, tinea versicolor, dermatophytosis);
• nail infections (onychomycosis), when other treatments have not been effective;
• other infections caused by fungi (coccidioidomycosis).

This medicine is also indicated for:

• preventing an infection of the tissues lining the brain (recurrence of cryptococcal meningitis) if you have already suffered from it and there is a high risk that the infection may occur again, even in children;
• preventing an infection of the mouth or throat (oropharyngeal or esophageal candidiasis) if you suffer from AIDS;
• preventing Candida infections if you have a weakened immune system;
• reducing the frequency of vaginal infections, when it recurs 4 times or more during a year (recurrent vaginal candidiasis);
• preventing Candida infections if you have a low number of white blood cells in your blood, for example if you suffer from blood diseases (malignant hematological pathologies) and are undergoing chemotherapy or if you receive a blood cell transplant (Hematopoietic Stem Cells).

This medicine can also be used in premature babies, infants and children and
adolescents from 0 to 17 years of age for:

• treating Candida infections of the mouth and throat;
• treating Candida infections of the organs and urinary tract;
• 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 low immune system.

2. What you need to know before taking GEMIFLUX

Do not take GEMIFLUX

• 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 GEMIFLUX” 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, used for some mental disorders;
• erythromycin, used to treat some infections caused by bacteria.

Warnings and precautions
Talk to your doctor or pharmacist before taking GEMIFLUX if:

• you suffer from kidney problems (impaired kidney function);
• you suffer from 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 suffer from heart problems (structural heart disease, electrolyte abnormalities) or if you are taking other medicines that can alter the normal heartbeat (see section “Other medicines and GEMIFLUX”);
• you develop signs of “adrenal insufficiency” in which 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);
• you are taking halofantrine, a medicine used to treat malaria, or terfenadine, a medicine used to treat allergies (see section “Other medicines and GEMIFLUX”);
• you have ever developed a severe skin rash or skin exfoliation, blisters and/or ulcers in the mouth after taking GEMIFLUX.

If you experience skin irritation (rash) or other more serious disturbances 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 are affected by AIDS.
Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) related to treatment with fluconazole have been reported. Stop taking Gemiflux and consult your doctor immediately if you notice any of the symptoms related to the serious skin reactions described in section 4.
Talk to your doctor or pharmacist if the fungal infection does not improve, alternative antifungal therapy may be necessary.

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

Other medicines and GEMIFLUX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take GEMIFLUX 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, as alterations in heartbeat may occur. Avoid taking terfenadine and GEMIFLUX at the same time if the dose of GEMIFLUX prescribed to you is 400 mg or more per day. If you need to take a dose of GEMIFLUX less than 400 mg and terfenadine, your doctor will need to monitor your health condition during treatment with the two medicines;
• astemizole, used to treat allergies;
• some medicines used to treat irregular heartbeat, such as quinidine;
• erythromycin, used to treat some infections caused by bacteria;
• pimozide, used for some mental disorders.

Tell your doctor if you are taking the following medicines because the dose may need to be adjusted or specific checks may be performed:

• halofantrine, a medicine used to treat malaria;
• rifampicin, rifabutin, azithromycin, used to treat some infections caused by bacteria;
• abrocitinib (used for the treatment of atopic dermatitis, also known as atopic eczema);
• alfentanil and fentanyl, medicines used as painkillers;
• amitriptyline, nortriptyline, medicines used to treat depression;
• amphotericin B, voriconazole used to treat some infections caused by fungi;
• medicines used to make the blood more fluid (warfarin);
• some medicines used to treat anxiety or as tranquillizers, 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);
• olaparib (used for the treatment of ovarian cancer);
• celecoxib, a medicine used to treat inflammation;
• some medicines used to treat some cancers (cyclophosphamide, vincristine, vinblastine);
• cyclosporine, everolimus, sirolimus and tacrolimus, medicines used after organ transplants to prevent rejection;
• losartan, a medicine used to treat high blood pressure;
• methadone, a medicine used to treat drug addiction;
• medicines used to treat inflammation (non-steroidal anti-inflammatory drugs - NSAIDs);
• medicines used to treat inflammation, asthma and allergies (prednisone);
• saquinavir, zidovudine, used to treat AIDS;
• medicines used to treat diabetes (chlorpropamide, glibenclamide, glipizide and tolbutamide);
• theophylline, used to treat some breathing problems;
• tofacitinib (used for the treatment of rheumatoid arthritis);
• tolvaptan, used to treat hyponatremia (low levels of sodium in the blood) or to slow the decline of kidney function;
• vitamin A-based medicines;
• ivacaftor (used for the treatment of cystic fibrosis);
• medicines used to prevent pregnancy (oral contraceptives);
• statins (atorvastatin, simvastatin, fluvastatin);
• amiodarone (used for the treatment of irregular heartbeat, “arrhythmia”);
• ibrutinib (used for the treatment of blood cancer);
• lurasidone (used for the treatment of schizophrenia);
• hydrochlorothiazide (a diuretic) .

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take GEMIFLUX if you are pregnant, suspect you are pregnant or are planning a pregnancy, unless your doctor tells you to.
If you are planning a pregnancy you should wait one week after a single dose of fluconazole before trying to conceive.
For longer cycles of therapy with fluconazole, consult your doctor to assess the need for adequate contraception during treatment, which should continue for one week after the last dose.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester of pregnancy may increase the risk that the baby is born with heart, bone and/or muscle malformations.
Cases of babies with birth defects affecting the skull, ears and thigh and elbow bones have been reported in women treated for three months or more with high doses (400-800 mg per day) of fluconazole for coccidioidomycosis. The link between fluconazole and these cases is unclear.
Breastfeeding
Avoid breastfeeding if you have taken GEMIFLUX at high doses or for prolonged periods.
You can breastfeed if you have taken a single dose of 150 mg or less of GEMIFLUX.

Driving and using machines
There is no data available to establish the effect of this medicine on the ability to drive and operate machines. However, if you experience side effects such as dizziness or convulsions, avoid driving or operating machines.

GEMIFLUX contains lactose and sodium
This medicine contains lactose, a type of sugar. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
Gemiflux capsules contains less than 1 mmol (23 mg) of sodium per capsule, that is to say essentially “sodium-free”.

3. How to take GEMIFLUX

Take this medicine following exactly the instructions of 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. Carefully
follow your doctor's instructions because an inadequate duration of treatment may not resolve the infection.
Do not open the capsule, swallow it whole regardless of meals.
The recommended doses of GEMIFLUX depending on the infection are listed below:

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.
For the prevention of cryptococcal meningitis, 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 infections
The recommended dose is 800 mg on the first day, then 400 mg once a day, the doctor will establish the
duration.

Treatment of infections of the oral mucosa, throat infections and mouth inflammation
from dentures
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 mucosal infections (candidiasis of the mucous membranes)
The recommended dose is 50 - 400 mg once a day for 7- 30 days until you are told to
stop.
The recommended dose for the prevention of oral infections (oral mucosa) 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 (vaginal candidiasis)
The recommended dose is 150 mg in a single administration.
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 and nail infections
The recommended dose varies depending on the infected area and may be 50
mg once a day, 150 mg once a week, or be between 300 mg and 400 mg once a week. The duration
of treatment varies from 1 to 4 weeks.
Foot nail infection (athlete's foot) may take up to 6 weeks and last until
the infected nail is replaced.

Prevention of Candida infections
If your immune defenses are low or you are prone to Candida infections, the recommended
dose is 200 - 400 mg once a day to be taken when you are at risk of contracting an infection.

Use in adolescents from 12 to 17 years
The dose will be established by the doctor.

Use in children up to 11 years
The dose will be established by the doctor based on the child's body weight.
The maximum recommended dose is 400 mg per day.

Treatment of infections of the mucosa and throat
The recommended dose is 3 mg per kg of body weight. On the first day, 6 mg
per kg of body weight may be administered.).
The dose and duration of treatment depend on the severity of the infection and the area to be treated.

Treatment of infection of the tissues lining the brain (cryptococcal meningitis) and other
Candida infections (endemic infections)
The recommended dose varies from 6 mg to 12 mg per kg of body weight.

Prevention of Candida infections
If the child has low immune defenses or is prone to Candida infections, the dose
recommended varies from 3 to 12 mg per kg of body weight.

Use in children aged 0 to 4 weeks
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, unless otherwise prescribed by a doctor.

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, unless otherwise prescribed by a doctor.

Use in the elderly
The same dose as provided for adults should be used unless you have kidney problems.

Use in patients with kidney problems
The doctor may adjust the dosage based on kidney function.

If you take more GEMIFLUX than you should
Symptoms of overdose may include hallucinations and altered behavior (paranoia).
In case of accidental ingestion/intake of an excessive dose of this medicine, immediately
inform your doctor or go to the nearest hospital.

If you forget to take GEMIFLUX
Do not take a double dose to make up for a missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking Gemiflux and contact your doctor immediately if you notice any of the following symptoms:

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

Some people experience allergic reactions, although serious 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;
• skin rashes;
• serious skin reactions, such as rashes that cause blisters (may affect the mouth and tongue).

GEMIFLUX may have effects on the liver. Symptoms of liver problems include:

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

If you experience any of these symptoms, stop taking Gemiflux and inform your doctor immediately.
The following side effects may occur:

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

• headache;
• stomach pain (abdominal pain), nausea;
• vomiting;
• diarrhea;
• skin irritation (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 (anemia);
• decreased appetite;
• drowsiness, insomnia;
• convulsions, altered sensitivity in the arms and legs (paresthesia), dizziness, altered taste;
• vertigo;
• constipation, digestive problems (dyspepsia), flatulence, dry mouth;
• liver disorders (cholestasis, jaundice, increased bilirubin);
• allergic reactions (hypersensitivity), increased sweating;
• muscle pain (myalgia);
• fatigue, malaise, decreased muscle strength (asthenia), fever.

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

• alteration of the levels of white blood cells (agranulocytosis, leukopenia, neutropenia);
• decrease in the levels of platelets in the blood (thrombocytopenia);
• severe allergic reaction (anaphylaxis);
• increased levels of cholesterol and fats in the blood (hypercholesterolemia, hypertriglyceridemia);
• decreased levels of potassium in the blood (hypokalaemia);
• tremor;
• heartbeat alterations (Torsades de Pointes, QT prolongation);
• liver problems (liver failure, hepatocellular necrosis), liver inflammation (hepatitis), damage to liver cells (hepatocellular damage);
• severe allergic skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis);
• swelling due to fluid accumulation (edema);
• hair loss (alopecia).

Frequency not known, but which may occur (frequency cannot be estimated on the basis of 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 experience any side effect, including 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 GEMIFLUX

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.
Store at a temperature not exceeding 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 GEMIFLUX 100 mg hard capsules contain

• The active ingredient is fluconazole. Each capsule contains 100 mg of fluconazole.
• The other ingredients are: lactose, starch, anhydrous colloidal silica, magnesium stearate and sodium lauryl sulfate. Coating: gelatin, titanium dioxide (E171).

What GEMIFLUX 150 mg hard capsules contain

• The active ingredient is fluconazole. Each capsule contains 150 mg of fluconazole.
• The other ingredients are: lactose, starch, anhydrous colloidal silica, magnesium stearate and sodium lauryl sulfate. Coating: gelatin, titanium dioxide (E171), indigotine (E132).

What GEMIFLUX 200 mg hard capsules contain

• The active ingredient is fluconazole. Each capsule contains 200 mg of fluconazole.
• The other ingredients are: lactose, starch, anhydrous colloidal silica, magnesium stearate and sodium lauryl sulfate. Coating: gelatin, titanium dioxide (E171), indigotine (E132), black iron oxide (E172), erythrosine (E127).

Description of the appearance of GEMIFLUX and contents of the pack
GEMIFLUX 100 mg hard capsules
Pack of 10 capsules.
GEMIFLUX 150 mg hard capsules
Pack of 2 capsules.
GEMIFLUX 200 mg hard capsules
Pack of 7 capsules.

Marketing authorisation holder
Eberlife Farmaceutici S.p.A. –Via G. Porzio , SNC– 80143 Napoli

Manufacturer
Lachifarma S.r.l. – Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Adriatica - Zona Industriale - 73010 Zollino (LE)