GEMIFLUX

Package leaflet: Information for the patient

GEMIFLUX 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Generic medicine
Please read all of this leaflet carefully before you start taking 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 pass it on to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, inform 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 taking 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 substance fluconazole, which belongs to a group of medicines called antifungals. Antifungals are used to treat infections caused by fungi and yeasts.

GEMIFLUX is indicated for the treatment of:

• fungal infections (mycoses) such as infections of the tissues covering the brain (cryptococcal meningitis);
• infections of the mouth, throat and mucous membranes in general (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 oral candidiasis, denture stomatitis);
• genital infections, in both women and men (acute or recurrent vaginal candidiasis, Candida balanitis);
• skin infections (tinea pedis, tinea corporis, tinea cruris, pityriasis versicolor, dermatomycoses);
• nail infections (onychomycosis), when other treatments have not been effective;
• other fungal infections (coccidioidomycosis).

This medicine is also indicated for:

• preventing infection of the tissues covering the brain (recurrence of cryptococcal meningitis) if you have already suffered from it and there is a high risk that the infection may reappear again, including in children;
• preventing mouth or throat infection (oropharyngeal or oesophageal candidiasis) if you have AIDS;
• preventing Candida infections if you have a weakened immune system;
• reducing the frequency of vaginal infections when they recur 4 or more times within a year (recurrent vaginal candidiasis);
• preventing Candida infections if you have a low number of white blood cells in the blood, for example if you have blood diseases (malignant haematological disorders) and are undergoing chemotherapy, or if you are receiving blood stem cell transplantation.

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

• treating Candida infections of the mouth and throat;
• treating Candida infections of internal organs and urinary tract;
• treating infections of the tissues covering the brain (cryptococcal meningitis) and preventing its recurrence if the child has previously suffered from it;
• preventing Candida infections if the child has a weakened immune system.

2. What you need to know before taking GEMIFLUX

Do not take GEMIFLUX

• if you are allergic to fluconazole, to medicines similar to it (azoles) 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 GEMIFLUX” 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, used for certain mental disorders;
  • erythromycin, used to treat certain bacterial infections.

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

• you have kidney problems (impaired renal function);
• you have liver problems, as serious issues including death may occur. 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 rhythm problems (structural heart disease, electrolyte abnormalities) or are taking other medicines that may affect normal heart rhythm (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 alofantrine, a medicine used to treat malaria, or terfenadine, a medicine used to treat allergies (see section “Other medicines and GEMIFLUX”);
• you have previously developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking GEMIFLUX.

If during treatment with this medicine you develop skin irritation (rash) 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 immediately.
These reactions may be more likely if you have AIDS.
Severe skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with fluconazole treatment. Stop taking Gemiflux 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 alternative antifungal therapy may be needed.

Children and adolescents
GEMIFLUX must 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 certain stomach problems;
• terfenadine, a medicine used to treat allergies, as changes in heart rhythm may occur. Avoid taking terfenadine and GEMIFLUX together if your prescribed dose of GEMIFLUX is 400 mg or more per day. If you need to take a dose of GEMIFLUX lower than 400 mg together with terfenadine, your doctor will monitor your health during treatment with both medicines;
• astemizole, used to treat allergies;
• certain medicines used to treat irregular heartbeats, such as quinidine;
• erythromycin, used to treat certain bacterial infections;
• pimozide, used for certain mental disorders.

Inform your doctor if you are taking any of the following medicines, as dose adjustments or specific monitoring may be necessary:

• alofantrine, a medicine used to treat malaria;
• rifampicin, rifabutin, azithromycin, used to treat certain bacterial infections;
• abrocitinib (used to treat 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 certain fungal infections;
• medicines used to make the blood less likely to clot (warfarin);
• certain medicines used for 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);
• olaparib (used to treat ovarian cancer);
• celecoxib, a medicine used to treat inflammation;
• certain medicines used to treat certain tumors (cyclophosphamide, vincristine, vinblastine);
• ciclosporin, everolimus, sirolimus and tacrolimus, medicines used after organ transplantation 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 certain breathing problems;
• 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-containing medicines;
• ivacaftor (used to treat cystic fibrosis);
• medicines used to prevent pregnancy (oral contraceptives);
• statins (atorvastatin, simvastatin, fluvastatin);
• amiodarone (used to treat irregular heartbeat, “arrhythmia”);
• ibrutinib (used to treat blood cancer);
• lurasidone (used to treat schizophrenia);
• hydrochlorothiazide (a diuretic).

Pregnancy and breastfeeding
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.

Pregnancy
Do not take GEMIFLUX if you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, 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 treatment cycles with fluconazole, consult your doctor to evaluate the need for adequate contraception during treatment, which should continue for one week after the last dose.
Taking fluconazole during the first or second trimester of pregnancy may increase the risk of miscarriage. Taking fluconazole during the first trimester of pregnancy may increase the risk of birth defects affecting the baby’s heart, bones and/or muscles.
Cases of babies born with malformations of 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 daily) of fluconazole for coccidioidomycosis. The link between fluconazole and these cases is not clear.

Breastfeeding
Avoid breastfeeding if you have taken GEMIFLUX at high doses or for prolonged periods.
You may breastfeed if you have taken a single dose of GEMIFLUX equal to or less than 150 mg.

Driving and using machines
There are no available data to determine the effect of this medicine on the ability to drive or use machines. However, if you experience side effects such as dizziness or seizures, avoid driving or using machines.

GEMIFLUX contains lactose and sodium
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Gemiflux capsules contain less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take GEMIFLUX

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 an inadequate duration of treatment may fail to resolve the infection.
Do not open the capsule; swallow it whole, regardless of meals.

The recommended doses of GEMIFLUX according to the type of infection are listed below:

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.
For prevention of cryptococcal meningitis, the recommended dose is 200 mg once daily; your doctor will determine the duration.

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 Candida infections
The recommended dose is 800 mg on the first day, followed by 400 mg once daily; your doctor will determine the duration.

Treatment of oral mucosal infections, throat infections, and denture-related mouth inflammation
The recommended dose is 200–400 mg on the first day, followed by 100–200 mg; your doctor will determine the duration.

Treatment of mucosal infections (mucosal candidiasis)
The recommended dose is 50–400 mg once daily for 7–30 days, or until you are instructed to stop.
The recommended dose for prevention of oral (oral mucosal) infections is 100–200 mg once daily, or 200 mg three times a week, for as long as you remain at risk of infection.

Treatment of genital infection (vaginal candidiasis)
The recommended dose is 150 mg as a single dose.
The recommended dose to reduce the frequency of vaginal infections is 150 mg every three days for a total of three doses (days 1, 4, and 7), followed by once weekly for 6 months while you remain at risk of infection.

Treatment of skin and nail infections
The recommended dose varies depending on the infected area and may be 50 mg once daily, 150 mg once weekly, or between 300 mg and 400 mg once weekly. The duration of treatment ranges from 1 to 4 weeks.
Athlete’s foot (fungal nail infection of the foot) may require up to 6 weeks of treatment and may continue until the infected nail is fully 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 daily, taken when you are at risk of infection.

Use in adolescents aged 12 to 17 years
The dose will be determined by the doctor.

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

Treatment of mucosal and throat infections
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 being treated.

Treatment of infections of the membranes covering the brain (cryptococcal meningitis) and other Candida infections (endemic infections)
The recommended dose ranges 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 recommended dose ranges from 3 mg to 12 mg per kg of body weight.

Use in children aged 3 to 4 weeks
The same dosage described above, but administered every 48 hours. 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 described above, but administered every 72 hours.
The maximum dose is 12 mg per kg of body weight every 72 hours, unless otherwise prescribed by a doctor.

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

Use in patients with kidney problems
Your doctor may adjust the dose based on kidney function.

If you take more GEMIFLUX than you should
Symptoms of overdose may include hallucinations and behavioral changes (paranoia).
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 GEMIFLUX
Do not take a double dose to make up for the missed 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 everybody gets them.
Stop taking Gemiflux 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 get any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. If you experience any of the following symptoms, inform your doctor immediately:

• sudden breathlessness, difficulty breathing, or tightness in the chest;
• 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).

GEMIFLUX 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 Gemiflux and contact your doctor immediately.
The following side effects may occur:
Common (may affect up to 1 in 10 people):

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

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

• reduced number of red blood cells (anaemia);
• decreased appetite;
• drowsiness, insomnia;
• seizures, altered sensation in arms and legs (paraesthesia), 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):

• changes in white blood cell levels (agranulocytosis, leucopenia, neutropenia);
• decreased levels 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 (liver failure, hepatocellular necrosis), inflammation of the liver (hepatitis), damage to liver cells (hepatocellular damage);
• severe skin allergic reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis);
• swelling due to fluid retention (oedema);
• loss of hair and body hair (alopecia).

Frequency not known (frequency cannot be estimated from the 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 large intestine) (drug reaction or rash with eosinophilia and systemic symptoms (DRESS)).

Reporting of side effects
If you get 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 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 below 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 GEMIFLUX 100 mg hard capsules contain

• The active substance is fluconazole. Each capsule contains 100 mg of fluconazole.
• The other components 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 substance is fluconazole. Each capsule contains 150 mg of fluconazole.
• The other components 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 substance is fluconazole. Each capsule contains 200 mg of fluconazole.
• The other components 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 size: 10 capsules.
GEMIFLUX 150 mg hard capsules
Pack size: 2 capsules.
GEMIFLUX 200 mg hard capsules
Pack size: 7 capsules.

Marketing Authorization Holder
Eberlife Farmaceutici S.p.A. – Via G. Porzio, SNC – 80143 Naples
Manufacturer
Lachifarma S.r.l. – Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Adriatica - Zona Industriale - 73010 Zollino (LE)