Elazor: detailed information

Package leaflet: Information for the patient

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

Fluconazole
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ELAZOR is and what it is used for
What you need to know before taking ELAZOR
How to take ELAZOR
Possible side effects
How to store ELAZOR
Contents of the pack and other information

1. What ELAZOR is and what it is used for

ELAZOR contains fluconazole as its active ingredient and belongs to a group of medicines
called "antifungals".
ELAZOR is used to treat fungal infections. The most common cause of fungal infections is a yeast called Candida; ELAZOR can therefore be used to prevent Candida infections.
Adults
Your doctor may prescribe this medicine to treat the following fungal infections:

cryptococcal meningitis (a fungal infection of the membranes surrounding the brain and spinal cord);
coccidioidomycosis (a disease affecting the bronchopulmonary system);
infections caused by Candida in the urinary tract, bloodstream, and organs (such as heart, lungs);
mucosal candidiasis, such as oral mucosal infection, throat infection, and denture-related mouth inflammation (stomatitis);
genital candidiasis (infection of the vagina or penis);
skin infections such as ringworm affecting the trunk (tinea corporis), groin itching (tinea cruris), athlete's foot (tinea pedis), and nail infections (onychomycosis).

ELAZOR may be prescribed to you:

to prevent recurrence of cryptococcal meningitis;
to prevent recurrence of mucosal candidiasis;
to reduce recurrences of vaginal candidiasis;
to prevent Candida infections (if your immune system is weak or not functioning properly).

Adolescents (from 12 years of age)
Your doctor may prescribe this medicine to treat the following fungal infections:

mucosal candidiasis, such as infection of the oral mucosa, throat infection, and denture-related mouth inflammation (stomatitis);
infections caused by Candida in the urinary tract, bloodstream, and organs (such as heart, lungs);
cryptococcal meningitis (a fungal infection of the membranes surrounding the brain and spinal cord).

ELAZOR may be prescribed to you:

to prevent Candida infections (if your immune system is weak or not functioning properly);
to prevent recurrence of cryptococcal meningitis.

2. What you need to know before taking ELAZOR

Do not take ELAZOR

if you are allergic to fluconazole or to any of the other ingredients of this medicine (listed in section 6);
if you are taking astemizole or terfenadine (antihistamine medicines used to treat allergies);
if you are taking cisapride (used to treat stomach disorders);
if you are taking pimozide (used to treat mental disorders);
if you are taking quinidine (used to treat heart arrhythmias);
if you are taking erythromycin (an antibiotic used to treat bacterial infections).

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

if you have liver or kidney problems;
if you suffer from heart diseases, including cardiac arrhythmia;
if allergic reactions or severe skin reactions occur (itching, skin redness, or breathing difficulties);
if you have abnormal levels of potassium, calcium, or magnesium in your blood;
if symptoms of "adrenal insufficiency" appear, as 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);
if the fungal infection does not improve, alternative antifungal therapy may be required;
if you have ever developed a severe rash or skin peeling, blisters, and/or mouth ulcers after taking ELAZOR.

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with ELAZOR treatment. Stop taking ELAZOR and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.
Adolescents
ELAZOR must not be used in pediatric patients for the treatment of ringworm (tinea capitis) and in pediatric patients with impaired kidney function.
Other medicines and ELAZOR
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
Inform your doctor immediately if you are taking:

astemizole, terfenadine (antihistamines used to treat allergies);
cisapride (used to treat stomach disorders);
pimozide (used to treat mental disorders);
quinidine (used to treat heart arrhythmias);
erythromycin (an antibiotic used to treat bacterial infections);
amiodarone (used to treat irregular heartbeat "arrhythmias");
halofantrine (used to treat malaria); as these medicines must not be taken with ELAZOR (see section: “Do not take ELAZOR if you”).

There are some medicines that may interact with ELAZOR. Inform your doctor if you are taking any of the following medicines:

rifampicin, rifabutin, azithromycin (antibiotics for the treatment of bacterial infections);
alfentanil, fentanyl (anesthetics);
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 for sleep or anxiety;
carbamazepine, phenytoin (used to treat epileptic seizures);
nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (used to treat hypertension, high blood pressure); hydrochlorothiazide (a diuretic);
ciclosporin, everolimus, sirolimus, or tacrolimus (used to prevent transplant rejection);
cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines) used to treat cancer; statins (atorvastatin, simvastatin, fluvastatin, and similar medicines) used to reduce high cholesterol levels;
methadone (used to treat pain);
celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs - NSAIDs);
oral contraceptives;
prednisone (a steroid);
zidovudine (also known as AZT) and saquinavir (used for HIV infection causing acquired immunodeficiency syndrome AIDS);
chlorpropamide, glibenclamide, glipizide, or tolbutamide used for diabetes;
theophylline (used to control asthma);
vitamin A (dietary supplement).

ELAZOR with food
You may take this medicine with or without food.
Pregnancy and breastfeeding
Do not take ELAZOR if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, unless instructed by 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 of the baby being born with bone and/or muscle malformations.
You must not take ELAZOR during pregnancy or breastfeeding unless prescribed by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Be aware that dizziness or seizures may occur while driving or using machines.
ELAZOR contains lactose
This medicine contains a small amount of lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take ELAZOR

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water, regardless of meals. It is best to take the capsules at the same time each day.
The recommended doses of ELAZOR, to be taken depending on the infection, are listed below:
Use in adults

Infection	Dose to take of ELAZOR
Treatment of cryptococcal meningitis	400 mg on the first day, then 200 mg to 400 mg once daily for a period of 6 to 8 weeks or longer, if necessary. In more severe cases of infection, doses may be increased up to 800 mg.
	Doses may be increased up to 800 mg.
Prevention of recurrence of cryptococcal meningitis	200 mg once daily until your doctor tells you to stop.
Treatment of coccidioidomycosis	200 mg to 400 mg once daily for a period of 11 to 24 months. Sometimes doses may be increased up to 800 mg.
Endemic Candida fungal infections	800 mg on the first day, then 400 mg once daily for usually 2 weeks or more, until symptoms resolve.
Mucosal candidiasis – dose depends on site of infection - Treatment of infections of the oral mucosa, throat, and denture-related stomatitis (inflammation of the mouth due to dentures)	Dose varies from 50 mg to 400 mg depending on the underlying infection and its severity. Generally 200 mg to 400 mg on the first day, then 100 mg to 200 mg once daily for 7 to 30 days and/or until your doctor tells you to stop.
Prevention of oral, pharyngeal, and denture-related mucosal infections (especially if your immune system is weakened or not functioning properly)	100 mg to 200 mg once daily, or 200 mg three times a week, for as long as you are at risk of developing an infection.
Genital candidiasis - Treatment of vaginal or penile infections	Single 150 mg dose.
Reducing recurrences of vaginal candidiasis (vaginal infections)	150 mg every three days for a total of 3 doses (day 1, 4, and 7), then 150 mg once weekly as maintenance dose for a period of 6 months.
Skin fungal infections such as ringworm affecting the trunk (tinea corporis), genital itching (tinea cruris), feet or athlete's foot (tinea pedis), nail infections (onychomycosis)	Dose varies depending on site of infection, underlying infection, and severity: 150 mg once weekly or 50 mg once daily for 2 to 4 weeks (athlete’s foot may require up to 6 weeks), 300 mg to 400 mg once weekly for 1 to 3 weeks (if infection affects multiple body sites), 150 mg once weekly for nail infections (onychomycosis); treatment for nail infections lasts until
	the healthy nail has fully regrown.
Prevention of Candida infections (if your immune system is weakened or not functioning properly)	200 mg to 400 mg once daily for as long as you are at risk of developing an infection.

Use in adolescents aged 12 years and older
Always take the dose prescribed by your doctor, who will choose the dose appropriate for your clinical condition. Your doctor will advise you on the most suitable dosage regimen.
Always take the medicine exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist.

Use in elderly patients
The same dose recommended for adults should be used unless you have kidney or liver problems.

Use in patients with kidney or liver problems
Your doctor will adjust the dosage according to kidney function. The same precaution applies to adolescents and children with impaired kidney function.
ELAZOR should be taken with caution if you have liver problems, especially if you are elderly.

If you take more ELAZOR than you should
Taking several ELAZOR capsules together may be dangerous for your health and may cause adverse effects. Immediately inform your doctor or go to the nearest hospital if you accidentally take several ELAZOR capsules.
Symptoms of overdose may include hallucinations and paranoid behaviour, such as hearing, seeing, sensing or believing things that are not real. In such cases, symptomatic treatment may be appropriate (with appropriate supportive measures and, if necessary, gastric lavage).

If you forget to take ELAZOR
Do not take a double dose to make up for the forgotten dose.
If you forget to take a dose, take it as soon as possible; however, if it is almost time for your next dose, skip the missed dose and take the next one at the usual time.
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 everybody will experience them.
In some patients, particularly those with serious underlying diseases such as AIDS or cancer, changes in liver, kidney or blood function have been observed during treatment with fluconazole.
Some people may experience allergic reactions, although severe allergic reactions are rare.
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 rash;
skin rashes;
allergic reactions (sometimes severe), including rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face.

ELAZOR may affect the liver. Symptoms of liver problems include:

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

Stop taking ELAZOR and contact your doctor immediately if you notice any of the following symptoms:

Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other side effects
The common side effects are:

headache;
stomach and abdominal discomfort, diarrhoea, nausea, vomiting;
increased liver function test values in blood tests;
skin rashes.

The uncommon side effects are:

reduction in red blood cells (anaemia), which may cause paleness, weakness or breathlessness;
decreased appetite;
insomnia, drowsiness;
seizures, dizziness, vertigo, tingling, prickling or numbness, altered taste;
constipation, indigestion, flatulence, dry mouth;
muscle pain;
liver damage and yellowing of the skin and eyes (jaundice);
skin rashes, swellings, blisters (urticaria), itching, increased sweating;
tiredness, general malaise and fever.

The rare side effects are:

reduction in white blood cells and platelets;
altered skin colouration (red or purplish);
high levels of cholesterol and fats in the blood;
low levels of potassium in the blood;
chills;
abnormal electrocardiogram (ECG), changes in heart rhythm and rate;
liver failure, hepatitis;
allergic reactions (sometimes severe), including rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face;
hair loss (alopecia).

Reporting of side effects

If you experience 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:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ELAZOR

Keep this medicine out of the sight and reach of children.
Do not use ELAZOR after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Store below 30°C.

6. Package contents and other information

What ELAZOR contains
ELAZOR 50 mg hard capsules

The active substance is fluconazole. Each hard capsule contains 50 mg of fluconazole.
The excipients are: capsule contents: lactose monohydrate, maize starch, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate.
capsule cap contents: gelatin, black iron oxide (E172), titanium dioxide (E171).

ELAZOR 100 mg hard capsules

The active substance is fluconazole. Each hard capsule contains 100 mg of fluconazole.
The excipients are: capsule contents: lactose monohydrate, maize starch, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate.
capsule cap contents: gelatin, titanium dioxide (E171).

ELAZOR 150 mg hard capsules

The active substance is fluconazole. Each hard capsule contains 150 mg of fluconazole.
The excipients are: capsule contents: lactose monohydrate, maize starch, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate.
capsule cap contents: gelatin, black iron oxide (E172), titanium dioxide (E171).

ELAZOR 200 mg hard capsules

The active substance is fluconazole. Each hard capsule contains 200 mg of fluconazole.
The excipients are: capsule contents: lactose monohydrate, maize starch, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate.
capsule cap contents: gelatin, titanium dioxide (E171), erythrosine, indigotine.

Description of the appearance of ELAZOR and package contents
ELAZOR 50 mg hard capsules: blister pack containing 7 capsules of 50 mg fluconazole.
ELAZOR 100 mg hard capsules: blister pack containing 10 capsules of 100 mg fluconazole.
ELAZOR 150 mg hard capsules: blister pack containing 2 capsules of 150 mg fluconazole.
ELAZOR 200 mg hard capsules: blister pack containing 7 capsules of 200 mg fluconazole.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 – 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)
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