ELAZOR 50 mg Hard Capsules

Зміст інструкції

1. ELAZOR 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What ELAZOR is and what it is used for
   2. What you need to know before taking ELAZOR
2. ELAZOR and immediately consult your doctor if you notice any symptoms related to
   1. How to take ELAZOR
   2. Possible side effects
   3. How to store ELAZOR
   4. Contents of the pack and other information
3. ELAZOR 100 mg hard capsules: blister containing 10 capsules of 100 mg of fluconazole.

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

Fluconazole

Read this leaflet carefully before you start 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 could 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 ELAZOR is and what it is used for
• 2. What you need to know before you take ELAZOR
• 3. How to take ELAZOR
• 4. Possible side effects
• 5. How to store ELAZOR
• 6. Contents of the pack and other information

1. What ELAZOR is and what it is used for

ELAZOR has fluconazole as its active ingredient and belongs to a group of medicines
called “ antifungals”.
ELAZOR is used for the treatment of fungal infections. The most common cause of
fungal infections is a yeast called Candida;ELAZOR can therefore be
used to prevent Candidainfections.

Adults
Your doctor may prescribe this medicine for the treatment of the following fungal
infections:

• cryptococcal meningitis(a fungal infection of the membranes surrounding the brain and spinal cord);
• coccidioidomycosis(a disease of the bronchopulmonary system);
• infections caused by Candidain the urinary tract, bloodstream and organs (such as heart, lungs);
• Candida mucositissuch as oral mucosal infection, throat infection and inflammation of the mouth from dentures (stomatitis);
• Candida genital infection(infection of the vagina or penis);
• skin infectionssuch as ringworm, which affects the trunk ( tinea corporis), itching in the genital area ( tinea cruris), on the feet or athlete's foot (tinea pedis), nail infections (onychomycosis).

ELAZOR may be prescribed for:

• preventing the recurrence of cryptococcal meningitis;
• preventing the recurrence of Candida mucositis;
• reducing recurrences of vaginal candidiasis;
• preventing Candidainfections (if your immune system is weak or not functioning properly).

Adolescents (12 years and older)
Your doctor may prescribe this medicine for the treatment of the following fungal
infections:

• Candida mucositissuch as oral mucosal infection, throat infection and inflammation of the mouth from dentures (stomatitis);
• infections caused by Candidain 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 for:

• preventing Candidainfections (if your immune system is weak or not functioning properly);
• preventing the recurrence of cryptococcal meningitis.

2. What you need to know before taking ELAZOR

Do not take ELAZOR

• if you are allergic to fluconazole or any of the other ingredients of this medicine (listed in section 6);
• if you are taking astemizole or terfenadine (antihistamines 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 (antibiotic used to treat bacterial infections).

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

• if you have problems with your liver or kidneys;
• if you suffer from heart disease, including heart arrhythmia;
• if allergic reactions or severe skin reactions occur (itching, skin redness or difficulty breathing);
• if you have abnormal levels of potassium, calcium or magnesium in your blood;
• if signs of “adrenal insufficiency” appear, as the adrenal glands do not produce an adequate amount of certain steroid hormones such as cortisol (chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain);
• if the fungal infection does not improve, an alternative antifungal therapy may be necessary;
• if you have ever developed a severe rash or skin exfoliation, blisters and/or mouth ulcers after taking ELAZOR.

Serious skin reactions including drug reaction with eosinophilia and
systemic symptoms (DRESS) related to treatment with ELAZOR have been reported. Stop taking

ELAZOR and immediately consult your doctor if you notice any symptoms related to

the serious skin reactions described in paragraph 4.

Adolescents
ELAZOR should not be used in paediatric age for the treatment of tinea capitis (scalp ringworm) and
in paediatric patients with impaired kidney function.

Other medicines and ELAZOR
Tell your doctor if you are taking, have recently taken or might take any
other medicine.
Tell your doctor immediatelyif you are taking:

• astemizole, terfenadine (antihistamine used to treat allergies);
• cisapride (used to treat stomach disorders);
• pimozide (used to treat mental disorders);
• quinidine (used to treat heart rhythm problems);
• erythromycin (antibiotic used to treat bacterial infections);
• amiodarone (used to treat irregular heartbeat ''arrhythmias”);
• halofantrine (used to treat malaria); because these medicines cannot be taken with ELAZOR (see paragraph: “Do not take ELAZOR if you”).

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

• rifampicin, rifabutin, azithromycin (antibiotics for the treatment of bacterial infections);
• alfentanil, fentanyl (anaesthetics);
• 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 sleeping or for anxiety;
• carbamazepine, phenytoin (used to treat seizures);
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used to treat hypertension, high blood pressure); hydrochlorothiazide (a diuretic);
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent rejection after transplantation);
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for cancer treatment; 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 that causes acquired immunodeficiency syndrome AIDS);
• chlorpropamide, glibenclamide, glipizide or tolbutamide used for diabetes;
• theophylline (used to control asthma);
• vitamin A (food supplement).

ELAZOR with food
You can take the medicine with or without food.

Pregnancy and breastfeeding
Do not take ELAZOR if you are pregnant, suspect you might be pregnant or are planning a
pregnancy or if you are breastfeeding, unless your doctor tells you to.
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 that the baby is born with malformations of bones and/or
muscles.

You must absolutely not take ELAZOR during pregnancy or breastfeedingunless
your doctor has prescribed it.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
You should be aware that dizziness or convulsions may occur while driving or
using machines.

ELAZOR contains lactose
This medicine contains a small amount of lactose. If you have been diagnosed with
lactose intolerance, contact your doctor before taking this medicine.

3. How to take ELAZOR

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

Use in adults

Use in adolescents from 12 years
Always take the dose prescribed by your doctor, who will choose the appropriate dose according to your clinical conditions. It will be up to the doctor to advise the most appropriate dosage.
Always take the medicine as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

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

Use in patients with kidney or liver problems
The doctor will modify the dosage based on kidney function. The same precaution should be taken for adolescents and children with impaired kidney function.
ELAZOR should be taken with caution if you suffer from liver problems, especially if you are elderly.

If you take more ELAZOR than you should
Taking many ELAZOR capsules together could be dangerous to your health and cause you problems. Immediately inform your doctor or go to the nearest hospital in case of accidental ingestion of many ELAZOR capsules.
Symptoms of an overdose may include hallucinations and paranoid behavior like feeling, seeing, perceiving and thinking things that are not real. In this case, symptomatic treatment (with adequate supportive measures and possibly gastric lavage) may be appropriate.

If you forget to take ELAZOR
Do not take a double dose to make up for the missed dose.
If you forget to take a dose, take it as soon as possible; if instead it is time to take the next dose, do not take the dose you forgot.
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 everybody gets them.
In some patients, particularly those suffering from serious conditions such as AIDS or cancer,
changes in liver, kidney or blood function have been observed during
treatment with fluconazole.
Some people experience allergic reactions, although severe allergic reactions occur
rarely.
If you experience any of the following symptoms seek medical attention 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;
• allergic reactions (sometimes severe), including skin rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face.

ELAZOR can 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).

Stop taking ELAZOR and see 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).

Other side effects
The side effects commonare:

• headache;
• stomach and abdominal discomfort, diarrhea, nausea, vomiting;
• increases in liver function values in blood tests;
• skin rashes.

The side effects uncommonare:

• reduction in red blood cells (anemia) which can cause paleness, weakness or shortness of breath;
• decreased appetite;
• insomnia, drowsiness;
• convulsions, dizziness, feeling faint, tingling, prickling or numbness, altered taste;
• constipation, difficulty digesting, flatulence, dry mouth;
• muscle pain;
• liver damage and yellowing of the skin and eyes (jaundice);
• skin rashes, swelling, blisters (urticaria), itching, increased sweating;
• fatigue, general feeling of being unwell and fever.

The side effects rareare:

• decrease in white blood cells and platelets;
• altered skin color (red or purple);
• high levels of cholesterol and fats in the blood;
• low levels of potassium in the blood;
• chills;
• altered electrocardiogram (ECG), changes in heart rate and rhythm;
• liver failure, hepatitis;
• allergic reactions (sometimes severe), including skin 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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 which is stated on the packaging after “Exp.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
Store at a temperature below 30°C.

6. Contents of the pack and other information

What ELAZOR contains
ELAZOR 50 mg hard capsules

• The active ingredient is fluconazole. Each hard capsule contains 50 mg of fluconazole.
• The excipients are: capsule content: lactosemonohydrate, corn starch, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate. capsule shell content: gelatin, black iron oxide (E172), titanium dioxide (E171).

ELAZOR 100 mg hard capsules

• The active ingredient is fluconazole. Each hard capsule contains 100 mg of fluconazole.
• The excipients are: capsule content: lactosemonohydrate, corn starch, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate. capsule shell content: gelatin, titanium dioxide (E171).

ELAZOR 150 mg hard capsules

• The active ingredient is fluconazole. Each hard capsule contains 150 mg of fluconazole.
• The excipients are: capsule content: lactosemonohydrate, corn starch, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate. capsule shell content :gelatin, black iron oxide (E172), titanium dioxide (E171).

ELAZOR 200 mg hard capsules

• The active ingredient is fluconazole. Each hard capsule contains 200 mg of fluconazole.
• The excipients are: capsule content: lactosemonohydrate, corn starch, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate.

capsule shell content: gelatin, titanium dioxide (E171), erythrosine,
indigo carmine.

Description of the appearance of ELAZOR and contents of the pack
ELAZOR 50 mg hard capsules: blister containing 7 capsules of 50 mg of fluconazole.

ELAZOR 100 mg hard capsules: blister containing 10 capsules of 100 mg of fluconazole.

ELAZOR 150 mg hard capsules: blister containing 2 capsules of 150 mg of fluconazole.
ELAZOR 200 mg hard capsules: blister containing 7 capsules of 200 mg of fluconazole.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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)

This leaflet was last updated: