LEFUNZOL <100 mg Hard capsule

Зміст інструкції

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

LEFUNZOL 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
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 their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4

Contents of this leaflet:

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

1. What Lefunzol is and what it is used for

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

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

• cryptococcal meningitis - a fungal infection of the brain;
• coccidioidomycosis - a disease of the bronchopulmonary system;
• infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract;
• candidiasis of the mucous membranes - infection of the oral mucosa, throat infection and inflammation of the mouth from dentures;
• genital candidiasis - infection of the vagina or penis;
• skin infections - e.g. athlete's foot, ringworm, itching in the genital area, nail infections.

Lefunzol may be prescribed for:

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

Children and adolescents (from 0 to 17 years)
Your doctor may prescribe this medicine for the treatment of the following fungal infections:

• candidiasis of the mucous membranes - infection of the oral mucosa, throat infection
• infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• cryptococcal meningitis - a fungal infection of the brain

Lefunzol 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 Lefunzol

Do not take Lefunzol

• if you are allergic to fluconazole, to other medicines that you have used for the treatment of fungal infections or to any of the other components of this medicine (listed in section 6). The symptoms may be itching, redness of the skin or difficulty in breathing;
• if you are taking astemizole, 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 Lefunzol:

• if you have liver or kidney problems;
• if you suffer from heart disease, including heart arrhythmia;
• if you have abnormal levels of potassium, calcium or magnesium in your blood;
• if severe skin reactions appear (itching, redness of the skin or difficulty in breathing);
• if signs of “adrenal insufficiency” appear, caused by the inability of the adrenal glands to produce an adequate amount of certain steroid hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain);
• if you have ever developed a severe rash or skin exfoliation, blisters and/or ulcers in the mouth after taking fluconazole. Severe skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) related to treatment with fluconazole have been reported. Stop taking Lefunzol and consult your doctor immediately if you notice any of the symptoms related to the severe 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.

Other medicines and Lefunzol
Tell your doctor or pharmacist 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 arrhythmias);
• erythromycin (antibiotic used to treat bacterial infections), as they cannot be taken with Lefunzol (see section: “Do not take Lefunzol”).

There are some medicines that can interact with Lefunzol. Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be necessary to ensure that the medicines continue to have the desired effect:

• rifampicin or rifabutin (antibiotics for the treatment of bacterial infections);
• abrocitinib (used for the treatment of atopic dermatitis, also known as atopic eczema);
• hydrochlorothiazide (a diuretic);
• 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 to help you sleep or for anxiety;
• carbamazepine, phenytoin (used to treat seizures);
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used to treat hypertension - high blood pressure);
• olaparib (used for the treatment of ovarian cancer);
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent transplant rejection);
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for the treatment of cancer;
• halofantrine (used for the treatment of malaria);
• amiodarone (used for the treatment of “arrhythmias”, irregular heartbeats);
• statins (atorvastatin, simvastatin, fluvastatin and similar medicines) used to reduce high cholesterol levels;
• methadone (used for the treatment of pain);
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs - NSAIDs);
• oral contraceptives;
• prednisone (steroid);
• zidovudine, also known as AZT;
• saquinavir (used in patients with HIV);
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide;
• theophylline (used for asthma control);
• tofacitinib (used for the treatment of rheumatoid arthritis);
• tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline of kidney function;
• vitamin A (dietary supplement);
• ivacaftor (alone or in combination with other drugs used to treat cystic fibrosis);
• ibrutinib (used for the treatment of blood cancer);
• lurasidone (used for the treatment of schizophrenia).

Lefunzol with food and drink
You can take the medicine with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect 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.
If you are planning a pregnancy you should wait one week after a single dose of fluconazole before trying to start pregnancy.
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.
Do not take fluconazole if you are or think you might be pregnant or are trying to become pregnant, unless your doctor has told you to. If you become pregnant during taking this medicine or within 1 week of the most recent dose, consult your doctor.
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 of the newborn having birth defects affecting the heart, bones and/or muscles.
Cases of children with birth defects affecting the skull, ears and bones of the thigh and elbow 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.
You can continue to breastfeed after taking a single dose of Lefunzol 150 mg. You should not breastfeed if you are taking repeated doses of Lefunzol.

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

Lefunzol contains lactose
This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Lefunzol

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

Use in adults

Use in adolescents from 12 to 17 years
Always take the dose prescribed by your doctor. It will be up to the doctor to advise either the recommended dose for adults or that for children.

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

Use in infants from 0 to 4 weeks
Use in infants aged 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.
Use in infants under 2 weeks:
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.
The doctor may sometimes prescribe doses different from these. Always take the medicine as indicated by the doctor. If you have any doubts, consult your doctor or pharmacist.

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

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

If you take more Lefunzol than you should
Taking too many capsules all at once may cause you problems. Immediately warn your doctor or go to the nearest hospital.
In case of accidental overdose, symptoms may include feeling, seeing, perceiving and thinking things that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be appropriate (with adequate supportive measures and possibly gastric lavage).

If you forget to take Lefunzol
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 it is time to take the next dose, do not take the forgotten dose.
If you have any doubts 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 gets them.
Stop taking Lefunzol 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).

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

Lefunzol can have effects on the liver. Symptoms of liver problems include:

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

If you experience any of these symptoms, stop taking Lefunzol and inform your doctor
immediately.
Other side effects
If any of the side effects gets worse, or if you notice any side effect

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

• headache;
• abdominal pain, diarrhea, nausea, vomiting;
• increases in liver function values in blood tests;
• rash.

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

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

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

• lower than normal levels of white blood cells, which help to fight infections, and platelets, which help blood to clot;
• altered skin color (red or purple) which may be caused by a reduction in platelets, other changes in blood cells;
• changes in the chemical composition of the blood (high levels of cholesterol, fats);
• low levels of potassium in the blood;
• tremor;
• altered electrocardiogram (ECG), changes in heart rate and rhythm;
• liver failure;
• 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.

Frequency not known, but may occur (frequency cannot be estimated from the 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 get any side effects, talk to 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 Lefunzol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The
expiry date refers to the last day of that month.
Store at a temperature below 30°C.
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.

6. Contents of the pack and other information

What Lefunzol contains

• The active ingredient is fluconazole.
• Each hard capsule contains 100 mg, 150 mg or 200 mg of fluconazole.
• The other ingredients are: capsule content :
• lactose
• starch
• anhydrous colloidal silica
• magnesium stearate
• sodium lauryl sulfate.

contents of the capsule shells:

• 100 mg hard capsules: gelatin, titanium dioxide (E171);
• 150 mg hard capsules: gelatin, titanium dioxide (E171), indigotine (E132);
• 200 mg hard capsules: gelatin, titanium dioxide (E171), indigotine (E132), black iron oxide (E172), erythrosine (E127)

Description of the appearance of Lefunzol and contents of the pack

• Lefunzol 100 mg hard capsules have a white body and a white cap. Box containing 10 capsules of 100 mg
• Lefunzol 150 mg hard capsules have a blue body and a blue cap. Box containing 2 capsules of 150 mg
• Lefunzol 200 mg hard capsules have a white body and a purple cap. Box containing 7 capsules of 200 mg

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (Potenza)

Manufacturer
Special Product’s Line S.p.A - Via Fratta Rotonda Vado Largo, 1 - 03012- Anagni (FR)