Lucandiol

Package leaflet: Information for the user

Lucandiol 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
Generic medicine
Please read all of 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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LUCANDIOL is and what it is used for

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

• Cryptococcal meningitis – a fungal infection of the brain.
• Coccidioidomycosis – a disease affecting the bronchopulmonary system.
• Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs) or urinary tract.
• Mucosal candidiasis – infection of the oral mucosa, throat infection, and denture-related stomatitis.
• Genital candidiasis – infection of the vagina or penis.
• Skin infections – e.g. athlete's foot, ringworm, genital itching, nail infections.

LUCANDIOL may be prescribed for you to:

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

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

• Mucosal candidiasis – infection of the oral mucosa, throat infection.

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• Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs) or urinary tract.
• Cryptococcal meningitis – a fungal infection of the brain.

LUCANDIOL may be prescribed for you to:

• prevent Candida infections (if your immune system is weakened or not functioning properly)
• prevent recurrence of cryptococcal meningitis.

2. What you should know before taking LUCANDIOL

Do not take LUCANDIOL

• if you are allergic to fluconazole or to any of the other ingredients of this medicine (listed in section 6), or to other medicines used to treat fungal infections. Symptoms may include itching, skin redness, or difficulty breathing;
• 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 cardiac arrhythmias);
• if you are taking erythromycin (an antibiotic used to treat bacterial infections).

Warnings and precautions
Talk to your doctor or pharmacist before taking LUCANDIOL.
Tell your doctor if:

• you have liver or kidney problems;
• you suffer from heart diseases, including cardiac arrhythmia;
• you have abnormal levels of potassium, calcium, or magnesium in your blood;
• you develop severe skin reactions (itching, skin redness, or difficulty breathing);
• you experience signs of 'adrenal insufficiency', where 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 have previously developed a severe skin rash or skin peeling, blisters, and/or mouth ulcers after taking fluconazole.

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with fluconazole treatment. Stop taking LUCANDIOL and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.
Contact your doctor or pharmacist if your fungal infection does not improve, as alternative antifungal therapy may be required.

Other medicines and LUCANDIOL
Inform your doctor or pharmacist if you are currently 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 cardiac arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with LUCANDIOL (see section: "Do not take LUCANDIOL").

Some medicines may interact with LUCANDIOL. Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring may be necessary to ensure these medicines continue to work as intended:

• rifampicin or rifabutin (antibiotics used to treat bacterial infections);
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema);
• alfentanil, fentanyl (anesthetics);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungals);
• medicines that thin the blood to prevent clot formation (warfarin or similar medicines);
• benzodiazepines (midazolam, triazolam, or similar medicines) used to help you sleep or for anxiety;
• carbamazepine, phenytoin (used to treat epileptic seizures);
• nifedipine, isradipine, amlodipine, felodipine, verapamil, and losartan (used to treat hypertension – high blood pressure);
• olaparib (used to treat ovarian cancer);
• ciclosporin, everolimus, sirolimus, or tacrolimus (used to prevent transplant rejection);
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines) used to treat cancer;
• halofantrine (used to treat malaria);
• 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; saquinavir (used in HIV patients);
• diabetes medicines such as chlorpropamide, glibenclamide, glipizide, or tolbutamide;
• theophylline (used to control asthma);
• 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 (dietary supplement);
• ivacaftor (used to treat cystic fibrosis);
• amiodarone (used to treat irregular heartbeat, "arrhythmias");
• hydrochlorothiazide (a diuretic);
• ibrutinib (used to treat blood cancer);
• lurasidone (used to treat schizophrenia).

LUCANDIOL with food and drink
You may take this medicine with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
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 assess the need for adequate contraception during treatment, which should continue for one week after the last dose.
Do not take LUCANDIOL if you are pregnant, think you may be pregnant, or are planning a pregnancy, unless instructed by your doctor. If you become pregnant while taking this medicine or within one week after the most recent dose, contact your doctor immediately.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of spontaneous abortion. Fluconazole taken during the first trimester may increase the risk of congenital heart, bone, and/or muscle defects in the newborn.
Cases of newborns 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 daily) of fluconazole for coccidioidomycosis. The causal relationship between fluconazole and these cases is not clear.
You may continue breastfeeding after a single 150 mg dose of LUCANDIOL. You must not breastfeed if you are taking repeated doses of LUCANDIOL.

Driving and using machines
Be aware that this medicine may cause dizziness or seizures while driving or operating machinery. If this occurs, do NOT drive or operate machinery.

LUCANDIOL contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

LUCANDIOL contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e., essentially 'sodium-free'.

3. How to take LUCANDIOL

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

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Use in children and adolescents
Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dosage or the pediatric dosage).
Children up to 11 years
The maximum recommended dose in children is 400 mg per day.
The dose will be based on the child's weight in kilograms.

Children aged 0 to 4 weeks
Use in children aged 3 to 4 weeks:
The same dosage described above, but administered once every 2 days. The recommended maximum dose
is 12 mg per kg of body weight every 48 hours.
Use in children under 2 weeks of age:
The same dosage described above, but administered once every 3 days. The recommended maximum dose
is 12 mg per kg of body weight every 72 hours.
Your doctor may sometimes prescribe doses different from these. Always take the medicine exactly as
instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Elderly
The same dose as for adults should be used unless you have kidney problems.
Patients with kidney problems
Your doctor may adjust the dosage according to your kidney function.
If you take more LUCANDIOL than you should
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Taking too many capsules at once could cause you problems. Contact your doctor immediately
or go to the nearest hospital.
In case of accidental overdose, symptoms may include sensing, seeing, feeling, and thinking things that
are not real (hallucinations and paranoid behaviour). Symptomatic treatment may be appropriate (with adequate supportive measures and, if necessary, gastric lavage).
If you forget to take LUCANDIOL
If you forget to take a dose, take it as soon as possible. If it is almost time for your next dose, do not take the missed dose. Do not take a double dose to make up for a forgotten dose.
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 everyone experiences them.
Some people may experience allergic reactions, although severe allergic reactions are rare.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. If you experience any of the following symptoms, contact 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).

LUCANDIOL 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 LUCANDIOL and contact your doctor immediately.
Stop taking Lucandiol 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 syndrome).

Other side effects:
If any of the side effects worsen, or if you notice any side effect not listed in this patient information leaflet, inform your doctor or pharmacist.
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

• lower than normal levels of white blood cells (which help defend against infections) and platelets (which enable blood clotting)
• altered skin colouration (red or purplish), which may be caused by a reduction in platelets or other changes in blood cells
• changes in blood chemistry (high levels of cholesterol, fats)
• low potassium levels in the blood
• chills
• abnormal electrocardiogram (ECG), changes in heart rhythm and rate
• liver failure
• allergic reactions (sometimes severe), including rashes with widespread blistering and skin peeling, severe skin reactions, swelling of the lips and face
• hair loss.

Frequency not known, but possible (frequency cannot be estimated from 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 colon) (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, consult 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 LUCANDIOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after Exp.
The expiry date refers to the last day of that month.
Do not store above 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 LUCANDIOL contains

• The active substance is fluconazole. Each hard capsule contains 100 mg, 150 mg, or 200 mg of fluconazole.
• The other components are: Capsule contents: monohydrate lactose, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate. Capsule coating: 100 mg hard capsules: gelatin, titanium dioxide (E171), yellow iron oxide (E172). 150 mg hard capsules: gelatin, titanium dioxide (E171). 200 mg hard capsules: gelatin, titanium dioxide (E171). 7/8

Description of the appearance of LUCANDIOL 100 mg, 150 mg and 200 mg hard capsules and package contents

• Lucandiol 100 mg hard capsules are yellow. They are available in blisters of 10 hard capsules.
• Lucandiol 150 mg hard capsules are white. They are available in blisters of 2 hard capsules.
• Lucandiol 200 mg hard capsules are white. They are available in blisters of 7 hard capsules.

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
JUST PHARMA S.R.L.
Via Aurelio Rossi 4
00136 Rome, Italy
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l.
Via Dante Alighieri, 71
18038 Sanremo (IM), Italy
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