LUCANDIOL 100 mg Hard Capsule

Зміст інструкції

1. Lucandiol 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What is LUCANDIOL and what is it 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. Package Contents and Other Information

Lucandiol 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 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 LUCANDIOL is and what it is used for
• 2. What you need to know before you take 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 is LUCANDIOL and what is it used for

LUCANDIOL contains the active ingredient fluconazole and belongs to a group of medicines called
“antifungals”.
LUCANDIOL 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.

LUCANDIOL 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.

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• 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.

LUCANDIOL 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 LUCANDIOL

Do not take LUCANDIOL

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

Tell your doctor if:

• you have liver or kidney problems
• you suffer from heart disease, including heart arrhythmia
• you have abnormal levels of potassium, calcium or magnesium in your blood
• you experience severe skin reactions (itching, redness of the skin or difficulty breathing)
• if you experience signs of ‘adrenal insufficiency’, where the adrenal glands do not produce enough 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 mouth ulcers after taking fluconazole.

Severe skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported related to treatment with fluconazole. Stop taking LUCANDIOL 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 the infection does not improve, an alternative antifungal therapy may be necessary.

Other medicines and LUCANDIOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor immediatelyif you are taking astemizole, terfenadine (antihistamines used to treat allergies) or cisapride (used to treat stomach disorders) or pimozide (used to treat mental disorders) or quinidine (used to treat heart arrhythmias) or erythromycin (antibiotic used to treat bacterial infections), as they cannot be taken with LUCANDIOL (see section: ''Do not take LUCANDIOL").
There are some medicines that can interact with LUCANDIOL .Tell your doctor if you are taking any of the following medicines as a dose adjustment or monitoring may be needed to ensure the medicines continue to have the desired effect:
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• rifampicin or rifabutin (antibiotics for the treatment of bacterial infections)
• abrocitinib (used for the treatment of atopic dermatitis, also known as atopic eczema)
• 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, felodipine, verapamil and losartan (used to treat hypertension - high blood pressure)
• olaparib (used to treat ovarian cancer)
• cyclosporine, 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 (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 down the decline in kidney function
• vitamin A (dietary supplement)
• ivacaftor (used for the treatment of cystic fibrosis)
• amiodarone (used for the treatment of irregular heartbeat, “arrhythmias”)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used for the treatment of blood cancer).
• lurasidone (used for the treatment of schizophrenia).

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, 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 LUCANDIOL if you are pregnant, suspect you are pregnant or are planning to become pregnant, unless your doctor tells you to. If you become pregnant while taking this medicine or within 1 week of the most recent dose, contact your doctor.
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Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester may increase the risk that the baby at birth will have defects affecting the heart, bones and/or muscles.
Cases of babies 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 LUCANDIOL 150 mg. You should not breastfeed if you are taking repeated doses of LUCANDIOL.

Driving and using machines
You should be aware that this medicine can cause dizziness or seizures while driving or using machines. If this happens, DO NOT drive or use machines.

LUCANDIOL contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

LUCANDIOL contains sodium.This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, that is to say essentially ‘sodium-free’.

3. How to take LUCANDIOL

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

Adults

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Use in children and adolescents
Adolescents aged 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dosage or the children's 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 as described above but administered once every 2 days. The maximum recommended dose
is 12 mg per kg of body weight every 48 hours.
Use in children under 2 weeks of age:
The same dosage as described above but administered once every 3 days. The maximum recommended 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 as directed by
your doctor. If you have any doubts, ask your doctor or pharmacist.

Elderly
The same dose as intended for adults should be used unless you have kidney problems.

Patients with kidney problems
Your doctor may adjust the dosage based on kidney function.

If you take more LUCANDIOL than you should
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Taking too many capsules all at once may cause you problems. Immediately inform your doctor
or go to the nearest hospital.
In case of accidental overdose, symptoms may include sensing, 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 LUCANDIOL
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. Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some people experience allergic reactions, although severe allergic reactions are rare.
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. If you experience any of the following symptoms seek immediate medical attention:

• 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 patches
• skin rashes
• severe skin reactions, such as rashes that cause blisters (may affect the mouth and tongue).

LUCANDIOL may 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).

If you experience any of these symptoms, stop taking LUCANDIOL and seek immediate medical attention.
Stop taking Lucandiol and seek immediate medical attention if you notice any of the following
symptoms:

• widespread rash, high temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity).

Other side effects:
If any of these side effects gets serious, or if you notice any side effects not listed here

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• reduction in red blood cells which can cause paleness, weakness or shortness of breath
• decreased appetite
• insomnia, drowsiness
• convulsions, dizziness, feeling faint, tingling, prickling or numbness 6/8
• altered taste
• constipation, difficulty digesting, flatulence, dry mouth
• muscle pain
• liver damage and yellowing of the skin and eyes (jaundice)
• swellings, blisters (urticaria), itching, increased sweating
• fatigue, general feeling of being unwell, fever.

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

• lower than normal levels of white blood cells (which help to fight infections), and platelets (which help the blood to clot)
• altered skin colour (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
• chills
• 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national
reporting system located 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 which is stated on the label after Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in 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 ingredient is fluconazole. Each hard capsule contains 100 mg, 150 mg or 200 mg of fluconazole.
• The other ingredients are: Capsule content: lactose monohydrate, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate. Capsule shell:100 mg hard capsules: gelatin, titanium dioxide (E171), yellow iron oxide (E 172). 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 Authorisation Holder and Manufacturer

Marketing Authorisation Holder
JUST PHARMA S.R.L.
Via Aurelio Rossi 4
00136 Roma

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l.
Via Dante Alighieri, 71
18038 Sanremo (IM)
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