Flucorta

Leaflet attached to the packaging: patient information

Flucorta, 50 mg, tablets

Flucorta, 100 mg, tablets

Flucorta, 200 mg, tablets

Fluconazole

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Flucorta and what is it used for
• 2. Important information before taking Flucorta
• 3. How to take Flucorta
• 4. Possible side effects
• 5. How to store Flucorta
• 6. Contents of the packaging and other information

1. What is Flucorta and what is it used for

Flucorta belongs to a group of antifungal medicines. The active substance is fluconazole.
Flucorta is used to treat infections caused by pathogenic fungi and can also be used to prevent yeast infections. The most common cause of fungal infections is yeast of the genus Candida.

Adults

The doctor may recommend using this medicine for the following fungal infections:

• -cryptococcal meningitis - a fungal infection of the brain;
• -coccidioidomycosis - a respiratory system disease;
• -infections caused by Candida yeast detected in the blood, internal organs (e.g. heart, lungs) or urinary tract;
• -yeast infections of the mucous membranes - infection of the mucous membrane of the mouth, throat, and mouth ulcers associated with the use of dental prostheses;
• -genital yeast infections - infections of the vagina or penis;
• -skin fungi - e.g. athlete's foot, fungal infections of the torso, groin, or nails.

Flucorta can also be used to:

• prevent relapses of cryptococcal meningitis;
• prevent relapses of yeast infections of the mucous membranes;
• prevent relapses of vaginal yeast infections;
• prevent yeast infections (in patients with a weakened and improperly functioning immune system).

Children and adolescents (from 3 to 17 years old)

The doctor may recommend using this medicine to treat the following fungal infections:

• yeast infections of the mucous membranes - infections of the mucous membrane of the mouth or throat;
• infections caused by Candida yeast detected in the blood, internal organs (e.g. heart, lungs) or urinary tract;
• cryptococcal meningitis - a fungal infection of the brain.

Flucorta can also be used to:

• prevent yeast infections (if the patient's immune system is weak and does not function properly);
• prevent relapses of cryptococcal meningitis.

2. Important information before taking Flucorta

When not to take Flucorta:

• if the patient is allergic to the active substance, other antifungal medicines, or any of the other ingredients of this medicine (listed in section 6); symptoms may include itching, skin redness, or difficulty breathing;
• if the patient is taking astemizole, terfenadine (antihistamines used to treat allergies);
• if the patient is taking cisapride (for stomach disorders);
• if the patient is taking pimozide (for mental disorders);
• if the patient is taking quinidine (for heart rhythm disorders);
• if the patient is taking erythromycin (an antibiotic for infection treatment).

Warnings and precautions

You should tell your doctor if:

• the patient has kidney or liver function disorders;
• the patient has heart disease, including heart rhythm disorders;
• the patient has abnormalities in potassium, calcium, or magnesium levels in the blood;
• the patient experiences severe skin reactions (itching, skin redness, difficulty breathing).

Before starting to take Flucorta, you should discuss it with your doctor or pharmacist.

Flucorta and other medicines

You should tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.
You should immediatelytell your doctor about taking astemizole, terfenadine (antihistamines used for allergies) or cisapride (used for stomach disorders), or pimozide (used for mental disorders), or quinidine (used for heart rhythm disorders), or erythromycin (an antibiotic used for infection treatment), as they should not be taken with Flucorta (see section "When not to take Flucorta").
There are also other medicines that may interact with Flucorta.
If the patient is taking any of the following medicines, they should make sure their doctor is informed:

• rifampicin or rifabutin (antibiotics for infection treatment);
• alfentanil, fentanyl (anesthetics);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungal medicines);
• blood thinning medicines that prevent blood clots (warfarin or similar medicines);
• benzodiazepines (midazolam, triazolam or other similar medicines) that facilitate sleep or have a calming effect;
• carbamazepine, phenytoin (used to treat epilepsy);
• nifedipine, isradipine, amlodipine, felodipine, and losartan (used to treat high blood pressure);
• cyclosporine, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection);
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or other similar medicines) used to treat cancer;
• halofantrine (used to treat malaria);
• statins (atorvastatin, simvastatin, and fluvastatin or other similar medicines) used to lower cholesterol levels;
• methadone (a pain reliever);
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (nonsteroidal anti-inflammatory medicines - NSAIDs);
• oral contraceptives;
• prednisolone (a steroid);
• zidovudine, also known as AZT; saquinavir (used in HIV patients);
• antidiabetic medicines, such as chlorpropamide, glibenclamide, glipizide, or tolbutamide;
• theophylline (used in asthma);
• vitamin A (dietary supplement).

Flucorta with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Flucorta should not be taken by pregnant or breastfeeding women unless the doctor recommends it.

Driving and using machines

When driving or operating machines, it should be taken into account that dizziness or seizures may occasionally occur.

Flucorta contains lactose monohydrate and sodium

Lactose monohydrate
The medicine contains lactose monohydrate (one 50 mg tablet contains 0.084 g of lactose monohydrate, one 100 mg tablet contains 0.08 g of lactose monohydrate, and one 200 mg tablet contains 0.16 g of lactose monohydrate). This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
Sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Flucorta

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The tablet should be swallowed whole, with a glass of water. The tablets are best taken daily at the same time . For children who cannot swallow the tablet and for young children who require precise dosing based on body weight, fluconazole is available in syrup form.
The recommended dosage, depending on the type of infection, is presented below.
The recommended dosage is as follows:

Adults

Adolescents from 12 to 17 years old

The dose prescribed by the doctor should be taken (as for adult patients or as for children).

Children from 3 to 11 years old

The maximum dose in children is 400 mg per day.
The dose will be determined based on the child's body weight in kilograms.

Elderly patients

The usual dose for adults is taken, unless the patient has kidney function disorders.

Patients with kidney function disorders

The doctor may recommend changing the dosage, depending on kidney function.

Taking more Flucorta than recommended

Taking too many tablets at once may cause discomfort. You should immediately contact the emergency department of the nearest hospital. Symptoms of possible overdose may include hearing, vision, or sensation disorders, thinking about untrue things (hallucinations and paranoid behavior). Symptomatic treatment (life-supporting treatment and stomach lavage, if necessary) may be indicated.

Missing a dose of Flucorta

A double dose should not be taken to make up for a missed dose. If a dose is missed, it should be taken as soon as remembered. If it is almost time for the next dose, the missed dose should not be taken.

Stopping Flucorta treatment

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some patients may experience allergic reactions, but severe allergic reactions are rare. If any of the following symptoms occur, you should immediately tell your doctor:

• sudden wheezing, difficulty breathing, or chest tightness;
• swelling of the eyelids, face, or lips;
• itching all over the body, skin redness, or red or itchy blisters, rash on the skin;
• severe skin reactions, such as blistering rash (which may also affect the mouth and tongue).

Flucorta may affect the liver. Liver-related symptoms include:

• feeling tired;
• loss of appetite;
• nausea and vomiting;
• yellowing of the skin or whites of the eyes (jaundice).

If any of these symptoms occur, you should stop taking Flucorta and immediately contact your doctor.

Other side effects

Additionally, if any side effects worsen or any side effects not listed in this leaflet occur, you should tell your doctor or pharmacist.
Common side effects (in 1 to 10 out of 100 patients):

• headache;
• abdominal pain, diarrhea, nausea, vomiting;
• increased liver function test values;
• rash.

Uncommon side effects (in 1 to 10 out of 1,000 patients):

• reduced red blood cell count, causing pallor, weakness, and shortness of breath;
• reduced appetite;
• insomnia, drowsiness;
• seizures, dizziness, balance disorders (feeling of spinning), sensation disorders, most often in the form of tingling, pricking, or numbness, changes in taste;
• constipation, indigestion, bloating, dry mouth;
• muscle pain;
• liver damage and yellowing of the skin and eyes (jaundice);
• blisters, hives, itching, increased sweating;
• feeling tired, unwell, fever.

Rare side effects (in 1 to 10 out of 10,000 patients):

• reduced white blood cell count and platelet count;
• red or purple skin discoloration, which may be a sign of reduced platelet count or changes in other blood cells;
• changes in blood biochemical parameters (high cholesterol, lipid levels in the blood);
• reduced potassium levels in the blood;
• tremors;
• ECG changes, heart rhythm disorders;
• liver failure;
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face;
• hair loss.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Flucorta

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister or container after: "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Flucorta contains

• The active substance of the medicine is fluconazole. Each tablet contains 50 mg, 100 mg, or 200 mg of fluconazole.
• The other ingredients are: lactose monohydrate, cornstarch, sodium carboxymethyl starch (type A), povidone, magnesium stearate.

What Flucorta looks like and what the pack contains

Flucorta is a tablet that is not coated.
The 50 mg and 100 mg tablets are white or light cream-colored, round, and biconvex.
The 200 mg tablets are white or light cream-colored and oblong.
The 50 mg tablets - the packaging contains 3, 7, or 14 tablets.
The 100 mg tablets - the packaging contains 7 or 28 tablets.
The 200 mg tablets - the packaging contains 7 or 14 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Tel.: (24) 357 44 44
Fax: (24) 357 45 45
e-mail: [email protected]

Date of last revision of the leaflet: