Flucorta
Poland
Table of Contents
Package leaflet: information for the patient
Flucorta, 50 mg, tablets
Flucorta, 100 mg, tablets
Flucorta, 200 mg, tablets
Fluconazole
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any doubts, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Table of contents
- What Flucorta is and what it is used for
- Important information before taking Flucorta
- How to take Flucorta
- Possible side effects
- How to store Flucorta
- Contents of the pack and other information
1. What Flucorta is and what it is 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 Candida infections. The most common cause of fungal infections are yeasts of the genus known in Latin as Candida.
Adults
Your doctor may prescribe this medicine for the following fungal infections:
- cryptococcal meningitis – a fungal infection of the brain;
- coccidioidomycosis – a respiratory system disease;
- infections caused by Candida yeasts detected in the blood, internal organs (e.g. heart, lungs), or urinary tract;
- mucosal yeast infections (thrush) – infection of the mucous membranes of the mouth, throat, and mouth sores associated with wearing dental prostheses;
- genital yeast infections – infections of the vagina or penis;
- skin fungal infections – e.g. athlete's foot, fungal infections of the trunk, groin, or nails.
Flucorta may also be used to:
- prevent recurrence of cryptococcal meningitis;
- prevent recurrence of mucosal yeast infections;
- prevent recurrence of vaginal yeast infections;
- prevent yeast infections (in patients with weakened or impaired immune systems).
Children and adolescents (aged 3 to 17 years)
Your doctor may prescribe this medicine to treat the following fungal infections:
- mucosal yeast infections (thrush) – infections of the mucous membranes of the mouth or throat;
- infections caused by Candida yeasts detected in the blood, internal organs (e.g. heart, lungs), or urinary tract;
- cryptococcal meningitis – a fungal infection of the brain.
Flucorta may also be used to:
- prevent yeast infections (in patients with weakened or poorly functioning immune systems);
- prevent recurrence of cryptococcal meningitis.
2. Information before using Flucorta
When not to use Flucorta:
- if the patient is allergic to the active substance, to other medicines used to treat fungal infections, or to 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 or terfenadine (antihistamine medicines used to treat allergies);
- if the patient is taking cisapride (used to treat stomach disorders);
- if the patient is taking pimozide (used to treat mental disorders);
- if the patient is taking quinidine (used to treat heart rhythm disorders);
- if the patient is taking erythromycin (an antibiotic used to treat infections).
Warnings and precautions
Tell your doctor if:
- the patient has impaired kidney or liver function;
- the patient has heart conditions, including heart rhythm disorders;
- the patient has abnormal blood levels of potassium, calcium, or magnesium;
- the patient experiences severe skin reactions (itching, skin redness, difficulty breathing).
Discuss with your doctor or pharmacist before starting treatment with Flucorta.
Flucorta and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
You must immediately inform your doctor if the patient is taking astemizole, terfenadine (antihistamines used for allergies), cisapride (used for stomach disorders), pimozide (used for mental disorders), quinidine (used for heart rhythm disorders), or erythromycin (an antibiotic used to treat infections), as these should not be used together with Flucorta (see section "When not to use Flucorta").
There are also other medicines that may interact with Flucorta.
If the patient is taking any of the following medicines, ensure that the doctor is informed:
- rifampicin or rifabutin (antibiotics used to treat infections);
- alfentanil, fentanyl (anaesthetic medicines);
- amitriptyline, nortriptyline (antidepressants);
- amphotericin B, voriconazole (antifungal medicines);
- medicines that reduce blood clotting and prevent blood clots (warfarin or similar medicines);
- benzodiazepines (midazolam, triazolam or similar medicines) used to help sleep or for calming;
- carbamazepine, phenytoin (used to treat epilepsy);
- nifedipine, isradipine, amlodipine, felodipine and losartan (used to treat high blood pressure);
- 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 or similar medicines) used to lower cholesterol levels;
- methadone (a painkiller);
- celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs - 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
This medicine can be taken with or without food.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Flucorta should not be used in pregnant or breastfeeding women unless otherwise advised by a doctor.
Driving and using machines
When driving or operating machinery, bear in mind that dizziness or seizures may occasionally occur.
Flucorta contains lactose monohydrate and sodium
Lactose monohydrate
This 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 certain sugars, the patient should consult a doctor before taking this medicine.
Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".
3. How to take Flucorta
This medicine should always be taken exactly as directed by the physician. In case of doubts, consult a doctor or pharmacist.
The tablet should be swallowed whole with a glass of water. It is best to take the tablets at the same time each day. For children who cannot swallow tablets and for young children in whom precise dosing according to body weight is necessary, fluconazole is available on the market in the form of a syrup.
The usual recommended dosage, depending on the type of infection, is presented below.
Adults
| Indication | Dosage |
| Treatment of cryptococcal meningitis | 400 mg on the first day, then 200 mg to 400 mg once daily for 6 to 8 weeks, or longer if necessary. Sometimes the dose may be increased to 800 mg |
| Prevention of relapse of cryptococcal meningitis | 200 mg once daily until the physician advises to stop treatment |
| Treatment of coccidioidomycosis | 200 mg to 400 mg once daily for 11 to 24 months, or longer if necessary. Sometimes the dose may be increased to 800 mg |
| Treatment of systemic Candida infections | 800 mg on the first day, then 400 mg once daily until the physician advises to stop treatment |
| Treatment of oral mucosal infections, throat infections, and denture-related stomatitis | 200 mg to 400 mg on the first day, then 100 mg to 200 mg until the physician advises to stop treatment |
| Yeast (fungal) mucosal infections – dose depends on the site of infection | 50 mg to 400 mg once daily for 7 to 30 days, until the physician advises to stop treatment |
| Prevention of oral and throat mucosal infections | 100 mg to 200 mg once daily, or 200 mg three times weekly, if the patient is at increased risk of infection relapse |
| Treatment of genital yeast infections | Single 150 mg dose |
| Prevention of vaginal infection relapses | 150 mg every third day, for a total of 3 doses (days 1, 4, and 7), then once weekly for 6 months (if the patient is at increased risk of infection relapse) |
| Treatment of skin and nail fungal infections | Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300 to 400 mg once weekly for 1 to 4 weeks (in tinea pedis, treatment may need to be continued for up to 6 weeks; in nail infections, treatment should continue until the infected nail is completely replaced by a new, healthy nail) |
| Prevention of yeast infections (in patients with weakened or impaired immune system) | 200 to 400 mg once daily, if the patient is at increased risk of infection relapse |
Adolescents aged 12 to 17 years
Administer the dose prescribed by the doctor (as in adult patients or as in children).
Children aged 3 to 11 years
The maximum dose in children is 400 mg per day.
The dose will be determined based on the child's body weight in kilograms.
| Indication | Daily dose |
| Yeast infections of the mucous membranes of the oral cavity and pharynx – dose and duration of treatment depend on the severity and location of the infection | 3 mg/kg body weight (on the first day, a dose of 6 mg/kg body weight may be administered) |
| Cryptococcal meningitis or systemic yeast infections of internal organs | 6 to 12 mg/kg body weight |
| Prophylaxis of yeast infections in children (when the immune system is not functioning properly) | 3 to 12 mg/kg body weight |
Elderly patients
The usual adult dose should be administered, unless the patient has renal function impairment.
Patients with renal function impairment
The physician may recommend adjustment of the dosage depending on renal function.
Use of a higher than recommended dose of Flucorta
Taking too many tablets at once may cause malaise. Immediate contact should be made with the emergency department of the nearest hospital. Symptoms of overdose may include disturbances of hearing, vision and sensation, thinking about unreal things (hallucinations and paranoid behavior). Symptomatic treatment may be indicated (supportive treatment of vital functions and gastric lavage, if necessary).
Missed dose of Flucorta
Do not take a double dose to make up for a missed dose. If a dose has been 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.
Discontinuation of Flucorta
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Allergic reactions may occur in some patients, although severe allergic reactions are rare.
If any of the following symptoms occur, you must tell your doctor immediately :
- sudden wheezing, difficulty breathing or tightness in the chest;
- swelling of the eyelids, face or lips;
- itching all over the body, redness of the skin or red, itchy blisters, skin rash;
- severe skin reactions, such as blistering rash (may also affect the mouth and tongue).
Flucorta may affect the liver. Liver-related symptoms include:
- feeling tired;
- loss of appetite;
- vomiting;
- yellowing of the skin or whites of the eyes (jaundice).
If any of the above symptoms occur, treatment with Flucorta must be stopped and you must contact your doctor immediately.
Other adverse reactions
Additionally, if any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Common adverse reactions (in 1 to 10 out of 100 patients):
- headache;
- abdominal pain, diarrhoea, nausea, vomiting;
- increased liver function test values;
- rash.
Uncommon adverse reactions (in 1 to 10 out of 1,000 patients):
- decrease in the number of red blood cells causing paleness, weakness and breathlessness;
- decreased appetite;
- insomnia, drowsiness;
- seizures, dizziness, balance disorders (sensation of spinning), sensory disturbances, most commonly as tingling, pricking or numbness, taste alterations;
- constipation, indigestion, bloating, dryness of the mouth;
- muscle pain;
- liver damage and yellowing of the skin and eyes (jaundice);
- blisters, urticaria, itching, increased sweating;
- feeling of fatigue, malaise, fever.
Rare adverse reactions (in 1 to 10 out of 10,000 patients):
- decrease in the number of white blood cells involved in the body's defence against infections and blood cells helping to stop bleeding;
- red or purple skin discolouration, possibly due to a decrease in the number of platelets or changes in other blood cells;
- changes in blood biochemical parameters (high cholesterol levels, blood lipids);
- low blood potassium levels;
- tremor;
- abnormalities in ECG, heart rhythm disorders;
- liver failure;
- allergic reactions (sometimes severe), including extensive blistering rash, skin peeling, severe skin reactions, swelling of the lips or face;
- hair loss.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.
5. How to store Flucorta
Keep this medicine out of sight and reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date stated on the carton, blister, or container after "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the package and other information
What Flucorta contains
- The active substance is fluconazole. Each tablet contains 50 mg, 100 mg or 200 mg of fluconazole.
- The other ingredients are: monohydrate lactose, corn starch, sodium carboxymethyl starch (type A), povidone, magnesium stearate.
What Flucorta looks like and contents of the pack
Flucorta is in the form of uncoated tablets.
50 mg and 100 mg tablets are white or light cream, round, biconvex.
200 mg tablets are white or light cream, oblong.
50 mg tablets – pack contains 3, 7 or 14 tablets.
100 mg tablets – pack contains 7 or 28 tablets.
200 mg tablets – pack contains 7 or 14 tablets.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: (24) 357 44 44
Fax: (24) 357 45 45
e-mail: [email protected]