Fluconazole Polfarmex

Leaflet accompanying the packaging: patient information

Fluconazole Polfarmex, 50 mg, tablets

Fluconazole Polfarmex, 100 mg, tablets

Fluconazole Polfarmex, 150 mg, tablets

Fluconazole Polfarmex, 200 mg, tablets

Fluconazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Fluconazole Polfarmex and what is it used for

Fluconazole Polfarmex belongs to a group of antifungal medicines. The active substance is fluconazole.
Fluconazole Polfarmex 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 taking this medicine for the following fungal infections:

• cryptococcal meningitis - a fungal infection of the brain;
• coccidioidomycosis - a disease of the respiratory system;
• Candida yeast infections 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;
• yeast infections of the genital organs - infections of the vagina or penis;
• fungal skin infections - e.g. athlete's foot, fungal infections of the torso, groin, and nails.

Fluconazole Polfarmex can also be used to:

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

Children and adolescents (from 3 to 17 years old)

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

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

Fluconazole Polfarmex can also be used to:

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

2. Important information before taking Fluconazole Polfarmex

When not to take Fluconazole Polfarmex:

• 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 used to treat infections).

Warnings and precautions

Tell your doctor if:

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

Fluconazole Polfarmex and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Immediately tell your doctor about 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 rhythm disorders), or erythromycin (an antibiotic used to treat infections), as they should not be taken with Fluconazole Polfarmex (see section "When not to take Fluconazole Polfarmex").
There are also other medicines that may interact with Fluconazole Polfarmex.
If the patient is taking any of the following medicines, they should make sure their doctor is informed:

• rifampicin or rifabutin (antibiotics used to treat infections);
• alfentanil, fentanyl (anesthetics);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungal medicines);
• blood thinning medicines, which prevent blood clots (warfarin or similar medicines);
• benzodiazepines (midazolam, triazolam, or other similar medicines) that help with 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 (which prevent transplant rejection);
• cyclophosphamide, vincristine (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 (non-steroidal 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 to treat asthma);
• vitamin A (dietary supplement).

Fluconazole Polfarmex 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 before taking this medicine.
If the patient plans to become pregnant, it is recommended to wait one week after taking a single dose of fluconazole before becoming pregnant. In the case of longer treatment cycles with fluconazole, the patient should discuss the need for appropriate contraception during treatment and for one week after the last dose with their doctor.
If the patient is pregnant, thinks they may be pregnant, or is trying to conceive, they should not take fluconazole unless their doctor recommends it. If the patient becomes pregnant or thinks they may be pregnant while taking this medicine or within one week of taking the last dose, they should contact their 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 birth defects of the heart, bones, and/or muscles.
There have been reports of children born with congenital skull, ear, and femur or elbow defects to mothers treated with fluconazole for coccidioidomycosis for at least 3 months with high doses (400-800 mg/day). The relationship between fluconazole use and these cases is unclear.
Breastfeeding
The medicine passes into human milk at concentrations lower than in serum. Breastfeeding can be continued after a standard single dose of 200 mg or less. Breastfeeding is not recommended after taking multiple doses of fluconazole or after taking a high dose.

Driving and operating machinery

When driving or operating machinery, consider that dizziness or seizures may occasionally occur.

Fluconazole Polfarmex contains lactose monohydrate and sodium

Lactose monohydrate
Fluconazole 50 mg contains 0.084 g of lactose monohydrate in one tablet.
Fluconazole 100 mg contains 0.08 g of lactose monohydrate in one tablet.
Fluconazole 150 mg contains 0.12 g of lactose monohydrate in one tablet.
Fluconazole 200 mg contains 0.16 g of lactose monohydrate in one tablet.
This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Fluconazole Polfarmex

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
Swallow the tablet whole with a glass of water. Tablets are best taken daily at the same time. For children who cannot swallow tablets and for young children, for whom precise dosing based on body weight is necessary, fluconazole syrup is available on the market.
The recommended dosage, depending on the type of infection, is presented below.

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

Elderly patients

The usual adult dose 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 than the recommended dose of Fluconazole Polfarmex

Taking too many tablets at once may cause discomfort. 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 flushing, if necessary) may be indicated.

Missing a dose of Fluconazole Polfarmex

Do not take a double dose to make up for a missed dose. If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, do not take the missed dose.
In case of any further doubts about taking this medicine, consult a 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, 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 a rash with blisters (which can also affect the mouth and tongue).

Fluconazole Polfarmex 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 these symptoms occur, stop taking Fluconazole Polfarmex and immediately contact your doctor.

Other side effects

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

• headache;
• stomach pain, diarrhea, nausea, vomiting;
• increased liver function test values;
• rash. Uncommon side effects (in 1 to 10 out of 1,000 patients):
• decreased red blood cell count, causing pallor, weakness, and shortness of breath;
• decreased appetite;
• insomnia, drowsiness;
• seizures, dizziness, balance disorders (feeling of spinning), sensation disorders, most often in the form of tingling, pricking, or numbness, taste changes;
• 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):
• decreased white blood cell count, which helps the body fight infections, and platelet count, which helps the blood to clot;
• red or purple skin discoloration, which may be a sign of a decrease in platelet count or changes in other blood cells;
• changes in blood biochemical parameters (high cholesterol, lipid levels in the blood);
• decreased 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 side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Fluconazole Polfarmex

Keep the medicine out of sight and reach of children.
Store in 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Fluconazole Polfarmex contains

• The active substance of the medicine is fluconazole. Each tablet contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole.
• Other ingredients are: lactose monohydrate, cornstarch, sodium carboxymethyl starch (type A), povidone, magnesium stearate.

What Fluconazole Polfarmex looks like and contents of the packaging

Fluconazole Polfarmex is a tablet that is not coated.
The 50 mg, 100 mg, and 150 mg tablets are white or light cream-colored, round, and convex on both sides.
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 150 mg tablets - the packaging contains 1 or 3 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
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: polfarmex@polfarmex.pl

Date of last revision of the leaflet: