Fluconazole Polfarmex

Package Leaflet: Information for the Patient

Fluconazole Polfarmex, 50 mg, tablets

Fluconazole Polfarmex, 100 mg, tablets

Fluconazole Polfarmex, 150 mg, tablets

Fluconazole Polfarmex, 200 mg, tablets

Fluconazole

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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 fungal infections. The most common cause of fungal infections is a yeast of the genus Candida.

Adults

Your doctor may prescribe this medicine for the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain;
• Coccidioidomycosis - a disease of the respiratory system;
• Infections caused by Candida yeast detected in the blood, internal organs (e.g., heart, lungs), or urinary tract;
• Fungal infections of the mucous membranes - infection of the mucous membrane of the mouth, throat, and mouth sores associated with the use of dental prostheses;
• Fungal 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 fungal infections of the mucous membranes;
• prevent relapses of fungal infections of the vagina;
• prevent fungal infections (in patients with a weakened immune system).

Children and Adolescents (from 3 to 17 years old)

Your doctor may prescribe this medicine to treat the following fungal infections:

• Fungal 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.

Fluconazole Polfarmex can also be used to:

• prevent fungal 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:

Warnings and precautions

Tell your doctor if:

• you have kidney or liver problems;
• you have heart disease, including heart rhythm disorders;
• you have abnormalities in potassium, calcium, or magnesium levels in your blood;
• you experience severe skin reactions (itching, redness of the skin, difficulty breathing).

Fluconazole Polfarmex with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Immediately tell your doctor if 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 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 you are taking any of the following medicines, make sure your doctor knows:

• rifampicin or rifabutin (antibiotics used to treat infections);
• alfentanil, fentanyl (anesthetics);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungal medicines);
• blood thinners, medicines that prevent blood clots (warfarin or similar medicines);
• benzodiazepines (midazolam, triazolam, or other similar medicines) that help you sleep or calm down;
• 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, 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
If you plan to become pregnant, it is recommended that you wait one week after taking a single dose of fluconazole before becoming pregnant. For longer treatment cycles with fluconazole, you should discuss the need for adequate contraception during treatment and for one week after the last dose with your doctor.
If you are pregnant, think you may be pregnant, or are trying to become pregnant, do not take fluconazole unless your doctor has told you to. If you become pregnant or think you may be pregnant while taking this medicine or within one week of taking the last dose, tell your 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 with birth defects of the skull, ears, and thigh and forearm bones born to mothers treated for coccidioidomycosis with high doses of fluconazole (400-800 mg per day) for at least 3 months. The relationship between fluconazole use and these reports is not clear.
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 multiple doses of fluconazole or after a high dose.

Driving and using machines

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 per tablet.
Fluconazole 100 mg contains 0.08 g of lactose monohydrate per tablet.
Fluconazole 150 mg contains 0.12 g of lactose monohydrate per tablet.
Fluconazole 200 mg contains 0.16 g of lactose monohydrate per tablet.
This should be taken into account in patients with diabetes. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Fluconazole Polfarmex

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablet whole with a glass of water. Tablets are best taken once a day 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 is available in a syrup form.
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 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 problems.

Patients with kidney problems

Your doctor may recommend a change in 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 gastric lavage, 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 you miss a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose.
If you have any further questions on 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 patients may experience allergic reactions, but severe allergic reactions are rare. If you experience any of the following symptoms, tell your doctor immediately:

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

Fluconazole Polfarmex may affect the liver. Symptoms from the liver include:

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

If you experience any of these symptoms, stop taking Fluconazole Polfarmex and contact your doctor immediately.

Other side effects

Additionally, if any of the side effects get worse or if you notice any side effects not listed in this leaflet, 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):
• 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, numbness, or prickling, 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):
• decreased white blood cell count and platelet count;
• red or purple discoloration of the skin, 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 you experience any side effects, including any 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluconazole Polfarmex

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the carton and blister or container after "EXP". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Fluconazole Polfarmex contains

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

What Fluconazole Polfarmex looks like and contents of the pack

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 pack contains 3, 7, or 14 tablets.
The 100 mg tablets - the pack contains 7 or 28 tablets.
The 150 mg tablets - the pack contains 1 or 3 tablets.
The 200 mg tablets - the pack 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: [email protected]

Date of last revision of the leaflet: