Fluconazole Polfarmex

Package Leaflet: Information for the Patient

Fluconazole Polfarmex, 50 mg/10 mL, Syrup

Fluconazole

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

• Keep this leaflet, you may need to read it again.
• 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 those 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 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 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 respiratory system disease,
• 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,
• Skin fungi - e.g. athlete's foot, body fungus, groin fungus, nail fungus.

Fluconazole Polfarmex can also be used to:

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

Children and Adolescents (from 0 to 17 years old)

The doctor may recommend taking 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 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:

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, redness of the skin, difficulty breathing).

Fluconazole Polfarmex and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or 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 "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 thinners, medicines that 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 (used 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 (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 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 become pregnant, 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 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 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 using machines

When driving or operating machinery, consider that dizziness or seizures may occasionally occur.
Fluconazole Polfarmex contains sorbitol (E 420), sucrose, sodium benzoate (E 211), sodium, glycerol, propylene glycol (E 1520), and citral (a component of strawberry flavor, liquid).

Sorbitol

The medicine contains 3.5 g of sorbitol (E 420) per 10 mL of syrup. Sorbitol in a dose of 10 g or more may have a mild laxative effect. Caloric value: 2.6 kcal/g of sorbitol. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, the patient should consult their doctor before taking the medicine or giving it to their child.

Sucrose

10 mL of syrup contains 4 g of sucrose. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Sodium benzoate (E 211)

The medicine contains 20 mg of sodium benzoate (E 211) per 10 mL of syrup. Benzoic acid salt may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 10 mL, which means the medicine is considered "sodium-free".

Glycerol

The medicine contains 0.68 g of glycerol per 10 mL of syrup.
The medicine may cause headache, stomach upset, and diarrhea.

Propylene glycol (E 1520)

10 mL of syrup contains 164.8 mg of propylene glycol (E 1520).
Before administering the medicine to a child under 4 weeks of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Before administering the medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Pregnant or breastfeeding women should not take this medicine without their doctor's recommendation. The doctor may decide to perform additional tests on such patients.
Patients with liver or kidney function disorders should not take this medicine without their doctor's recommendation. The doctor may decide to perform additional tests on such patients.

Citral

A component of strawberry flavor, liquid.

3. How to take Fluconazole Polfarmex

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
It is best to take the medicine at the same time every day.
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 28 days 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.

Dosage in newborns (from 0 to 4 weeks of age)

Newborns from 3 to 4 weeks of age
The same dose as above, but given every other day. The maximum dose is 12 mg/kg of body weight every 48 hours.
Newborns under 2 weeks of age
The same dose as above, given every 3 days. The maximum dose is 12 mg/kg of body weight every 72 hours.
Sometimes the doctor may recommend a different dosage. The medicine should always be taken as recommended by the doctor. In case of doubts, consult a doctor or pharmacist.

Elderly patients

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

Patients with kidney function disorders

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

Taking a higher dose of Fluconazole Polfarmex than recommended

Taking too high a dose of the medicine at one time 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 behaviors). Symptomatic treatment (life-sustaining treatment and stomach 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 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, redness of the skin, or hives, rash on the skin,
• severe skin reactions, such as blistering rash (which may also affect the mouth and tongue).

Fluconazole Polfarmex may affect the liver. Symptoms of liver disorders 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 if 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,
• abdominal pain, diarrhea, nausea, vomiting,
• increased liver function test values,
• rash.

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

• decrease in red blood cell count, causing pallor, weakness, and shortness of breath,
• decrease in appetite,
• insomnia, drowsiness,
• seizures, dizziness, balance disorders (feeling of spinning), sensation disorders, most often in the form of tingling, numbness, or prickling, 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, malaise, fever.

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

• decrease in 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 biochemistry parameters (high cholesterol, lipid levels in the blood),
• decrease in 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 those 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 181 C
02-222 Warsaw
Phone: +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 will help gather more information on the safety of the medicine.

5. How to store Fluconazole Polfarmex

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C in the original packaging.
Protect from light.
After opening the package, the medicine should be used within 6 months.
Do not use this medicine after the expiry date stated on the carton and bottle after: "Expiry date" or "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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Fluconazole Polfarmex contains

• The active substance of the medicine is fluconazole. 10 mL of syrup contains 50 mg of fluconazole.
• Other ingredients are: sucrose, liquid sorbitol, non-crystallizing (E 420), glycerol (E 422), propylene glycol (E 1520), hydrochloric acid, diluted, sodium benzoate (E 211), strawberry flavor, liquid (contains, among others, propylene glycol (E 1520), citral), purified water.

What Fluconazole Polfarmex looks like and what the pack contains

Bottles made of brown glass or plastic with a capacity of 150 mL, in a cardboard box.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Phone: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: polfarmex@polfarmex.pl

Date of last revision of the leaflet: